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- From: lynng@alsirat.com
- Newsgroups: misc.kids.info,misc.answers,news.answers
- Subject: misc.kids FAQ on Childhood Vaccinations, Part 3/4
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- Archive-name: misc-kids/vaccinations/part3
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- Last-Modified: October 23, 1999
-
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- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 3f. Influenza
- [This section last updated on October 23, 1999.]=20
-
- Q3f.1 What is influenza, and what are the risks of the disease?=20
-
- Influenza has a fairly high mortality rate among the elderly and the chroni=
- cally ill. Complications include pneumonia, neurological
- complications, myocardia, heart block, and peripheral vasoconstriction.=20
-
- Q3f.2 How common is influenza?=20
-
- Outbreaks of flu occur almost every year, generally in the winter, and can =
- cause thousands to be hospitalized.=20
-
- Q3f.3 How effective is the influenza vaccine?=20
-
- About 70-80% in young, healthy adults. About 50% effective in adults over 6=
- 0. (For studies on older adults, see JAMA 1994
- Dec 7, N Engl J Med 1994.) For a summary of recent studies showing benefits=
- in elderly adults, young children in day care,
- and healthy adults, see Journal Watch for January 1, 1996, Volume 16, Numbe=
- r 1, "Top Medical Stories of 1995." Of
- particular interest to parents is a study published in Arch Pediatr Adolesc=
- Medicine, Oct 1995, 149:1113, in which children at
- high risk for otitis media (ear infections) showed 32% fewer cases during t=
- he flu season when they received the flu vaccine.=20
-
- Note that influenza vaccine protects against influenza only, and not agains=
- t other respiratory infections.=20
-
- An intranasal flu vaccine has shown efficacy in trials and may be available=
- within a year.=20
-
- Q3f.4 How long does the influenza vaccine last?=20
-
- It has to be repeated every year, as the strains of influenza vary from yea=
- r to year.=20
-
- Q3f.5 What are some of the risks of the influenza vaccine?=20
-
- Public confidence in flu shots was reduced by the swine flu controversy of =
- 1976-1977. Of the nearly 48 million people who
- were vaccinated that year, about 500 came down with a rare paralytic condit=
- ion called Guillaine-Barre syndrome. This was
- many more than could normally be expected to come down with this disease (t=
- hough still a small percentage of all the
- vaccinated people). After this year, there were changes to the vaccine, and=
- medical sources (Berkeley, PDR) report that the
- vaccine has not been clearly associated with Guillaine-Barr syndrome since =
- that time.=20
-
- Adverse reactions include local tenderness, and, infrequently, fever, "most=
- often [affecting] people who have had no exposure
- to the influenza virus antigens in the vaccine (e.g. small children)." (PDR=
- ) Allergic reactions also occur.=20
-
- Q3f.6 When is the influenza vaccine recommended?=20
-
- It is recommended for people who are over 65 and for people with various ch=
- ronic illnesses, particularly those affecting the
- lungs (including asthma) or the heart. Candidates among children include si=
- milar groups to those for pneumococcal vaccine:
- sickle cell, chronic renal and metabolic disease, diabetes, chronic pulmona=
- ry disease, long-term aspirin therapy, and significant
- cardiac disease (Catalana).=20
-
- In the US, the rate of vaccination for influenza in the groups for whom the=
- vaccine is recommended is only 20%. Among
- children, the rate is 1-7% (Catalana).=20
-
- The antiviral drugs amantadine and rimantadine are also effective against i=
- nfluenza A, but not influenza B.=20
-
- Q3f.7 When is the influenza vaccine contraindicated?=20
-
- Egg allergy, hypersensitivity to thimerosal. Delay in case of an active neu=
- rological disease or fever. (PDR) The AHFS gives the
- same contraindications, but adds a history of Guillaine-Barre syndrome and =
- bleeding disorders which would contraindicate
- intramuscular injection.=20
-
- Vaccine components capable of causing adverse reactions: chick embryo compo=
- nents, formaldehyde, thimerosal (Travel
- Medicine Advisor).=20
-
- Q3f.8 Is it OK to be vaccinated for influenza during pregnancy?=20
-
- It depends. When this topic has come up on misc.kids, people have reported =
- different recommendations from their doctors.
- And, when I consulted the PDR, I found the same result: the PDR says that t=
- he risks of the vaccine (especially during the first
- trimester) have to be weighed against the risks of a particular patient get=
- ting the flu, and that "The clinical judgment of the
- attending physician should prevail at all times in determining whether to a=
- dminister the vaccine to a pregnant woman."=20
-
- The CDC, in the October 8, 1999 issue of MMWR, recommended that "Pregnant w=
- omen with high-risk medical conditions
- should be vaccinated before the start of the influenza season regardless of=
- their stage of pregnancy. Pregnant women without
- high-risk medical conditions, but who will be in their second or third trim=
- ester during the influenza season, are at elevated risk
- of complications and should be vaccinated. Some experts prefer to vaccinate=
- these women during the second trimester to
- avoid a coincidental association with spontaneous abortion, which is common=
- in the first trimester, and because exposures to
- vaccines traditionally have been avoided during the first trimester. "=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
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- =3D=3D=3D=3D
- Section 3g. Pneumococcal vaccine
- [This section last updated September 18, 1999.]=20
-
- Q3g.1 What is pneumococcal disease, and what are the risks of the disease?=
- =20
-
- It causes ear infections and sinusitis in children, and sometimes meningiti=
- s and pneumonia.=20
-
- Q3g.2 How common is pneumococcal disease?=20
-
- From=20Nelson Textbook of Pediatrics, Behrman and Vaughn, eds.,14th edition=
- ,
- 1992:
-
- ------------------------------------------------------------------------
- Pneumococcus (_Streptococcus pneumoniae_) is a normal inhabitant of the
- upper respiratory tract (as many as 91% of children between 6 mo and 4
- 1/2 yr of age carry this bacterium at some time). Pneumococcus is the most
- common cause of bacteremia (bacteria in the blood), bacterial pneumonia,
- and bacterial otitis media (middle ear infections). Pneumococcus causes
- 25-30% of acute middle ear infections. It is also high on the list for
- bacterial causes of meningitis. =20
- ------------------------------------------------------------------------
-
- There has been recent evidence of antibiotic-resistant pneumococci (see JAM=
- A 1994; 271:1831; and MMWR 1994; 43:23;
- articles summarized in Journal Watch, January 15, 1995 in the paper edition=
- and February 7, 1995 in the electronic edition).=20
-
- Q3g.3 How effective is the pneumococcal vaccine?=20
-
- It protects against 23 strains of pneumococcus, 85% of those which cause ea=
- r infections and almost all of those which cause
- pneumonia and meningitis. Harrison's Internal Medicine estimates its effect=
- iveness at 60-80%.=20
-
- Some recent articles discussing (and debating about) the effectiveness of p=
- neumococcal vaccine can be found in Arch Intern
- Med 1994 Dec; 154:373, 154:2666 and 154:2531; these articles and others are=
- summarized in "Feature: Does Pneumococcal
- Vaccine Live Up to Its Reputation?" in the February 28, 1995 Journal Watch =
- (electronic form) or Mar 1, 1995 Journal Watch
- (print form). Other relevant articles are in the Annals of Internal Medicin=
- e 1988;108:616-625 and the New England Journal of
- Medicine for 11/21/91.=20
-
- Q3g.4 How long does the pneumococcal vaccine last?=20
-
- According to a chart I got from Kaiser, one dose is good for life, except f=
- or immune suppressed or immunodeficient patients,
- who should get a booster two years later. _Travel Medicine Advisor_ also sa=
- ys that no booster is required. _AHFS Drug
- Information_, however, says that antibodies are elevated at least five year=
- s in healthy adults, but decline to prevaccination levels
- after ten years in some.=20
-
- The reason for the apparent conflict in recommendations is that allergic re=
- actions are more common after the booster shots,
- but, at the same time, the booster shots are useful for maintaining immunit=
- y. For this reason, there has been some debate about
- the booster shots; the most recent recommendation is "revaccination with pn=
- eumococcal vaccine after six years in people with
- high-risk chronic conditions" (Journal Watch for Oct 18, 1994). (An example=
- is a person without a functioning spleen.) The
- 23-valent vaccine was introduced in 1993; prior to that the vaccine was onl=
- y 14-valent.=20
-
- Journal Watch for Oct 18, 1994 summarizes an article in the Archives of Int=
- ernal Medicine (1994 Oct 10; 154:2209-14) on
- pneumococcal boosters. "Antibody levels wane significantly within six years=
- after vaccination, necessitating revaccination of
- high-risk patients. This interesting study evaluated immunogenicity associa=
- ted with revaccination." Shots of pneumococcal
- vaccine were found to increase antibody levels "at least 1.4-fold in about =
- 55 percent" of both previously unvaccinated adults
- and those who had been vaccinated 5.5 to 9 years previously.=20
-
- Q3g.5 What are some of the risks of the pneumococcal vaccine?=20
-
- Discomfort at injection in 30-40% of recipients, and fever in 5-20% of reci=
- pients. (Catalana)=20
-
- Q3g.6 When is the pneumococcal vaccine recommended?=20
-
- It is recommended for children 2 or older who are at increased risk of pneu=
- mococcal infection. Conditions which increase risk
- of pneumoccoal infection include HIV positive status, functional or anatomi=
- c asplenia, and sickle cell or other
- hemoglobinopathies. It is also recommended for adults 65 or older and adult=
- s with significant cardiovascular or pulmonary
- disorders, splenic dysfunction, asplenia, Hodgkin's Disease, multiple myelo=
- ma, cirrhosis, alcoholism, renal failure, CSF leaks,
- or immunosuppressive conditions.=20
-
- Work is underway now to develop and test a pneumococcal conjugate vaccine (=
- analogous to the HiB conjugate vaccine) to
- allow immunization of those younger than 24 months (which is the age group =
- most affected by S. pneumoniae). This might open
- up a new indication for pneumococcal vaccine: prevention of middle ear infe=
- ctions. As of 1997, four different conjugate
- pneumococcal vaccines for infants were in Phase II/III trials (Williams, 19=
- 97)=20
-
- Q3g.7 When is the pneumococcal vaccine contraindicated?=20
-
- It should not be given to children under 2. It also shouldn't be given to p=
- eople who have already been vaccinated (except for
- booster shots for those in the highest risk categories).=20
-
- Vaccine components capable of causing adverse reactions: phenol, polysaccha=
- rides, thimerosal (Travel Medicine Advisor).=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
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- =3D=3D=3D=3D
- Section 3h. Meningococcal vaccine [This section last updated on September 1=
- 8, 1999.]
-
- Q3h.1 What is meningococcal disease, and what are the risks of the disease?=
- =20
-
- Meningococcal disease is a rare disease which causes meningitis as well as =
- widespread blood infection, leading to shock and
- death.=20
-
- Q3h.2 How common is meningococcal disease?=20
-
- About 2,500 cases a year in the US, but tens of thousands annually in sub-S=
- aharan Africa.=20
-
- Q3h.3 How effective is the meningococcal vaccine?=20
-
- The current vaccine not highly immunogenic in children under 2, or very lon=
- g lasting, and it is children under 2 who have the
- highest rate of the disease. Research is being done on conjugate vaccines w=
- hich would produce a greater immune response.
- Global cooperation would be needed to make these affordable in developing c=
- ountries. (Williams, 1997)=20
-
- Q3h.4 How long does the meningococcal vaccine last?=20
-
- I don't have this information.=20
-
- Q3h.5 What are some of the risks of the meningococcal vaccine?=20
-
- Adverse reactions are infrequent and mild, mostly redness at the injection =
- site for 1-2 days. Up to 2% of children vaccinated
- will experience transient fever (Health Information for the International T=
- raveller, 1992).=20
-
- Q3h.6 When is the meningococcal vaccine recommended?=20
-
- For children with certain types of immune disorders and during epidemic out=
- breaks. It is also given to children travelling to
- certain areas, and is required for pilgrims to Mecca for the annual Haj (as=
- of 1992, according to the CDC).=20
-
- Q3h.7 When is the meningococcal vaccine contraindicated?=20
-
- I haven't found any, except pregnancy (when it should be given only in case=
- of an outbreak).=20
-
- Vaccine components capable of causing adverse reactions: phenol, polysaccha=
- rides, thimerosal (Travel Medicine Advisor).=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 3i. Varicella (chicken pox) vaccine=20
-
- [Note: The varicella section has been modified slightly and updated. Inform=
- ation is from FDA press releases on 1/28/94 and
- 3/17/95 and and an article in Infectious Diseases in Children newsletter {v=
- ol 8(2) February l995}. It has been further updated
- based on the July 12, 1996 recommendation by ACIP. This section last update=
- d on September 25, 1999. I have some
- additional information on zoster which I will be merging into this section =
- in my next update.]=20
-
- Q3i.1 What is chicken pox, and what are the risks of the disease?=20
-
- Varicella or chickenpox is a highly contagious disease caused by varicella =
- zoster virus. Complications are rare in normal
- children, but more common in children with immune deficiencies. The disease=
- is somewhat more severe in adults, and can be
- serious for newborns and pregnant women. Possible (infrequent) complication=
- s include hemorrhagic varicella, encephalitis,
- pneumonia, and bacterial skin infection. Possible complications in pregnanc=
- y include premature birth and congenital varicella,
- and mortality (of the infant, not the mother) is high. "It is estimated tha=
- t there are about 9,600 chicken-pox related
- hospitalizations annually, with 50 to 100 deaths." (FDA announcement, Janua=
- ry 28, 1994) Another risk, unfortunately on the
- increase, is invasive group A streptococcal infections, to which children i=
- ll with varicella may be susceptible.=20
-
- A study of the effects of congenital varicella and herpes zoster (Enders G;=
- et al. Consequences of varicella and herpes zoster in
- pregnancy: prospective study of 1739 cases. Lancet 1994 Jun 18; 343:1548-51=
- ., summarized in Journal Watch Summaries for
- July 1, 1994.) followed 1373 women with varicella and 366 women with herpes=
- zoster acquired during the first 36 weeks of
- pregnancy. Nine of the infants had congenital varicella syndrome, with defe=
- cts ranging from "multisystem involvement to limb
- hypoplasia and skin scars." There were no cases of congenital varicella syn=
- drome among infants whose mothers had varicella
- after 20 weeks or among those whose mothers received anti-varicella-zoster =
- immunoglobulin after they were exposed.=20
-
- Q3i.2 How common is chicken pox?=20
-
- An estimated 3.7 million Americans are affected by chickenpox each year, wi=
- th more than 90% of the cases occurring in
- persons under 15 years of age. 33% of cases are estimated to occur in child=
- ren ages 1 to 4, and 44% in children ages 5 to 9
- (estimates from January 28, 1994 FDA announcement).=20
-
- In tropical regions, chicken pox is less common, and many people may reach =
- adulthood without immunity (adult immigrants
- from tropical to temperate regions may therefore be at risk).=20
-
- I do not have data on how varicella incidence has been affected by the avai=
- lability of the vaccine, but vaccine coverage is still
- (as of 1999) fairly low for this particular vaccine.=20
-
- Q3i.3 What is Herpes Zoster?=20
-
- Following chickenpox infection, the varicella zoster virus persists in a la=
- tent form in sensory nerve ganglia without any signs of
- illness. The virus can be reactivated causing herpes zoster or shingles, wh=
- ich is a painful small blister-like rash in the distribution
- of one or more sensory nerve roots. It is estimated that 15% of the populat=
- ion will experience zoster during their lifetimes.
- Zoster develops most frequently among the elderly and among individuals who=
- are immunocompromised. Most people only
- have one episode of herpes zoster; fewer than 4% will have repeated episode=
- s. Postherpetic neuralgia is a common
- complication; this complication is more common among the elderly (25-50% of=
- those over 50 who have shingles, but only 10%
- of all people who have shingles.=20
-
- (Information on the effect of the vaccine on herpes zoster will be added to=
- this FAQ later.)=20
-
- Q3i.4 What is the current recommendation for the chicken pox vaccine be par=
- t for children?=20
-
- The chickenpox (varicella) vaccine was first licensed for use among high-ri=
- sk children in several European countries in 1984, in
- Japan in 1986, and in Korea in 1988. It has been used for healthy children =
- in Japan and Korea since 1989. This vaccine was
- licensed by FDA on March 17, l995. It is manufactured by Merck and Co. Inc.=
- under the trade name "Varivax." On July 12,
- 1996, ACIP came out with its recommendations for the new vaccine. ACIP reco=
- mmends that all children be routinely
- vaccinated at 12-18 months of age. The American Academy of Pediatrics recom=
- mends that it be given to everyone over the
- age of one who is not already immune to chicken pox. Currently it is approv=
- ed by the FDA for a single injection in children
- ages 12 months to 12 years, and two injections 4-8 weeks apart for adolesce=
- nts and adults--ages 13 and older-- who have
- not contracted chickenpox. Since the vaccine has been shown to be safe and =
- effective when given at the same time as measles,
- mumps and rubella vaccines, it is likely many physicians will give it eithe=
- r at the 12 or 15 month checkup. Research is underway
- for development of a combination measles, mumps, rubella and varicella vacc=
- ine to avoid the need for a second injection. It is
- unknown when this product may become licensed.=20
-
- Q3i.5 What is the current recommendation for adults?=20
-
- *************************************************************************
- [Contributed shortly before the vaccine was licensed.]
- From=20J Thompson (jet14@columbia.edu):
-
- I think it is almost guaranteed that adults will be able to get the
- varicella vaccine. The only area where there is _no_ scientific controversy
- over the wisdom of using this vaccine is in adults who are not immune.
- Varicella in adults is a dangerous disease, sometimes leading to
- hospitalization, and usually lasting two to three weeks.
- *************************************************************************
-
- ACIP recommends that people 13 years and older be assessed for varicella im=
- mune status, and that those who are not immune
- be vaccinated. Priority should be given to vaccinating those at highest ris=
- k for exposure and for transmitting the disease. There
- is an antibody titre which can be done on adults who are not sure whether t=
- hey are immune to chicken pox.=20
-
- Q3i.6 How effective is the chicken pox vaccine?=20
-
- Clinical trials, which span a decade and involved more than 11,000 persons =
- in the United States, indicate that it is 70-90
- percent effective in preventing chickenpox. Studies also show that almost a=
- ll of the vaccinated patients who got chickenpox had
- a milder form of the disease.=20
-
- Q3i.7 How long does the chicken pox vaccine last?=20
-
- We don't know yet. It is estimated to last at least six years. (Lancet, Apr=
- il 16, 1994) "Children immunized as long as six years
- earlier continued to be well protected. . . . So far, the US data show pers=
- istence of antibodies for three to four years after
- immunization; data from Japan show persistence of antibodies for seven to 1=
- 0 years in healthy children." (Gershon)=20
-
- Q3i.8 What reactions have been reported following the chickenpox vaccine?=
- =20
-
- Adverse reactions reported were mild and included redness, hardness and swe=
- lling at the injection site, fatigue, malaise and
- nausea. The vaccine has been used in Japan routinely for more than 10 years=
- with no complications.=20
-
- Q3i.9 Will a second dose be necessary in younger children?=20
-
- The question of a "booster" dose remains uncertain at this point. The manuf=
- acturer has agreed to perform postmarketing studies
- to determine the long-term effects of the vaccine and whether there is a ne=
- ed for a booster immunization.=20
-
- Q3i.10 For which groups is the chicken pox vaccine especially recommended?=
- =20
-
- People with HIV, nephrosis, severe asthma, and similar chronic diseases, bu=
- t especially leukemia. Conditions for vaccination of
- leukemic children are: remission for at least a year, off maintenance thera=
- py for a week before and a week after getting the
- vaccine, and cellular immunity intact. (Catalana)=20
-
- Q3i.11 When is the chicken pox vaccine contraindicated?=20
-
- *************************************************************************
- From=20the April 1995 issue of Medical Sciences Bulletin, published by=20
- Pharmaceutical Information Associates (pialtd@ix.netcom.com) and=20
- available by Email subscription as MSB-L.
-
- Use of Varivax is contraindicated for patients who are hypersensitive to an=
- y
- component of the vaccine; those with a history of anaphylactoid reaction to
- neomycin; those with active febrile infections, pregnancy, blood dyscrasias=
- or
- other malignancies, or primary or acquired immunodeficiency; and those
- undergoing immunosuppressive therapy.
- *************************************************************************
-
- The July 12, 1996 ACIP recommendation lists, for the most part, the same gr=
- oups, but adds people who have experienced an
- anaphylactoid reaction to gelatin, and people who have a family history of =
- congenital or hereditary immune deficiency in parents
- or siblings (unless their own immune competence has been clinically substan=
- tiated or confirmed by a laboratory). Pregnant
- women should not be vaccinated, as the effect on the fetus is unknown.=20
-
- Although no adverse reactions from taking aspirin after the vaccine have be=
- en reported, it is recommended that people
- receiving the varicella vaccine refrain from taking aspirin for 6 weeks aft=
- erwards, because of the association between aspirin
- and Reyes syndrome following varicella.=20
-
- Q3i.12 Is there a gamma globulin for chicken pox?=20
-
- Yes, but it is only available to people at especially high risk from chicke=
- n pox. It needs to be given within 72 hours of exposure.
- More common on misc.kids is the concern of adults who haven't had chicken p=
- ox, but aren't otherwise at high risk from
- exposure. The varicella immune globulin isn't likely to be available to the=
- se people, but something else is available: acyclovir.
- This antiviral drug will lessen the severity of chicken pox if it is given =
- promptly, as soon as the rash first begins to appear.=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 3j. BCG (tuberculosis) vaccine
- [This section last updated on September 25, 1999, based on the ACIP recomme=
- ndation which was published in MMWR on
- April 26, 1996, and which can be found at ftp://ftp.cdc.gov/pub/Publication=
- s/mmwr/rr/rr4504.pdf]=20
-
- Q3j.1 What is tuberculosis, and what are the risks of the disease?=20
-
- Tuberculosis is a chronic bacterial infection that is spread by inhaling dr=
- oplets sprayed into the air by someone infected with TB
- (it can also be spread through unpasteurized milk). It isn't as contagious =
- as a cold (you need to inhale a higher concentration of
- the droplets to catch it). The disease most commonly affects the lungs, the=
- bones of the spine or large joints, and the kidneys,
- but can reach almost any organ of the body.=20
-
- Q3j.2 How common is tuberculosis?=20
-
- In 1930, mortality was 101.5 per 100,000 population in the US. It declined =
- steadily, and in 1970 was 18.3 per 100,1000
- population (Historical Statistics). 37.1 thousand cases were reported in 19=
- 70, and the number was down to 25.7 thousand in
- 1990 (Statistical Abstracts). Unfortunately, while that number represents a=
- decrease from 1970, it represents an *increase*
- from 1985. In 1985, after decades of decline, TB cases began to rise again =
- in the US, and have continued to rise ever since. A
- similar increase has occurred in several other industrialized countries (TB=
- was never really brought under control in the Third
- World). Moreover, new, multi-drug-resistant strains of TB have emerged. The=
- AIDS epidemic has worsened the TB situation.
- (Ryan) The percentage of cases of drug-resistant TB varies in different are=
- as. A Morbidity and Mortality Weekly Report
- article summarized in the June 15, 1994 HICN726 Medical News gives the inci=
- dence overall in New Jersey as 5% of the
- state's TB patients, the incidence in Jersey City as 13%, and the incidence=
- in New York City as 19%.=20
-
- A joint statement by ACIP and the Advisory Council for the Elimination of T=
- uberculosis, published in MMWR, Volume 45,
- No. RR-4, April 26, 1996 states that the incidence of TB declined through 1=
- 984, increased from 1985 through 1992, and
- declined slightly in 1993 and 1994. 57% of the total number of TB cases wer=
- e reported in five states: California, New York,
- Florida, Illinois, and Texas. Overall incidence rates are twice as high for=
- men as for women.=20
-
- Q3j.3 How effective is the BCG vaccine?=20
-
- The AHFS Drug Information, 1992 says that its effectiveness is unknown, "Di=
- agnostic and clinical evidence has generally
- demonstrated a reduction` in the incidence of tuberculosis." Tuberculin sen=
- sitivity is highly variable, depending on the strain, and
- the relationship between tuberculin sensitivity and immunity has not been a=
- dequately studied.=20
-
- _The Forgotten Plague_ says that results of research varied in different co=
- untries. In Great Britain, a Medical Research Council
- survey of 50,000 children showed an 80% reduction in the infection rate aft=
- er vaccination, leading Great Britain to introduce
- BCG vaccination of school children in the 1950s. In the US, the results wer=
- e the opposite, so the US has not used the vaccine.
-
- A New York Times article ("Tuberculosis Vaccine Found Surprisingly Effectiv=
- e in Studies", New York Times, 03/02/94, P.
- C14), recently reported that "A new statistical study by the Centers for Di=
- sease Control and Prevention reports that the
- vaccine, known as BCG, reduced the risk of full-fledged tuberculosis of the=
- lung by 50 percent and death by 71 percent." A
- study reported in J Infect Dis in August 1994 concluded that BCG vaccine is=
- effective, but local reactions are common.=20
-
- The joint ACIP and ACET report in the April 26, 1996 MMWR says that there a=
- re different strains of BCG vaccine in use
- worldwide, and they differ in their ability to induce an immune response to=
- tuberculin. Reported rates of efficacy may also have
- been affected by methods of vaccine administration and the characteristics =
- and environment of the populations to which the
- vaccine was given. Protective efficacy rates for different studies of diffe=
- rent BCG strains have ranged from 0% to 80%. Two
- recent meta-analyses of the published literature have attempted to calculat=
- e summary estimates of efficacy. The first analyzed
- data from 10 randomized clinical trials and 8 case-control studies since 19=
- 50. It estimated protective efficacy against meningeal
- and miliary TB in children in clinical trials as 88%, and the efficacy in c=
- ase-control studies as 75%. There was too much
- variability in data on efficacy against pulmonary TB for them to come up wi=
- th a summary efficacy rate. The second
- meta-analysis reviewed 14 clinical trials and 12 case-control studies. They=
- estimated the overall efficacy of the vaccine in
- clinical trials to be 51%, with higher efficacy for children than for adult=
- s.=20
-
- Q3j.4 How long does the BCG vaccine last?=20
-
- It is of limited duration (Ryan). _AHFS Drug Information_ says that several=
- studies showed tuberculin sensitivity lasting 7-10
- years.=20
-
- Q3j.5 What are some of the risks of the BCG vaccine?=20
-
- It rarely has serious side effects. (See _AHFS Drug Information_ for a list=
- .) The most common reactions are local. More
- severe local reactions include ulceration at the vaccination site, regional=
- lymphadenitis with draining sinuses, and purulent
- drainage at the puncture site. The most serious reaction is disseminated BC=
- G infection; BCG osteitis of the epiphyses of the
- long bones, particularly epiphyses of the legs, can occur from 4 months to =
- 2 years after vaccination. The rate varies from 0.01
- cases per million vaccinees, in Japan, to 32.5 and 43.4 cases per million v=
- accinees, in Sweden and Finland, respectively.
- Reactions may be more frequent among people with symptomatic HIV infection.=
- =20
-
- *************************************************************************
- From=20J Thompson (jet14@columbia.edu):
-
- The main strategy of TB control in the US is monitoring those at risk o=
- f
- exposure to the disease for signs of TB infection. The main method used is
- something called a "PPD" (which stands for purified protein derivative, i.e=
- .
- proteins purified from TB). A PPD is "placed" (injected subcutaneously) and
- then the site of injection is monitored (usually at 48 hrs. after the
- injection). Anyone who has mounted an immune response to a TB infection wil=
- l
- exhibit redness and swelling at the site of the PPD injection (the criterio=
- n
- for calling a "true positive" PPD is that the inflammation must be at least
- 10 mm. wide). Also, this reaction must take place at a 1-2 day delay to be
- diagnostic for TB infection (anything sooner is allergy, not a sign of
- infection).
- OK, what does all this have to do with BCG? Well, BCG, since it is very
- similar to TB, can cause a positive PPD. Thus, widespread immunization with
- BCG makes it more difficult to screen for TB, since the screening will pull
- up many people who are not infected. The reaction due to BCG drops over
- time, but it is still a problem, so that (combined with the low
- effectiveness) has ruled out BCG in the US. Of course, now that
- drug-resistant strains are becoming more common, opinions might change...
- *************************************************************************
-
- Q3j.6 When is the BCG vaccine recommended?=20
-
- BCG vaccine is given in developing countries because it is easy to administ=
- er, inexpensive, and rarely has serious side effects.
- Some industrialized countries (e.g. Great Britain, France, Scandinavia) hav=
- e also used it, for vaccination of children in general
- and of household contacts of people with TB. Others (e.g. the US, the Nethe=
- rlands) have not.=20
-
- Because of the low rate of new infections, the availability of low-cost iso=
- niazid prophylaxis for people who are exposed, and
- the availability of effective treatment which quickly make patients non-con=
- tagious and cures them, the BCG vaccine hasn't been
- considered necessary in the US. There might be some changes in these recomm=
- endations with the increase in
- multiple-drug-resistant strains (one misc.kids poster reports that her city=
- college system is now requiring TB shots). In the
- meantime, the FDA has approved a new combination tuberculosis drug, Rifater=
- , which combines isoniazid, rifampin, and
- pyrazinamide, in hopes of making it easier for patients to take their medic=
- ation and thus increasing patient compliance (antibiotic
- treatment which is discontinued too early increases the development of drug=
- resistant TB strains).=20
-
- In the US, the AAP, ACIP, and the American Thoracic Society recommend BCG f=
- or infants and children intimately exposed
- to TB that is "persistently untreated, ineffectively treated, or resistant =
- to isoniazid and rifampin and who cannot be removed
- from the source of exposure or placed on long-term preventive therapy." The=
- AAP and ACIP also recommend it for children
- in groups with a rate of new TB infections greater than 1% annually "and fo=
- r whom the usual surveillance and treatment
- programs have failed or are not feasible." (_AHFS Drug Information_) ACIP a=
- lso recommends vaccination for children who
- are continually exposed to a patient who is infected with a strain of TB wh=
- ich is resistant to isoniazid and rifampin (MMWR,
- April 26, 1996). It is recommended for travel only for people who will be i=
- n a high risk environment for a long time without
- access to TB skin testing. It is currently not recommended for health care =
- workers (skin testing and isoniazid is considered to
- be enough), but this recommendation is periodically reevaluated because of =
- the incidence of TB in AIDS patients.=20
-
- BCG also has some use against certain tumors (in particular, bladder cancer=
- ).=20
-
- *************************************************************************
- From=20J Thompson (jet14@columbia.edu):
-
- The TB "shots" a poster on misc.kids referred to ("one misc.kids poster
- reports that her city college system is now requiring TB shots") are most
- likely PPD, not BCG. I believe that all schools receiving federal funding
- (and I know that all schools I have attended) require either a PPD or the
- (less accurate but easier to administer) "tine test" as part of the
- pre-matriculation physical.
- *************************************************************************
-
- Q3j.7 When is the BCG vaccine contraindicated?=20
-
- Hypersensitivity to the vaccine, positive TB skin test, recent smallpox vac=
- cination, burn patients, various immune deficiencies or
- immunosuppressive therapy (see _AHFS Drug Information_ for a list). In case=
- of eczema or other skin disease, give it in a
- different area of the skin. Although no harmful effects to the fetus are as=
- sociated wtih BCG vaccination, its use is not
- recommended during pregnancy.=20
-
- Vaccine components capable of causing adverse reactions: Triton WR 1339 (Tr=
- avel Medicine Advisor).=20
-
- Q3j.8 What are some other methods of controlling tuberculosis?=20
-
- Tuberculin skin screening and use of drugs such as isoniazid. Pasteurizatio=
- n of milk and testing of cows for tuberculosis are also
- useful.=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 3k. Hepatitis A=20
-
- [Hepatitis A: The following was taken from an article in JAMA (March 22/29,=
- l995--Vol 273 (12) 906-907) and information
- from the *draft* hepatitis A vaccine recommendation which was, as of April =
- l995, under consideration by the ACIP It has
- since been updated based on the ACIP and AAP recommendations as of December=
- 1996, the CDC Vaccine Information
- Statement on hepatitis A as of 8/25/98, and articles at Medscape. This sect=
- ion last updated September 19, 1999.]=20
-
- Q3k.1 What is hepatitis A and what are the risks of the disease?=20
-
- There are several forms of hepatitis (infection of the liver) which cause j=
- aundice, nausea and weakness. Hepatitis A is caused
- by infection with hepatitis A virus (HAV) which is acquired primarily throu=
- gh a fecal-oral route, most often from person to
- person. It can also occur via ingestion of contaminated food or water. The =
- illness consists of mild flu-like symptoms or severe
- nausea lasting for weeks. Hepatitis A does not become chronic and is rarely=
- fatal. In children under 6, most cases (>70%) of
- hepatitis A are asymptomatic, and if illness occurs, it is usually not acco=
- mpanied by jaundice. Among older children and adults,
- the illness is usually symptomatic, and jaundice occurs in >70% of cases. S=
- ymptoms usually last for <2 months, but 10-15% of
- people infected have illness or relapses for up to 6 months. 11-22% of peop=
- le who have hepatitis A are hospitalized, and
- hepatitis A is responsible for an estimated 100 deaths a year (these number=
- s from the ACIP recommendation on hepatitis A -
- the AAP recommendation gives similar, but not identical, numbers).=20
-
- Hepatitis A should not be confused with hepatitis B, which is less contagio=
- us but more serious. Hepatitis B becomes chronic in
- 5-10% of those infected. Complications include hepatic necrosis, cirrhosis =
- of the liver, chronic active hepatitis, and
- hepatocellular carcinoma.=20
-
- Some sources of general information on hepatitis can be found in the hepati=
- tis B section of this FAQ.=20
-
- Q3k.2 How common is hepatitis A?=20
-
- During the past several decades, the incidence of hepatitis A in the U.S. h=
- as been cyclic, with nationwide epidemics occurring
- every 10-15 years; the last occurred in l989. Between epidemics, hepatitis =
- A continues to occur at relatively high levels.
- Nationally, CDC estimates that around 75,000 cases occur annually. Children=
- play an important role in HAV transmission,
- with highest rates among those aged 5-14 years. Rates are substantially hig=
- her, in the Western US states than in other US
- regions. The highest rates of hepatitis A are among children 5-14 years of =
- age. In the US, 33% of the population has evidence
- of prior hepatitis A infection, as determined by a survey conducted from 19=
- 88-1991 (reported in the ACIP recommendation
- for hepatitis A). Prevalence is generally higher among Native Americans and=
- Mexican Americans. Hepatitis A is the most
- common vaccine preventable illness among travelers. It can be avoided by av=
- oiding contaminated food and drink, but many
- travelers succumb to temptation, assume food at hotels is safe, buy from st=
- reet vendors, etc. Incidence is 1.6 per 1000
- person-months of travel among travelers to developing countries (including =
- those who stay in luxury hotels), and 20 per 1000
- among backpackers and others who eat and drink in poor hygienic conditions.=
- Incidence is 0.05 to 0.10 per 1000
- person-months of travel in Southern Europe. (JAMA Sept 21, 1994 p. 885)=20
-
- Q3k.3 Who is at risk for acquiring hepatitis A?=20
-
- International travelers and individuals residing in hepatitis A endemic are=
- as are at risk for acquiring disease. Other risk groups
- include homosexual men, injecting drug users, hemophilic patients, veterina=
- ry workers and certain research occupations
- working with infected animals (particularly people working with non-human p=
- rimates). Workers at day care centers, institutions
- for the developmentally disabled, food service establishments and healthcar=
- e settings are also at some increased risk.=20
-
- Q3k.4 Is there a vaccine to protect against hepatitis A?=20
-
- Yes, the FDA licensed the hepatitis A vaccine for use in persons 2 years of=
- age and older on February 22, l995. An ACIP
- recommendation was published in the MMWR for December 27, 1996. The America=
- n Academy of Pediatrics also published
- a policy statement in December 1996. The vaccine has been in use in Europe =
- since 1992.=20
-
- Q3k.5 How is it to be administered?=20
-
- According to the labeling, the vaccine is given in a two-dose schedule to a=
- dults 18 years of age and older, the second dose
- being given 6-12 months after the first. Children and adolescents 2-18 year=
- s of age are given 3 doses. The second dose is
- given 1 month after the first and the third dose 6-12 months later. It is a=
- dministered by intramuscular injection in the deltoid
- (upper arm), and can be given with other vaccines without loss of immunogen=
- icity.=20
-
- Q3k.6 How effective is the vaccine?=20
-
- A single dose of the vaccine induced antibodies in 88% to 96% of subjects b=
- y two weeks and in 97% to 100% by one month.
- Completion of the full vaccine schedule is recommended to ensure high antib=
- ody levels and long-term protection. Efficacy trials
- in children and adolescents show it is 94% (or more) effective against ende=
- mic hepatitis A virus.=20
-
- According to the AAP recommendation for hepatitis A, on December, 1996: "Cl=
- inical studies suggested a possible
- herd-immunity effect if more than 80% of the estimated susceptible individu=
- als were vaccinated. A single dose of Havrix in
- Alaskan native villages with endemic HAV disease resulted in a dramatic dec=
- rease in cases within 8 weeks of vaccination. A
- similar abrupt decrease in HAV cases was observed after two doses of vaccin=
- e in two Slovak Republic villages experiencing a
- large community outbreak. In the Vaqta trial in New York State, no cases of=
- clinical and confirmed hepatitis A occurred in
- vaccine groups more than 21 days after the first dose, and the calculated p=
- rotective efficacy was 100%. "=20
-
- Q3k.7 How long does immunity last?=20
-
- Firm data on long-term protection are limited because the vaccine was under=
- investigation for only 4 years before being
- approved in 1995. Estimates of antibody persistence derived from kinetic mo=
- dels of antibody decline suggest that the
- protective levels of anti-HAV could persist for at least 20 years.=20
-
- Q3k.8 What are some of the risks of the vaccine?=20
-
- Information on adverse events comes from prelicensure clinical studies worl=
- dwide and reports following vaccine licensure in
- Europe, the US, and Asia. No serious adverse events have been attributed to=
- the vaccine. Side effects include soreness and
- redness at the injection site, headache and fatigue. In very rare cases, th=
- ere is a severe allergic reaction within a few minutes to
- a few hours of the shot.=20
-
- Q3k.9 When is hepatitis A vaccine contraindicated?=20
-
- The vaccine should not be administered to persons with a history of hyperse=
- nsitivity reactions to any of the vaccine
- components, including alum or the preservative (2-phenoxyethanol). Because =
- it is inactivated, no special precautions need be
- taken when vaccinating immunocompromised individuals. The inactivation also=
- means that they theoretical risk to a fetus is low,
- but there are no data to determine the safety of the vaccine during pregnan=
- cy. People mildly ill at the time of vaccination may
- get the vaccine, but people moderately to severely ill should wait until th=
- ey recover.=20
-
- Q3k.10 What groups at risk are be included in a recommendation to receive h=
- epatitis A vaccination?=20
-
- ACIP recommends the vaccine for:=20
-
- 1. Persons 2 years of age or older traveling or working in countries with h=
- igh or intermediate endemicity of infection. The
- vaccine series should be started at least one month before travelling.=20
-
- 2. Persons living in communities with high rates of HAV infection; for exam=
- ple, American Indian, Alaska Native, Pacific
- Islander, and some religious communities.=20
-
- 3. Men who have sex with men.=20
-
- 4. People who use street drugs (injected or non-injected).=20
-
- 5. People who work with hepatitis A infected primates or with hepatitis A i=
- n a research setting should be vaccinated. No other
- groups have been shown to be at increased risk for hepatitis A due to occup=
- ational exposure.=20
-
- 6. Persons with chronic liver disease.=20
-
- 7. Persons who use clotting factor concentrates.=20
-
- 8. Since people who work as food handlers can contract hepatitis A and pass=
- the disease to others, they may be vaccinated in
- areas where state and local health authorities determine such vaccination t=
- o be cost effective.=20
-
- The AAP recommends the vaccine for the first six of the groups listed above=
- , and suggests consideration of potential use for
- child care center staff and attendees, custodial care institutions, hospita=
- l personnel, food handlers, and people with hemophilia.=20
-
- In 1999, ACIP recommended hepatitis A vaccine for all children aged 2 years=
- and older in the 11 Western states where
- incidence is especially high (at least 20 cases per 100,000 people, twice t=
- he national average). These states are: Arizona,
- Alaska, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dako=
- ta, Utah and Washington.=20
-
- Any healthy individual 2 years of older may receive hepatitis A vaccine at =
- the discretion of the physician and patient or parent.=20
-
- Q3k.11 Is it possible that hepatitis A vaccine (like hepatitis B vaccine) m=
- ight eventually be recommended for routine
- administration to children and adults?=20
-
- Those in public health say that control of hepatitis A infection will be fa=
- cilitated by the development of vaccines that combine
- hepatitis A with other routine childhood immunizations. The CDC's draft sta=
- tement notes the important role of children in
- hepatitis A transmission, and that "it is likely that routine childhood vac=
- cination will be the only way to significantly decrease
- hepatitis A rates in the U.S."=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 3l Rotavirus vaccine
- [This section last updated on October 23, 1999.]=20
-
- Q3l.1 What is rotavirus, and what are the risks of the disease?=20
-
- Rotavirus is one of the major causes of gastroenteritis among infants and s=
- mall children in most countries. Symptoms are fever,
- vomiting, diarrhea, and dehydration, with vomiting and dehydration more com=
- mon than with other diarrheas. The illness
- normally lasts 3-9 days, and becomes chronic only in immunodeficient childr=
- en.=20
-
- Group A rotavirus is a major cause of infant mortality in many parts of the=
- world. 873,000 infants and children under 5 die per
- year of rotavirus in developing countries. Non-group A rotavirus is less fr=
- equent, and is epidemic only in China. In tropical
- climates, rotavirus infection occurs year round, while in temperate climate=
- s it is seasonal. Rotavirus can survive for hours on
- human hands and for days on inanimate surfaces, and resists common disinfec=
- tants.=20
-
- Rehydration therapy makes death infrequent in developed countries. On the o=
- ther hand, it is one of the most common causes of
- hospitalization among infants during the winter months. Cecil Textbook of M=
- edicine estimates that it is responsible for 35-52%
- of the cases acute diarrheal illness needing hospitalization in infants and=
- young children, in US.=20
-
- Q3l.2 How common is rotavirus?=20
-
- The AAP Committee on Infections Diseases estimates that rotavirus is respon=
- sible for 3 million cases of diarrhea, 50,000
- hospitalizations, and 20 to 40 deaths each year in the United States.=20
-
- Q3l.3 What is the current status of the rotavirus vaccine?=20
-
- On October 15, 1999, Wyeth Lederle Vaccines announced that it has withdrawn=
- its RotaShield vaccine from the market and
- has requested the immediate return of all doses of the vaccine. The company=
- 's press release can be accessed at the web
- address below. http://www.ahp.com/releases/wa_101599.htm=20
-
- A brief history of the release and withdrawal of this vaccine follows.=20
-
- After years of research (animal studies beginning in 1983, and human trials=
- in 1987) into an effective rotavirus vaccine (with a
- couple of candidates being rejected), a live, oral, tetravalent rotavirus v=
- accine was approved by the FDA on August, 1998.
- This vaccine is composes of one rhesus monkey virus, and three genetically =
- engineered combinations of rhesus monkey and
- human rotavirus. In the December, 1998 issue of Pediatrics, the AAP Committ=
- ee on Infections Diseases recommended that
- the vaccine be added to the standard vaccination schedule, with shots being=
- given at 2, 4, and 6 months, with the understanding
- that it might take time to incorporate the new vaccine into the schedule.=
- =20
-
- On July 18, 1999, US health officials recommended postponement of rotavirus=
- vaccine. Shipments have temporarily been
- suspended. The company which makes the vaccine is working with the CDC to i=
- nvestigate reports of bowel obstruction among
- infants who received the vaccine. An additional reason for postponement was=
- the fact that the rotavirus season, in the US,
- occurs during the winter, allowing several months for investigation of thes=
- e adverse reactions, before a decision needed to be
- made about whether the vaccine should be used prior to this year's rotaviru=
- s season. Results of a case-control study were
- expected to be available by October, 1999. Additional studies could continu=
- e into next year. Further information from the
- CDC about rotavirus vaccine and intussusception can be found at http://www.=
- cdc.gov/nip/Q&A/genqa/Rotavirus.htm and at
- http://www.cdc.gov/nip/news/rotavirus.htm.=20
-
- Q3l.4 How effective is the rotavirus vaccine?=20
-
- Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
- retaining the answer to this question, in case it
- should be later reintroduced in some form.=20
-
- The rotavirus vaccine doesn't confer full immunity, but protects against se=
- vere illness (this is also the case with natural immunity
- from prior rotavirus infections). Trials by the manufacturer, used for FDA =
- approval, showed the following results:=20
-
- Trial 1: None of the infants receiving the vaccine got dehydrated, compared=
- to 3% in the placebo group. 11% fewer in vaccine
- group needed a visit to the doctor. 88% showed elevated IgA titers.=20
-
- Trial 2: 9% of infants in placebo group saw a doctor for diarrhea and vomit=
- ing, compared with 2% in vaccine group. None in
- the vaccine group needed hospitalization.=20
-
- Both trials were by the manufacturer, and not published in the medical lite=
- rature at the time of approval.=20
-
- A third trial, in Finland, showed similar results.=20
-
- Q3l.5 Is the rotavirus vaccine effective for breastfeeding infants?=20
-
- Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
- retaining the answer to this question, in case it
- should be later reintroduced in some form.=20
-
- For infants receiving the full three doses, breastfeeding infants show the =
- same level of immunity as formula-fed infants. For
- infants receiving only one dose, immunity may be less among breastfed infan=
- ts.=20
-
- Q3l.6 How long does the rotavirus vaccine last?=20
-
- Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
- retaining the answer to this question, in case it
- should be later reintroduced in some form.=20
-
- Efficacy persisted for two years in US and Finnish trials. Since followup h=
- as only been done for two years, it is not known
- whether efficacy persists beyond that time.=20
-
- Q3l.7 What is intussusception?=20
-
- Intussusception is a bowel obstruction in which one segment of the bowel be=
- comes enfolded within another segment.=20
-
- Q3l.8 What is the relationship between the rotavirus vaccine and intussusce=
- ption?=20
-
- 15 cases of intussusception, possibly associated with administration of the=
- rotavirus vaccine, have been reported to VAERS.
- These cases were analyzed in "Intussusception Among Recipients of Rotavirus=
- Vaccine -- United States, 1998-1999,"
- MMWR 48(27);577-581, 1999, Centers for Disease Control.=20
-
- VAERS reports of intussusception were reviewed, and parents or guardians or=
- health-care providers contacted by phone for
- clinical and demographic data. Data on vaccine distribution was also obtain=
- ed from the manufacturer.=20
-
- 13 of the 15 developed intussusception after the first dose, and 12 of the =
- 15 developed symptoms within a week of receiving
- any dose. Intussusception confirmed radiologically in all. 8 needed surgica=
- l reduction. All recovered. 14 were spontaneous
- reports, and one was obtained through active postlicensure surveillance. Ac=
- cording to the report, "The manufacturer had
- distributed approximately 1.8 million doses of RRV-TV as of June 1, 1999, a=
- nd estimated that 1.5 million doses (83%) had
- been administered. Given this information, 14-16 intussusception cases amon=
- g infants would be expected by chance alone
- during the week following receipt of any dose of RRV-TV.=20
-
- As part of a preliminary analysis of postlicensure adverse events, cases of=
- intussusception during December 1, 1998-June 10,
- 1999 were identified in Northern California and Minnesota, and the rate in =
- vaccinated and unvaccinated children was
- compared. Vaccinated children showed a statistically higher incidence of in=
- tussusception.=20
-
- A further announcement by the FDA, made on September 14, 1999, reported tha=
- t the number of cases of intussusception that
- may be related to the rotavirus vaccine (15 as of July 7), is now up to 99,=
- including two deaths. The FDA's Dr. Kathryn
- Carbone, one of the initial reviewers of the rotavirus data, reported to a =
- gathering of the FDA's Vaccines and Related
- Biological Products Advisory Committee that all these cases are still under=
- investigation, and it is not clear yet whether the two
- deaths or the other cases were caused by the vaccine.=20
-
- Further study is being done.=20
-
- Q3l.9 Why was a connection between the rotavirus vaccine and intussusceptio=
- n not observed prior to FDA approval of the
- vaccine?=20
-
- Approval by the FDA only requires trials on about 5,000-10,000 subjects. Ra=
- re reactions to a new drug or vaccine will
- therefore be unknown at the time of FDA approval.=20
-
- Q3l.10 What other reactions have been reported following the rotavirus vacc=
- ine?=20
-
- Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
- retaining the answer to this question, in case it
- should be later reintroduced in some form.=20
-
- Mild, fever, for usually less than 24 hours. Fever after the first dose is =
- more common in older children, for which reason it is
- recommended that the vaccination series be begun by the time a baby is six =
- months old. All doses should be given by 12
- months, because data regarding the safety and efficacy of vaccine administr=
- ation to older children are not available.=20
-
- Irritability, decreased appetite, and decreased activity, were reported mor=
- e often than with the placebo for five days. Diarrhea
- was not reported more often than with the placebo.=20
-
- Q3l.11 Can the rotavirus vaccine be effectively used in developing countrie=
- s?=20
-
- Price may be the major barrier, as it is one of the more expensive vaccines=
- (and not likely to get cheaper if any modified
- version is reintroduced later).=20
-
- Q3l.12 When is the rotavirus vaccine contraindicated?=20
-
- Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
- retaining the answer to this question, in case it
- should be later reintroduced in some form.=20
-
- The rotavirus vaccine should not be given in case of: Infants with hypersen=
- sitivity to aminoglycoside antibiotics, amphotericin B,
- or monosodium glutamate that are components of the vaccine, or an anaphylac=
- tic reaction to a previous dose of the rotavirus
- vaccine.=20
-
- Until further data are available, this live-attenuated vaccine should not b=
- e given to children who are immunosuppressed or
- immunodeficient. Babies of women who are HIV-infected should not get the va=
- ccine unless these babies have tested as
- HIV-negative at the age of two months or older.=20
-
- The rotavirus vaccine should be postponed in case of: Acute vomiting and di=
- arrhea (efficacy is uncertain in this case).
- Moderate or severe fever.=20
-
- The rotavirus vaccine may be given in case of: Breastfeeding, premature bir=
- th, and low grade fever. The vaccine can be given
- at same time as DTaP or DTP, HiB, hepatitis B, or IPV/OPV, and there is no =
- need to adjust the timing for antibody-containing
- blood products. Infants living with people known or suspected to be immunoc=
- ompromised may be immunized.=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 3m. Other vaccines which are available
- [This section last updated September 17, 1999.]=20
-
- Q3m.1 What other vaccines are available and when are they given?=20
-
- Other vaccines available include vaccines for cholera, Japanese encephaliti=
- s, typhoid, yellow fever, rabies, plague, Lyme
- disease, and anthrax. _Travel Medicine Advisor_ also mentions a vaccine for=
- typhus, but, according to the 1996-1997 edition
- of the CDC Yellow Book (CDC Health Information for International Travel), "=
- production of this vaccine has been
- discontinued in the US and there are no plans for commercial production of =
- a new vaccine." Since other countries may offer
- typhus vaccination (though, to the best of my knowledge, it is not required=
- for travel to any country), I am drawing information
- for this vaccine from a German web site. Immune globulins are also availabl=
- e for a variety of diseases.=20
-
- For more information on these other vaccines, check the _American Hospital =
- Formulary Service Drug Information_ (a better
- source than the PDR in this case) and _Health Information for Travelers_, w=
- hich is put out by the CDC every year (vaccination
- and booster schedules for all of these vaccines can be found there, as can =
- information on where these diseases are common
- and what vaccination requirements various countries have for entrance). The=
- latter can be purchased from the Superintendent
- of Documents, U.S. Government Printing Office, Washington, D.C. 20402, and =
- most local health departments have a copy
- which can be consulted, sometimes by telephone. It can also be found in som=
- e public libraries. The CDC also has a
- Worldwide Web site which can be accessed for travel information: http://www=
- .cdc.gov/. The International Association for
- Medical Assistance to Travellers (IAMAT), which has affiliated institutions=
- in over 115 countries, puts out a _World
- Immunization Chart_. The address of the U.S. affiliate is IAMAT, 736 Center=
- Street, Lewiston, N.Y. 14092. The World
- Health Organization produces a publication on international travel; it is c=
- alled _INTERNATIONAL TRAVEL AND
- HEALTH: Vaccination Requirements and Health Advice_, and copies may be orde=
- red from WHO Distribution and Sales,
- CH-1211, Geneva 27, telephone (41 22) 791 2476; fax (41 22) 788 0401. The p=
- rice is 15 Swiss Francs; in developing
- countries: 10.50 Swiss Francs. Further information about rabies can be foun=
- d in books on mountaineering and spelunking (the
- one I consulted is _Medicine for Mountaineering_, by James A. Wilkerson, M.=
- D.). Hepatitis B, hepatitis A, and
- meningococcus vaccines are given for travel, so people interested in travel=
- vaccinations may want to check the sections of this
- FAQ dealing with those vaccines.=20
-
- Anthrax vaccine, in the US, is mainly used by the military as a protection =
- against biological warfare; small quantities are also
- made available to people with an occupational exposure, such as veterinaria=
- ns and lab workers. Since vaccines given by the
- military to soldiers are outside the scope of a FAQ primarily concerned wit=
- h vaccines which might be given to children, I will
- not be discussing the anthrax vaccine further.=20
-
- Cholera is an intestinal infection spread by contaminated food and water. C=
- holera vaccination is about 25-50% effective in
- reducing clinical illness for 3-6 months after vaccination (with the greate=
- st protection during the first two months). (_Health
- Information for Travellers_ gives the effectiveness as 50%, and AHFS Drug I=
- nformation gives it as 25-50%.) Boosters are
- every six months for travelers who will be staying for a long time in chole=
- ra-endemic areas. Serious reactions are rare. Since
- the effectiveness is so low, neither the CDC nor the WHO actually recommend=
- s the vaccine, but some countries require it.
- According to AHFS Drug Information, "_Cholera vaccine does not prevent tran=
- smission of infection_, and should not be used
- to manage contacts of imported cholera cases or to control the spread of in=
- fection."=20
-
- Vaccine components capable of causing adverse reactions: bacterial componen=
- ts (Travel Medicine Advisor). The vaccine
- should not be given to children under 6 months.=20
-
- Japanese encephalitis B vaccine, licensed in 1993, is given to travelers "w=
- ho expect to go beyond the usual tourist routes or to
- spend extended time in rural areas in disease endemic regions" (Harrison's)=
- Its efficacy is estimated at 80-90%. Anaphylactic
- and severe delayed allergic reactions are common, so people who receive thi=
- s vaccine should be observed for ten days.=20
-
- Lyme disease vaccine, licensed on December 21, 1998, is licensed (as of Sep=
- tember, 1999) only for people 15 years or older,
- though that age limit may soon be eliminated. It is recommended for adults =
- and older teens who spend lots of time outdoors in
- Lyme-endemic areas. You should still protect yourself against ticks if usin=
- g the vaccine, both because the vaccine isn't 100 per
- cent effective and because ticks also carry other diseases. In a randomized=
- , double-blind, multicenter trial involving 10,936
- people living in the northeastern and upper north central United States, th=
- e vaccine efficacy at preventing Lyme disease was
- 50% (MMWR, January 22, 1999 / 48(02);35-36,43). The duration of immunity is=
- unknown. Side effects included local
- reactions, transient myalgia or arthralgia, influenza-like illness, fever, =
- and chills.=20
-
- It is unlikely that your child will ever need a plague vaccination. The dis=
- ease is found among rural rodents in some areas,
- including the Western third of the US, but urban outbreaks are now rare. Va=
- ccination is only recommended for people at
- increased risk due to research or field activities in epizootic areas. An a=
- lternative for people at increased risk is tetracycline
- prophylaxis. _AHFS Drug Information_ gives the vaccine's effectiveness as 9=
- 0% for 6-12 months. Other measures for
- avoiding plague in epizootic areas are getting rid of wild rodent food and =
- shelter, defleaing dogs and cats weekly, avoiding sick
- or dead rodents, and routine bacteriologic precautions in labs.=20
-
- Vaccine components capable of causing adverse reactions: phenol, beef prote=
- in, soya, casein (Travel Medicine Advisor).=20
-
- Rabies, an almost universally fatal disease transmitted by saliva and brain=
- tissue of infected animals, is rare in the US but more
- common in some countries where pet vaccination is not common. Dogs are the =
- main reservoir in developing countries, but all
- animal bites should be evaluated. The most common animal vectors in the US =
- are carnivorous small animals (such as skunks,
- racoons, foxes, coyotes, and bobcats) and bats. There has been a recent inc=
- rease in racoon rabies in the mid-Atlantic and
- northeastern states of the US (MMWR 29 Apr 1994), and programs to institute=
- oral rabies vaccination of racoons, foxes and
- coyotes have been initiated in some state (similar programs have been used =
- to control fox rabies in Canada and Europe). More
- than 50% of rabies cases in the US come from exposure to rabid dogs outside=
- the US. The disease is most commonly spread
- by animal bites, but can also be caught through non-bute exposure, includin=
- g contact between infected saliva or brain tissue and
- pre-existing cuts, scratches, open wounds, or mucuous membranes. There are =
- also cases of aerosolized transmission in medical
- laboratories and caves inhabited by rabid bats, and transmission through co=
- rnea transplants from people who had died of
- undiagnosed (before the transplant) cases of rabies. The chance of infectio=
- n is more likely in case of bite or non-bite exposure
- to the head, neck, face, shoulders, or hands, than with similar exposure to=
- the trunk or legs.=20
-
- In case of exposure to rabies, the wound should be immediately and thorough=
- ly cleaned with soap and water. "Although not
- included in the ACIP recommendations, some clinicians also rinse the wound =
- thoroughly with water or 0.9% sodium chloride
- solution and then cleanse with a topical antiseptic (e.g. povidone-iodine).=
- " (AHFS Drug Information 1992) It is also important
- to promptly vaccinate anyone exposed to rabies (and give rabies immune glob=
- ulin if the person has not been previously
- vaccinated), as the disease is, for all practical purposes, always fatal on=
- ce rabies symptoms begin to show up. (A few people
- have recently survived after symptoms appeared, but they all had serious br=
- ain damage.) Pre-exposure vaccination is given to
- people who live in or visit rabies endemic areas and to people whose profes=
- sions or activities put them at extra risk, such as lab
- workers, veterinarians, and spelunkers. The highest travel risk is where do=
- g rabies is still endemic.=20
-
- There is some drug interference between chloroquine (an anti-malarial drug)=
- and rabies vaccine, but intramuscular injection can
- take care of the problem. Need for boosters depends on risk category, and r=
- anges from regular tests of antibody levels every
- six months, with vaccination when they drop, for rabies lab workers, to no =
- pre-exposure vaccination for most people.
- Post-exposure, unvaccinated people get rabies immune globulin and rabies va=
- ccine, while previously vaccinated people get
- rabies vaccine alone, in a smaller amount. Adverse effects include local re=
- actions (30-74% of vaccinees) and mild systemic
- reactions (e.g. headache, nausea, 5-40% of vaccinees). About 6% of vaccinee=
- s have a reaction characterized by urticaria,
- pruritis, and malaise. Rarely, anaphylactic shock may occur. Because rabies=
- is so deadly, pregnancy is *not* a contraindication
- to postexposure vaccination.=20
-
- Vaccine components capable of causing adverse reactions: neomycin, phenol r=
- ed, thimerosal (Travel Medicine Advisor).=20
-
- The following posting from sci.med, by Achim Lohse, provides further inform=
- ation about rabies vaccine (the side effect under
- discussion is anaphylactic shock):=20
-
- ----------------------------Original message----------------------------
- ...
-
- In Canada (at least as of two years ago) there is only one rabies
- vaccine availble, and the manufacturer supplies it only in one-millitre
- vials, with strict instructions to use the entire vial for one injection
- only. At $60 + per vial, the series of three costs over $180. I was
- fortunate to have a physician who had worked among fur trappers up north,
- and had some familiarity with the vaccine. He informed me that if
- injected _intra_dermally, a dose of only 0.1 millilitre is enough.
- I confirmed this with the local public health nurse, who showed me that it
- had been standard public health procedure in British Columbia for five
- years to use the 10% dose intradermally (10 trappers would arrange to
- share the contents of a standard vial).
-
- Later investigation via Medline showed that this particular vaccine
- human diploid cell (HDCV) is not only the most expensive to produce,
- but may also have a significantly higher rate of side-effects when
- compared to the much less expensive purified chick embryo vaccine.
-
- I had a taste of physician non-acceptance when my physician was away
- after administering the first in the series of three shots. He assumed
- any of the other five doctors in the rural practice could and would complet=
- e
- the series. NOT! I was turned down flat by the two experienced doctors
- on duty, and had to get my shot from the public health nurse.
-
- Rabies antibodies (assuming the initial titres are adequate) are considered
- to be reliably adequate for only three years, after which a booster is
- required (and with the HDVC adverse reactions have most often been
- experienced with the booster). The alternative is to get a Rabies titre
- test, but I understand (anyone have figures?) that this is quite expensive,
- and in Canada's health system, may simply not be available on demand in
- some provinces (unless you can persuade a sympathetic public health officia=
- l
- of the need).
-
- >However, since it's unusual for people to get rabies and the
- >vaccine does work fine after exposure, it will probably not be
- >part of the usual childhood vaccines.
- >
- >Mike K
-
- As someone noted in a previous post, the urgency of treatment depends on
- the proximity of the infection site to the brain. A report from a
- researcher from pre-war Yugoslavia (Zagreb) indicated that there wolf
- attacks resulting in bites to the face and neck have resulted in death,
- due to inability to get the antibody titres high enough in time. One possib=
- le
- strategy to improve this situation (suggested to me by Richard Passwater's
- book "Selenium as Food and Medicine") is to take a large dose of selenium
- concurrent with or within a few hours of vaccination. He reports that this
- has greatly increased antibody titres with other vaccines.
-
- Finally, aside from the risk of not being able to get to treatment in time
- after clear exposure, there is the very real danger of unnoticed infection,
- expecially in children, by having a cut finger or lip, etc. come in contac=
- t
- with saliva from the tongue or coat of an infected animal. There is even
- one reported instance of a spelunker dying after supposedly no other exposu=
- re
- than inhaling saliva droplets from rabid bats. Since unvaccinated victims
- can't be treated successfully once symptoms appear, pre-vaccination is the
- only available protection for this last type of exposure.
-
- Achim
-
- lohseach@max.cc.uregina.ca achim.lohse@f45.n140.z1.fidonet.org
- ------------------------------------------------------------------------
-
- From: Achim Lohse=20
- Subject: rabies vaccine - update
-
- Hi Lynn. I did a little more reasearch on rabies vaccine in the past two
- days, and learned that the Canadian manufacturer - Connaught Labs, also
- markets the vaccine in the U.S.. In fact, it markets two versions in the
- U.S., both are human deploid cell vaccines (HDCV), but one, called
- "Merieux" is marketed in a 0.1 ml format for intradermal injection. In
- Canada, ironically, this form is not available, and only the 1 ml
- intramuscular form is marketed (suggested retail about CDN$75 per vial).
-
- I wasn't able to get any us prices, but was given a U.S. information number=
- :
-
- 1-800-VACCINE , which of course, doesn't work from my (Canadian) calling ar=
- ea.
-
- I wasn't able to learn whether HDCV is the still the _only_ type of rabies
- vaccine available in the U.S. (it is the only typpe in Canada).
-
- Finally, I learned that there are two methods of testing rabies antibody ti=
- tre
- (to find out if you need a booster). The preferred one is the
- neutralization assay type, in which diluted serum is mixed with infected
- cell culture and checked for reaction. The titre is reported as the highes=
- t
- dilution ratio that provokes a reaction, with 1:32 being the minimal
- acceptable titre. If titre is at 1:32, then retesting or boosting is
- adviseable in a year to maintain adequate protection. I couldn't get
- any details about the other method, called complement fixation, except that
- the local expert considered it less reliable. BTW - for Alberta and
- Saskatchewan (and possibly other Canadian provinces) all rabies titre testi=
- ng
- is done by the _Ontario_ Provincial Laboratory, so it's a slow and costly
- undertaking.
-
- regards,
-
- Achim
-
- lohseach@max.cc.uregina.ca
-
- ------------------------------------------------------------------------
-
- Smallpox vaccine is no longer given, because smallpox has been eliminated b=
- y vaccination. The virus is currently kept in labs in
- the US and Russia, just in case it is needed at some point (there has been =
- talk of destroying the last samples, but the virus
- recently got a reprieve). Since the elimination of smallpox is one of the m=
- ajor triumphs of vaccination, which is mentioned in
- many medical texts which I consulted as an argument in favor of vaccination=
- , I'll also mention at this point that smallpox
- mortality was 25-30%, that it infected 90% of the population at risk, and t=
- hat there were 10-15 million cases worldwide as
- recently as 1967. The last natural case was reported in 1977, and the last =
- cases were reported in 1978, as a result of an
- escape of the virus from a lab (the lab director committed suicide while un=
- der quarantine). (Kiple) The only people who still
- need to be vaccinated for smallpox are the people who work in the labs wher=
- e the virus is kept.=20
-
- Vaccine components capable of causing adverse reactions: polymyxin B, strep=
- tomycin, chlortetracycline, neomycin, phenol,
- brilliant green dye, glycerin (Travel Medicine Advisor).=20
-
- Typhoid is spread by contaminated food and water. The vaccine protects 70-9=
- 0% of recipients. There are two forms of the
- vaccine: oral (live), and parenteral (killed). The oral vaccine shouldn't b=
- e given to immune-compromised people. Otherwise,
- there are few adverse reactions, mostly local discomfort and sometimes feve=
- r and malaise. Boosters are every three years for
- parenteral and five years for oral vaccine.=20
-
- Vaccine components capable of causing adverse reactions: phenol, bacterial =
- components (Travel Medicine Advisor).=20
-
- The following posting from sci.med gives further information on typhoid vac=
- cine:=20
-
- ------------------------------------------------------------------------
- From: "Mark A. Shelly"=20
- Subject: Re: Oral form of typhoid vaccine
-
- >A typhoid vaccination is recommended for a trip to Costa Rica. My family
- >doctor said that the last time she gave someone a prescription for the
- >vaccine they came back with an oral vaccine. Since then she hasn't been
- >able to find any information comparing the oral to the injectable form:
- > - efficacy
- > - scheduling (the injectable form requires 2 doses, the first a month
- > before the trip)
- > - side effects (she says that the injectable form tends to make you feel
- > sick, the oral form may be an improvement).
-
- Oral typhoid vaccine is a live but weakened (attenuated) strain (Ty21a) of
- the Salmonella germ that causes typhoid fever.
-
- The oral vaccine is probably equal to the injected vaccine in efficacy, at
- about 80%.
-
- It is given orally on an empty stomach every other day for 4 doses (total
- elapsed time 6 days). It must be kept refrigerated but not frozen, a signif=
- icant
- limitation to use in other countries. You can't be taking antibiotics at th=
- e
- same time.
-
- It is very well tolerated. (The injected form has 80+% side effects). If yo=
- u
- have weakened immunity, or if you are too young to take pills, you shouldn'=
- t
- use this vaccine.
-
- I almost never recommend the injected form of typhoid vaccine. Typhoid
- vaccine is recommended for travel to areas with poor water supplies when
- the trip is over 3 weeks and when your eating will be "high risk".
-
- Hope this helps
-
- Mark Shelly
- mshelly@medicine.rochester.edu
- ------------------------------------------------------------------------
-
- Typhus vaccine (not available in the US) is described by Andreas Kaunzner's=
- travel medicine Web site
- (http://members.aol.com/reisemed/impfung/typhus.htm). According to this sit=
- e, there are two different typhus vaccines on the
- market in Germany. One is a live oral vaccine, which is given in three dose=
- s, and gives protection for about three years, if one
- stays in a region where typhus is endemic; otherwise its immunity lasts for=
- about a year. The most common side effect, seen in
- fewer than 1% of those receiving the vaccine, is stomach trouble. General s=
- ymptoms such as fever and chills can appear, and
- very seldom a rash. The other is a killed vaccine, which may be given to ad=
- ults and children two years or older, and which
- provides immunity for at least three years. Its side effects are described =
- as "typical side effects of vaccinations" (local reactions,
- fever, and allergic reactions) appearing only seldom. Kabel 1 Online has a =
- chart of German travel vaccine recommendations
- (http://www.kabel1.de/reise/1998/06/26/11/) which says that typhus vaccine =
- is given for trips of more than three months. The
- CDC, on the other hand, recommends hygiene and, in areas where tick typhus =
- is endemic, tick removal and tick repellant;
- typhus vaccine production has been discontinued in the US.=20
-
- Yellow fever is a viral infection which is spread by mosquitos. Yellow feve=
- r vaccine is a live vaccine which can be given only at
- certain vaccination centers. Many countries require this vaccination for en=
- try. A booster is needed every ten years.
- Contraindications include egg allergy and immune deficiency. Reactions are =
- mostly mild.=20
-
- Vaccine components capable of causing adverse reactions: chick embryo compo=
- nents (Travel Medicine Advisor).=20
-
- Travelers may also want to take anti-malarial drugs, bring insect repellant=
- containing N,N diethylmethylbenzamide, and avoid
- unboiled water, raw vegetables, fruit they haven't peeled themselves, under=
- cooked fish and shellfish, and food kept at room
- temperature. Other sources of travel health information are _Fielding's Tra=
- velers' Medical Companion_ and the US State
- Department Citizen's Emergency Center, which provides information on a vari=
- ety of foreign travel risks 24 hours a day at
- 202-647-5225. CDC Travelers' Health Section, 404-332-4559, and Immunization=
- Alert, 203-487-0611, have up-to-date
- information on vaccinations for international travel.=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 3n. Vaccines under development=20
-
- [This section most recently updated on September 18, 1999. References inclu=
- de the Report of the Technical Review Group
- Meeting, 7-8 June 1998 WHO Global Program for Vaccines and Immunization Vac=
- cine Research and Development
- (http://www.who.org/gpv-documents/DocsPDF/www9845.pdf), a New England Journ=
- al of Medicine editorial on malaria
- vaccine development at http://www.nejm.org/content/1997/0336/0002/0128.asp,=
- reports on AIDS vaccine research at
- http://www.iapac.org/ and http://www.nih.gov/news/pr/may98/od-15a.htm, an I=
- ntellihealth report on vaccine news for 1999
- (http://www.intelihealth.com/IH/ihtIH?t=3D18784&p=3D~br,IHW|~st,408|~r,WSIH=
- W000|~b,*|), Lon Morgan's Web site on
- vaccine developments: http://fp1.cyberhighway.net/~lmorgan/developments/vac=
- cine_development.htm, and National Institute of
- Health information on clinical trials at http://www.niaid.nih.gov/.]=20
-
- Q3n.1 What vaccines are currently under development?=20
-
- New vaccines under development include vaccines for HIV (vaccines are being=
- tested both to improve the immune response in
- those already infected and to resist infection), respiratory syncytial viru=
- s (Rathone), malaria, leprosy, gum disease, herpes,
- shigella, dengue, cervical cancer, type I diabetes, and other illnesses, as=
- well as an intranasal flu vaccine, new versions of the
- pneumococcal, meningococcal, and TB vaccines. Harrison's Internal Medicine =
- has a list of vaccines in human trial, and a list of
- those toward which priority efforts are being targetted.=20
-
- As of May, 1998, the National Institutes of Health had evaluated 23 vaccine=
- candidates and 10 adjuvants (substances that
- might enhance the effect of a vaccine) in 49 Phase I and Phase II clinical =
- trials to determine the safety of the vaccine candidates
- and their effect on the human immune system. These studies have been conduc=
- ted with 2,900 volunteers. Despite all these
- vaccine candidates, the variation of retroviruses and the virus transmissio=
- n directly from cell to cell by fusion pose significant
- obstacles. It's anyone's guess when (and if) an AIDS vaccine will be ready.=
- Two articles which discuss AIDS vaccine
- development are "Vaccine Against AIDS?" in the British medical journal Lanc=
- et ((02/26/94) Vol. 343, No. 8896, P. 493) and
- "AIDS Vaccine: Shooting Blanks or Loaded for Bear?" in Men's Fitness ((03/9=
- 4) Vol. 10, No. 3, P. 118). Information about
- efforts to produce an AIDS vaccine is sometimes posted in sci.med.aids, and=
- references, updates, and current information is
- available by gophering to odie.niaid.nih.gov. If you have gopher, gopher od=
- ie.niaid.nih.gov will get you there. The AIDS FAQ
- (available from the pub/usenet/sci.med.aids directory of rtfm.mit.edu) desc=
- ribes some other Internet resources with information
- about AIDS.=20
-
- When I wrote this section in 1994, I had, "The malaria vaccine has shown po=
- sitive results in Phase I/II trials, which were
- reported on February 18, 1994 issue in the British medical journal _Vaccine=
- _ (volume 12 no. 4, pp 328-336; 1994). (A
- report on an earlier trial can be found in the medical journal Lancet, volu=
- me 341, pp 705-710; l993). More details can also be
- found in a WHO press release kept on gopher.who.ch. The first results of Ph=
- ase III trials are expected to be available in
- October 1994." Unfortunately, the years since then have not seen as much pr=
- ogress toward a malaria vaccine as was hoped. It
- is known to be possible to induce immunity to malaria, as letting volunteer=
- s be bit by irradiated mosquitos has done so. But
- translating that into an effective vaccine has proved tricky. An editorial =
- in The New England Journal of Medicine -- January 9,
- 1997 -- Vol. 336, No. 2 reported that, though one vaccine has shown efficac=
- y, recent trials in malaria endemic areas couldn't
- confirm that efficacy. An improved subunit vaccine reported in the same iss=
- ue of NEJM, but needs to be tested in malaria
- endemic areas. WHO has malaria vaccine as a high priority, and aims to have=
- an effective and affordable vaccine within the
- next decade.=20
-
- Respiratory syncytial virus (RSV) is a major respiratory pathogen among inf=
- ants and young children which results in an
- "estimated 90,000 hospitalizations among infants in the US every winter" (W=
- illiams, 1997). Trials have indicated that the
- vaccine is safe and immunogenic (produces antibodies), but there are mixed =
- results so far on efficacy.=20
-
- Shigella is one of the leading causes of diarrhoeal illnesses. A shigella v=
- accine is moving toward clinical trials soon.=20
-
- The vaccine for periodontitis (gum disease) has shown some positive results=
- in macaque monkeys (less bacterially induced
- bone loss in the vaccinated monkeys), indicating that a human periodontitis=
- vaccine is feasiable. Full-fledged clinical trials,
- however, may be a decade away.=20
-
- Q3n.2 What other research is being done to improve vaccines?=20
-
- Research is being done to improve existing vaccines (such as the research w=
- hich resulted in the new acellular pertussis
- vaccine). This includes efforts to decrease the number of visits, the numbe=
- r of doses, and the number of injections, to move
- immunization as early in life as possible (including research into the valu=
- e of giving vaccines to pregnant women to provide
- protection to infants very early in life), to decrease adverse effects, to =
- increase protection, and to increase thermal stability. One
- area being explored is whether it is possible to combine more vaccines in a=
- single shot. Micro-encapsulation is an attempt to
- encase vaccines in microcapsules which will be released over time, mimickin=
- g repeated injections. Trans-disease vaccinology is
- an attempt, by genetic engineering, to create vaccines which protect agains=
- t more than one disease. Efforts are also under way
- to produce a heat-resistant polio vaccine. (Hartveldt) (There is also a Uni=
- ted Press International article from 3/25/94, included
- in the CDC AIDS Daily Summary for March 28, 1994, which discusses the effor=
- t to make a vaccine which will be effective
- against a variety of different viruses.)=20
-
- A major vaccine safety problem is the widespread reuse of syringes in devel=
- oping countries, due to scarcity, resale value, and
- cultural resistance to waste. In response to this problem, monodose, dispos=
- able vaccines, and solid, non-injected vaccines are
- being looked at. Solid vaccines would also eliminate the cost of keeping va=
- ccines cold (a major factor in vaccine delivery costs,
- and reduce the cost of wasted vaccines. Other research on different vaccine=
- delivery methods includes work on an intranasal
- flu vaccine and on an aerosol measles vaccine.=20
-
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
- =3D=3D=3D=3D
- Section 4. References=20
-
- AAP recommendations (found at http://www.aap.org).=20
-
- ACIP recommendations (found at http://www.cdc.gov/nip)=20
-
- AMA Drug Evaluations Annual, 1993.=20
-
- The American Medical Association Family Medical Guide. Random House, New Yo=
- rk. 1987.=20
-
- The American Hospital Formulary Service Drug Information, 1992. Published b=
- y the American Society of Hospital
- Pharmacists.=20
-
- Boughton, Clement R. "Varicella-zoster vaccine." The Medical Journal of Aus=
- tralia. Vol. 159. 4 October 1993.=20
-
- California Morbidity, a Biweekly Report from the Division of Communicable D=
- isease Control, part of the State of California
- Health and Welfare Agency. Issues from October 31, 1987, May 21, 1993, and =
- November 19, 1993.=20
-
- Catalana, Paul, MD. "The 'Other' Childhood Immunizations." Emergency Medici=
- ne, October 15, 1992. Center for Disease
- Control. _Health Information for International Travel_, 1992.=20
-
- Center for Disease Control Vaccine Information Statements (found at http://=
- www.cdc.gov/nip).=20
-
- Clements, C. John, Strassburg, Marc, Cutts, Felicity T. and Torel, Carol. "=
- The epidemiology of measles." In _World Health
- Statistics Quarterly, Vol 45, No 2/3, 1992.=20
-
- FDA. "Advisory Committee Discusses Chickenpox Vaccine." January 28, 1994. (=
- Pulled off of fdabbs.fda.gov. Connect with
- login bbs to find this and other FDA information.)=20
-
- Fettner, Ann Giuici. _The Science of Viruses._ Quill. William Morrow, New Y=
- ork, 1990.=20
-
- Galazka, Artur. "Control of Pertussis in the World." In _World Health Stati=
- stics Quarterly_, Vol 45, No 2/3, 1992.=20
-
- Gershon, Anna A. "Varicella - Immunization Practices in Children." Hospital=
- Practice. Sept. 15, 1990.=20
-
- Ghendon, Y. "Influenza - its impact and control." In _World Health Statisti=
- cs Quarterly, Vol 45, No 2/3, 1992.=20
-
- Harrison's Principles of Internal Medicine, Eleventh Edition. McGraw Hill B=
- ook Company, 1987.=20
-
- Hartveldt, Frank. "The Children's Vaccine Initiative." World Health 46th ye=
- ar, No. 2, March-April 1993.=20
-
- Historical Statistics of the United States, Colonial Times to 1970. Bicente=
- nnial Edition. US Department of Commerce, Bureau
- of the Census.=20
-
- Hull, Harry F. and Ward, Nicholas A. "Progress towards the global eradicati=
- on of poliomyelitis." In _World Health Statistics
- Quarterly, Vol 45, No 2/3, 1992.=20
-
- Journal Watch, 9-1-93. "Infant HBV Vaccination: Doubts Remain."=20
-
- Kiple, Kenneth E., Editor. _The Cambridge World History of Human Disease_.=
- =20
-
- The Lippincott Manual of Nursing Practice, Fourth Edition. 1986.=20
-
- Mandell/Douglas/Bennett. Principles and Practice of Infectious Diseases, Th=
- ird Edition, 1990.=20
-
- The Medical Letter on Drugs and Therapeutics, Vol. 34 (Issue 875), July 24,=
- 1992.=20
-
- The Merck Manual, Sixteenth Edition. Merck Research Laboratories, 1992.=20
-
- Nossal, Sir Gustav. "Prospects for new vaccines." World Health 46th year, N=
- o. 2, March-April 1993.=20
-
- Onorato, Ida M., MD, Wassilak, Steven G. Md, Meade, Bruce, PhD. "Efficacy o=
- f Whole-Cell Pertussis vaccine in Preschool
- Children in the United States." JAMA, May 27, 1992, Vol. 267, No. 20.=20
-
- Pantell, Robert H., MD, Fries, James F., MD, and Vickery, Donald M., MD. _T=
- aking Care of Your Child: A Parents' Guide
- to Medical Care._ Third Edition.=20
-
- The Physician's Desk Reference, 1993.=20
-
- Rathone, Mobeen H., MD. "Childhood Immunizations: An Update." Infections in=
- Medicine, June 1992.=20
-
- Ryan, Frank, M.D. _The Forgotten Plague: How the Battle Against Tuberculosi=
- s Was Won - And Lost_. Little, Brown, and
- Company, 1993.=20
-
- Shapiro, Eugene D., MD "Editorial: Pertussis Vaccines: Seeking a Better Mou=
- setrap." JAMA, May 27, 1992, Vol. 267, No.
- 20.=20
-
- Smith, Alice Lorraine. Principles of Microbiology. The C. V. Mosby company.=
- St. Louis, Toronto, and London, 1992.=20
-
- Statistical Abstracts of the United States, 1992.=20
-
- Travel Medicine Advisor. May 1993.=20
-
- Trollfors, B. and others. "A Placebo-Controlled Trial of a Pertussis-Toxoid=
- Vaccine." NEJM, Vol 333, Number 16, October
- 19, 1995.=20
-
- University of California, Berkeley. _The Wellness Encyclopedia._ From the e=
- ditors of the UC Berkeley Wellness Letter.
- Houghton Mifflin Company, Boston, 1991.=20
-
- Viral Hepatitis Prevention Board. Safety of hepatitis B vaccination program=
- mes.
- http://esoc-www.uia.ac.be/esoc/VHPB/statement.html=20
-
- Whitman, Cynthia, Belgharbi, Lahevari, Gasse, Francois, Torel, Carol, Matte=
- i, Vittoria, and Zoffman, Henrik. "Progress
- towards the global elimination of poliomyelitis." In _World Health Statisti=
- cs Quarterly, Vol 45, No 2/3, 1992.=20
-
- WHO. The Work of WHO 1990-1991. Biennial Report of the Director General.=20
-
- Wilkerson, James A., M.D. Medicine for Mountaineering, Third Edition. The M=
- ountaineers, Seattle, Washington, 1985.=20
-
- Williams, Amelia L., Ph.D. News and Perspectives: New Vaccines for Childhoo=
- d Immunization. Drug Benefit Trends
- 9(3):10-11,15-22, 1997. (Found on Medscape.)=20
-
- Wyngaarden/Smith/Bennett. Cecil Textbook of Medicine, 19th edition, 1992.=
- =20
-
- Electronic resources consulted:=20
-
- American Association of Pediatrics Web site. http://www.aap.org=20
-
- CDC AIDS DAILY SUMMARY (regularly posted on sci.med.aids)=20
-
- CDC National Immunization Program Web site. http://www.cdc.gov/nip/=20
-
- Degos, Francoise. Immunisation contre le virus de l'h=E9patite B : bilan de=
- quinze ann=E9es de vaccination.
- http://www.john-libbey-eurotext.fr/articles/aB80DA9A7/index.htm=20
-
- fdabbs.fda.gov (login using name "bbs") (more recently, http://www.fda.gov)=
- =20
-
- gopher.who.ch (gopher gopher.who.ch, also:=20
-
- telnet gopher.who.ch login:gopher) (more recently, http://www.who.org)=20
-
- HICNet Medical News Digest (available from LISTSERV@ASUACAD.BITNET; regular=
- ly posted to sci.med)=20
-
- Immunization Action Coalition Web site. http://www.immunize.org=20
-
- Journal Watch Summaries (regularly posted to sci.med by jwatch@world.std.co=
- m)=20
-
- Le point sur la vaccination contre l'h=E9patite B http://www.sante.gouv.fr/=
- htm/pointsur/vaccins/effets_sec_hep_b.htm=20
-
- Levy-Bruhl, Daniel et al. Comparaison entre les Risques de Premieres Attein=
- tes Demyelinisantes Centrales Aigues et les
- Benefices de la Vaccination Contre L'Hepathite B. http://www.rnsp-sante.fr/=
- beh/1999/9909/index.html=20
-
- Medscape http://www.medscape.com=20
-
- Also available on the net is the Morbidity and Mortality Weekly Report (MMW=
- R). It is available by Worldwide Web at:=20
-
- http:/www.cdc.gov/; Go to publications and scientific data, then Morbidity =
- and Mortality Weekly Report, OR=20
-
- by gopher at Duke University.=20
-
- Morgan, Lon. Immunization, Vaccines, Vaccination in the Modern World http:/=
- /fp1.cyberhighway.net/~lmorgan/=20
-
- Swiss Medical Weekly. http://www.smw.ch=20
-
- A list of Internet and Bitnet Health Sciences resources, compiled by Lee Ha=
- ncock, can be ftped from the pub/nic directory of
- ftp.sura.net.=20
-