Safety of Vaccination

Vaccine Safety - Introduction

1) Greatest success story in public health: reduction of infectious diseases resulting from the use of vaccines.
a) Eradication of smallpox
b) Near elimination of wild polio virus
c) Reduced preventable infectious diseases (measles, pertussis, diphtheria)

2) During the last 10 years, the FDA has recalled only three vaccine lots: one was mislabeled, another was contaminated during production, and the third was recalled after the FDA discovered potential manufacturing problems at a production plant.

3) Prior to approval by FDA, vaccines are tested extensively by scientists to ensure they are effective and safe. But no vaccine is 100% safe or effective. (depends on individual immune systems)
- Mice, guinea pigs, rabbits, monkeys
- FDA approves clinical studies
- Human subjects (voluntary), computers used to predict how the vaccine will interact with the immune system
- 3 phases: small (20-100 volunteers) a few months,
larger (several hundred volunteers) months to years,
larger still (several hundreds to thousands) several years.

4) Agencies involved in vaccine safety regulation:
a) National Vaccine Program Office (NVPO) under National Childhood Vaccine Injury Act (NCVIA)
- Vaccine Adverse Event Reporting System (VAERS) by CDC and FDA in 1990
- National Vaccine Injury Compensation Program (NVICP)
b) Department of Health and Human Services (DHHS)
- Centers for Disease Control and Prevention (CDC),
- Food and Drug Administration (FDA)
- National Institutes of Health (NIH)
- Health Resources and Services Administration (HRSA).

5) In the last decade, numerous changes in vaccine production and administration have reduced the number of side effects and resulted in safer vaccines. (e.g A more purified acellular pertussis (aP) vaccine has been licensed for use and has replaced the whole cell pertussis vaccine used in DTP (diphtheria, tetanus, pertussis vaccine) – less mild and serious side effects.)


Six Common Misconceptions By CDC 29 May 2007 (will be explained)

1) Diseases had already begun to disappear before vaccines were introduced, because of better hygiene and sanitation.
2) The majority of people who get disease have been vaccinated.
3) There are "hot lots" of vaccine that have been associated with more adverse events and deaths than others. Parents should find the numbers of these lots and not allow their children to receive vaccines from them.
4) Vaccines cause many harmful side effects, illnesses, and even death - not to mention possible long-term effects we don't even know about.
5) Vaccine-preventable diseases have been virtually eliminated from the United States, so there is no need for my child to be vaccinated.
6) Giving a child multiple vaccinations for different diseases at the same time increases the risk of harmful side effects and can overload the immune system.

References:
http://www.who.int/immunization_safety/aefi/immunization_misconceptions/en/print.html
http://www.cdc.gov/vaccines/vac-gen/6mishome.htm
http://www.cdc.gov/vaccines/vac-gen/side-effects.htm#dtap