Vaccine safety
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November 12, 2019
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Vaccines are popular among the public. Vaccines prevent diseases. This translates into extended life expectancy, reduced need for antibiotics, safe travel, and decreased infant and child mortality, to name a few. Of late though, controversy regarding vaccine safety has made many to opt-out of them.
A few reasons for concern remain:
- The association between MMR (Measles, Mumps, Rubella) vaccine and autism (a developmental disorder)
- Oral Polio Vaccine and flaccid paralysis ( a disease affecting nerves and associated muscles)
- Vaccines for H1N1, Meningococcal C, Hepatitis-B and HPV have also been under scrutiny.
International health bodies like WHO (World Health Organization) and ICH (International Conference on Harmonization) have set guidelines relevant to clinical development of vaccines.
- If a vaccine is safe after non-clinical trials in animals, clinical trials with human volunteers are next.
- Vaccines undergo three phases of trials, and in phase 3, thousands of volunteers participate.
- The results are compared with people who have received a placebo or other vaccine.
Regulatory approval of vaccines:
- Only if a vaccine’s benefits outweigh the potential risks, the FDA (Food and Drug Administration), grants a license for the vaccine to be used by the public.
- After the vaccines are licensed, PRISM (Post-Licensure Rapid Immunization Safety Monitoring), reveals even the rarest of side effects.
- CBER (Center for Biologics and Evaluation and Research) regulates vaccine products.
- FDA inspects vaccine manufacturing facilities to make sure all batches of vaccines are safe, pure, and potent.
While individual freedom of choice is an important principle, those who refuse vaccination may pose a risk to themselves and others. The benefits of vaccines are strongly evident but the debate regarding their safety is far from over.
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Disclaimer: Don’t follow any suggestions in this article without consulting a qualified doctor
Sources:
- ‘Ensuring the Safety of Vaccines in the United States’- https://www.cdc.gov/vaccines/hcp/conversations/ensuring-safe-vaccines.html
- ‘Controversies and challenges of vaccination’- https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0508-z