FDA Approvers Pfizer COVID-19 Vaccine
On August 31, 2021, the United States Food and Drug Administration fully approved their first-ever vaccine for the prevention of COVID-19: the Pfizer-BioNTech vaccine. The clinical trials for the vaccine’s approval included over 44,000 people and showcased a 91% effectiveness in preventing Coronavirus transmissions in persons age 16 and older when compared to a placebo.
The FDA’s website reports: “In public health emergencies, such as a pandemic, the development process may be atypical… The U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations, and pharmaceutical companies to develop a coordinated strategy for prioritizing the development of the most promising vaccines.” Though, this does not mean that the vaccine is unsafe, as the FDA website continues: “Efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, the integrity of the vaccine review process, or safety.”
The Pfizer-BioNTech vaccine is an mRNA vaccine. Unlike other types of vaccinations, it does not contain a live, weakened strain of the coronavirus to foster immunity. Rather, it utilizes messenger RNA to introduce harmless surface proteins from the coronavirus into the body. The immune system produces antibodies to target these proteins, as one’s body would when fighting off a real COVID-19 infection. These same antibodies are available to protect the individual from the Coronavirus when exposed. Therefore, a vaccinated person will be less likely to contract the virus and less likely to become seriously ill if they do.
Overall, the vaccine has gone through extensive testing, and it meets the FDA’s rigorous safety standards for use by persons age 16 and older. The vaccine has not yet been fully approved for those under 16; however, it is authorized for emergency use for anyone as young as 12. Additionally, further testing is underway for use in children between the ages of 6 months and 11 years.