On August 23, the Food and Drug Administration (FDA) approved the Pfizer/BioNTech COVID-19 vaccine, the first vaccine against the novel coronavirus to receive full approval.
The vaccine has been under an emergency use authorization since December 11, 2020, for individuals ages 16 and older, but the full approval comes from expanded safety and efficacy data released by the manufacturer this April. An analysis of 927 confirmed cases found that the vaccine had 91.3% efficacy against symptomatic disease up through 6 months after the second dose.
The vaccine is still under emergency use authorization (EUA) for adolescents ages 12-15, the agency said.
Ohio Department of Health Director Bruce Vanderhoff, MD, released the following statement regarding the FDA’s approval of the Pfizer COVID-19 vaccine, now known as Comirnaty.
“For some time, I have said I believe it is a matter of when, not if, the Pfizer vaccine receives full FDA approval. Now, that day has come. Full approval of this safe, effective COVID-19 vaccine can give Ohioans an added layer of confidence when choosing to be vaccinated. The Pfizer COVID-19 vaccine was built upon decades of research on mRNA vaccines, and was thoroughly evaluated and tested in one of the largest vaccine clinical trials in history. The world’s most comprehensive vaccine safety monitoring system has closely observed the more than 200 million doses that have been administered in the United States, including more than 6 million doses administered in Ohio. This action by the FDA validates the confidence of so many physicians, scientists, and public health experts in the safety and efficacy of the Pfizer COVID-19 vaccine. For any Ohioan who has been waiting to receive the vaccine until full approval is granted, today is the day. Pfizer vaccines are readily available at providers across the state, and COVID-19 vaccines are our best protection against the virus.”