Five Things to Know About the FDA’s Approval of Pfizer-BioNTech’s COVID-19 Vaccine

What does the FDA approval of the Pfizer-BioNTech’s COVID-19 vaccine mean?

Today’s announcement means the public can be very confident that this vaccine is safe, effective and meets the highest standards for manufacturing quality. Since becoming available for emergency use in individuals 16 years of age and older in Dec. 2020, more than 92 million people in the U.S. have received two doses of this vaccine. The Food and Drug Administration (FDA) spent the past several months reviewing updated data from clinical trials, which supported the emergency use authorization (EUA) late last year. This data showed the vaccine to be 91% effective in preventing COVID-19 disease. The most common reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. It also proved the vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death. With full FDA approval, the Pfizer-BioNTech vaccine will be marketed under the name Comirnaty (koe-mir’-na-tee).

What age is the vaccine fully approved for?

Comirnaty is fully approved for individuals 16 years of age and older. The vaccine also continues to be available under the EUA for kids 12 through 15 years of age, and for the administration of a third dose in certain immunocompromised individuals.

Why is the vaccine still under EUA for individuals under 16?

While the vaccine became available under EUA for 16 years and older in Dec. 2020, authorization was not expanded for 12-15 year olds until May 2021. Much like the emergency authorization process, the FDA will need more time to review data for this younger population before it can grant full approval.

Do you still recommend the vaccine for kids under 16?

Yes, Pfizer-BioNTech’s COVID-19 vaccine is recommended for children 12 years and older. Many people mistakenly believe that children cannot become ill from COVID-19 and this is simply not true. Unfortunately, children and teens can become very ill from the virus and need hospitalizations, even intensive and life-saving care. The Pfizer-BioNTech vaccine is safe for children and teens, and protects them from potentially developing severe illness and long-term issues.

What does this approval mean for children under 12?

At this time, no COVID-19 vaccine has been authorized for children under the age of 12. This means it’s vitally important for this population to wear a mask around non-family members, stay six feet apart from others and practice frequent handwashing. Families can also protect these children by ensuring those closest to the child (parents, older siblings, grandparents) are all vaccinated. This will help decrease the chances of the child becoming exposed to COVID-19.

Watch the video above to hear Nicholas Rister, M.D., pediatric infectious diseases specialist at Cook Children's, answer these questions and more.