On Monday, August 23, the Pfizer-BioNTech COVID-19 vaccine became the first fully approved COVID-19 vaccine in the United States. The vaccine will now be marketed as “Comirnaty” and is now fully approved for everyone 16 years old and older.

What about 12-15 year olds?

The vaccine will also still be available under Emergency Use Authorization (EUA), for younger children ages 12-15. The authorization of 3rd doses in the immunocompromised will also continue to be used under an EUA. The FDA has advised COVID-19 vaccine manufacturers should include at more vaccine recipients 12 to <16 years of age who are followed for at least 6 months after completion of the vaccination regimen before they are included in full licensure. More adolescents in the clinical trials would not only satisfy the above expectation for this age group but would also provide for a more robust overall safety database.

How did the FDA come to this decision?

The Pfizer-BioNTech COVID-19 vaccine was first issued EUA on December 11, 2020 based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trials, including analyzing effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. The FDA granted this application Priority Review.

What is Priority Review?

Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review).

What are the side effects?

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially severe outcomes including hospitalization and death.

What about the Moderna vaccine?

Moderna applied for full FDA approval in June. We expect to see an announcement about full approval for the Moderna COVID-19 vaccine within the next six weeks.

What about the Johnson & Johnson vaccine?

Johnson & Johnson has not yet submitted its application for full FDA approval, but is expected to do so by the end of the year.

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