The Food and Drug Administration has given their full approval for Pfizer-BioNTech’s Covid-19 vaccine on Monday, marking the first covid vaccine to receive FDA approval.
Previously, vaccines had been distributed and administered to patients via the FDA’s emergency use authorization which allows for the quick availability of medical products needed during public health crises. Vaccines administered under emergency use authorization still go through rigorous safety and efficacy testing of two months of safety monitoring data on tens of thousands of study participants, the time period in which side effects are most likely to occur.
In contrast to the shorter study length required for emergency use authorization, full approval from the FDA requires vaccine manufacturers to submit six months of study data. The FDA also toured manufacturer facilities to ensure the safe and sterile production of the vaccines.
Emergency use authorization was given for the Pfizer-BioNTech vaccine for individuals 16 years of age or older in December before being extended to those between the ages of 12 and 15 in May. Full approval for the Pfizer vaccine has only been given to those 16 or older. Approval for those younger than 16 is still being evaluated as data collection continues to meet the FDA’s study length requirements.
Currently, the Moderna and Johnson & Johnson vaccines are still being administered under emergency use authorization. Moderna has applied to the FDA’s full authorization process, while Johnson & Johnson says they are hoping to apply later this year. Booster shots also do not have full approval from the FDA and are too being administered under emergency use authorization.
Vaccines advocates hope that the FDA’s first full approval of a covid vaccine will encourage those who are still not vaccinated to receive the shots in the face of plateauing country-wide vaccination rates.
Top Photo Credit: Agência Brasília, CC BY 2.0 <https://creativecommons.org/licenses/by/2.0>, via Wikimedia Commons