The US Food and Drug Administration (FDA) made multiple changes to the emergency use authorization for the Pfizer/BioNTech vaccine.
The US Food and Drug Administration (FDA) made multiple amendments to the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19.1 The main takeaway from this expansion is that booster doses are now authorized for everyone aged 12 years and older. The decision is the result of real-world data from Israel that showed the protective qualities of the vaccine outweighed any potential risks for receiving it. No cases of myocarditis or pericarditis were noted in the studied population of 6300 people.
Furthermore, the timing of the booster dose following the initial 2 dose vaccination has been shortened to a 5-month interval. Israeli data were also used to make this determination, with no negative safety effects found with the shorter time between doses. Additionally, the preliminary data indicate that a booster dose appears to increase antibody activity and be effective against the Omicron variant.
Finally, the amendments also include a third dose in the primary series for certain immunocompromised children aged 5 to 11 years. Any child who has received a solid organ transplant or who has a condition that is considered to be an equivalent level of immunocompromised may not have an adequate response to a 2-dose series. A third dose for all other children or a booster is still not currently recommended, but the FDA is monitoring the situation and will update the EUA if needed.
Acting FDA Commissioner Janet Woodcock, MD, stressed the importance of receiving both timely vaccination and booster in the release for the amendments, saying, “With the current wave of the Omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing, and social distancing to in order to effectively fight COVID-19.”
1. US Food and Drug Administration. Coronavirus (COVID-19) Update: FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 vaccine. Published January 3, 2022. Accessed January 3, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine