FDA Amends Pfizer Covid Vaccine EUA

FDA has amended the Pfizer/BioNTech emergency use authorization for their Covid-19 vaccine to: 

•          expand the use of a single booster dose to include those ages 12-15;
•          shorten the time between the completion of primary vaccination with the product and a booster dose to at least five months; and
•          allow for a third primary series dose for certain immunocompromised children ages 5 through 11.

An agency statement says FDA has determined that the protective health benefits of a single booster dose of the Pfizer/BioNTech vaccine outweigh the potential risks in those ages 12-15. It says the determination was made through a review of real-world data from Israel. The data showed there were no new safety concerns following a booster in this age group and no new cases of myocarditis or pericarditis reported to date in those individuals, the agency says.