This week, the US Food and Drug Administration (FDA) approved of a booster shot for the Pfizer-BioNTech (Pfizer) COVID-19 vaccine for at-risk individuals in the US. The FDA has amended the prior emergency use authorisation for Pfizer’s COVID-19 vaccine to now include a third booster dose to be given at least six months after the second dose; it will prioritise those over 65 and adults over 18 with health conditions putting them at high-risk of severe COVID-19.

The FDA’s booster decision includes a significant gray area in its third booster approval category – “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19, including severe COVID-19.”

Acting FDA commissioner Janet Woodcock said this category could also include “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

Read: WHO Director-General “appalled” over global COVID-19 vaccine inequity

The Advisory Committee on Immunization Practices (ACIP) will decide what constitutes a “high-risk” individual and will offer their recommendations to the Centers for Disease Control and Prevention (CDC) at the soonest available date.

It is important to note that the FDA’s booster approval is limited to only the Pfizer COVID-19 vaccine, and offers no insight for Americans who previously received the Moderna or Johnson & Johnson vaccines. There is currently no advice or approval for booster shots for those vaccines, and there is no suggestion those who initially received the Pfizer vaccine can receive a booster of a different vaccine.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” added Woodcock. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

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