FDA Authorizes Pfizer Covid Booster Shots For Seniors And High-Risk Patients — But Not For All Americans

Topline
Wednesday's approval by the Food and Drug Administration for booster shots of Pfizers coronavirus vaccination for seniors Americans and those who are at high risk from Covid-19 was granted. This comes days after an advisory panel for the agency endorsed giving extra vaccine doses to certain vulnerable individuals, but rejected booster shots for the entire population.

Nurse Melanie Albor fills up a syringe containing the Moderna Covid-19 vaccination at Tracy's affordable housing... [+] community, California, on February 25, 2018. Los Angeles Times via Getty Images

The Key Facts

Wednesday's FDA update to its emergency authorization for Pfizers vaccine gave greenlight to a third dose. This vaccine is for seniors, high-risk adults, and those who are frequently exposed in institutional or workplace settings to the coronavirus. According to the FDA, patients should receive booster shots no later than six months after their two previous doses. Although the FDA did not specify frequent occupational or institutional exposure, Dr. Janet Woodcock, FDA Commissioner, stated Wednesday that booster shots are only authorized for certain populations, such as teachers, health care workers, and grocery workers. This was a larger designation requested by Pfizer, but it was rejected Friday by FDAs Vaccines and Related Biological Products Advisory Committee.

Important Quote

Woodcock stated that the pandemic is constantly changing and dynamic. Every day new data on vaccine safety and effectiveness becomes available. We will continue to assess the rapidly changing science and inform the public as we learn more about COVID-19 vaccines' safety and effectiveness, including the use a booster dose.

What to Watch

Wednesday and Thursday are the Centers for Disease Control and Preventions advisory boards. They will be discussing booster shots and could vote to determine who should prioritize additional doses.

Important Background

VRBPAC members unanimously supported Pfizer booster shots last week for high-risk elderly patients. However, they voted 16-2 against additional doses for everyone ages 16 years and older. Some panel members stated that there is not enough data to conclude that patients require a third dose of vaccines or that Pfizers vaccine's effectiveness in preventing severe illness and death has decreased over time. Although the vote ended the plans of the Biden administration to distribute additional vaccine shots en masse to patients, Dr. Anthony Fauci, the top federal infectious disease expert, told CNN that he expected more data about booster shots to arrive in coming weeks. He said that this is not the end.

Tangent

Johnson & Johnson announced Tuesday that patients are protected against symptomatic Covid-19 infections by receiving a second dose of its single-dose vaccine. Fauci said Sunday that more information on booster shots for Moderna or Johnson & Johnson's Covid-19 vaccines will be available in the coming weeks.

Continue reading

FDA Advisory Panel Recommends Against Pfizer's Covid BoostersExcept for People Over 65 (Forbes).

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