A committee of experts from the FDA (Food and Drug Administration) unanimously voted to make the third dose of the Pfizer vaccine against coronavirus available to people over 65 and particularly at risk of severe disease. Experts were against offering it to a wider population six months after the last injection.
The panel of the Food and Drug Administration, composed of 19 external experts, voted unanimously in favor of recognizing that the benefits of an additional dose of BioNTech-Pfizer against COVID-19 outweigh the risks in people over 65 years of age and particularly at risk of severe disease. This category also includes medics and workers in other high-risk professions.
Experts are negative about the use of the third dose for everyone
At the same time, by 16-3 votes, the body negatively assessed the use of the third dose among people over 16 years of age, pointing to insufficient data from the research.
The FDA’s Advisory Committee on Immunization and Related Biologicals thus questioned the Biden administration’s plan to offer additional doses of Pfizer and Moderna to most Americans from September 20.
During several hours of deliberations broadcast over the Internet, experts expressed dissatisfaction with the insufficient data on the safety of the additional dose and with Pfizer’s reliance on data from Israel, which in their opinion may not be adequate to the situation in the US.
Recommendations for the third dose in the US and Israel
So far, the additional dose can only be taken by people with reduced immunity, although according to official data over a million Americans have done so against the recommendation, on their own.
Israel recommended that the third dose of the preparation be administered to people over 40 in August.
Also in August, the Biden administration announced it plans to release a third dose of mRNA vaccines to all Americans age 16 and over eight months after the second injection. Later, this period was changed to 6 months.
This decision was supported, inter alia, by Acting FDA chief Janet Woodcock, as well as head of the Centers for Disease Control and Prevention (CDC) Rochelle Walensky and the president’s chief medical adviser, Dr. Antony Fauci. At the same time, they emphasized, as did Biden, that the implementation of these plans was dependent on the approval of the FDA. The negative opinion of the panel is not binding on the agency, but rarely goes against the opinion of the experts.
Main photo source: CAROLINE BREHMAN / PAP / EPA