The panel, made up of 19 outside experts, voted unanimously in favor of concluding that the benefits of an additional dose of BioNTech-Pfizer against COVID-19 outweigh the risks in people over 65 years of age and especially at risk of serious illness. This category also includes physicians and workers in other high-risk occupations.
At the same time, by 16-3 votes, the body negatively evaluated the use of the third dose among people over 16 years old, citing insufficient research data.
Thus, the Food and Drug Administration’s Advisory Committee on Immunization and Related Biological Substances has questioned the Biden administration’s plan to provide additional doses of Pfizer and Moderna to most Americans beginning September 20.
During several hours of online deliberations, experts expressed dissatisfaction with the insufficient data regarding the safety of the additional dose and Pfizer’s reliance on data from Israel, which in their opinion may not be appropriate for the situation in the United States.
So far, the extra dose can only be taken by people with reduced immunity, although more than a million Americans have done so against the recommendation, according to official data.
Israel recommended the third dose of the preparation for people over 40 years of age in August.
Also in August, the Biden administration announced that 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.
That decision was endorsed, inter alia, by Acting FDA chief Janet Woodcock, as well as Centers for Disease Control and Prevention (CDC) chief Rochelle Wallinsky and the chief medical advisor to the president, Dr. Anthony Fauci. At the same time, they emphasized, as did Biden, implementation of these plans is dependent on approval by the Food and Drug Administration. The negative opinion of the commission is not binding on the agency, but it rarely contradicts the opinion of experts.
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