The Centers of Disease and Control and prevention (CDC) endorsed Pfizer and BioNTech’s COVID-19 booster shots on Sept. 22 for people 65 years or older, those at high risk of developing COVID symptoms, or of high risk of developing “serious complications” due to “frequent or occupational” exposure. 

The Federal Drug Administration (FDA) recently approved a third dose for this population on Wednesday. AP News reports this action represents a scaled back version of the Biden administration’s plan to give third doses to nearly all American adults to help protect against this highly contagious Delta Variant. 

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others," acting FDA Commissioner Janet Woodcock said in a statement. 

There were some roadblocks for the dispensing of booster shots as advisors for the CDC made their own detailed recommendations about the timeline, recipient groups and voiced uncertainties during the meeting. 

According to AP, the FDA’s decision was expected after the agency’s own panel of advisors overwhelmingly rejected the Biden plan last week. 

“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,” Woodcock said.

Vaccinated individuals are able to receive their booster dose six months after receiving their second Pfizer shot under FDA approval whereas the Biden plan called for eight months. Many are opposed to the booster vaccination including the World Health Organization and other global health advocates.

“We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions about COVID-19 vaccines. We appreciate the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding the use of a booster dose for those with institutional or occupational exposure to SARS-CoV-2,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research in a statement. “The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision. We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data.” 

The FDA reports their process for authorizing emergency use of single booster doses through the analysis of safety and immune response data from a subset of participants from the original clinical trial of the Pfizer-BioNTech COVID-19 Vaccine. Additional consideration was given on real world data on the vaccine’s efficacy over a period of time provided internally and internationally. 

Approximately six months after their second dose, the immune response of approximately 200 participants aged 18 through 55 who received a second dose were assessed for antibody response against the virus. The FDA additionally reports the antibody response against the virus one month after a booster dose of the vaccine compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response. 


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