FDA mulls approval of COVID vaccine booster shots

The agency could decide Sept. 17 to make the Pfizer version available for adults.

In August, health officials in the Biden administration recommended an additional dose for all Americans 18 and over who received the Pfizer or Moderna vaccine, proposing a booster eight months after being fully vaccinated.

“Recent data makes clear that protection against mild and moderate disease has decreased over time,” Surgeon General Dr. Vivek Murthy said during an August briefing on COVID-19 vaccinations. “This is likely due to both waning immunity and the strength of the widespread delta variant.”

Currently the Food and Drug Administration is only looking at approving the Pfizer vaccine available for a third dose. FDA regulators need more time to evaluate the other vaccines. On Sept. 5, Chief Medical Advisor Dr. Anthony Fauci confirmed that the rollout of Moderna’s vaccine booster could come later than Pfizer’s. The Vaccines and Related Biological Products Advisory Committee will meet on Sept. 17 to discuss the third dose and specifically address Pfizer’s application to administer a third dose of its vaccine.

“We believe that that third dose will ultimately be needed to provide the fullest and continual extent of protection that we think people need from the virus,” Murthy said. “Our plan is to stay ahead of this virus by being prepared to offer COVID-19 booster doses to fully vaccinated adults 18 years and older.” 

Murthy said the FDA will evaluate booster shots for those younger than 18, and the administration will follow FDA recommendations for minors.

Along with a Pfizer and Moderna booster, on Aug. 25, Johnson & Johnson said a booster dose of its COVID-19 vaccine increases antibody responses in those who received the company’s one-dose vaccine, based on interim data from an early trial. The White House expects those who received the Johnson & Johnson vaccine will also need a booster dose. 

The current Centers for Disease Control and Prevention’s recommendation is for an additional dose of the two-dose vaccine for certain immunocompromised people; 18 and older for the Moderna vaccine, and 12 and older for the Pfizer vaccine. Citing a lack of data, the FDA has not authorized a second dose of the Johnson & Johnson vaccine, and the CDC has not recommended a second dose for immunocompromised people who received it. 

San Benito County Public Information Officer David Westrick said the county has not yet released information to him on the status of booster administration in the county. Westrick said as far as he knew and according to many national news outlets, there is no plan to mix-and-match the vaccines. Individuals should receive a booster of the same vaccine and all boosters will be free. 

Research is underway to determine if children ages 5-11 can be given the Pfizer vaccine. Following that it will be determined if children 2-4 can be given the vaccine. Dosage would be modified for age. 


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Carmel de Bertaut

Carmel has a BA in Natural Sciences/Biodiversity Stewardship from San Jose State University and an AA in Communications Studies from West Valley Community College. She reports on science and the environment, arts and human interest pieces. Carmel has worked in the ecological and communication fields and is an avid creative writer and hiker. She has been reporting for BenitoLink since May, 2018 and covers Science and the Environment and Arts and Culture.