FDA to weigh Moderna, J&J COVID-19 booster shots in October meetings
Americans could soon see a major increase in access to COVID-19 vaccine booster shots.
On Friday, the U.S. Food and Drug Administration (FDA) announced its Vaccines and Related Biological Products Advisory Committee (VRBPAC) would meet on Oct. 15 and 15 to discuss the Moderna and Johnson & Johnson booster shots.
Vaccines produced by both companies are already authorized by the FDA for emergency use. Along with the fully-approved Pfizer jab, the vaccines have played a crucial role in protecting Americans from severe illness and death.
But there is evidence showing that protection diminishes several months after being injected.
"The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations," said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
In this photo illustration, a vial and a medical syringe seen displayed in front of the Food and Drug Administration (FDA) of the United States logo. FDA finds the COVID-19 vaccine. (Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Get
The VRBPAC’s Oct. 14 meeting will be to discuss amending Moderna’s emergency use authorization (EUA) to allow Americans 18 and older to receive a booster dose. J&J’s EUA will be evaluated for the same reason the following day.
So far, only Pfizer’s vaccine is authorized to be administered as a booster shot. On Sept. 22, the FDA authorized a third dose for Pfizer recipients who are 65 and older or run a high risk of severe illness.
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Pfizer’s booster is also authorized for "individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19."
It is not, however, authorized for anyone previously inoculated with the Moderna or J&J vaccine — thus the urgency in getting those boosters authorized.
Pfizer was the first pharmaceutical company to market last December when the FDA granted them EUA. In August, they became the first company to receive full FDA approval for their vaccine. And they’re still the lone vaccine authorized for kids between 12 and 17.
Pfizer has revealed data from its juvenile clinical trials showing the vaccine offers 5 to 11-year-olds coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots.
RELATED: Pfizer COVID-19 vaccine for children likely won't be available until November
The FDA said it anticipates receiving a request from Pfizer to expand its EUA to include children 5-11. The VRBPAC is tentatively scheduled to meet for that discussion on Oct. 26.
"We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults," said Dr. Janet Woodcock, acting FDA commissioner.
This story was reported from Atlanta.