Moderna has joined the ranks of vaccine manufacturers who have submitted a bivalent COVID-19 booster to the Food and Drug Administration for emergency use authorization as the Biden administration eyes a fall rollout for the updated shots.
Moderna said it could be ready to ship the updated boosters designed to provide protection against both the original COVID-19 virus from 2020 and omicron subvariants BA.4 and BA.5, which now account for most positive COVID-19 cases in the United States, for people 18 and older beginning in September if approved.
PFIZER AND BIONTECH ASK FDA TO AUTHORIZE OMICRON-SPECIFIC COVID BOOSTER
Pfizer and BioNTech already submitted their own omicron-specific booster for people ages 12 and older for authorization. Both manufacturers will need approval from the FDA and a recommendation from the Centers for Disease Control and Prevention before proceeding with public distribution.
The FDA is expected to review the updated shots in the coming weeks, though it’s unclear if they will seek advice from an outside advisory panel composed of public health and science experts. So far, no meetings are scheduled for the Vaccines and Related Biological Products Advisory Committee, which the FDA occasionally turns to for outside input. The committee previously recommended in June that manufacturers develop vaccines for the newer subvariants of the omicron strain.
The CDC’s Advisory Committee on Immunization Practices, a group that advises the agency on how to administer new vaccines, has already posted a notice that it will hold a two-day meeting between Sept. 1 and Sept. 2 to discuss the redesigned vaccines.
The Department of Health and Human Services has already secured agreements with Moderna and Pfizer to purchase 171 million doses of their bivalent boosters. The government plans to offer the boosters to those who have already received the initial two-shot series, prioritizing vaccinations for those with the highest risk of developing severe COVID-19 infections, including long-term care residents and people ages 65 years and older.
Supply of the boosters will be “sufficient but finite,” the CDC advised.
Despite the Biden administration gearing up for distribution in anticipation of a potential uptick in COVID-19 cases as people head indoors during the fall and winter, some public health experts have expressed doubt that the boosters will make an impact on the people most at risk for severe illness.
“Deaths are concentrated in unvaccinated people and people with serious health conditions,” John Moore, a virologist at Weill Cornell Medicine, told the New York Times. Moore argued that the shots could add little protection against the coronavirus from vaccines already on the market, which could backfire and decrease overall public confidence in COVID-19 vaccines if another wave of cases were to come.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
Unlike previous vaccines, Moderna and Pfizer and BioNTech’s updated booster has not been widely tested on humans and is reliant on preclinical trials from testing on mice.
Anthony Fauci, the chief medical adviser to the president, told the outlet that researchers also use animal data to update the flu vaccine each year.
