CAMBRIDGE, Mass. — Moderna announced on Wednesday that it had asked the Food and Drug Administration to allow the use of a booster shot dose of its COVID-19 vaccine.
In a news release, Moderna said it has begun submitting data for its two-shot dose booster to the FDA. The data is for the use of a booster dose at 50 micrograms, the company stated.
“We are pleased to initiate the submission process for our booster candidate at the 50 (microgram) dose with the FDA,” Stéphane Bancel, Moderna’s CEO, said in a statement. “Our submission is supported by data generated with the 50 (microgram) dose of our COVID-19 vaccine, which shows robust antibody responses against the delta variant.”
We just announced the submission of initial data to the @US_FDA for our COVID-19 vaccine booster. Read more: https://t.co/4jeCvDMCjF pic.twitter.com/7XRiq8uGGL
— Moderna (@moderna_tx) September 1, 2021
The FDA is considering booster shots of the Pfizer/BioNTech vaccine, but so far has only allowed people with weakened immune systems to receive third doses,
Around 3% of the U.S. population, or 7 million people, are considered immunocompromised.
Moderna officials said in a news release that they expect to submit data to the European Medicines Agency and other regulatory authorities worldwide in the coming days.
The Centers for Disease Control and Prevention said on Wednesday that a group of its advisers will meet to discuss Pfizer’s booster shot application on Sept. 17, The Washington Post reported. The panel’s recommendations are not binding, the newspaper reported.
It was not clear whether CDC advisers will discuss the Moderna booster, according to Reuters.
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Moderna said neutralizing antibodies had waned “significantly” prior to boosting approximately six months after the second dose.
“We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2,” Bancel said. “We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies.”
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