Moderna seeks FDA approval for updated COVID vaccine
Moderna announced Tuesday that it has requested emergency approval for its updated COVID-19 vaccine from the Food and Drug Administration.
Why it matters: Doses of the updated vaccine, which better target new coronavirus variants, will be ready to ship next month if the FDA grants clearance, according to a Moderna news release.
- Competitor Pfizer Inc. and BioNTech SE also announced Monday that they have applied for FDA approval for their new booster dose.
The big picture: Public health officials have been eyeing a long-term strategy for COVID vaccinations, addressing the risk of new variants and the need for new boosters, Axios' Adriel Bettelheim reports.
- The boosters would come in time for immunity defense ahead of the fall and winter, when cases may go up.
Details: The sought approval is for Moderna's BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222.
- It's a booster dose for adults 18 years and older.
What they're saying: "The FDA has been working closely with vaccine manufacturers over the past several months to ensure that modified COVID-19 vaccines are available this fall, following FDA’s review for safety and effectiveness," FDA spokesperson Abby Capobianco told Axios.
- "The agency will work expeditiously to evaluate this and any other submissions once received in order to make modified COVID-19 vaccines available for booster vaccination in this timeframe," she added.
- "We have worked closely with the FDA to ensure that Americans will have access to Moderna's updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster," Stéphane Bancel, CEO of Moderna said in a news release.
Context: Clinical trials to study tweaked versions of the Pfizer and Moderna vaccines have been underway for months.
- The FDA had said in April that it would decide this summer whether to recommend these updated versions for use later in the year.