Moderna’s Omicron-Tailored Booster To Be Largely Available This Fall
Moderna's chief medical officer said the drugmaker will have "large amounts" of its bivalent covid booster shot by then, and that its vaccine for the youngest kids would be ready for FDA review in June. Meanwhile, pressure grows on the agency to move quickly toward approval.
The Hill:
Moderna Expects ‘Large Amounts’ Of Omicron Booster Available By Fall
Moderna’s Chief Medical Officer Paul Burton said on Sunday that his company was preparing to provide large amounts of its vaccine booster against omicron and other COVID-19 variants this fall. “We’re confident by the fall of this year we should have large amounts of that new booster vaccine that will protect against Omicron and other variants,” Burton said in an interview on CBS’s “Face the Nation.” Last month, Moderna announced that its new bivalent COVID-19 booster shot was more effective against all variants than the company’s currently available coronavirus vaccine. (Beals, 5/1)
Reuters:
Moderna Says Its Vaccine For Ages Under 6 Will Be Ready For U.S. Review In June
Moderna Inc's chief medical officer said on Sunday the company's vaccine for children under 6 years old will be ready for review by a Food and Drug Administration panel when it meets in June. Moderna sought emergency use authorization from the FDA on Thursday. An advisory panel of experts to the U.S. drug regulator will meet in June to review the request. (Chiacu, 5/2)
Pressure rises for a June rollout —
Axios:
Pressure Builds For COVID Vaccines Approval For Littlest Kids
Moderna's request for authorization of its COVID-19 vaccine in children under six years is amping up pressure on the Food and Drug Administration to act quickly on the shots. Thursday's request from the vaccine maker threw another wrinkle in the delicate regulatory dance over when kids under 5 can be vaccinated at a time when plenty of parents are expressing growing frustration with the wait. The FDA would prefer to evaluate data and simultaneously make decisions about how Moderna and Pfizer-BioNTech's vaccines work on small children, to give parents more of a comparison, the New York Times writes. That could take as long as June. (Reed, 5/2)
The Washington Post:
Vaccines For Young Kids Could Be Available As Soon As June, A Top FDA Official Says
A top Food and Drug Administration official pledged Friday not to delay the rollout of coronavirus vaccines for the youngest children and said at least one of the two shots under review could become available in June. The remarks by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, came in an interview about the agency’s new, but tentative, timeline for handling vaccine issues during the next two months. The FDA announced plans to convene meetings with its outside advisers on June 8, 21 and 22 to consider emergency use authorizations for pediatric coronavirus shots and to hold additional sessions for other pressing vaccine matters. (McGinley and Johnson, 4/29)
