The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use in the U.S. Distribution, however, will remain a challenge.
The company is the second this month to report promising results for a Covid-19 vaccine even as the virus rages across the U.S.
Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare.
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.
Protocols - essentially the blueprints for clinical trials - are typically kept under wraps until studies are complete, but Pfizer and Moderna have made the ones for their SARS-CoV-2 trials public in a transparency push.
The company said at its R&D day that the Phase III COVE trial of mRNA-1273 had enrolled 25,296 of its planned 30,000 participants, while slightly more than 10,000 had received the first and second doses of the vaccine.
Amid growing concern that the Trump administration is trying to get a vaccine rushed to market, nine biotech and pharma CEOs signed a letter pledging to uphold high scientific and ethical principles.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.
The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.
The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
Whether responses are durable and protective is under evaluation, but mRNA-1273 produced neutralizing antibody titers multiple times higher than those of recovered patients. Moderna's stock rose 17% on the Nasdaq when markets opened Wednesday.
The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine to do so.
The company said Thursday that it had finalized the design of the protocol for its upcoming randomized, placebo-controlled trial of its closely watched messenger RNA-based vaccine, mRNA-1273.
Physicians commented that although the data for mRNA-1273 are encouraging, whether the vaccine will actually be effective remains unclear, while other important questions also remain to be answered.
News media reported that Moncef Slaoui would divest his shares in Moderna, which netted him at least $3 million after the company reported promising preliminary data on its Covid-19 vaccine Monday.