FDA finds Moderna’s COVID-19 vaccine to be safe, 94 percent effective
The Food and Drug Administration found Moderna’s coronavirus vaccine to be safe and highly effective, bolstering the shot’s chances of being cleared for emergency use this week.
In a 54-page report released Tuesday, FDA staff affirmed the Massachusetts biotech firm’s finding that the vaccine is about 94 percent effective and poses no safety concerns that would prevent the agency from granting it an emergency use authorization.
The analysis came ahead of a Thursday meeting where the FDA’s Vaccines and Related Biological Products Advisory Committee is expected to recommend that emergency approval, which would make Moderna’s vaccine the second to be rolled out across the country. The first shots from Pfizer and BioNTech were jabbed into Americans’ arms on Monday.
In its own 84-page report, Moderna said the data show “that the known and potential benefits of the Moderna COVID-19 vaccine outweigh the known and potential risks.”
As with Pfizer’s vaccine, the FDA said Moderna’s shot was similarly effective across racial, ethnic and gender groups and that it worked well in people with medical issues that put them at a high risk of severe COVID-19 infections.
The clinical trial of Moderna’s vaccine also produced strong evidence that it prevents serious cases of the virus, given that all 30 participants who came down with severe infections had received a placebo rather than the vaccine.
But the shot’s efficacy did vary somewhat depending on the recipient’s age, the FDA said — it was 95.6 percent effective in adults aged 18 to 64 and 86.4 percent effective in those 65 and older.
Participants in Moderna’s 30,000-person trial also reported some common side effects such as headache, fatigue, muscle aches and pain at the injection site, the FDA said. Pfizer’s shot has caused similar side effects.
The FDA said there were no “anaphylactic or severe hypersensitivity reactions” in the study that were closely related to Moderna’s vaccine. Some people in the UK suffered severe allergic reactions after receiving Pfizer’s shot.
The FDA will reportedly move quickly to grant the emergency approval for Moderna’s vaccine just as it did for Pfizer’s, which received the clearance a day after the vaccine panel recommended it. Both shots use so-called messenger RNA, genetic material that provokes an immune response to the virus by directing the body to create a tiny amount of coronavirus spike proteins.
Enlarge Image A nurse prepares a syringe during a study of a COVID-19 vaccine.[/caption]
Moderna says it will have about 20 million vaccine doses available in the US by the end of the year, enough to inoculate roughly 10 million people with two doses apiece. Pfizer, meanwhile, expects to have about 50 million doses on hand globally this year, with about half allocated to the US.
The feds expect that 20 million Americans will be able to get their first shots by the end of the month, followed by another 30 million in January.
Moderna shares were down about 0.8 percent at $153.91 as of 9:35 a.m. Tuesday.