US FDA confirms 94.1% efficacy of Moderna vaccine, says it's safe

Between Pfizer and Moderna, Operation Warp Speed officials have said 20 million people in the US are expected to get their first shots by year-end
Moderna Inc.’s vaccine is safe and effective for preventing Covid-19 in people ages 18 and older, US regulators said, clearing the way for a second shot to quickly gain emergency authorisation and add to the country’s sprawling immunisation effort.

The Food and Drug Administration’s staff said in a report on Tuesday that the experimental vaccine is 94.1 per cent effective at preventing symptomatic Covid-19, confirming earlier results released by the company.

The report was posted online, ahead of a meeting on Thursday of agency advisers who will vote whether to recommend authorisation before a final FDA decision. The agency doesn’t have to follow the advice of the independent vaccine experts, though it often agrees with its advisory panels. Last week, the FDA authorized a similar vaccine from Pfizer and BioNTech SE after an advisory panel voted 17-4, with one abstention, to support its authorisation.

The FDA got a much deeper look at Moderna’s clinical-trial data than the numbers previously released to the public by the company. The agency found the shot was similarly effective across racial and ethnic groups and those with underlying medical conditions. It was 86.4 per cent effective in people age 65 and over, according to the report, and 95.6 per cent effective in those 18 to 65. The most common systemic side effects were fatigue and headache.

Both the Moderna Pfizer products are based on messenger RNA technology that hasn’t been previously used in human vaccines. Because both are two-dose vaccines, people will need to return to their care providers weeks after their initial shot for a booster. 

Between Pfizer and Moderna, Operation Warp Speed officials have said 20 million people in the US are expected to get their first shots by year-end.

Rising cases

Covid-19 cases and hospitalizations are rising across the country, increasing pressure to get the pathogen under control. While health officials are hopeful that the immunisation push will begin to slow a pandemic that has killed more than 300,000 Americans, it isn’t yet known what effect the vaccines have.

Pfizer and BioNTech’s vaccine was cleared first in the UK, where there were a few reports of serious reactions that led regulators to advise against anyone with a history of significant allergies getting the shot. The FDA told facilities where the vaccine would be administered to have medication on hand to treat possible allergic reactions. Moderna’s vaccine isn’t yet approved in any other countries and hasn’t yet been used on anyone outside of a clinical trial.The FDA staff’s analysis of Moderna’s trial data found 11 cases of Covid-19 in the group that received the vaccine and 185 in those that got a placebo instead.

There were three cases of Bell’s palsy, or temporary facial paralysis on one side, in patient’s who got the vaccine, compared to one such case in the placebo group. 

The FDA report concluded that current data is “insufficient to determine a causal relationship.”




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