Updated: December 15, 2020, 8:32:44 pm
The coronavirus vaccine manufactured by Moderna is highly protective of adults and prevents serious cases of COVID-19. That emerges from data released Tuesday by the U.S. Food and Drug Administration.
Based on the encouraging results, the agency plans to issue an emergency clearance for use of the vaccine on Friday, according to people familiar with the FDA’s plans. The decision would give millions of Americans access to a second coronavirus vaccine as early as next week.
The FDA review confirms Moderna’s previous assessment that its vaccine was a 94.1% effectiveness rate in a trial against 30,000 people. Side effects, including fever, headache, and fatigue, were uncomfortable but not dangerous, the agency found.
The success of Moderna’s vaccine has become even more important to fighting the pandemic as other vaccination efforts have stalled. The hopeful news comes at a time with a record number of coronavirus cases overwhelming hospitals and an ever-increasing death toll that hit a bleak milestone of 300,000 on Monday.
The data release is the first step in a public review process that includes a one-day meeting on Thursday by an independent panel of experts. You will hear from Moderna, FDA scientists, and the public before they vote on whether to recommend approval. The panel is expected to vote yes, and the FDA generally follows the experts’ recommendations.
Distribution of roughly 6 million doses could then begin next week, adding significantly to the millions of doses already delivered by Pfizer and BioNTech, the companies that developed the first coronavirus vaccine, which received emergency clearance on Friday . Health workers received the first shots of the Pfizer BioNTech vaccine on Monday with an efficacy rate of 95%.
The introduction of vaccines has been eagerly anticipated and is one of the most ambitious vaccination campaigns ever carried out in the United States.
Last summer, the federal government signed contracts with Moderna and Pfizer to dispense a total of 200 million cans in the first quarter of 2021. Since both vaccines require two doses, these contracts guaranteed enough doses for 100 million people.
Last week the government announced that it had purchased an additional 100 million doses of Moderna for the second quarter, bringing the number of Americans who can be vaccinated to 150 million. That leaves the question of how and when the 180 million or so other Americans will be covered.
Both vaccines are made available to the public free of charge.
Moderna’s vaccine worked equally well in white volunteers and in color communities. There was also no significant difference between protecting men and women or between healthy volunteers and those at risk for severe COVID-19 who developed conditions such as obesity and diabetes. For people aged 65 and over, the study found an estimated effectiveness of 86.4%, which is below the overall estimate of 94.1%. However, the apparent difference was not statistically significant.
So far, FDA reviews have shown two possible differences between vaccines, but the results may reflect a lack of data rather than real differences. The Pfizer BioNTech study showed that the vaccine began protecting against the coronavirus within about 10 days of the first dose. The experiment with the vaccine from Moderna, however, did not show such a noticeable effect after the first dose.
However, in the early days of the Moderna study, there were fewer cases of COVID-19 among study participants, making it more difficult to measure the differences between the vaccinated group and the placebo group. In either case, health officials have said that for both vaccines, two doses are essential for complete protection.
A second difference concerns the ability to prevent serious diseases. Moderna presented more evidence that its vaccine can, according to the review. In his study, 30 volunteers developed severe cases of COVID. All of them belonged to the placebo group, with no cases among the vaccinated people.
In the Pfizer BioNTech study, the results were less convincing. There were 10 severe cases in the placebo group and one in the vaccinated group. These numbers are too few to assess the vaccine’s ability to prevent serious diseases.
“The data available for these results did not allow firm conclusions,” said the FDA.
The documents released on Tuesday made it clear that side effects were particularly common after the second dose, but usually lasted only one day. Experts say people may need to take a day off after the shot.
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