Updated: December 15, 2020 8:32:44 PM
The coronavirus vaccine produced by Moderna is extremely protective for adults and prevents severe cases of COVID-19, according to data released Tuesday by the US Food and Drug Administration.
Based on the encouraging results, the agency intends to grant emergency authorization for the use of the vaccine on Friday, people familiar with the FDA’s plans said. The decision would give millions of Americans access to a second coronavirus vaccine starting next week.
The FDA’s review confirms Moderna’s previous assessment that its vaccine had a efficiency rate of 94.1% in a trial of 30,000 people. Side effects, including fever, headache and fatigue, were unpleasant but not dangerous, the agency found.
The success of the Modern vaccine has become all the more important in combating the pandemic as other vaccination efforts have faltered. The hopeful news comes at a time of a record number of coronavirus cases that are overwhelming hospitals and a growing number of deaths, which reached a grim stage of 300,000 on Monday.
Data communication is the first step in a public review process, which will include an all-day meeting on Thursday by an independent expert advisory group. They will hear from Moderna, FDA scientists and the public before voting on whether to recommend authorization. The group is expected to vote yes, and the FDA generally follows the experts’ recommendations.
The distribution of about 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 to receive emergency clearance on Friday. Healthcare workers received their first photos on Monday with the Pfizer-BioNTech vaccine, which has a 95% efficacy rate.
The launch of the vaccine was highly anticipated and is one of the most ambitious immunization campaigns ever conducted in the United States.
The federal government signed agreements last summer with Moderna and Pfizer to deliver a total of 200 million doses in the first quarter of 2021. Because both vaccines require two doses, these contracts guaranteed enough doses for 100 million people.
Last week, the government announced that it had purchased another 100 million doses from Moderna for the second quarter, increasing the number of Americans who can be vaccinated to 150 million. But that still leaves the question of how and when the approximately 180 million Americans will be covered.
Both vaccines will be provided to the public free of charge.
The Moderna vaccine has worked just as well for white volunteers and communities of color. There was also no significant difference between its protection for men and women or between healthy volunteers and those at risk of severe COVID-19, who had conditions such as obesity and diabetes. For people aged 65 and over, the study provided an estimated efficacy of 86.4%, lower than the overall estimate of 94.1%. But the apparent difference was not statistically significant.
To date, two potential revisions between vaccines have emerged from FDA reviews, but the results may reflect a lack of data rather than genuine differences. The Pfizer-BioNTech study showed that their vaccine started to protect against the coronavirus about 10 days after the first dose. In contrast, the study of the Moderna vaccine did not reveal such a striking effect after the first dose.
But fewer cases of COVID-19 occurred among study participants in the early days of the Moderna study, making it more difficult to measure the differences between the vaccinated group and the placebo group. In any case, health officials said that for both vaccines, two doses are essential for complete protection.
A second difference involves the ability to prevent severe disease. Modern has produced more evidence that its vaccine can do this, according to the review. In its process, 30 volunteers developed severe cases of COVID. All were in the placebo group, with no cases among people who were vaccinated.
In the Pfizer-BioNTech study, the findings were less convincing. There were 10 severe cases in the placebo group and one in the vaccinated group. These numbers are too small to assess the vaccine’s ability to prevent serious disease.
The data available for these results did not allow firm conclusions, the FDA said.
Documents released on Tuesday made it clear that side effects were particularly common after the second dose, but usually lasted only a day. Experts say that people may have to take a day off from work after being shot.
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