Updated: December 15, 2020 8:32:44 pm
The success of Moderna’s vaccine has become even more crucial to fighting the pandemic as other vaccine efforts have failed.
The coronavirus vaccine made by Moderna is highly 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 findings, the agency intends to grant an emergency authorization for 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 review confirms Moderna’s earlier assessment that its vaccine had a 94.1% effectiveness rate in a trial of 30,000 people. Side effects, such as fever, headache and fatigue, were unpleasant but not dangerous, the agency found.
The success of Moderna’s vaccine has become even more crucial to fighting the pandemic as other vaccine efforts have failed. The hopeful news comes at a time of record numbers of coronavirus cases that are overwhelming hospitals and a rising death toll, reaching a grim milestone of 300,000 on Monday.
The data release is the first step in a public review process that will include a one-day meeting Thursday by an independent advisory panel of experts. They will listen to Moderna, FDA scientists, and the public before voting on whether to recommend authorization. The panel is expected to vote yes, and the FDA generally follows the experts’ recommendations.
Distribution of around 6 million doses could begin next week, adding significantly to the millions of doses already being shipped by Pfizer and BioNTech, the companies that developed the first coronavirus vaccine that received emergency authorization on Friday. . Healthcare workers received their first injections Monday of the Pfizer-BioNTech vaccine, which has a 95% efficacy rate.
The launch of the vaccine has been 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 administer a total of 200 million doses in the first quarter of 2021. Because both vaccines require two doses, those contracts guaranteed sufficient doses for 100 million people.
Last week, the government announced that it had purchased another 100 million doses of 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 roughly 180 million other Americans will be covered.
Both vaccines will be provided to the public free of charge.
Moderna’s vaccine worked equally well in white volunteers and in communities of color. There was also no significant difference between their protection for men and women, or between healthy volunteers and those at risk for severe COVID-19 who had conditions such as obesity and diabetes. For people over 65, the trial provided an estimated efficacy of 86.4%, lower than the overall estimate of 94.1%. But the apparent difference was not statistically significant.
So far, two possible differences between vaccines have emerged from FDA reviews, but the findings may reflect a paucity of data rather than genuine differences. The Pfizer-BioNTech trial showed that their vaccine began to protect against coronavirus within 10 days of the first dose. The Moderna vaccine trial, by contrast, did not reveal such a striking effect after the first dose.
But fewer cases of COVID-19 occurred among the trial participants in the early days of the Moderna trial, making it difficult to measure the differences between the vaccinated group and the placebo group. In any case, health officials have said that for both vaccines, two doses are essential for complete protection.
A second difference involves the ability to prevent serious illness. Moderna produced more evidence that its vaccine can do it, according to the review. In their trial, 30 volunteers developed severe cases of COVID. All were in the placebo group, with no cases among the vaccinated people.
In the Pfizer-BioNTech trial, the findings were less convincing. There were 10 severe cases in the placebo group and one in the vaccinated group. Those numbers are too small to assess the vaccine’s ability to prevent serious disease.
“The data available for these results did not allow for firm conclusions,” the FDA said.
Documents released Tuesday made it clear that side effects were particularly common after the second dose, but typically lasted only a day. Experts say that people may need to take a day off after receiving the injection.
.
