Updated: December 15, 2020 8:32:44 PM
The modern-day coronavirus vaccine made by Moderna is highly protective for adults and prevents severe cases of COVID-19, according to data released Tuesday by the U.S. Food and Drug Administration.
Based on the encouraging findings, the agency intends to give urgent permission to use the vaccine on Friday, said people familiar with the FDA’s plans. The decision would give millions of Americans access to a second vaccine against coronavirus starting next week.
The FDA’s review confirms Moderna’s earlier assessment that its vaccine has efficiency of 94.1% in a lawsuit of 30,000 people. Side effects, including fever, headache and fatigue, were unpleasant but not dangerous, the agency found.
The success of Moderna’s vaccine has become all the more crucial in combating the pandemic as other vaccine efforts have faltered. The hopeful news comes in a time of record numbers of coronavirus cases that overwhelm hospitals and of an ever-increasing number of deaths that reached a sad milestone of 300,000 on Monday.
The data release is the first step in a public review process that will include a full-day meeting on Thursday by an independent advisory panel of experts. They will hear from Modern, FDA scientists and the public before voting on whether to recommend authorization. The panel will vote yes, and the FDA generally follows the recommendations of experts.
Distribution of about 6 million doses could then begin next week, significantly adding to the millions of doses already shipped by Pfizer and BioNTech, the companies that developed the first coronavirus vaccine, given an urgent release on Friday. Health workers received the first shots on Monday of the Pfizer-BioNTech vaccine, which has an effectiveness of 95%.
The launch of vaccines 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 deliver 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 an additional 100 million doses of Moderna for the second quarter, increasing the number of Americans 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 delivered free of charge to the public.
Moderna’s vaccine worked just as well on white volunteers and in colored communities. 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 65 or older, the test gave an estimated efficiency of 86.4%, lower than the overall estimate of 94.1%. But the apparent difference was not statistically significant.
To date, two possible differences between the vaccines have emerged from FDA reviews, but the findings could reflect a lack of data rather than genuine differences. The Pfizer-BioNTech trial showed that their vaccine began to protect against the coronavirus within about 10 days of the first dose. The trial of Moderna’s vaccine, on the other hand, did not reveal such a knock-on effect after the first dose.
But fewer cases of COVID-19 occurred among trial participants in the early days of the Modern trial, making it difficult to measure differences between the vaccinated group and the placebo group. In any case, health officials said that for both vaccines two doses are essential for full protection.
A second difference involves the ability to prevent severe illness. Modern has produced more evidence that its vaccine can do just that, according to the review. In its trial, 30 volunteers developed severe cases of COVID. All were in the group with a placebo, with no cases among the vaccinated people.
In the Pfizer-BioNTech lawsuit, 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 measure the vaccine’s ability to prevent serious illness.
“The available data for these results did not allow for firm conclusions,” the FDA said.
The documents released on Tuesday explained that side effects were especially common after the second dose, but usually lasted only during the day. Experts say people may need a day off work after the shooting.
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