WASHINGTON – The coronavirus vaccine made by Moderna is very protective, according to new data released Tuesday, paving the way for its emergency clearance this week by federal regulators and the start of its distribution across the country.
The Food and Drug Administration intends to clear the vaccine for use on Friday, people familiar with the agency’s plans said. The move would give millions of Americans access to a second coronavirus vaccine as early as Monday.
Data included in an FDA review confirms Moderna’s earlier assessment that its vaccine had a 94.1% effectiveness rate in a trial involving 30,000 people. The 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 the fight against the pandemic as other vaccination efforts have failed. The encouraging news comes at a time when the record number of coronavirus cases is crushing hospitals and the steadily rising death toll, which hit a grim threshold of 300,000 on Monday.
The release of the data is the first step in a public review process that will include a one-day meeting on Thursday by an independent expert advisory committee. They will hear from 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 expert recommendations.
The distribution of around six million doses could then begin next week, adding significantly to the millions of doses already shipped by Pfizer and BioNTech, the companies that developed the first coronavirus vaccine to receive emergency clearance on Friday. latest. Healthcare workers received the first injections of the Pfizer-BioNTech vaccine on Monday, which has a 95% effectiveness rate.
The rollout of the vaccine has been eagerly awaited and is one of the most ambitious vaccination campaigns ever carried out 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 sufficient doses for 100 million people. .
Last week, the government announced 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. But that still leaves the question of how and when the estimated 180 million other Americans will be covered.
Both vaccines will be provided free to the public.
Moderna’s vaccine has become a symbol of the triumphs of government scientists during the pandemic. After China released the genetic sequence for the new virus in early January, scientists at Moderna and the National Institutes of Health were able to focus on designing a vaccine in just two days. Unlike Pfizer, Moderna has a close relationship with Operation Warp Speed, the federal program designed to get a vaccine to market quickly. Nearly $ 2.5 billion in federal funds helped Moderna buy raw materials, expand its factory, and increase its workforce by 50%.
Moderna’s success contrasts with two other large-scale projects that the United States hoped to increase its vaccine supply for: one from pharmaceutical companies Sanofi from France and GlaxoSmithKline from Great Britain, and another from Anglo-Swedish drug maker AstraZeneca and the University of Oxford.
AstraZeneca and Oxford ended up using two different doses in clinical trials in Britain and Brazil. At one level, the efficiency was 62 percent, and at the other it was 90 percent. It is not clear from these confusing results when AstraZeneca will have sufficient data to obtain emergency use authorization.
Meanwhile, Sanofi and GlaxoSmithKline received disappointing results from their vaccine in early clinical trials. Although it produced a promising immune response in volunteers under the age of 50, it failed to do so in older people. The companies are currently planning a new round of trials with a different version of the vaccine. The delay means they are unlikely to deliver vaccines before the end of 2021.
Moderna’s vaccine worked in both 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 for severe Covid-19 who had conditions like obesity and diabetes. For people 65 and older, the trial provided an estimated efficacy of 86.4 percent, lower than the overall estimate of 94.1 percent. But the apparent difference was not statistically significant.
So far, two potential differences between vaccines have emerged from FDA reviews, but the results may reflect a lack of data rather than real differences. The Pfizer-BioNTech trial showed that their vaccine began to protect against the coronavirus around 10 days after the first dose. Moderna’s vaccine trial, on the other hand, did not find such a striking effect after the first dose.
But fewer cases of Covid-19 occurred among trial participants in the early days of the Moderna trial, making it more difficult to measure the differences between the vaccinated group and the placebo group. Either way, health officials have said that for both vaccines, two doses are essential for full protection.
A second difference concerns the ability to prevent serious illness. Moderna has produced more evidence that its vaccine can do this, according to the journal. In his trial, 30 volunteers developed severe cases of Covid. All were in the placebo group, with no cases among those vaccinated.
In the Pfizer-BioNTech trial, the results were less convincing. There were 10 serious 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 any definitive conclusions to be drawn,” the FDA said.
Documents released on Tuesday made it clear that side effects were particularly common after the second dose, but usually only lasted a day. Experts say people may need to take time off work after being vaccinated.
During the Moderna trial, researchers also kept an eye out for volunteers who developed new disorders. In a multi-month trial with 30,000 volunteers, it’s normal for some to suffer from conditions unrelated to the vaccine, health experts say. Comparing the rates between people who receive the vaccine and the placebo – as well as general baseline rates – can help identify serious concerns and rule out coincidences.
During the Moderna trial, three vaccinated participants developed a form of temporary facial palsy called Bell’s palsy, while one participant on the placebo also experienced it. Bell’s palsy, which can last for weeks or more, can be triggered by viral infections and other causes. Some 40,000 people develop the disease each year in the United States. Years of intense research have failed to find evidence that any vaccine routinely recommended in the United States causes Bell’s palsy.
In the review published Tuesday, the FDA said, “There is insufficient information currently available to determine a causal relationship with the vaccine.”
In the Pfizer-BioNTech trial, four cases were detected in the vaccine group, including one in a person with a history of the disease, and none in the placebo group.
Dr Peter Marks, the FDA’s main vaccine regulator, said Monday in an interview with JAMA that the cases of Bell’s palsy in the trial were likely not caused by the vaccine and that the apparent difference between the two groups of volunteers was a matter of luck.
“Our working assumption is simply that this is a base rate imbalance, as we’ve seen in other essays,” he said.
In its review of the Moderna vaccine released Tuesday, the FDA said it plans to recommend tracking Bell’s palsy cases as the vaccines roll out.
“We’re going to be asking questions about this, just to close this question,” Dr Marks said on Monday.
The FDA analysis did not find any serious allergic reactions to the Moderna vaccine. The same was true in the Pfizer-BioNTech clinical trial, but when vaccinations began in Britain outside of this trial, two people with a history of severe allergies had a serious and potentially fatal reaction called anaphylaxis.
British health officials have said people with a history of anaphylaxis should avoid the Pfizer-BioNTech vaccine.
But in the United States, the Centers for Disease Control and Prevention has said that people with severe allergies can be vaccinated safely, with close monitoring for 30 minutes after receiving the vaccine.
Moderna and Pfizer-BioNTech vaccines are similar in their ingredients, but not the same, so it is not clear whether an allergic reaction to one would occur with the other. Both are made up of genetic material called mRNA enclosed in a bubble made from a mixture of fats. The two companies use different fats.
Moderna has requested permission to vaccinate people 18 years and older, like those in her study. The Pfizer-BioNTech vaccine was cleared for people as young as 16 years old because the trial had younger volunteers. Both companies are conducting trials on children as young as 12 and plan to start studying even younger children.
Sharon LaFraniere contributed to the reporting.
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