Moderna applies for FDA authorization for its Covid-19 vaccine

Pharmaceutical company Moderna applied on Monday to the US Food and Drug Administration for authorization of its Covid-19 vaccine.

The company asked the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.

“This is striking,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “These are amazing data.”

Moderna’s chief medical officer said he became emotional when he saw the data Saturday night.

Pfizer Covid-19 vaccine vials.

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“It was the first time I allowed myself to cry,” Dr. Tal Zaks said. “We have a full expectation to change the course of this pandemic.”

Moderna is the second company to apply to the FDA for emergency use authorization for a coronavirus vaccine. Pfizer applied on November 20 with data showing similarly high efficacy.

The FDA will meet with its advisory committee in December to review Pfizer’s and Moderna’s applications.

The first vaccinations in the United States are expected to take place “towards the latter part of December,” according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Moderna said it also planned to apply for authorization from the European Medicines Agency on Monday.

Moderna’s new data

On Monday, Moderna released updated efficacy data for its Phase 3 clinical trial.

Starting in July, Moderna gave either its vaccine or a placebo – a shot of saline that does nothing – to some 30,000 people in the United States. With high rates of coronavirus throughout the country over the next following months, many of those study subjects developed Covid-19.

But there was a big difference between the group that got the vaccine and the group that got the placebo.

Health workers store blood samples in dry ice during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images

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Among the approximately 15,000 people who received the vaccine, 11 developed Covid-19.

Among the approximately 15,000 people who received the placebo, 185 developed Covid-19.

That amounts to a 94.1% efficacy for Moderna’s vaccine.

None of the 11 people who received the vaccine became severely ill, but 30 of the 185 who received the placebo became severely ill, and one of them died.

The vaccine had similar efficacy rates for elderly people and for people in racial minority groups, Zaks said.

In Pfizer’s Phase 3 clinical trial, the vaccine proved to be 95% effective, and one study participant who received the vaccine developed a severe case of Covid-19.

While the two vaccines are not identical, both Pfizer and Moderna use messenger RNA to elicit an immune response in the human body. The vaccines are given in two doses a few weeks apart, and can cause side effects, such as a fever or body aches for a few days.

Next steps

The FDA is scheduled to meet with its Vaccines and Related Biological Products Advisory Committee on December 10 to review Pfizer’s application and on December 17 to review Moderna’s application.

BARCELONA, SPAIN - OCTOBER 16: A health care worker administers a flu vaccine to a woman at a temporary vaccination centre during the second wave of Coronavirus (COVID-19) pandemic on October 16, 2020 in Barcelona, Spain. Catalan regional government started yesterday an early flu vaccine campaign as a measure against the coronavirus pandemic. (Photo by David Ramos/Getty Images)

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Offit, who is a member of that panel, said it will be important to look and see why some people still got Covid-19 even after being vaccinated.

“Were they more likely to be older? Were they more likely to be African-American or obese or have underlying medical problems like diabetes?” said Offit, a vaccine expert at the University of Pennsylvania.

If the FDA grants the vaccine emergency use authorization – and it’s expected that it will – within a day or two, an advisory committee to the US Centers for Disease Control and Prevention will make a recommendation about who should get the shots first. That group will likely include health care workers and nursing home residents.

After the CDC issues those recommendations, shots can go into arms.

Zaks said as the pandemic rages on, he looks forward to seeing the vaccines in action.

By the end of 2020, Moderna expects to have approximately 20 million doses of its vaccine available in the United States, and it’s on track to manufacture 500 million to 1 billion doses globally next year, according to the company’s press release Monday.

“The magnitude of this achievement and the implications of what it means to what’s ahead of us in the context of what’s going on around us is – it’s just overwhelming emotionally,” Zaks said.