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(CNN) – The pharmaceutical company Moderna on Monday applied to the United States Food and Drug Administration for authorization of its COVID-19 vaccine.
The company asked the FDA to review an expanded data set showing that the vaccine is 94.1% effective in preventing Covid-19 and 100% effective in preventing severe cases of the disease.
“This is surprising,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “This is amazing data.”
Moderna’s medical director said he was thrilled when he saw the data Saturday night.
“It was the first time that I allowed myself to cry,” Dr. Tal Zaks said. “We fully expect to change the course of this pandemic.”
Moderna is the second company to apply to the FDA for an emergency use authorization for a coronavirus vaccine. Pfizer applied on November 20 with data showing equally high efficacy.
The FDA will meet with its advisory committee in December to review the Pfizer and Moderna applications.
The first vaccinations in the United States are expected to take place “toward the end 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.
New data from Moderna
On Monday, Moderna released updated efficacy data for its phase 3 clinical trial.
Starting in July, Moderna administered her vaccine or a placebo, an injection of saline that does nothing, to about 30,000 people in the United States. With high rates of coronavirus across the country over the next several months, many of the 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.
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 equates to an efficacy of 94.1% for Moderna’s vaccine.
None of the 11 people who received the vaccine became seriously ill, but 30 of the 185 who received the placebo became seriously ill and one of them died.
The vaccine had similar efficacy rates for older people and for people from racial minority groups, Zaks said.
In Pfizer’s phase 3 clinical trial, the vaccine was shown to be 95% effective, and a 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 fever or body aches for a few days.
Next steps
The FDA is scheduled to meet with its Vaccine and Related Biologics Advisory Committee on December 10 to review Pfizer’s application and on December 17 to review Moderna’s application.
Offit, who is a member of that panel, said it will be important to look and see why some people still get Covid-19 even after they have been vaccinated.
“Were they more likely to be older? Were they more likely to be African American or obese or to have underlying medical problems such as diabetes?” said Offit, a vaccine expert at the University of Pennsylvania.
If FDA grants authorization for emergency use of the vaccine, and is expected to do so, within a day or two, an advisory committee from the U.S. Centers for Disease Control and Prevention will make a recommendation on who should get the shots first. That group will likely include healthcare workers and nursing home residents.
After the CDC issues those recommendations, vaccines can go up in arms.
Zaks said that as the pandemic continues, he hopes to see 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 is on track to manufacture 500 million to 1 billion doses globally next year, according to the press release from the US. company on Monday.
“The magnitude of this achievement and the implications of what it means for what awaits us in the context of what’s going on around us is just emotionally overwhelming,” Zaks said.
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