Biotech company Moderna will apply Monday for an emergency use authorization from the U.S. Food and Drug Administration after receiving more good news about the safety and effectiveness of its candidate COVID-19 vaccine.
Moderna will be the second vaccine maker to request authorization from the federal government after similarly positive results for Pfizer and its German collaborator BioNTech’s candidate vaccine.
Moderna’s latest findings, according to a company press release, showed that of 196 people in the clinical trial who caught COVID-19, 185 of them had received the placebo, while only 11 received the active vaccine. That works out to an effectiveness rate above 94%.
Of the 30 participants who suffered severe disease, all were in the placebo group, which suggests the vaccine prevents both mild and serious disease. One placebo recipient died.
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Effectiveness was consistent across age groups, as well as race and ethnicity. The 196 participants with cases of COVID-19 included 33 adults over 65 and 42 who identified as Hispanic, Black, Asian American or multiracial.
The Moderna vaccine, called mRNA-1273, also has been shown to be safe, with no new safety concerns identified. It caused side effects in the majority of recipients, usually fever and aches lasting a day or two.
The Cambridge, Massachusetts-based company, said it expects that the FDA’s advisory committee will discuss mRNA-1273 on Dec. 17, a week after it meets to discuss Pfizer’s vaccine, and authorization is expected to come a few days after each meeting.
“These results are stunning,” said Dr. Robert Wachter, chairman of the department of medicine at the University of California-San Francisco, adding that he is particularly impressed by the vaccine’s success in preventing serious disease. “This is a remarkably effective vaccine and, with results like that, a game-changer.”
Moncef Slaoui, who co-leads the government’s Operation Warp Speed, which has overseen the development of Moderna’s vaccine and helped finance production of Pfizer’s, also was impressed with the results and the novel mRNA technology behind both.
“I think the Moderna data continue to support how exceptionally effective mRNA vaccines are,” he said. He also touted the effectiveness against severe disease, “and also 87% protection in subjects above the age of 65, the most impacted group in our population.”
Dr. Peter Hotez, a pediatrician and co-director of the Texas Children’s Hospital Center for Vaccine Development, called the news “really impressive, with the caveat that it’s a company press release.”
Hotez said the vaccine provided so much protection against serious illness that it may be unethical to continue allowing participants in other clinical trials to receive a placebo.
Moderna’s president, Dr. Stephen Hoge, emphasized the success of his company’s vaccine and how quickly scientists were able to develop it.
“Everything on this has gone faster than expected,” he said. “The data is truly exciting.”
Hoge said the company decided to file for FDA authorization at this point, he said, because “there’s nothing more we would do. … We passed the baton.”
Moderna trial conducted ‘to the gold standard’
The trial has been the same size and scope as for any vaccine. The only reason the company is requesting an emergency authorization instead of full FDA approval is because no one wants to wait a year or two to see how long the vaccine remains protective. Long-term effectiveness will be determined later, and people will receive booster shots if needed.
“These vaccines have developed tremendous amounts of data,” Hoge said. “The Phase 3 ones – ourselves and Pfizer – have been conducted to the gold standard. Hopefully, people have confidence” in them.
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The pressure is now on, Hoge said, to produce the promised number of vaccine doses: 20 million in the next month and at least 80 million more next year for the U.S. alone.
The company has started producing vaccine at its plant in Norwood, Massachusetts, and will ramp up production in the next month with help from contract manufacturer Lonza Biologics, which has a facility in Portsmouth, New Hampshire.
To win FDA authorization, companies have to show three things: their vaccine is safe, it’s more than 50% effective, and it can be produced reliably and safely.
Both Moderna, whose vaccine was developed in collaboration with government scientists, and Pfizer/BioNTech have now met all three requirements.
To prove safety, the companies had wait until two months after half of their trial participants had received the candidate vaccine.
If someone is going to have a bad reaction to a vaccine, it is likely to occur in the first six weeks after vaccination. Both companies reached that mark without seeing any major or life-threatening problems among trial participants.
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Most volunteers did suffer temporary side effects, including muscle aches, headaches and fatigue for a day or two after vaccination. Side effects were generally worse after the second dose of the two-dose regimen.
Pfizer/BioNTech showed earlier this month that its candidate vaccine, BNT162b2, was 95% effective and submitted a request for FDA authorization Nov. 20.
Moderna released interim effectiveness results this month showing equal effectiveness: Out of 95 trial participants diagnosed with COVID-19, 90 had received a placebo.
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There was concern this fall that the companies or the government would try to shorten vaccine development by relying on interim effectiveness results. But because so many people are contracting COVID-19 every day in the United States, it took only a little more than a week for an additional 95 people in Moderna’s trial to catch the virus.
Vaccine makers determine effectiveness by comparing the number of trial participants who come down with the disease at least two weeks after the second dose of either the vaccine or the placebo.
Statistically, once more than about 150 illnesses have been recorded, the effectiveness seen in those cases is very likely to hold true for the larger population.
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The mRNA technology behind Moderna and Pfizer/BioNTech’s candidate vaccines turns the body’s cells into tiny factories producing the “spike” protein found on the surface of the virus that causes COVID-19. Once the immune system learns to recognize the spike protein, it will attack if it sees it again during an infection.
Novavax, another vaccine developer, which targets the spike protein in a different way, provided an update early Monday on its clinical trials.
Two of the three late-stage trials for its NVX-CoV2373 have reached full enrollment, the Gaithersburg, Maryland-based company said, with more than 20,000 participants receiving doses. In a U.K. trial of 15,000 participants, more than a quarter of the volunteers are over 65, and many volunteers had medical conditions that would make them more susceptible to a severe case of COVID-19, the company said.
More than 4,400 volunteers have signed on to an earlier-stage trial in South Africa, including 245 participants who have medically stable HIV.
Novavax expects to start its large, Phase 3 clinical trial in the United States and Mexico in the coming weeks – slightly later than the company had suggested before. The company has selected more than 100 trial sites, as well as some alternates, and expects to manufacture its vaccine at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.
The U.S. government has awarded Novavax $1.6 billion to test and deliver 100 million doses of its candidate vaccine.
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Pfizer has been promised $1.95 billion to manufacture 100 million doses of its vaccine, and Moderna has received the same to develop, test and manufacture an equal number of doses.
Johnson & Johnson, and teams from AstraZeneca and Oxford University and Sanofi and GlaxoSmithKline, also have received more than $1 billion each from U.S. taxpayers for their candidate vaccines. Sanofi/GSK have not yet started late-stage safety and effectiveness trials, and the other two are well underway.
AstraZeneca/Oxford has faced scrutiny over interim results from trials in the U.K. and Brazil, released last week, showing 60% effectiveness when its vaccine was given in two equal doses and 90% among a much smaller group that accidently received a half-dose the first time.
Slaoui, of Operation Warp Speed, said he sees no reason why AstraZeneca/Oxford’s vaccine should be more effective with a smaller dose, and he and his team are investigating the results and whether they should change the protocols for the American trial.
“I am concerned that nobody will want to get the ‘inferior vaccine’; that is why we are working with AZ to understand whether the 90% level is real and how to reproduce it,” he said.
Hoge, of Moderna, said people should wait for more results before drawing conclusions about the trial. Although AstraZeneca/Oxford is technically a competitor, he said, he hopes its vaccine is eventually authorized.
“We need more than two vaccines,” Hoge said. “We’re not going to get our lives back with two. We need three to four to get our lives back.”
Contact Karen Weintraub at firstname.lastname@example.org.
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This article originally appeared on USA TODAY: Moderna requests emergency FDA authorization for COVID-19 vaccine