Moderna follows Pfizer, seeks FDA consent for vaccine
Biotech company Moderna was to 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 is 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 said its latest findings showed that of 196 people in the clinical trial who caught COVID-19, 185 had received the placebo, while only 11 received the active vaccine. That’s an effectiveness rate above 94%.
Of the 30 participants who suffered severe disease, all were in the placebo group, which suggests the vaccine prevents mild and serious disease. One
placebo recipient died.
Effectiveness was consistent across age groups, 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.
Moderna said it expects the FDA’S advisory committee to 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 is 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.
Dr. Stephen Hoge, Moderna president, 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 filed for FDA authorization now, he said, because “there’s nothing more we would do. ... We passed the baton.”
The trial has been the same size and scope as with 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.
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. The company started producing vaccine at its plant and will ramp up production in the next month with help from contract manufacturer Lonza Biologics.
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.
Moderna, whose vaccine was developed in collaboration with government scientists, and Pfizer/biontech met the requirements.
To prove safety, the companies had wait until two months after half of their trial participants had received the candidate vaccine.
A bad reaction to a vaccine is likely to occur within six weeks of vaccination. Both companies reached that mark without seeing any major or life-threatening problems among trial participants.
Most volunteers suffered 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: Of 95 trial participants diagnosed with COVID-19, 90 had received a placebo.
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, 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 likely to hold true for the larger population.