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Pfizer ultimately did not receive government funding for research and development, although Warp Speed provided $ 1.95 billion in July to secure 100 million shots, a deal the government said would support the mass production.
Moderna’s advanced stage clinical trial was slightly smaller than Pfizer’s, with 30,000 participants rather than its competitor’s 44,000. Both injections are about 95% effective for the general population, although Pfizer’s is more effective for adults over 65, at 94% versus 86% for Moderna.
But that may not be a statistically significant difference, said Steven Joffe, a health policy expert at the University of Pennsylvania and a member of the Data Safety Monitoring Board. overseeing several vaccine trials under the auspices of Operation Warp Speed.
“They and most of the other companies except Pfizer have had a lot of help from the government and Warp Speed,” Joffe said, adding that Moderna’s success “is nonetheless a great achievement.”
Moderna executives said at the FDA advisory board meeting on Thursday that they did not see any serious allergic reactions in the trial; two incidents, one in the placebo group, were not considered to be related to the shooting itself. The data comes as US and UK regulators strive to better understand severe reactions to the Pfizer vaccine in people with severe allergies. These reactions have occurred outside of clinical trials, where people with severe allergies are rarely included.
The FDA panel voted 20-0 to recommend the vaccine, with Michael Kurilla, a scientist from the National Institutes of Health, abstaining because he said he was “very uncomfortable” with a general recommendation for them. people over 18. Due to the severity of the pandemic and limited supplies, “I would prefer it to be more targeted to people at high risk for illnesses and more threatening illnesses,” he said.
Moderna’s vaccine has several logistical advantages over Pfizer’s. Unlike Pfizer, Moderna opted for the US government to distribute its vaccine, handing one of the biggest challenges of the vaccination campaign to military personnel and commercial distributors guided by General Gustave Perna, Chief Operating Officer of Warp Speed.
Moderna’s shot can also be stored in most regular freezers, while Pfizer needs ultra-cold freezers or containers filled with dry ice which make this vaccine more difficult to ship and store.
With FDA clearance expected on Friday, the company faces its biggest test to date. Warp Speed officials say more than 4 million doses are ready to ship to states by Monday, with the remainder of the country’s 200 million-dose order to arrive over the next six months.
“I’m sure there are some good people out there, but this is their first product,” Loss said. “Every time you do something for the first time, there is the possibility of mistakes, of uncertainty.”
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