The FDA is expected to authorize the vaccine on Friday.
The nation’s second coronavirus vaccine, produced by Moderna, could be on its way to thousands of sites nationwide by this weekend — a major accomplishment for a company that has never before brought a product to market.
An independent Food and Drug Administration advisory committee on Thursday endorsed the shot for adults 18 and over, and the agency is expected to issue an emergency use authorization on Friday.
But while the maker of the first authorized shot, Pfizer, is a global pharmaceutical giant that has pumped out dozens of blockbusters including Viagra and even ChapStick, Moderna had never had a vaccine reach late-stage trials before it became the first of dozens of coronavirus vaccine hopefuls to hit that milestone this summer.
Now the 10-year-old Massachusetts biotech is the cornerstone of the United States’ strategy to defeat a virus that has killed more than 308,000 Americans so far.
The Trump administration last week doubled its vaccine order from Moderna to 200 million doses after Pfizer said it wouldn’t be able to deliver more vaccine until the third quarter of 2021. The success of the country’s immunization campaign could depend on Moderna’s ability to deliver those shots without delay — a potentially tricky task for a firm without extensive manufacturing facilities of its own, with a vaccine based on cutting-edge technology.
"They’re untested, that’s the main thing. This is their first rodeo,” said Ira Loss, senior health analyst with Washington Analysis.
Moderna, which has not yet responded to multiple requests for comment, benefited from nearly $1 billion in government funding for the development and testing of its vaccine, given through the government’s Operation Warp Speed vaccine initiative. The National Institute of Allergy and Infectious Diseases helped Moderna develop its shot and ran clinical trials on its behalf.
And in August, the Trump administration inked a $1.5 billion dollar deal with Moderna for 100 million doses — guaranteeing a market for the product if it proved safe and effective, a move that federal officials said would help with large-scale manufacturing.
Betting that its vaccine would work, the company had already signed a deal in May with Swiss manufacturing giant Lonza AG to produce up to 1 billion shots a year at facilities in the U.S. and Switzerland. While Moderna has an in-house manufacturing setup in Norwood, Mass., the 200,000-square-foot factory is far eclipsed by global demand for coronavirus vaccines.
The alliance with Lonza was a major step toward mass production at a time when it was still unclear whether the messenger RNA technology used in the Moderna vaccine would succeed. Pfizer’s vaccine, which the FDA authorized last week, is the first mRNA shot for any disease to be put into mass use.
“Moderna didn’t have manufacturing capacity. Pfizer has it because they are a much larger company,” said Sen. Steve Daines, a Montana Republican who pressed to include $10 billion funding for vaccine development and manufacturing in Congress’ initial pandemic relief package, the CARES Act passed in March.
That funding was crucial for “dual tracking” research and mass-manufacturing, particularly for smaller companies like Moderna, said Daines, who added that he spoke with Moderna CEO Stéphane Bancel and Pfizer CEO Albert Bourla in the days ahead of the multitrillion-dollar relief package.
“I knew it was the best $10 billion we were going to spend in the entire $2.2 trillion package because it was going to end the pandemic,” Daines said.
Pfizer ultimately did not receive government funding for research and development, though Warp Speed in July provided $1.95 billion to secure 100 million shots, a deal the government also said would support mass manufacturing.
Moderna’s late-stage clinical trial was slightly smaller than Pfizer’s, with 30,000 participants rather than its competitor’s 44,000. Both shots are roughly 95 percent effective for the general population, although Pfizer’s was more effective for adults over 65, at 94 percent to Moderna’s 86 percent.
But that may not be a statistically significant difference, said Steven Joffe, a University of Pennsylvania health policy expert and member of the Data Safety Monitoring Board overseeing several vaccine trial under the auspices of Operation Warp Speed.
"They and most of the other companies, Pfizer excepted, had a lot of help from the government and Warp Speed," Joffe said — adding that nonetheless, Moderna's success "is a big achievement."
Moderna executives said Thursday at the FDA advisory committee meeting that they did not see serious allergic reactions in the trial; two incidents, one in the placebo group, were not seen to be related to the shot itself. The data comes as U.S. and U.K. regulators scramble to better understand severe reactions to the Pfizer vaccine in people with serious allergies. Those reactions happened outside of clinical trials, where people with serious allergies are rarely included.
The FDA panel voted 20-0 to recommend the vaccine, with Michael Kurilla, a National Institutes of Health scientist, abstaining because he said he was "very uncomfortable" with a blanket recommendation for people over 18 years old. Because of the severity of the pandemic and limited supplies, "I would prefer to see it more targeted to people at high risk of more threatening illness and disease," he said.
Moderna's vaccine has several logistical advantages over Pfizer's. Unlike Pfizer, Moderna opted for the U.S. government to distribute its shot, handing one of the biggest challenges of the vaccination push to military personnel and commercial distributors guided by Gen. Gustave Perna, Warp Speed’s chief operating officer.
Moderna’s shot can also be stored in most regular freezers, while Pfizer’s needs ultra-cold freezers or containers filled with dry ice that make that vaccine more challenging to ship and store.
With FDA authorization expected Friday, the company faces its biggest test yet. Warp Speed officials say that more than 4 million doses are ready to ship to states by Monday, and the remainder of the country’s 200 million dose order will stream in over the next six months.
"I’m sure they’ve got good people there, but this is their first product," said Loss. "Anytime you do something for the first time, there is the possibility of mistakes, uncertainty."
Source: Politics, Policy, Political News Top Stories https://www.politico.com/news/2020/12/17/fda-advisory-panel-recommends-use-of-moderna-vaccine-447942