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June 2, 2021

Moderna just applied for full FDA vaccine approval. Here’s why that matters.

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    Moderna on Tuesday filed for full FDA approval of its Covid-19 vaccine, making it the second drugmaker to seek full approval for a Covid-19 vaccine after Pfizer and BioNTech did so last month.

    Your top resources on the Covid-19 vaccines

    Moderna files for FDA approval

    Currently, Moderna's vaccine is available in the United States to people ages 18 and older under an emergency use authorization (EUA). To receive the EUA, Moderna presented extensive safety and efficacy data to FDA, including two months of follow-up data on more than 30,000 clinical trial participants. However, FDA requires at least six months of follow-up data to support a full approval.

    A full approval would allow the Moderna vaccine the vaccine to stay on the market after the public health emergency associated with the current Covid-19 epidemic ends, according to Robert Califf, former FDA commissioner. An approval also would allow Moderna to advertise the vaccine on TV and other platforms, Califf said.

    According to Paul Offit, a voting member of FDA's Vaccines and Related Biological Products Advisory Committee, once a company applies for full FDA approval, scientists at the agency conduct a further review of clinical trial data—above and beyond the review already conducted for the EUA. "They want to make sure that the company has fairly and accurately displayed all [that] data," Offit said.

    "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission," Stéphane Bancel, CEO of Moderna, said.

    In addition to seeking full FDA approval for its vaccine in adults, Moderna also is expected to ask FDA expand its current EUA to allow the vaccine to be given to adolescents, the New York Times reports.

    Moderna announces plans to ramp up vaccine production

    Moderna also announced Tuesday that it had entered into an agreement with Thermo Fisher Scientific to manufacture and package its vaccine.

    Under the agreement, Thermo Fisher's commercial manufacturing site in North Carolina will be used for fill/finish vaccine manufacturing services and to supply packaging for millions of vaccine doses, Moderna said.

    "The addition of Thermo Fisher to our network will support our efforts to scale up our manufacturing ability," Juan Andres, Moderna's chief technical operations and quality officer, said.

    Moderna has agreed to supply the U.S. government with 300 million doses of its vaccine. So far, more than 151 million doses of the vaccine have been distributed throughout the country, and as of May 30, about 124.5 million shots of the vaccine had been administered, Reuters reports.

    The U.S. vaccination effort so far

    Moderna's announcement comes as just more than half of the U.S. population has received at least one shot of a Covid-19 vaccine. According to CDC, as of Tuesday, 50.8% of Americans have received at least one shot, while 40.9% have received all required vaccine doses. Meanwhile, 62.8% of American adults have received at least one shot of a Covid-19 vaccine, while 51.7% have received all required vaccine doses.

    And while vaccination rates have slowed compared to mid-April, polling from the Kaiser Family Foundation suggests that some vaccine-hesitant individuals are seeking out vaccination, as around one-third of people who previously said they intended to "wait and see" whether they'd get vaccinated now say they've either made a vaccine appointment or intend to do so.

    "I think there are many people who were on the fence, who were worried about things moving too rapidly and about possible side effects," William Schaffner, medical director of the National Foundation for Infectious Diseases, said. "But those concerns are being allayed as they see more of their friends and acquaintances celebrating getting vaccinated" (Morello, Politico, 6/1; Reuters, 6/1 [1]; Lovelace, CNBC, 6/1; Slotnik, New York Times, 6/1; Reuters, 6/1 [2]).

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