Moderna seeks full FDA approval for its COVID-19 vaccine

The Moderna logo is seen at the Moderna campus in Norwood, Mass., on Dec. 2, 2020, where the biotechnology company is mass producing its COVID-19 vaccine. Joseph Prezioso/AFP via Getty Images/TNS

Moderna Inc. said it is seeking a full approval for its COVID-19 vaccine, a move that could make a shot cleared on an emergency basis during the pandemic into a stable source of revenue for years to come.

The company said in a statement Tuesday that it will submit data to the Food and Drug Administration on a rolling basis in coming weeks to support the application for use of the vaccine in people 18 and older.

Moderna’s shot, which like rival Pfizer Inc.’s is based on messenger RNA technology, has been shown to be highly effective in preventing symptomatic COVID-19. Along with the Pfizer vaccine, it has been a linchpin of the U.S. immunization campaign. More than 124 million doses have been administered in the U.S., according to the statement.

Pfizer applied to the FDA for a full approval of its vaccine on May 7.

If regulators grant Moderna’s request, it would mark the company’s first approved product. Moderna went public in 2018 as a celebrated but unproven biotech company with little revenue, but it logged $1.94 billion in sales in the first quarter of this year.

Moderna’s vaccine is one of three — along with the shots made by Pfizer and its partner BioNTech SE and Johnson & Johnson — with emergency-use authorization in the U.S., a designation that can be revoked at any time and lasts only as long as the state of emergency itself.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in April that the review process typically takes six months, but that U.S. regulators would attempt to move faster than that in clearing COVID vaccines and therapies.

Moderna shares were up 0.1% in premarket trading in New York.

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