Moderna seeks full FDA approval of its Covid-19 vaccine

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

Background: Moderna’s vaccine is currently available for people 18 and over under an emergency authorization from FDA, after a late-stage clinical trial in the U.S. found the shot to be 94 percent effective in adults. The company is the second vaccine maker, after Pfizer and its partner BioNTech, to seek full FDA approval.

Moderna has since expanded its research to test the vaccine in younger people. Moderna said last month that its shot proved 100 percent effective in teens ages 12 to 17 enrolled in a late-stage clinical trial. The company is also studying the vaccine in children from 6 months to 11 years old.

The shot, which is the company’s first product to reach market, uses the same messenger RNA technology as the Covid-19 vaccine from Pfizer and its partner BioNTech. The United States has purchased 300 million doses of the Moderna vaccine, enough to inoculate 150 million people.

What’s next: In addition to studying the safety and efficacy of its vaccine in people younger than 18, Moderna is also conducting trials to determine whether a third dose of its shot or a dose of a modified vaccine can protect against key Covid-19 variants.

The company said in early May that that both a third dose of its original vaccine and a booster aimed specifically at the B.1.351 variant were both effective against B.1.351 and a related variant, P. 1, in preliminary data. Health experts are concerned that B.1.351 — first spotted in South Africa — and the P.1 variant first seen in Brazil are less susceptible to current vaccines.



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