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FDA gives full approval to Moderna’s Covid-19 shot

The Food and Drug Administration has approved Moderna’s Covid-19 vaccine, the company announced Monday, making it the second to be fully licensed for use in the United States.

The approval for people ages 18 and older will make it easier for schools and workplaces to require vaccination against the virus, now that there are two approved products to choose from, including Pfizer-BioNTech’s Covid shot. It will also allow Moderna to market its vaccine directly to consumers.

FDA allowed emergency use of the vaccine in adults and older teenagers beginning in December 2020. In June, Moderna asked the agency to expand that authorization to include adolescents as young as 12 but announced in October it would delay seeking authorization for children ages 6 to 11 until regulators assess the shot’s myocarditis risk in teens. The company is still awaiting a decision from FDA on whether adolescents may get the vaccine.

The company is currently conducting trials in children as young as 6 months old.

The vaccine, now known as Spikevax, is Moderna’s first product to receive FDA licensure.

“We are grateful to the U.S. FDA for their thorough review of our application,” CEO Stéphane Bancel said in a statement.

Background: Like the vaccine from Pfizer and BioNTech, Moderna’s shot uses mRNA technology to trick the body’s cells into making harmless versions of the coronavirus spike protein. The immune system then creates protective antibodies based on these spike proteins.

The United States has purchased 500 million doses of the shot.

Moderna reported in early August that its shot is 93 percent effective six months after the second dose but that officials believed boosters would be necessary for adequate protection into the winter. The Biden administration announced Aug. 18 it would recommend booster doses for American adults eight months after their second shots of an mRNA vaccine, with the rollout anticipated by late September pending regulatory approval from the FDA.

The CDC endorsed offering additional doses of Pfizer’s and Moderna’s vaccines on Aug. 13 to certain immunocompromised individuals who may not have mounted a sufficient immune response after the primary two-dose series.

What’s next: Moderna is waiting to hear whether FDA will authorize its vaccine for use in teens. The company is running clinical trials of booster shots for adults and initial inoculations in children.

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