Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization.


Moderna mentioned on Tuesday that its coronavirus vaccine, licensed solely for use in adults, was powerfully effective in 12- to 17-year-olds, and that it deliberate to apply to the Food and Drug Administration in June for authorization to use the vaccine in adolescents.

If authorized, its vaccine would develop into the second Covid-19 vaccine out there to U.S. adolescents. Federal regulators authorized the Pfizer-BioNTech vaccine this month for 12- to 15-year-olds.

The Pfizer shot was initially licensed for use in folks 16 and older, whereas Moderna’s has been out there for these 18 and up.

Proof of the vaccines’ efficacy and security for adolescents is serving to college officers and different leaders as they plan for the autumn. On Monday, Mayor Bill de Blasio mentioned that all public college college students in New York City, the most important college system within the United States, would return to in-person learning in the fall.

New York’s transfer comes as a number of states have indicated that they will prohibit distant studying, together with Connecticut, Illinois, Massachusetts and New Jersey.

The Moderna outcomes, which the corporate introduced in a statement, are primarily based on a medical trial that enrolled 3,732 folks ages 12 to 17, two-thirds of whom obtained two vaccine doses. There have been no instances of symptomatic Covid-19 in totally vaccinated adolescents, the corporate reported. That interprets to an efficacy of 100 %, the identical determine that Pfizer and BioNTech reported in a trial of their vaccine in 12- to 15-year-olds.

“These look like promising results,” mentioned Dr. Kristin Oliver, a pediatrician and vaccine professional at Mount Sinai Hospital in New York. “The more vaccines we have to protect adolescents from Covid, the better.”

Moderna additionally reported that a single dose of its vaccine had 93 % efficacy towards symptomatic illness.

“Those cases that did occur between the two doses were mild, which is also a good indicator of protection against disease,” Saskia Popescu, an infectious illness epidemiologist at George Mason University, mentioned in an e mail.

The unintended effects have been in line with what has been reported in adults: ache on the website of the injection, headache, fatigue, muscle ache and chills. “No significant safety concerns have been identified to date,” the corporate mentioned.

The adolescents within the examine will be monitored for a 12 months after their second dose.

The outcomes have been introduced in a information launch that didn’t include detailed information from the medical trial. And Dr. Rasmussen mentioned that the vaccines’ efficacy could be trickier to consider in youngsters, who’re much less probably to develop symptomatic illness than adults.

Nevertheless, she mentioned, the outcomes are in step with what scientists anticipated and counsel “that adolescents respond to the vaccine comparably to adults who receive it.”

Moderna mentioned it deliberate to submit the information for publication in a peer-reviewed journal.



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