Moderna expands research on childhood vaccines to better assess safety

Moderna said Monday it plans to expand research on the COVID-19 vaccine in young children to better detect rare side effects such as a type of heart inflammation recently noted by U.S. health authorities.

The company said it is in talks with the Food and Drug Administration to attract more participants under the age of 12. She set out to test the vaccine on about 7,000 children, some of whom are only 6 months old. The Cambridge, Massachusetts-based company said by email that it has yet to decide how many children can be added.

The announcement comes in response to a surge in COVID-19 cases in the United States, and schools are gearing up to welcome students into classrooms. At the same time, regulators continue to look at cases of a rare type of heart inflammation called myocarditis, which has been reported in a small number of teens who have received Moderna or Pfizer shots.

Pfizer said Monday that if it makes changes to vaccine testing in children, then it will provide an update. The New York-based company is testing the vaccine for about 4,500 children in the United States and Europe.

The FDA said it could not comment on discussions with the companies, but added that “we mainly work with sponsors to ensure that the number of participants in clinical trials is adequate to identify safety signals.”

This was first reported by the New York Times.

U.S. officials and independent medical experts said last month that the benefits of the vaccines far outweigh the risks of a side effect that has been reported in several hundred people under 30. But any safety concerns about the vaccine could slow the acceptance of the vaccine, especially among parents who are afraid to take it. any risk to the health of their children.

Pfizer currently has the only US vaccine approved for children 12 and older, while Moderna is awaiting an FDA decision on its use in the coming days.

While adolescents receive the same dose as adults, younger children may need smaller doses. This additional complexity adds time to drug manufacturers for research and the timing of their use.

Moderna said Monday it expects to receive enough data to apply for FDA approval for young children by the end of this year or early 2022.

Pfizer previously said it expects to apply in September for children ages 5-11. The results for the two younger age groups, which started testing a little later, should be available by October or November, the company said.

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