Moderna completes FDA submission for use of COVID shot in adolescents, kids -Breaking
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© Reuters (Reuters) – Moderna (NASDAQ:) Inc has made all necessary submissions required by the U.S. Food & Drug Administration for emergency use authorization of its COVID-19 vaccine in adolescents and children, it said on Wednesday.
It is asking for approval to use its vaccines in three age groups: adolescents 12-17 years old, six-year-olds and children six-11 years. It said that submissions were received for each group on May 9.
Moderna’s vaccination is currently approved for adults aged 18 and over by the FDA. But, other countries have been denied its use as U.S. regulators sought additional safety data.
However, the European Union and Australia have all approved the use of the vaccine in children aged six-17 years old.
Company sought U.S. permission to administer COVID shots to children below 6 years of age in April.
To review the request, a panel of advisors to the U.S. regulator for drugs will meet in June.
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