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US FDA advisors overwhelmingly support Moderna COVID vaccine for ages 6-17




June 14 (Reuters) – Advisors to the US Food and Drug Administration on Tuesday unanimously recommended that the agency approve Moderna Incs (MRNA.O) COVID-19 vaccine for children and teens ages 6 to 17 years.

Around 77 million people in the United States have received at least two doses of Moderna̵[ads1]7;s vaccine, which has long been available to people aged 18 and older.

The committee of external experts will on Wednesday evaluate the Moderna syringe for children under 6 years, and Pfizer (PFE.N) and BioNTechs (22UAy.DE) COVID vaccine for children under 5 – and in both cases as young as 6 months.

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It is unlikely that there will be significant immediate demand for the Moderna shots for 6- to 17-year-olds. The Pfizer / BioNTech vaccine was approved for children aged 5 to 11 in October, and approval for teenagers went before that with months.

Yet only about 30% of those aged 5 to 11 and 60% of 12- to 17-year-olds are fully vaccinated in the United States, according to data from the US Centers for Disease Control and Prevention (CDC).

A Pharmacist Holds a Vial of Modern Coronavirus (COVID-19) Vaccine in West Haven, Connecticut, USA, February 17, 2021. REUTERS / Mike Segar

“I want to give parents as many choices as possible, and let them make the decisions about this for their children,” said committee member and UC Berkeley professor Dr. Arthur Reingold at the meeting.

The FDA – which generally follows the recommendations of its advisers, but is not obliged to do so – will probably soon approve the Moderna vaccine for ages 6-17. The CDC must also recommend the use of the vaccine. A committee of advisers will meet on Friday and Saturday.

There has long been concern that the Moderna vaccine, which is given at a higher dose than the Pfizer / BioNTech syringe, can cause types of heart inflammation known as myocarditis and pericarditis in higher incidence, primarily in younger men.

Some European countries have restricted the use of the Modern vaccine to younger age groups after surveillance suggested that it was associated with a higher risk of heart inflammation, and the FDA delayed the review of the shot to assess the risk of myocarditis.

U.S. regulators presented data at Tuesday’s meeting suggesting that Moderna’s vaccine may have a higher risk of heart inflammation in young men, but said the findings were inconsistent across various safety databases and were not statistically significant, meaning they may be due to coincidences. .

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Reporting of Manas Mishra in Bengaluru; Additional reporting by Michael Erman in New Jersey; Edited by Jason Neely and Bill Berkrot

Our standards: Thomson Reuters Trust Principles.



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