US FDA advisers overwhelmingly back Moderna Covid-19 vaccine for ages 6-17

Around 77 million people in the United States have received at least a two-dose course of Moderna's vaccine. PHOTO: AFP

WASHINGTON (REUTERS) - Advisers to the US Food and Drug Administration on Tuesday (June 14) unanimously recommended that the agency authorise Moderna's Covid-19 vaccine for children and teens aged six to 17 years.

Around 77 million people in the United States have received at least a two-dose course of Moderna's vaccine, which has long been available for people aged 18 and older.

The committee of outside experts is scheduled on Wednesday to consider the Moderna shot for children under six years old, and Pfizer-BioNTech's Covid-19 vaccine for children under five - and in both cases as young as six months.

There is unlikely to be significant immediate demand for the Moderna shots for six to 17 years. The Pfizer-BioNTech vaccine was authorised for children aged five to 11 in October, and approval for teenagers preceded that by months.

Yet only around 30 per cent of those aged five to 11 and 60 per cent of 12- to 17-year-olds are fully vaccinated in the US, according to data from the Centres for Disease Control and Prevention.

"I'd like to give parents as many choices as possible, and let them make the decisions about this for their children," committee member and University of California, Berkeley professor Arthur Reingold said at the meeting.

The FDA - which generally follows the recommendations of its advisers but is not obligated to do so - is likely to authorise the Moderna vaccine for aged six to 17 soon. The CDC also needs to recommend the vaccine's use. A committee of its advisers is scheduled to meet on Friday and Saturday.

There have long been concerns that the Moderna vaccine, which is given at a higher dose than the Pfizer-BioNTech shot, may cause types of heart inflammation known as myocarditis and pericarditis at higher rates, primarily in younger males.

Some countries in Europe have limited use of Moderna's vaccine for younger age groups after surveillance suggested it was tied to a higher risk of heart inflammation, and the FDA delayed its review of the shot to assess the myocarditis risk.

US regulators presented data at the meeting on Tuesday suggesting that Moderna's vaccine may have a higher risk of heart inflammation in young men, but said the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.

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