FDA clears Pfizer, BioNTech COVID booster for younger teens

The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of Pfizer and BioNTech's Comirnaty shot as it tries to keep the Omicron variant under control.

The US regulator has also reduced the time between completion of the first two doses of Comirnaty and a third dose to five months from six as a wave of new COVID-19 cases caused by Omicron has started washing over the country.

That's still longer than some other countries, including the UK which has pared down the time between the second and third doses to three months.

The number of new COVID-19 cases in the US has doubled in the last few days to an average of around 418,000 a day, according to Reuters, while figures suggest there were more than a million new cases in the country yesterday, the highest number recorded since the start of the pandemic.

A third primary series dose has also been authorised by the FDA for some children aged between five and 11 years old, such as those who are immunocompromised so may not have a sufficiently robust immune response to two doses.

All the changes to the emergency authorisation for Comirnaty will be reviewed by the Centres for Disease Control and Prevention (CDC) at a meeting tomorrow, according to the agency.

Pfizer and BioNTech's vaccine was cleared by the FDA for emergency use after completion of a primary series in people 16 years of age and older last year.

Peter Marks, director of the FDA's Centre for Biologics Evaluation and Research (CBER), said that a booster dose of the currently authorised vaccines "may help provide better protection against both the Delta and Omicron variants."

He went on: "In particular, the Omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines."

The US is also seeing a spike in hospitalisations due to COVID-19, but there are reportedly being seen mainly in unvaccinated people. At last count, 62% of the eligible US population has received a full primary course of injections with a third also boosted.

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The FDA said it had concluded that Comirnaty boosters provide continued protection against COVID-19, including against hospitalisation and death, outweighing the potential risks in adolescents.

It reviewed real world evidence from Israel on the administration of over 4.1 million third doses of its vaccine given at least five months after the primary regimen revealed no new safety concerns in adolescents aged 12 to 17, including around 6,300 12- to 15-year-olds.

There have been cases of heart inflammation seen with Comirnaty in younger age groups, but the FDA said there were "no new cases of myocarditis or pericarditis reported to date in these individuals."