Pfizer seeks US FDA approval for Covid boosters for teens aged 16-17

As concerns grow about the impact of the new Omicron variant, Pfizer announced on Tuesday it was seeking US authorization for booster shots for adolescents aged 16 and 17.

So far, FDA has approved emergency use authorizations (EUAs) for boosters only for those aged 18 and over, six months after the primary series of the Pfizer or Moderna Covid vaccine, or two months after the Johnson & Johnson booster.

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"Today, we submitted a request to the @US_FDA to expand the emergency use authorization of a booster dose of our COVID-19 vaccine to include 16- and 17-year-olds," Pfizer CEO Albert Bourla wrote on Twitter.

"It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant." 

Due to the mutation pattern detected on the Omicron variant, experts fear that protection offered by the current vaccine generation may be compromised.

Within a few weeks, lab results will reveal whether or not the hypothesis is correct. However, US health authorities are insisting that everyone who is eligible for a booster get one, to ensure protection against severe Covid, even if not infection itself.

While Omicron has been detected in more than a dozen countries, it has yet to be detected in the United States, where Delta accounts for more than 99 per cent of all infections.

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There is disagreement among health experts regarding boosters for healthy teens, who are at less risk of developing severe Covid, especially when males exposed to the Pfizer and Moderna messenger RNA vaccines, are at higher risk of developing vaccine-linked myocarditis.

"If the FDA takes this action, it will be a total gamble," tweeted Vinay Prasad, a haematologist-oncologist at the University of San Francisco with expertise in biostatistics and epidemiology.

(With inputs from agencies)