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Pfizer asks FDA to authorize vaccine for children aged 5-11

Pfizer announced on Thursday that it had submitted a request for an Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA), several weeks after it began submitting trial data from five- to 11-year-olds to the US regulator.

Should the FDA grant Pfizer’s request, the pharma firm’s vaccine would be the first Covid-19 shot authorized for children so young. Pfizer’s two-shot regimen has already been given an EUA for children aged 12 to 15, and is fully approved for anyone over 16.

The FDA could issue an authorization by the end of this month. White House coronavirus adviser Dr. Anthony Fauci told MSNBC in September, “We could start vaccinating children, hopefully before the end of October.”

However, the FDA will need to consider whether Pfizer’s data makes a clear enough case for pediatric vaccination, and what dosage would be appropriate for kids so young. The FDA does not always march in lockstep with the Biden administration, and even within the agency, there is sometimes dissent. Last month, an FDA panel voted overwhelmingly against rolling out booster shots of Pfizer’s jab to American adults, shutting down President Joe Biden’s promise to make these boosters available by September 20.

The FDA ended up approving booster shots for elderly people and those at heightened risk of Covid-19 – which, according to the agency, includes teachers and healthcare workers.

With the FDA set to make a decision in the coming weeks, schoolchildren in certain areas will face mandatory vaccination if the agency greenlights Pfizer’s application. California Governor Gavin Newsom issued a mandate last week requiring all eligible grade school kids to be vaccinated against Covid-19. At present, the order only applies to children over 11 but would affect kids as young as five if the FDA sides with Pfizer and grants the authorization.

Children are far less likely to suffer from serious illness or death as a result of Covid-19. Fewer than 500 children under 18 have died of the coronavirus in the US since the pandemic began, accounting for 0.07% of all Covid-19 deaths, according to data from the Centers for Disease Control and Prevention (CDC). In the UK, researchers recently found that a child’s chance of dying from Covid-19 is somewhere around one in 500,000.

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