US drugs regulator authorises BioNTech/Pfizer Covid vaccine for under-16s

Adolescents in the US are set to get vaccinated against Covid-19 after the country’s drugs regulator allowed BioNTech/Pfizer’s vaccine to be given to under-16s for the first time. 

The Food and Drug Administration on Monday extended its emergency authorisation for inoculation of 12 to 15-year-olds after studies suggested it was 100 per cent effective at preventing coronavirus. 

The US move came after Canada last week became the first country to approve BioNTech/Pfizer’s vaccine for under-16s. President Joe Biden has set a goal of vaccinating 70 per cent of all Americans by July 4.

Dr Janet Woodcock, the acting head of the FDA, said: “Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data.”

The BioNTech/Pfizer vaccine being administered to adults contains a 30mg dose and the same jab will be given to children, making it easy for vaccination centres and pharmacies to expand the rollout. 

“This vaccine is just the same dose and regimen as what’s being given out already,” Woodcock said. “All those sites can simply extend down to the younger age groups.”

Albert Bourla, chief executive of Pfizer, said the authorisation “represents a significant step forward in helping the US government broaden its vaccination programme and help protect adolescents ages 12–15 before the start of the next school year”.

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The Centers for Disease Control and Prevention’s vaccine advisory committee will meet on Wednesday and vote on the FDA’s recommendation, after which US states will decide when to begin vaccinating children, which could start as soon as Thursday.

The US has rolled out one of the fastest coronavirus vaccination programmes in the world, having administered more than 260m doses, according to the latest data from the CDC. The rapid vaccine drive has helped bring cases to an 11-month low of about 24,000 new infections per day on Sunday.

In recent weeks the pace of vaccinations has slowed, however, as experts warn that all those most eager to receive a jab have already done so. The Biden administration recently announced a package of measures to make getting vaccinated easier and more attractive to those who have not yet done so.

Allowing children to be vaccinated is one way to speed up the take-up. But it is also contentious because younger populations face a minute risk of becoming severely ill or dying after contracting coronavirus, while billions of vulnerable adults across the world are yet to receive a vaccine.

In the US, 332 people under the age of 18 have died from Covid-19 since the pandemic began, compared with more than 560,000 adults, according to the CDC.

Some argue that vaccinating children diverts valuable jabs away from adult populations, further delaying the rollout for vast swaths of the developing world that are yet to be vaccinated. Some health professionals also question the ethics of vaccinating children in order to primarily stop severe disease in adults.

“It’s very reasonable to say we’re going to immunise children so that we’re going to protect the rest of society but ethically there has to be a benefit for the individual themselves,” said James Conway, a paediatric infectious disease specialist at the University of Wisconsin-Madison.

All of the big western pharmaceutical companies are trialing their jabs in children, some as young as six months old. 

Moderna has completed its studies on 12 to 17-year-olds and will submit data to the US regulator in the coming weeks.