FDA green lights BioNTech/Pfizer jab for 5 to 11-year-olds

The US Food and Drug Administration has authorised the use of the BioNTech/Pfizer Covid-19 vaccine for children aged five to 11 years, paving the way for the US to become the first country in the world to green light that jab for younger children.

The agency said its emergency use authorisation was based on a “thorough and transparent” evaluation of safety and efficacy data, which showed the vaccine was 90.7 per cent effective at preventing Covid-19 in children within the age group.

Advisers at the Centers for Disease Control and Prevention will meet next week to discuss further clinical recommendations and guidelines for a proposed nationwide roll out of jabs. The US has about 28m children aged between five and 11.

The Biden administration has prioritised rolling out the jab to younger age groups in an effort to prevent large-scale outbreaks in schools and better protect communities from the highly infectious Delta strain of the virus.

However, authorities may face a battle to persuade families to bring their children for jabs. A recent survey by the Kaiser Family Foundation showed almost a third of parents would “definitely” not get their kids vaccinated.

Janet Woodcock, acting FDA commissioner, said the comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that the vaccine meets the agency’s high standards.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorisation. Vaccinating younger children against Covid-19 will bring us closer to returning to a sense of normalcy,” she said.

The BioNTech/Pfizer jab for children aged five through 11 years will be administered in “kid-sized” doses, which are a third of the size of jabs for people aged 12 years and over. The vaccine is administered in two jabs three weeks apart.

Sonja Rasmussen, professor at the University of Florida College of Medicine, said vaccinating younger children would play an important role in preventing them from becoming seriously ill.

“Although children are at lower risk than adults from Covid-19, they’re not at ‘no risk’. Some children get severely ill and more than 140 children ages five to 11 years have died from Covid-19 in the United States. Getting the vaccine can prevent these tragic outcomes,” she said.

Pfizer said this week the US government had purchased an additional 50m doses of the BioNTech/Pfizer vaccine, which will help support the rollout of jabs for younger children.

Albert Bourla, Pfizer chair and chief executive, said the authorisation by the FDA was a day that many parents, eager to protect their young children from the virus, had anticipated.

“With this FDA authorisation, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control,” he said.

Pfizer’s mRNA vaccine has been authorised for use in the US for people aged 12 and older. Moderna, which also makes an mRNA vaccine for Covid-19, this week said it intends to submit data to the FDA on the efficacy of its jab in younger people.