US FDA authorises Pfizer’s vaccine for use in children aged 12 to 15

US regulators on Monday expanded the emergency use authorisation for Pfizer and its partner BioNTech’s COVID-19 vaccine to include children ages 12 to 15, starting a race to protect middle and high school students before they head back to class after summer holidays.

This is the first COVID-19 vaccine in America authorised for use in younger teens and adolescents; it had previously been authorised for people age 16 and older. Americans age 18 and older are receiving Moderna and Johnson & Johnson shots.

The Food and Drug Administration’s decision on Monday will widen the US’s inoculation programme even as vaccination rates in the country show a dip.

“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,” Acting FDA commissioner Janet Woodcock said. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorisations.”

“We know that every time an American, including members of our own families, receives a COVID-19 vaccine dose, you are putting your trust in us,” she said.

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It was a “relatively straightforward” decision, said Dr Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, which is responsible for regulating vaccines.

The FDA looked at safety and efficacy data, as well as the immune responses of some of the children who were vaccinated, and compared them to the immune responses of older teens and adults who got the shot.

“The response to the vaccine was excellent and in fact it was even better, really, in the younger age group than it was in the 16-25 age group,” Marks said. “The safety profile was very similar in 12-15-year-olds as in 16-25-year-olds.”

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is scheduled to meet on Wednesday to advise the CDC on whether to recommend use of the vaccine in the age group. Vaccinations are not expected to begin until after that recommendation.

Expanding authorisation to children 12 to 15 opens vaccination to 17 million more people – roughly another 5 per cent of the population. That means 85 per cent of the US population is eligible to receive a COVID-19 vaccine.

“The light at the end of the tunnel is growing, and today it got a little brighter,” President Joe Biden said in a statement.