We could find out if Pfizer’s COVID-19 vaccine works in kids aged 2 to 11 by September

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Trial data from Pfizer’s coronavirus vaccine for the youngest age-group, 6 months to 2 years, would be ready to show to the FDA later this year. Getty
  • We could know if Pfizer’s vaccine works in kids aged 2 to 11 by September, according to Albert Bourla, Pfizer CEO.
  • Bourla said Tuesday that vaccine data for kids 6 months to 2 years was expected November-time.
  • Exact timelines depend on how well the trials go and whether regulators approve it.
  • See more stories on Insider’s business page.

Trial results showing how well Pfizer’s coronavirus vaccine works in kids as young as two could be ready for regulators by September, Albert Bourla, Pfizer’s CEO said Tuesday.

Bourla told reporters and analysts during Pfizer’s quarterly earnings call that the company expected to have definitive trial data to submit to the Food and Drug Administration (FDA) for two age groups: two to five years old, and five to 11 years old.

Data for children six months to two years old was expected in November, he said.

The exact timeframe for getting kids vaccinated depends on how well the trials go and whether regulators give Pfizer’s vaccine the green light for use in younger age groups.

Pfizer said on March 31 that its COVID-19 vaccine, co-developed with German firm BioNTech, was highly effective and “well-tolerated” in adolescents.

The company is awaiting FDA authorization for 12 to 15 year olds, which is expected next week.

Pfizer’s COVID-19 shot is already available in the US for everyone over 16 years old. So far, more than 53 million US adults have received a double dose of Pfizer’s two-dose vaccine, according to the Centers for Disease Control and Prevention.

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President Joe Biden said during an address Tuesday that the final decision on the vaccine’s authorization in 12 to 15 year olds was up to the FDA, but the administration had plans in place to get American adolescents immunized as soon as possible.

“Although serious illness at the age range is rare, they can still get sick and spread the virus to others,” Biden said. “So my hope is that if the vaccine is authorized, parents will take advantage of it and get their kids vaccinated.”

Pediatric experts have previously told Insider that cases in children rise when there’s lots of coronavirus infections around, so maintaining low infection rates in the community was fundamental.

Dr. Scott Gottlieb, the former head of the US Food and Drug Administration, said in March that the infection rates in under-16s in Israel – where more than half of the population is fully immunized with Pfizer’s shot – “dropped dramatically” once adults got vaccinated as infection rates fell.