Pfizer submits data seeking US approval of COVID vaccine for young kids — report

Pfizer Inc and BioNTech have begun submitting data to US regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5, Bloomberg reported on Tuesday, despite weaker than expected immune responses in their clinical trial of 2- to 4-year-olds.

The drug companies want the US Food and Drug Administration to clear the shot as a two-dose vaccine, though they expect a three-shot regimen may ultimately become standard, the Bloomberg report said, citing people familiar with the data.

Pfizer and BioNTech are testing a 3 microgram dose of the vaccine in the age group, compared with a 10 microgram dose in 5- to 11-year-olds and a 30 microgram dose in people aged 12 and older.

Authorization of a vaccine for younger children could help harried parents who have had to contend with quarantines and closures of pre-schools and daycare centers.

In December, Pfizer said it was amending its clinical trial to test a three-dose version of the vaccine because the lower-dose generated an immune response in 2- to 4-year-olds that was inferior to the response measured in 16- to 25-year-olds. In 6- month- to 24-month-old children, the vaccine generated an immune response in line with 16- to 25-year-olds.

Last month, Pfizer said it expected to have those results by April. The rolling submission, if approved, would allow the company and health officials to proceed with shots for those under age 5 until the rest of the data becomes available.

"The appropriateness of any EUA for under 5 for the vaccine will depend on what the data show beyond the antibody levels, for example any evidence of a clinical benefit," said Dr. Walid Gellad, a professor at the University of Pittsburgh medical school. "Many parents are waiting for the day a vaccine will be available for this young age group."

Representatives for Pfizer, as well as for the FDA and the Department of Health and Human Services, could not immediately be reached for comment on the Bloomberg report.

In a statement late on Monday, Pfizer said it had yet to seek approval and was "continuing to collect and analyze data from both two and three doses in our younger age cohort."

The vaccine is already approved for emergency use in children in the United States ages 5 and older. It has full approval for adults.

The FDA has also authorized a third booster dose of the Pfizer/BioNTech shot for adults and children aged 12 and older. It gave the green light for a two-dose vaccine for children ages 5 to 11.

It remains unclear how many parents will choose to vaccinate their young children. Vaccinating children has been slow in the United States, and only around 22% of 5- to 11 year-olds have been fully vaccinated since the campaign to vaccinate that age group began in November. -- Reuters