AP source: US urges Pfizer to request COVID vaccines for under-5s

WASHINGTON — U.S. regulators are urging drugmaker Pfizer to seek emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old pending data on a three-dose treatment , aiming to pave the way for the shootings as early as late February, a person familiar with the matter told The Associated Press on Monday.

The company’s application was due by Tuesday.

Early data from Pfizer has shown the vaccine – which is given to young children at one-tenth the strength of the adult vaccine – is safe and produces an immune response. But last year, Pfizer announced that the two-dose vaccine had been shown to be less effective in preventing COVID-19 in children aged 2 to 5, and regulators encouraged the company to add a third dose. under study, thinking that another dose would boost the vaccine. similar efficacy to booster doses in adults.

Now the Food and Drug Administration is pushing the company to submit its two-dose data-based application for potential approval in February, then return for further approval once it has study data on the third dose, which is expected in February. March, the person familiar with the matter said. The two-step approval process could mean young children could be vaccinated more than a month sooner than previous estimates, assuming the FDA and Centers for Disease Control and Prevention give the shots the go-ahead.

The person spoke on condition of anonymity to discuss sensitive regulatory issues. The person said the decrease in effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible omicron variant of COVID-19. Allowing young children to be vaccinated with a two-dose injection sooner would ultimately accelerate when they could get the stronger protection expected from a third dose.

That would be good news for parents of young children, with the last remaining age group without COVID-19 vaccine approvals.

Young children are much less likely than adults to develop serious complications or die from COVID-19, but disease incidence in this age group has increased amid the national spike in omicron variant cases. Most cases and deaths occur in older people, especially those who are unvaccinated.

Accelerating Authorization of Pediatric Care vaccines against COVID-19 has been a priority for more than a year of the Biden administration, which considers them essential to reopen and keep schools and daycares open – and to free up parents busy with child care responsibilities to return in the labor market.

Vaccines for children aged 5 to 12 were approved by US regulators in November, although vaccine uptake has been slower than US officials had hoped.

Pfizer’s primary series is given three weeks apart. The third dose for young children is being studied for administration at least two months after the second dose.

News of the earlier regulatory review was first reported by The Washington Post.