U.S. regulators are urging drug maker Pfizer to apply for emergency approval for a two-dose COVID-19 vaccine regimen for children aged 6 months to 5 years, pending data on a three-dose course to clear the way for vaccines. already at the end of February, a person familiar with the matter told The Associated Press.
The company’s application is expected to be filed on Tuesday.
Early data from Pfizer showed that the vaccine, given to young children at a dose one-tenth the adult dose, is safe and elicits an immune response. But last year, Pfizer announced that the two-dose vaccine was less effective at preventing COVID-19 in children aged 2 to 5, and regulators urged the company to add a third dose to the study, believing that one more dose would boost the vaccine’s effectiveness. . efficacy is very similar to booster doses in adults.
Now the Food and Drug Administration is pushing the company to apply for potential approval based on two dose data in February, and then return for additional approval after receiving data from a third dose study, which is expected in March. , said a person familiar with the situation. The two-step authorization process could mean young children could be vaccinated more than a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention give the green light to vaccinations.
The man spoke on condition of anonymity to discuss sensitive regulatory issues. The person said the drop in effectiveness of the two-dose vaccine was not unexpected given the emergence of a highly contagious micromicron variant of COVID-19. Allowing young children to be vaccinated with two doses sooner will eventually speed up the process when they can get the expected stronger protection from the third dose.
This would be welcome news for parents of young children, the last remaining age group without COVID-19 vaccine approval.
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Young children are much less likely than adults to develop serious complications or die from COVID-19, but incidence among the age group has risen amid a nationwide surge in cases from the omicron variant. Most cases and deaths occur among the elderly, especially among the unvaccinated.
Accelerating the authorization of pediatric COVID-19 vaccines has been a priority for more than a year of the Biden administration, which believes they are critical to reopening and keeping schools and daycare centers open and freeing up parents with childcare responsibilities. to return to working life.
Vaccines for children ages 5 to 12 were approved by US regulators in November, though vaccine rollout has been slower than US officials had hoped.
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The Pfizer Primary Series is held at three-week intervals. A third dose for young children is being studied for at least two months after the second dose.
News of the earlier regulatory scrutiny was first reported by The Washington Post.