The Pfizer COVID-19 vaccine could be available for children under 5 as soon as the end of next month, according to reports.
An emergency use authorization request is expected to be made to the US Food and Drug Administration (FDA) as early as Tuesday, a person familiar with the matter confirmed to The Associated Press.
If successful, it would clear the way for a two-dose regimen to be available for children 6 months to 5 years old as soon as late February, the source said.
Pfizer previously acknowledged that the two-dose shot proved less effective at preventing COVID-19 in kids ages 2-5 than older children, and regulators encouraged the company to add a third dose to the study.
But the FDA has pushed the pharmaceutical giant and its partner, BioNTech, to submit its application based on the two-dose data while still testing the effectiveness of a third shot for later, the AP said.
The two-step authorization process could mean that the young children — the last remaining group not yet vaccinated — could get jabbed more than a month earlier than previous estimates.
“The idea is, let’s go ahead and start the review of two doses,” one insider told The Washington Post, which first revealed the new timeline.
“If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in,” the source said.
Pfizer already presented updated trial data about the shots last Friday to federal health officials, including Dr. Anthony Fauci, an administration official told the Washington paper.
“There’s interest in seeing this move forward,” a Biden administration official told the paper. “To get to three, you have to get two shots first.”
While not as effective as with older children, the doses — which are one-tenth the strength of the adult shot — have still been shown to be safe and produce an immune response, early data showed.
The decreased effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible Omicron variant, the AP’s insider said.
Still, there is concern about the likely uptake of the shots for young children, who are far less likely than adults to develop serious complications or to die from COVID-19. Most cases and deaths occur among older people, especially those who are unvaccinated.
However, the Biden administration believes the shots are critical to keeping open schools and day care centers — and for freeing up parents occupied by childcare responsibilities to return to the workforce.
With Post wires