The authorization could be official by the end of February.
A covid-19 vaccine for the youngest American children may be here sooner than expected. This week, Pfizer will reportedly
apply for an emergency use authorization of their low-dose vaccine for children under five. Should the Food and Drug Administration grant the authorization, the vaccine could be available as a two-dose series by the end of the month. But there are still questions about whether the current clinical data will be enough to convince the FDA, and it’s likely that a third dose would be recommended down the line, regardless.
Monday evening. It’s expected to call for the vaccine to be authorized as a two-shot schedule for children between six months and five years old. These shots would contain one-tenth the dose as the standard adult dose.last December by the company. They reported that children between the ages of two to five did not develop a robust-enough immune response to the two-dose vaccine when compared to younger individuals between the ages of 16 to 25.
At the time, Pfizer announced that it would extend the trial further by adding a third dose to the schedule for children 6 months to under 5 years of age. If the results from this trial went well, they then planned to submit for the EUA sometime in the “first half of 2022.” The third-dose trial is still ongoing. But it now appears that Pfizer will argue for the vaccine to be given as a two-dose series initially, with the expectation that the subsequent data will validate the added benefit of a third dose. It’s a decision that’s reportedly being encouraged by the Biden administration, in hopes of speeding along the rollout of the vaccine to younger children.
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