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.
Pfizer’s submission for an EUA could be made as soon as later today, the Washington Post first reported 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.
The timing of the plan is surprising, however, given the preliminary results presented 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. However, children between six months to two years did appear to have a similar immune response as younger adults.
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.
“We know that two doses isn’t enough, and we get that,” an anonymous source familiar with the administration’s thinking told the Post. “The idea is, let’s go ahead and start the review of two doses. 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 latest peak of the pandemic in the U.S. does seem to be winding down, though cases, hospitalizations, and deaths remain at some of the highest levels seen during the pandemic. Vaccines are highly effective at reducing the risk of severe illness, and children, in general, face a much lower risk of harm from covid-19 than other age groups. But cases and hospitalizations have surged in the pediatric population this winter. Though a vaccine for children ages 5 to 11 was approved last October, their vaccination rate remains far lower than other age groups.
As with previous regulatory decisions concerning the covid-19 vaccines, experts assembled by the FDA and the Centers for Disease Control and Prevention are expected to meet later this month to review the latest trial data and offer their own non-binding recommendations for or against authorization.