A Biden administration official said there is consensus among health officials
Amid surging cases, the US is set to make the covid vaccine available to kids aged six months to five years by the end of February.
Pfizer and its German partner BioNTech are understood to be filing for an emergency authorisation to the FDA as early as Tuesday, reports the Washington Post. The FDA urged companies to file the application so that regulators could start analysing the two-shot data.
The Washington Post notes “knowledgeable individuals” who cannot speak publicly at this point.
Disappointing initial results indicated that two shots are not sufficient in triggering immune responses in all age groups. With data on three shots not available until at least March, it is expected that regulators will authorise the third dose at a later date.
“We know that two doses isn’t enough, and we get that,” said one individual. “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.”
In January, Pfizer announced it would be adding the third dose as kids between the ages of two and four did not have the same immune response as older children who received a larger dose.
However that isn’t to say the scientific community is unified in its beliefs.
“I would say it’s certainly fine to release an under-5 [year-old] covid vaccine on the basis of immunobridging data, but there has to be sufficiently robust immune response,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.
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