Pfizer and Moderna near two major milestones as FDA fuels vaccine review

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The US Food and Drug Administration (FDA) is only months away from two major milestones involving the COVID-19 vaccines: full approval for Pfizer’s vaccine, as well as authorization to administer the vaccines to children under the age of 12. The latter milestone is expected to arrive this winter, while the full COVID-19 vaccine approval may kick off in early 2022.

Many people have been awaiting the FDA’s authorization for vaccinating kids under the age of 12. The wait may almost be over with the FDA telling NBC that it may grant the authorization by early winter, with rapid approval of the vaccine for this age group not too long after.

The move would be a major relief for families who have young kids that aren’t vaccinated against the virus. The urgency among some parents to vaccinate their young kids skyrocketed with the CDC’s controversial decision to remove mask mandates for vaccinated individuals in the US — effectively bringing mask use to an end, as there’s no way to verify that unmasked individuals have been vaccinated.

Meanwhile, the FDA has also granted priority review for Pfizer’s COVID-19 vaccine, paving the way for full approval in the relatively near future.

According to Pfizer, which announced [PDF] the news today, the priority review is for potential approval of the mRNA vaccine for people ages 16 and older — though, as the FDA told NBC, the agency also anticipates approving the vaccine for young kids soon after authorization arrives.

Pfizer says that it sent its Phase 3 trial clinical data on the vaccine to the FDA in May as part of its Biologics License Application. The FDA granted Pfizer’s COVID-19 vaccine EUA for kids ages 12 to 15 in May.

While the application review process for full approval often takes around half a year, the FDA’s decision to grant Pfizer priority designation means the decision is expected by January 2022 at the latest. Moderna and Pfizer trial data on the COVID-19 vaccine in kids under the age of 12 are expected to arrive this fall.

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