FDA, Pfizer abandon 2-shot COVID vaccine in youngsters below 5, citing new information

A small person looks at the band-aid being applied to their arm.

Enlarge / A toddler getting a vaccination on February 19, 2021, in Bonn, Germany. (credit score: Getty | Ute Grabowsky)

The Meals and Drug Administration, Pfizer, and BioNTech introduced on Friday that they’re abandoning plans to pursue the authorization of a two-dose routine of COVID-19 vaccines for kids ages 6 months to four years. As an alternative, they’ll once more put the potential for an authorization on maintain as they await information on the efficacy of a 3rd dose for the youngest youngsters. That information is now anticipated in early April.

In a press launch this afternoon, Pfizer and its accomplice BioNTech reported that COVID-19 instances amongst youngsters enrolled within the preliminary two-dose trial “proceed to build up in keeping with the research protocol, and extra information are being generated as a result of charges of an infection and sickness stay excessive in youngsters of this age, particularly as a result of current omicron surge.”

“Provided that the research is advancing at a speedy tempo, the businesses will await the three-dose information as Pfizer and BioNTech proceed to imagine it might present the next degree of safety on this age group,” the press launch continued.

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