UK health regulator authorizes Pfizer/BioNTech COVID vaccine for infants as young as 6 months

‘Expected side effects were in-keeping with what can be anticipated from the vaccine in this age group,’ regulator says

Britain’s health regulator on Tuesday authorized the use of a Pfizer/BioNTech coronavirus vaccine for infants and children aged six months to 4 years.

In a statement, the Medicines and Healthcare products Regulatory Agency (MHRA) said that the Comirnaty COVID vaccine has met its required safety, quality, and effectiveness standards.

“This presentation is specially designed for this new age group and given at a lower dose compared to that used in individuals aged 5 to 11 years (3 micrograms compared with 10 micrograms),” MHRA said.

It said that before the decision, the agency reviewed data from an ongoing clinical trial involving 4,526 participants and noted that expected side effects “were in-keeping with what can be anticipated from a vaccine in this age group.”

“It is given as three injections in the upper arm, with the first two doses given 3 weeks apart, followed by a third dose given at least 8 weeks after the second dose,” the statement added.

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