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New Covid bivalent vaccine approved by the MHRA


New Covid bivalent vaccine approved by the MHRA

A Covid vaccine that targets the original strain of the disease as well as the Omicron BA.4 and BA.5 sub-variants has been approved by the Medicines and Healthcare products Regulatory Agency.

The regulator said the updated booster, the second Covid bivalent vaccine from Pfizer-BioNTech, was approved after it met its standards of safety, quality and effectiveness. It has been passed for use in people aged 12 and above.

The MHRA said its decision to approve the vaccine was “endorsed by the Commission on Human Medicines after a careful review of the evidence” and was based on “all available evidence on the original Pfizer-BioNTech Covid-19 vaccine and its adapted vaccines".

“In each dose of the booster vaccine, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.4-5),” the MHRA said.

It said the new bivalent vaccine has the same common side effects “as those seen for other versions of the vaccine” which the MHRA described as “typically mild and self-resolving, with no new safety concerns identified".

Bivalent vaccines from Pfizer-BioNTech and Moderna targeting the Omicron BA.1 sub-variant had already been approved and last week, the MHRA gave Novavax's Covid booster for adults the green light.

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