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Pfizer/BioNTech’s second bivalent COVID-19 booster approved by MHRA

The adapted vaccine targets the original virus and Omicron BA.4 and BA.5 strains


Pfizer/BioNTech’s jointly developed bivalent COVID-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and is designed to target both the original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 strains.

In each dose of the booster vaccine, 50% of the vaccine targets the original virus strain and the other 50% specifically targets Omicron (BA.4-5).

The updated booster is the second bivalent vaccine produced by Pfizer/BioNTech to be granted MHRA approval, having successfully met the regulator’s criteria for safety, quality and effectiveness.

The vaccine has already been approved for use as a booster dose in those aged 12 years and above, following a review of evidence by the Commission on Human Medicines, which advises ministers on the safety, efficacy and quality of medicinal products.

The approval is supported by evidence provided on the original Pfizer/BioNTech COVID-19 vaccine and its adapted vaccines, including extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent original/omicron BA.1 vaccine and safety data from an on-going clinical trial.

The data demonstrated that the most common side effects recorded with the new bivalent vaccine were the same as results seen for other versions of the vaccine. It was reported that side-effects were typically mild and self-resolving, and no new safety concerns were found.

All approved COVID-19 booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19. For the UK autumn booster campaign, the MHRA advises people to come forward for their booster vaccination when invited to do so.

The MHRA’s approval of the updated bivalent COVID-19 booster vaccine follows on from Pfizer/BioNTech’s most recent update, in which the companies provided a clinical data update for their Omicron BA.4/BA.5-adapted bivalent vaccine for use in adults.

The updated results, announced on 4 November, from the phase 2/3 clinical trial demonstrated a substantially higher immune response in adults, compared to the original vaccine.

It has been suggested in a recent publication in The Lancet that COVID-19 vaccines have prevented up to 20 million deaths in the first year of use.

Article by
Fleur Jeffries

10th November 2022

From: Research, Regulatory



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