Bivalent Covid-19 vaccine approved by UK medicine regulator in world’s first

The UK have become the first country in the world to approve a next generation bivalent Covid-19 vaccine after a series of clinical trials led by researchers St George’s University Hospitals NHS Foundation Trust and the National Institute for Health and Care Research (NIHR).

Results from the trials indicated that the vaccine triggered a substantially more effective immune system response against the Omicron variant, when compared with some of the first vaccines.

As well as being effective against the Omicron variant and its sub-variants BA.4 and BA.5, the new jab also works against the original 2020 strain, ultimately giving people more comprehensive protection against the virus.

Dr Catherine Cosgrove, Chief Investigator for the study and Adult Lead at the Vaccine Institute at St George’s University Hospitals NHS Foundation Trust, said: "This is fantastic news for all of the participants and research staff involved in the Omicron booster study.

“The efforts from everyone who has taken part have helped provide extremely useful data when it comes to understanding how we can protect people against infections as we look towards the winter. Today's approval is a testament to all of the hard work of running the innovative study across the UK this year."

Researchers enlisted the help of more than 2,800 participants across 26 UK sites, with approval for the vaccine from the Medicines and Healthcare products Regulatory Agency (MHRA) coming earlier this week.

Side effects to the vaccine were described as “mild and self-resolving” with no serious safety concerns identified during the trials.

Dr June Raine, MHRA Chief Executive said: “I am pleased to announce the approval of the bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 variant as well as the original 2020 strain.

“The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.

“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this will include the vaccine approved today.”

The Joint Committee on Vaccination and Immunisation will now advise on how to deploy the vaccine ahead of the winter months.

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