The UK has become the first country to approve a COVID vaccine that targets both the original strain and the Omicron variant.
The Moderna jab was given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.
The booster dose, known as “Spikevax bivalent Original/Omicron”, contains 25 micrograms of Omicron vaccine and 25 micrograms of original coronavirus vaccine.
A vaccine that works for two infections is known as bivalent.
The Joint Committee on Vaccination and Immunisation will advise on how the deployment of the jab is handled.
The vaccine has also been submitted for approval with the authorities in Australia, Canada and the EU.
It is expected that the EU will approve the dose by September.
Dr June Raine, chief executive of the MHRA, said: “I am pleased to announce the approval of the Moderna 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.”
Stephane Bancel, chief executive of Moderna, described the jab as a “next generation COVID-19 vaccine” that will play an “important role in protecting people in the UK from COVID-19” over the winter.
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“We are delighted with the MHRA’s authorisation of Spikevax Bivalent Original/Omicron, our next generation COVID-19 vaccine,” Mr Bancel said.
“This represents the first authorisation of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the COVID-19 pandemic.
“This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months.”
Mr Bancel said the jab has “consistently shown superior breadth of immune response” over alternatives in clinical trials.
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The government’s independent science advisory body the Commission on Human Medicines also approved the jab.
Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines said it had “independently reviewed the data on safety, quality and effectiveness and agrees with the MHRA’s decision”.
He said: “The virus, SARS-CoV-2, is continually evolving in order to evade the immunity provided by vaccines. This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine.”
According to the latest data, 126,504,756 vaccine doses have been administered in the UK.
This includes 45,188,570 first doses, 42,520,292 second doses, and 33,436,351 third or booster doses, as of 10 August.