UK Becomes First Country To Approve Covid Vaccine Targeting Both Original Strain And Omicron Variant

Manufactured by the US firm Moderna, the vaccine targets the original coronavirus as well as the Omicron variant BA.1.

The UK on Monday became the first country to approve a Covid-19 vaccine that targets both the 2020 original strain and the Omicron variant of the novel coronavirus, the Medicine and Healthcare products Regulatory Agency (MHRA) said in a statement. Manufactured by the US firm Moderna, the bivalent vaccine targets the original coronavirus as well as the Omicron variant BA.1, which led to a spurt in cases in the UK last winter.

The MHRA said it had approved the vaccine for adult booster doses "after it was found to meet the UK regulator's standards of safety, quality and effectiveness" and to prompt a "strong immune response" against both strains.

The bivalent vaccine, 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.

Data from clinical trials showed that a booster with the bivalent Moderna vaccine triggered a strong immune response against both Omicron (BA.1) and the original 2020 strain. The vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.

The most recent Covid wave in the UK was fuelled by the BA.4 and BA.5 Omicron variants. It also caused breakthrough reinfections and deaths.

Side effects of the bivalent vaccine were the same as those seen for the original Moderna booster dose and were typically "mild and self-resolving", and no serious safety concerns were identified.

"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," Dr June Raine, MHRA chief executive, said in a statement.

"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," Dr Raine further said.