MHRA approves Moderna’s bivalent Covid booster  

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s Covid-19 booster vaccine that targets two coronavirus variants. 

Moderna’s ‘Spikevax’ booster dose targets the original coronavirus strain as well as the Omicron variant. Known as a bivalent vaccine, Spikevax was approved following data that show it triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain1 

The booster dose was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5. 

No serious safety issues were reported during the trial and most side effects were mild and self-resolving.  

Official comments  

Dr June Raine, MHRA Chief Executive, 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. 

“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.” 

“We are delighted with the MHRA’s authorisation of Spikevax Bivalent Original/Omicron, our next-generation Covid-19 vaccine. 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,” said Stéphane Bancel, Chief Executive Officer of Moderna.  

“mRNA-1273.214 has consistently shown superior breadth of immune response over mRNA-1273 in clinical trials. This bivalent vaccine has an important role to play in protecting people in the UK from Covid-19 as we enter the winter months.” 



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