ADC Reviews

UK approves first Omicron bivalent vaccine


On August 15, the UK Medicines and Health Products Administration (MHRA) approved the bivalent vaccine mRNA-1273.214 produced by Moderna against both the Omicron variant BA.1 and the original strain of the new crown. This is the world’s first approved booster vaccine against the Omicron variant.

The mRNA-1273.214 vaccine is an upgraded version of the Moderna vaccine, which is already in use and is divided into the first, second and booster doses. This will be the first dose of the vaccine approved in the UK for both virus strains. Moderna’s chief medical officer, Dr. Paul Burton, has previously said the new vaccine can boost a person’s antibodies to such high levels that it may only require an injection once a year.

Moderna chief executive Stephane Bancel said it was a “next-generation Covid-19 vaccine” that would “play an important role in protecting Britons from Covid-19 over the winter”. Bancel said: “We are delighted that the MHRA has approved our next-generation Covid-19 vaccine, Spikevax Bivalent Original/Omicron.

Bancel added that this was the first bivalent vaccine approved for Omicron, further underscoring the leadership role of Public Health England in helping to end the outbreak. Bancel said: “This bivalent vaccine has played an important role in protecting Britons from Covid-19 as we head into winter. In clinical trials, the injectable vaccine’ has consistently shown wider coverage than other alternative vaccines. immune response’.”

The new coronavirus is an RNA virus, which is prone to errors in the process of virus replication, resulting in virus mutation. Since the outbreak of the new crown epidemic in early 2020, there have been four widely prevalent main variants of Alpha, Beta, Delta and Omicron and a large number of non-widely prevalent variants, which have resulted in waves of ups and downs and repetitions of the global epidemic.

The approval is based on Phase II/III clinical data of the mRNA-1273.214 vaccine, which both met the primary endpoint. Vaccinated with mRNA-1273.214 as a booster, the recipients were able to generate a strong immune response against the Omicron BA.1 variant and the original SARS-CoV-2 strain. At the same time, a small sample study also found that the vaccine can produce a good immune response to the Omicron variant BA.4 and BA.5 that are circulating around the world.

This autumn and winter, the British government will arrange for some residents to be injected with the mRNA-1273.214 vaccine as a booster shot. Moderna has also submitted the vaccine to the governments of Australia, Canada and the European Union for review. The EU is expected to approve the vaccine for use by September.