UK regulator gives Moderna conditional approval for Omicron-specific vaccine

Britain, the first country to approve a coronavirus vaccine in late 2020, has now given the green light to a variant-adapted shot that targets both the original and Omicron version of the virus.

The bivalent vaccine made by the U.S. drug company Moderna conditional approval was given by the UK medicines regulator MHRA as a booster for adults on Monday.

Britain's Joint Committee on Vaccination and Immunisation JCVI is expected to issue a recommendation soon on how the vaccine should be deployed in the country.

The MHRA's decision was based on clinical trial data that showed the booster triggered a strong immune response against Omicron BA. It said that it was 1 and the original 2020 virus.

Moderna said in June that the variant-adapted shot raised virus-neutralizing antibodies by eight-fold against Omicron when given as a fourth dose.

The MHRA cited a exploratory analysis in which the shot was found to generate a good immune response against the currently dominant Omicron offshoots BA. Trial data showed that Moderna's variant-adapted booster generated virus-neutralizing antibody levels against the subvariants that were 1.69 times higher than those given the original booster.

There is no correlation between neutralizing antibody levels and vaccine effectiveness against disease, in particular severe disease.

The MHRA added on Monday that no serious safety concerns were identified with the new Moderna formulation.

The UK government said last month a vaccine booster programme would begin in early autumn and that shots would be offered to over 50 s, individuals in clinical risk groups, frontline workers and care homes staff.

While existing COVID 19 vaccines continue to provide good protection against hospitalization and death, the effectiveness of vaccine has taken a hit as the virus has evolved.

MHRA Chief Executive June Raine said in a statement that the first generation of COVID 19 vaccines being used in the UK continue to provide important protection against the disease and save lives.

As the disease continues to evolve, this bivalent vaccine gives us a sharpened tool in our armoury to protect us against this disease. The UK Health and Security Agency, UKHSA, which oversees vaccine procurement and other responsibilities, did not respond to a request for comment.

European Medicines Agency EMA officials expect COVID variant-adapted vaccines to be approved in the European Union by September, and have signalled that the regulator is open to using shots targeting the older BA. The 1 variant this autumn, targeted newer subvariants, is further behind in clinical development.

The U.S. Food and Drug Administration FDA has said it will seek the inclusion of the newer BA. 5 of the 5 offshoots of Omicron in any new shots used domestically.

On Monday, the chief of the Serum Institute of India -- a company that produces AstraZeneca's COVID 19 vaccine under the brand Covishield -- said he expected an Omicron-specific vaccine in the country in six months. Moderna expects to approve further approvals for the adapted vaccine in Australia, Canada, and the EU in the coming weeks, as it signed a 1 billion pound $1.2 billion deal with the British government to build the country's first mRNA vaccine facility earlier this year.

Pfizer Inc. and BioNTech have also been testing versions of their mRNA vaccine modified to combat Omicron variants.

Sanofi and partner GSK are working on a protein-based vaccine that targets the Beta subvariant, which dominated for some time last year.