Britain, the first country to approve a coronavirus vaccine in late 2020, has now given the first green light to a vaccine adapted to a variant that targets both the original and Omicron versions of the virus. The UK medicines regulator (MHRA) gave the so-called bivalent vaccine produced by the US pharmaceutical company Moderna conditional approval as a booster for adults on Monday. Britain’s Joint Committee on Vaccination and Immunization (JCVI) is now expected to issue a recommendation soon on how the vaccine should be developed in the country. The MHRA’s decision was based on clinical trial data that showed the booster elicited “a robust immune response” against both Omicron (BA.1) and the original 2020 virus, it said. Moderna in June said trial data showed that when given as a fourth dose, the modified vaccine raised virus-neutralizing antibodies against Omicron eightfold. The MHRA also cited an exploratory analysis in which the shot was found to generate a “good immune response” against the currently dominant Omicron BA.4 and BA.5 offshoots. According to Moderna, test data showed that its variant-adapted booster generated levels of virus-neutralizing antibodies against the sub-variants that were 1.69 times higher than those who received the original booster. However, the correlation between levels of neutralizing antibodies and vaccine effectiveness against disease – particularly severe disease – remains unclear. No serious safety concerns were identified with the new Moderna formulation, the MHRA added on Monday. The UK government said last month a vaccine boost program would start in the “early autumn” and that vaccines would be offered to people over 50, people in clinical risk groups, frontline workers and care home staff. While existing vaccines for COVID-19 still provide good protection against hospitalization and death, vaccine effectiveness has taken a hit as the virus has evolved. “The first generation of COVID-19 vaccines used in the UK continue to provide important protection against the disease and save lives,” said MHRA chief executive June Raine. “What this bivalent vaccine gives us is a sharpened tool in our arsenal to help us protect against this disease as the virus continues to evolve.” The UK Health and Safety Executive (UKHSA), which oversees the supply of vaccines among other responsibilities, did not immediately respond to a request for comment. European Medicines Agency (EMA) officials expect vaccines adapted to the COVID-19 variant to be approved in the European Union by September, and have indicated the regulator is open to using shots targeting the older BA.1 variant this year fall, given those specifically targeting younger Subvariants are further back in clinical development. Instead, the US Food and Drug Administration (FDA) said it would seek specific inclusion of Omicron’s newer BA.4 and BA.5 offshoots in any new vaccines used domestically. On Monday, the head of the Serum Institute of India – which makes AstraZeneca’s COVID-19 vaccine under the brand name Covishield – said he expected an Omicron-specific vaccine in the country in six months, NDTV reported. Moderna, which 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, said on Monday it expects further approvals for the tailored vaccine in Australia, Canada and the EU in the coming weeks. Pfizer Inc and BioNTech are also testing versions of their mRNA vaccine that have been modified to fight the Omicron variants. Meanwhile, Sanofi and partner GSK are working on a protein-based vaccine that targets the Beta subvariant, which dominated for some time last year. Sign up for it Fact sheet on the coronavirus to read the day’s top coronavirus news, features and explanations written by Globe reporters and editors.
