British health authorities, on August 15, 2022, authorised the use of Moderna’s Omicron variant-specific COVID-19 vaccine booster for adults, the first country to do so. The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval to Moderna’s bivalent vaccine, Spikevax, which combines mRNA sequences that code for the SARS-CoV-2 spike protein from both the original and the Omicron BA.1 variant.
The U.K. government had, in July, said all adults over 50 would be offered a COVID-19 vaccine booster dose (no vaccine was specified) in the autumn.
The vaccine provided a “strong immune response” against the original strain of the virus as well as the BA.1 strain, MHRA Chief Executive June Raine said in a statement.
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“Like all medicines, the vaccine can cause side effects, although not everybody gets them,” said a patient information sheet on Spikevax, published by the UK government. Included in the possible side effects are an increased risk of myocarditis/pericarditis (inflammation of the heat muscle/ pericardium , the lining around the heart). A few cases of capillary leak syndrome (CLS), i.e., the leakage of fluid from small blood vessels, have also been reported.
“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,” Ms Raine said.
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