UK drug regulators have become the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that aims to protect against the original virus and the Omicron variant. In a statement on Monday, the Medicines and Healthcare products Regulatory Agency said it had given the green light to Moderna’s combination “bivalent” vaccine, which will be used as a booster shot for adults. Each dose of the booster will target both the original COVID-19 virus first identified in 2020 and the omicron BA.1 variant first obtained in November. British regulators said the side effects were similar to those seen for Moderna’s original booster shot and were typically “mild and self-limiting.” “What this (combination) vaccine gives us is a sharpened tool in our arsenal to help us protect against this disease as the virus continues to evolve,” said Dr June Raine, head of the regulator’s health and the drugs of britain. Such an approach is used with flu vaccines, which are adjusted each year based on circulating variants and can protect against four strains of flu. Stephane Bancel, CEO of Moderna, said in a statement that it was the first regulatory approval for a vaccine targeting the omicron variant, predicting that the booster will play an “important role” in protecting people against COVID-19 in the winter . . Britain’s health officials have not yet decided whether or not the modified vaccine will be used in its autumn strategy. In July, the government said everyone 50 and over would get a COVID booster in the fall. On Friday, Germany’s health minister said the European Medicines Agency may clear modified COVID-19 boosters next month. In June, the US Food and Drug Administration told vaccine manufacturers that any booster vaccines modified for the fall should include protection against the newer variants of omicron, namely BA.4 and BA.5, not the BA.1 subvariant included in the latest version of Moderna shot. Last month, the FDA said it was no longer considering approving a second COVID-19 booster for all adults, but would instead focus on revamped vaccines for the fall that target newer viral subtypes. Both Moderna and Pfizer are currently making updated versions of their vaccine to include BA.5 in addition to the original COVID-19 virus. According to the World Health Organization, the most recent global increase in COVID-19 is due to the BA.5 omicron subvariant, which is responsible for about 70% of virus samples shared with the world’s largest public virus database. The BA.5 subvariant is even more virulent than the original version of omicron and has some genetic differences that previous vaccines may not address. Scientists have warned that the ongoing genetic evolution of COVID-19 means that drugmakers will likely be one step behind the virus in their efforts to adapt their vaccines. “The virus is unlikely to stand still, and the immunity targeted by Omicron may push the virus down other evolutionary paths,” warned Jonathan Ball, professor of virology at Britain’s University of Nottingham. However, he said the new Moderna vaccine will likely still be protective. “Unless there is a major change in the virus, immunity will continue to protect the vast majority from serious disease caused by emerging variants,” he said in a statement. AP Medical Writer Lauran Neergaard in Washington, DC contributed
