UK regulators first OK with Moderna’s updated COVID booster

The UK’s pharmaceuticals regulator has approved the world’s first updated version of Moderna’s coronavirus vaccine, which is intended to protect against the original virus and Omicron variants.

In a statement Monday, the Drugs and Healthcare Regulatory Agency said it had given the green light to Moderna’s combined “bivalent” vaccine, which will be used as a booster shot in adults.

Each booster shot dose targets both the original COVID-19 virus, first detected in 2020, and the Omicron BA.1 variant, first detected in November. UK regulators said the side effects were similar to those seen with Moderna’s first booster shot and were typically “mild and self-resolving”.

Dr June Lane, head of the UK’s health care and medicines regulator, said: “What this (combined) vaccine gives us will help protect us from this disease as the virus continues to evolve. It’s a honed tool in your arsenal.

Such an approach is used in influenza vaccination. Vaccination can be adjusted annually according to the circulating variant and protect against four influenza strains.

Moderna CEO Stephan Bancel said in a statement that this is the first regulatory approval of a vaccine aimed at combating the Omicron subspecies, and the booster will protect people from COVID-19 in the winter. It is predicted that it will “play an important role” in doing so.

UK health officials have yet to decide whether the fine-tuned vaccine will be used in the autumn strategy. Announced.

On Friday, Germany’s health minister said the European Medicines Agency could clear a fine-tuned COVID-19 booster next month.

In June, the U.S. Food and Drug Administration told vaccine makers that booster shots tailored for the fall would include the latest, meaning BA.4 and BA.5, rather than the BA.1 subvariant included in the latest version of Moderna. Schott.

Last month, the FDA no longer considered approving a second COVID-19 booster for all adults, but instead opted for an improved vaccine for the fall targeting the latest virus subvariant. He said he would focus.

Moderna and Pfizer are now creating an updated version of the vaccine that includes BA.5 in addition to the original COVID-19 virus.

According to the World Health Organization, the latest global surge in COVID-19 is caused by the omicron subvariant BA.5, which accounts for approximately 70% of shared virus samples in the world’s largest public virus database. The subvariant BA.5 is even more infectious than the original version of omicron and has some genetic differences that early vaccines cannot address.

Scientists warn that COVID-19’s continued genetic evolution means drug companies are one step behind the virus in their efforts to tailor a vaccine.

Jonathan Ball, professor of virology at the University of Nottingham in the UK, warned that “the virus is unlikely to be quiescent, and omicron-targeted immunity could push the virus down other evolutionary pathways.” Still, he said the new Moderna vaccine is likely still protective.

“As long as the virus doesn’t change significantly, immunity will continue to protect the majority from severe illness caused by new variants,” he said in a statement.

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