UK regulator allows Moderna’s updated COVID-19 booster kit

LONDON – 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 Omicron variant.

In a statement on Monday, the Health Care and Drug Administration said it had given the green light to Moderna’s “bivalent” combination vaccineto be used as a booster shot for adults.

Each booster dose will target both the original COVID-19 virus first detected in 2020 and the Omicron BA.1 variant first detected in November. UK regulators say known side effects are similar to those seen for Moderna’s original booster and are usually “mild and resolve on their own.”

Dr June Raine, head of the UK’s medicines and healthcare regulator, said: “What this (combined) vaccine gives us is a sharp tool in the UK’s arsenal. us to help protect us against this disease as the virus continues to grow.

Such an approach is used with flu shots, which are adjusted each year depending on the variants circulating and can protect against four strains of flu.

Stephane Bancel, CEO of Moderna, said in a statement that this is the first regulatory authorization for a vaccine aimed against the Omicron variant, predicting that the booster will have “important role” in protecting people against COVID-19 in the winter. .

British health officials have yet to decide whether the modified vaccine will be used in the country’s autumn strategy. In July, the government said everyone aged 50 and over would get a COVID booster shot in the fall.

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

In June, the US Food and Drug Administration told vaccine manufacturers that any Enhanced photo refined for fall would have to include protection against the latest Omicron variants, ie BA.4 and BA.5not the BA.1 subvariable in Moderna’s latest image.

Last month, the FDA said it was no longer considering a second COVID-19 booster authorization for all adults but would instead focus on improved fall vaccines aimed at latest virus subtype.

Read more: Why you shouldn’t wait for the COVID-19 Boosters update

Both Moderna and Pfizer are are now producing updated versions of their vaccines including BA.5 in addition to the original COVID-19 virus.

According to the World Health Organization, the latest global increase in COVID-19 is driven by the Omicron subvariant BA.5, which is responsible for about 70% of virus samples shared with the microbiological database. The world’s largest public withdrawal. The subvariant BA.5 is even more infectious than the parent version of omicron and has some genetic differences that earlier vaccines may not have resolved.

Scientists have warned that COVID-19’s continued genetic evolution means drug makers may be one step behind the virus in their efforts to tailor vaccines.

Jonathan Ball, professor of virology at the UK’s University of Nottingham, warned: “The virus’s inability to stand still, and immunity targeting Omicron, could push the virus down other evolutionary pathways. However, he said the new Moderna vaccine still offers protection.

“Unless there is a major change in the virus, immunity will continue to largely protect against serious diseases caused by emerging variants,” he said in a statement.


AP Medical Writer Lauran Neergaard of Washington, DC contributed.

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