UK regulators allow Moderna’s updated COVID-19 booster

LONDON — Britain’s medicines regulators have become the first in the world to authorize an updated version of Moderna’s coronavirus vaccine which aims to protect against the original virus and the Omicron variant.

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

Each dose of the booster will target both the original COVID-19 virus which was first detected in 2020 and the Omicron BA.1 variant which was first detected in November. UK regulators said side effects were similar to those seen for the original Moderna booster and were generally “mild and self-limiting”.

“What this (combined) vaccine gives us is a sharp tool in our arsenal to help protect us against this disease as the virus continues to evolve,” said Dr June Raine, head of the UK health body. regulation of health care and medicines.

Such an approach is used with influenza vaccines, which are adjusted annually based on circulating variants and can protect against four influenza strains.

Stephane Bancel, chief executive of Moderna, said in a statement that this was the first regulatory approval for a vaccine aimed at combating the Omicron variant, predicting the recall would have an “important role” to play in protecting patients. people against COVID-19 in winter. .

British health officials have yet to decide whether or not the modified vaccine will be used in its fall strategy. In July, the government said everyone aged 50 and over would receive a COVID booster in the fall.

On Friday, Germany’s health minister said the European Medicines Agency may authorize modified COVID-19 boosters next month.

In June, the US Food and Drug Administration told vaccine makers that any modified booster shots for the fall should include protection against the latest variants of Omicron, i.e. BA.4 and BA.5, not the BA.1 subvariant included in the latest Moderna release. shot.

Last month, the FDA said it was no longer considering allowing a second COVID-19 booster for all adults, but would instead focus on revamped vaccines for the fall that target new viral subvariants.

Read more: Why you shouldn’t wait for updated COVID-19 boosters

Moderna and Pfizer are currently preparing updated versions of their vaccine to include BA.5 in addition to the original COVID-19 virus.

According to the World Health Organization, the latest global outbreak of COVID-19 was caused by Omicron’s BA.5 subvariant, which is responsible for around 70% of virus samples shared with the largest database. of public viral data in the world. The BA.5 subvariant is even more infectious than the original omicron version and has some genetic differences that earlier vaccines may not resolve.

Scientists have warned that the continued genetic evolution of COVID-19 means drugmakers are likely to be one step behind the virus in their efforts to adapt their vaccines.

“The virus is unlikely to stand still and Omicron-targeted immunity could push the virus down other evolutionary pathways,” warned Jonathan Ball, professor of virology at Britain’s University of Nottingham. Still, he said the new Moderna vaccine would likely still be protective.

“Unless there is a major change in the virus, immunity will continue to protect the vast majority of severe disease caused by emerging variants,” he said in a statement.


AP Medical Writer Lauran Neergaard in Washington, DC contributed.

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