UK regulator first to authorize Moderna’s updated COVID booster

UK drug regulators are the first in the world to approve an updated version of Moderna’s coronavirus vaccine, which should protect against the original virus and 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 shot for adults.

Each dose of the booster injection targets both the original COVID-19 virus first detected in 2020 and the Omicron BA.1 variant first picked up in November. UK regulators said the side effects were similar to those of Moderna’s original booster injection and were mostly “mild and self-dissolving”.

“What this [combination] The vaccine gives us an honed tool in our arsenal to help protect us from this disease as the virus continues to evolve,” said Dr June Raine, the UK’s chief health and medicine regulator.

Such an approach is used with flu shots, which are adjusted annually to the variants in circulation and which can protect against four flu strains.

Stephane Bancel, the CEO of Moderna, said in a statement that it was the first regulatory authorization for a vaccine targeting the Omicron variant, and predicted the booster would play an “important role” in protecting people against COVID-19 in winter .

Fall Vaccines

UK health officials have not yet decided whether the modified vaccine will be used in its autumn strategy. In July, the government said anyone 50 and older could get a COVID booster in the fall.

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

The National Advisory Committee on Immunization (NACI) says it will provide more information this fall about what type of booster to offer when more information on multivalent vaccines becomes available. (Evan Mitsui/CBC)

In June, Canada’s National Advisory Committee on Immunization (NACI) recommended that only those at risk of serious illness from COVID-19 should receive a booster shot this fall in anticipation of a future surge, regardless of how many boosters they have. received earlier.

This recommendation applies to anyone aged 65 and over. NACI said people ages 12 to 64 can receive additional doses in the fall.

Many provinces and territories have already moved to offer four doses of the original vaccines this summer. NACI said it will make recommendations on the type of booster to be given when evidence on multivalent vaccines becomes available.

In June, the U.S. Food and Drug Administration told vaccine makers that any booster shots adjusted for the fall must contain protection against the latest Omicron variants, meaning BA.4 and BA.5, not the BA.1 subvariant which is included in Moderna’s latest 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 fall vaccines targeting the latest viral subvariants.

Both Moderna and Pfizer are currently brewing updated versions of their vaccine containing BA.5 alongside the original COVID-19 virus.

According to the World Health Organization, the latest global increase in COVID-19 has been caused by Omicron subvariant BA.5, which accounts for about 70 percent of virus samples shared with the world’s largest public virus database.

The BA.5 subvariant is even more contagious 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 drug manufacturers are likely to be one step behind the virus in their efforts to tailor their vaccines.

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

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

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