U.K. clears vaccine tailored to Omicron

The U.K. has granted the world’s first approval for a COVID-19 vaccine targeting a variant in a bid to sharpen its response to an evolving coronavirus.

The country’s Medicines and Healthcare products Regulatory Agency cleared Moderna Inc.’s bivalent mRNA booster vaccine for adults, according to a statement Monday, in a move paving the way for it to potentially form part of Britain’s fall booster campaign.

Moderna’s bivalent shot targets two strains — half of the dose works against the original version of the coronavirus, while the other half protects against BA.1, an early version of the Omicron variant that fuelled new COVID infections last winter.

The existing shots currently widely used around the world have been developed based on the original wild-type coronavirus that emerged in the central Chinese city of Wuhan.

“What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve,” said June Raine, chief executive officer of the MHRA, which was also the first regulator in the world to approve a COVID vaccine.

The MHRA said data from a clinical trial showed that a booster with the bivalent Moderna vaccine triggered a strong immune response against both Omicron BA.1 and the original 2020 strain.

It added that an exploratory analysis showed the updated shot also generated a good immune response against the latest Omicron subvariants BA.4 and BA.5, which have emerged as the dominant strains across many countries.

Nations around the world have rolled out booster shots since early this year to shore up protection against Omicron.

As the virus has mutated, it has been able to sidestep immunities generated by existing shots and has caused more breakthrough infections, though most only resulted in mild disease.

Developers of some of the world’s most widely used COVID shots, ranging from Pfizer Inc. and Moderna to China’s Sinovac Biotech Ltd. to Sinopharm, have since started developing new shots targeting Omicron.

The U.K. is planning another round of booster shots for anyone aged 50 or above and those with weak immune systems in the fall to boost protection against the latest circulating variants among vulnerable groups. The MHRA said the country’s joint committee on vaccination and immunization will advise on any potential rollout of a bivalent shot.

Moderna has submitted admissions with regulators in the EU, Australia and Canada for this bivalent booster.

In the U.S., the government has inked a deal with Moderna to secure 66 million doses of another bivalent booster that targets the BA.4 and BA.5 Omicron subvariants. A panel of experts advising the U.S. Food and Drug Administration in June recommended the inclusion of an Omicron-specific element to existing COVID shots to help prepare the country against a potential surge later this year.