UK first to confirm Omicron COVID shot with Moderna nod

A nurse at Glangwili General Hospital in Carmarthen, Wales, England prepares a dose of Moderna coronavirus disease (COVID-19) vaccine, April 7, 2021. via Jacob King/Pool, REUTERS

LONDON, August 15 (Reuters) – The UK, which was the first country to approve a coronavirus vaccine in late 2020, has now given the first green light for a variant-adapted vaccine targeting both the original and Omicron version of the virus.

The UK drug regulator (MHRA) has awarded the so-called bivalent vaccine made by the US pharmaceutical company Moderna. (MRNA.O) Conditional approval as support for adults on Monday.

Later on Monday, the UK’s Joint Committee on Vaccination and Immunization (JCVI) supported the use of the variant-adapted vaccine in the country’s support campaign that began in September.

The MHRA’s Moderna decision was based on clinical trial data showing that the enhancer triggered a “strong immune response” against both Omicron (BA.1) and the original virus.

In June, Moderna said trial data showed that the variant-adapted shot increased virus-neutralizing antibodies to Omicron eightfold when given as a fourth dose. Read more

The MHRA also cited an exploratory analysis that found the vaccine to elicit a “good immune response” against the already dominant Omicron branches BA.4 and BA.5.

According to Moderna, trial data showed that the variant-adapted enhancer produced virus-neutralizing antibody levels against sub-variants that were 1.69 times higher than those given the original enhancer.

However, the relationship between neutralizing antibody levels and vaccine efficacy against disease – particularly severe illness – remains unclear.

The MHRA added on Monday that no serious safety concerns were identified in the new Moderna formulation.

While existing COVID-19 vaccines continue to provide good protection against hospitalization and death, the effectiveness of the vaccine has taken a hit as the virus evolves.

“What this bivalent vaccine is giving us is a sharpened tool in our arsenal to help protect us against this disease as the virus continues to evolve,” MHRA Chief Executive Officer June Raine said in a statement. she said.

Jonathan Ball, professor of molecular virology at the University of Nottingham, however, added that the virus is unlikely to remain dormant, and Omicron-targeted immunity could push the virus into other evolutionary pathways.

“In that case we’ll be like Alice and the Red Queen in the Mirror – we’ll have to keep running to stay in the same place.”

ADDITIONAL APPROVALS

European Medicines Agency (EMA) officials expect vaccines adapted for the COVID variant to be approved in the European Union by September, signaling that the regulator is open to using vaccines targeting the older BA. lagging behind in clinical development.

In response, the U.S. Food and Drug Administration (FDA) said it will seek specific inclusion of the new BA.4 and BA.5 branches of Omicron in any new vaccines used domestically.

On Monday, the head of the Serum Institute of India, which produces AstraZeneca’s COVID-19 vaccine under the Covishield brand, said he expects an Omicron-specific vaccine in the country within six months, NDTV reported. Read more

Moderna, which signed a £1bn ($1.2bn) deal with the British government earlier this year to build the country’s first mRNA vaccine facility, said Monday it expects further approvals for the adapted vaccine in Australia, Canada and the EU. next weeks.

Pfizer Inc. (PFE.N) and BioNTech (22UAy.DE) They are also testing versions of mRNA vaccines that have been modified to combat Omicron variants.

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Reporting Editing in London by Natalie Grover by David Goodman, Mark Potter and Marguerita Choy

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