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UK first approves Omicron COVID shot with Moderna

UK first approves Omicron COVID shot with Moderna
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A nurse prepares a dose of the Moderna coronavirus disease (COVID-19) vaccine at Glangvilly General Hospital in Carmarthen, Wales, United Kingdom on April 7, 2021. Jacob King/Pool via REUTERS

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  • The UK JCVI supports the use of bivalent shooting in the autumn booster campaign
  • Moderna sees Australia, Canada, EU approvals coming soon

LONDON, Aug 15 (Reuters) – Britain, the first country to approve a coronavirus vaccine in late 2020, has also given the first green light to a shot adapted to a variant that targets both the original and Omicron versions of the virus.

The UK medicines regulator (MHRA) has approved a bivalent vaccine developed by the US drug company Moderna. (MRNA.O) conditional approval as an adult booster on Monday.

On Monday, the UK’s Joint Committee on Vaccines and Immunization (JCVI) backed the use of the variant-adapted shot in the country’s booster campaign starting in September.

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

Moderna said in June that trial data showed that the variant injection boosted virus-neutralizing antibodies against Omicron eightfold when given as the fourth dose. read more

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

According to Moderna, test data showed that its variant-adapted booster had 1.69 times higher virus-neutralizing antibody levels against the subvariants than the original booster.

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

The MHRA added on Monday that no serious safety concerns had been identified with the new Moderna formulation.

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

“What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve,” MHRA chief executive June Raine said in a statement.

Jonathan Ball, professor of molecular virology at the University of Nottingham, added that it is unlikely that the virus will stand still, and that Omicron-targeted immunity could push the virus down other evolutionary paths.

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

ADDITIONAL APPROVALS

European Medicines Agency (EMA) officials expect vaccines adapted to the COVID variant to be approved in the European Union by September, and the regulator has said it is open to using shots targeting the older BA.1 variant this fall, given those targeting the new subvariants. lags behind in clinical development.

In contrast, the US Food and Drug Administration (FDA) has said it will seek to specifically include Omicron’s newer BA.4 and BA.5 arms in any new shots used domestically.

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

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

Pfizer Inc (PFE.N) and BioNTech (22UAy.DE) They are also testing versions of the mRNA vaccine modified to fight the Omicron variants.

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

Our standards: Thomson Reuters Trust Principles.

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