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The UK is the first to approve the Omicron Covid shot with modern approval

The UK is the first to approve the Omicron Covid shot with modern approval
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A nurse prepares a dose of the modern coronavirus disease (COVID-19) vaccine at Glangwillie General Hospital in Carmarthen, Wales, Britain, April 7, 2021. Jacob King/Poole via REUTERS

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  • UK JCVI to determine how shots should be deployed
  • The UK launched another Covid booster program in the autumn
  • Moderna sees Australia, Canada, EU approvals soon

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

The UK Medicines Regulator (MHRA) has approved a so-called bivalent vaccine made by the US drug company Moderna. (mRNA.O) Conditional approval as a booster for adults on Monday.

Britain’s Joint Committee on Vaccination and Immunization (JCVI) is now expected to soon issue a recommendation on how the vaccine should be deployed in the country.

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The MHRA’s decision was based on clinical trial data showing that the booster triggered “a strong immune response” against both Omicron (BA.1) and the original 2020 virus, it said.

Moderna said in June that test data showed that when given as a fourth dose, the variant-adapted shot boosted virus-neutralizing antibodies against Omicron eightfold. Read more

The MHRA also cited an exploratory analysis that found the shot to produce a “good resistance” against the currently dominant Omicron branches BA.4 and BA.5.

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

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

No serious safety concerns have been identified with the new modern formulation, the MHRA added on Monday.

The UK government said last month that a vaccine booster program would start “in early autumn” and those shots would be given to over-50s, people in clinical risk groups, frontline workers and care home staff. Read more

Although existing COVID-19 vaccines offer good protection against hospitalization and death, vaccine efficacy has been affected as the virus evolves.

“First-generation COVID-19 vaccines in the UK continue to provide vital protection against the disease and save lives,” June Raine, chief executive of the MHRA, said in a statement.

“What this bivalent vaccine gives us is a sharp tool in our armor that will help protect us against this disease as the virus continues to evolve.”

The UK Health and Safety Agency (UKHSA), which oversees vaccine procurement among other duties, did not immediately respond to a request for comment.

More approvals

European Medicines Agency (EMA) officials expect modified vaccines for COVID to be approved in the European Union by September, and have indicated that the regulator is open to using shots targeting older BA.1 vaccines this fall, specifically targeting new subvariants. Further lag in clinical development.

In contrast, the US Food and Drug Administration (FDA) said it would require specific inclusion of Omicron’s new BA.4 and BA.5 branches in any new shots used internally.

On Monday, the head of India’s Serum Institute — which makes 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 earlier this year signed a 1 billion pound ($1.2 billion) deal 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 European Union. coming week

Pfizer Inc. (PFE.N) and biotech (22UAy.DE) Omicron is also testing modified versions of their mRNA vaccine to combat the variant.

Meanwhile, Sanofi (SASY.PA) and partner GSK (GSK.L) is working on a protein-based vaccine that targets the beta subvariant, which dominated for a time last year.

($1 = 0.8270 pounds)

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

Our values: Thomson Reuters Trust Policy.

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