UK first to approve Omicron COVID shot with Moderna nod

A nurse prepares a dose of the modern coronavirus disease (COVID-19) vaccine at Glangvilly General Hospital in Carmarthen, Wales, Britain, on April 7, 2021. Jacob King/Pool via REUTERS

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  • UK’s JCVI to decide how to deploy the shot
  • The UK is launching 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 targeting the original and Omicron version of the virus.

The UK medicines regulator (MHRA) 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 Immunization and Immunization (JCVI) is now expected to soon issue recommendations on how to deploy the vaccine in the country.

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

Moderna said in June that trial data showed that the variant-adapted shot raised virus-neutralizing antibodies against Omicron eightfold when the fourth dose was given. Read on

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

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

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

The MHRA added on Monday that it had not identified any serious safety concerns with the new Moderna formulation.

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

While existing COVID-19 vaccines offer good protection against hospitalization and death, vaccine effectiveness has been severely compromised as the virus evolves.

“The first generation of Covid-19 vaccines to be used in the UK are providing significant protection against the disease and saving lives,” MHRA chief executive Jun Ren said in a statement.

“What this bivalent vaccine gives us is a sharp tool in our arsenal to help protect us against this disease as the virus evolves.”

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

Further approvals

European Medicines Agency (EMA) officials expect approval of Covid variant-adapted vaccines in the European Union by September, and the regulator has indicated it is open to using shots targeting the old BA.1 variant this fall, specifically targeting new subvariants. Further behind in clinical development.

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

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

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 expected further approvals for the adapted vaccine in Australia, Canada and the EU. weeks to come.

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

Meanwhile, Sanofi (SASY.PA) and partner GSK (GSK.L) For some time in the past year they have been working on a protein-based vaccine targeting the dominant beta subvariant.

($1 = 0.8270 pounds)

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

Our Standards: Principles of Thomson Reuters Trust.

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