UK first to approve Omicron COVID shot with Moderna nod

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

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  • UK JCVI supports use of bivalent shot in autumn booster campaign
  • Moderna sees approvals soon for Australia, Canada and the EU

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

The British drug regulator (MHRA) on Monday granted conditional approval to the so-called bivalent vaccine from the American drug company Moderna (MRNA.O) as a booster for adults.

Hours later, the country’s Joint Vaccination and Immunization Committee (JCVI) recommended that all adults in the UK be offered boosters this fall. read more

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

Moderna said in June that trial data showed that when given as a fourth dose, the variant-modified injection increased virus-neutralizing antibodies against Omicron by an eight-fold. read more

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

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

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

No serious safety issues were identified with the new Moderna formulation, the MHRA added Monday.

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

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

“What this bivalent vaccine gives us is an honed tool in our arsenal to help protect us against this disease as the virus continues to evolve.”

FURTHER APPROVALS

European Medicines Agency (EMA) officials expect the vaccines adapted to the COVID variant to be approved in the European Union by September, and have indicated that the regulator is open to the use of injections targeting the older BA this fall. 1 variant, as they specifically target newer sub-variants. further behind in clinical development.

In contrast, the U.S. Food and Drug Administration (FDA) has said it will aim to specifically include Omicron’s newer BA.4 and BA.5 offshoots in new shots used domestically.

On Monday, the head of the Serum Institute of India — which produces 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 more

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

Pfizer Inc (PFE.N) and BioNTech (22UAy.DE) also tested versions of their mRNA vaccine modified to fight Omicron variants.

Meanwhile, Sanofi (SASY.PA) and partner GSK (GSK.L) are working on a protein-based vaccine targeting the Beta subvariant, which dominated for some 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 Standards: The Thomson Reuters Trust Principles.

The Valley Voice
The Valley Voicehttp://thevalleyvoice.org
Christopher Brito is a social media producer and trending writer for The Valley Voice, with a focus on sports and stories related to race and culture.

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