Moderna vaccine adapted to Ômicron receives 1st approval in the UK

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The UK, the first country to approve a coronavirus vaccine in late 2020, has now also given the first green light for a version of the vaccine adapted to the virus. Omicron variant . The immunizer targets both the original version of SARS-CoV-2 and the highly transmissible strain of the virus.

The UK drug regulator (MHRA) gave the so-called bivalent vaccine made by US pharmaceutical company Moderna conditional approval as an adult booster on Monday.

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

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

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In June, Moderna said trial data showed that when given as a fourth dose, the variant-adapted vaccine increased virus-neutralizing antibodies against Omicron by eightfold.

The MHRA also cited an exploratory analysis in which the application generated a “good immune response” against the currently dominant Omicron sublines BA.4 and BA.5.

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

No serious safety events have been identified with Moderna’s new formulation, the MHRA added on Monday.

The UK government said last month that a booster vaccine program would start in “early autumn” and that vaccines would be offered to people over 50, individuals in clinically at risk groups. , frontline workers and nursing home workers.

While existing Covid-19 vaccines continue to provide good protection against hospitalization and death, vaccine effectiveness has been affected as the virus has evolved.

“The first generation of 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 a sharp tool in our arsenal to help us protect against this disease as the virus continues to evolve.”

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

other approvals

European Medicines Agency (EMA) experts say they expect vaccines adapted to the Ômicron variant to be approved in the European Union by September and have signaled that the regulator is open to using injections targeting the older BA.1 variant this fall. , as those specifically targeting the newer subvariants are further behind in clinical development.

In contrast, the US Food and Drug Administration (FDA) has stated that it will seek specific inclusion of the new BA.4 and BA.5 branches of Ômicron in any new vaccines used domestically.

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

Pfizer and BioNTech are also testing versions of their mRNA vaccine modified to combat subvariants of Omicron.

Meanwhile, Sanofi and partner GSK are working on a protein-based vaccine that targets the Beta subvariant, which dominated for some time last year.

Source: CNN Brasil

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