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UK first to approve COVID vaccine for Omicron

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UK, the first to ratify coronavirus Vaccines in late 2020, now also for the original vaccine and Omicron virus version.

Britain’s Medicines Regulatory Agency (MHRA) on Monday gave conditional approval to a so-called bivalent vaccine made by US drug company Moderna as a booster for adults.

The UK’s Joint Committee on Vaccinations and Immunisation (JCVI) is now expected to make recommendations soon on how to deploy vaccines in the country.

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

Moderna said in June that trial data showed that the mutant-adapted injection boosted virus-neutralizing antibodies against Omicron eight-fold when administered as a fourth dose.

The MHRA also cited an exploratory analysis in which the vaccine was found to generate favorable immune responses against the currently dominant Omicron branches, BA.4 and BA.5.

The agency added that no serious safety concerns were identified with the new formulation.

The UK government said last month that a vaccine booster programme would begin in “early autumn” to provide vaccines to individuals in their 50s, in clinical risk groups, frontline workers and nursing home workers.

Although there is Coronavirus disease Vaccines continue to provide good protection against hospitalizations and deaths, but their effectiveness has taken a hit as the virus has progressed.

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

“This bivalent vaccine gives us a sharp tool in our arsenal to help protect us from 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.

European Medicines Agency (EMA) officials expect a vaccine adapted to the COVID variant to be approved in the EU in September, saying regulators are willing to use a vaccine against the older BA. New sub-variant vaccines are further behind clinical development.

In contrast, the US Food and Drug Administration (FDA) said it would seek to specifically incorporate Omicron’s new BA.4 and BA.5 branches in any new lenses used domestically.

In addition to Moderna, partners Pfizer and BioNTech have also been testing versions of their mRNA vaccines against the Omicron variant.

Meanwhile, Sanofi and partner GlaxoSmithKline (GSK) are developing a protein vaccine targeting the Beta subvariant, which dominated last year.



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