Moderna’s Omicron COVID-19 booster approved by UK medicines regulator

Great Britain is the first country in the world to authorize a COVID-19 booster that aims to protect people against both the original strain and the Omicron variant, giving the green light to Moderna’s “bivalent” vaccine to be used as an adult booster shot.

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) announced in its statement on Monday that “an updated version of the COVID-19 vaccine made by Moderna that targets two coronavirus variants (known as a ‘bivalent’ vaccine) has been approved for adult booster doses…after it was found to meet the UK regulator’s standards of safety, quality, and effectiveness.”

The MHRA’s statement explains that “in each dose of the booster vaccine, ‘Spikevax bivalent Original/Omicron’, half of the vaccine (25 micrograms) targets the original virus strain from 2020 and the other half (25 micrograms) targets Omicron.”

“What this (combination) vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve,” said MHRA Chief Executive Dr. June Raine.

British drug regulators have based their decision on clinical trial data showing that “a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain.”

“In an exploratory analysis the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5,” the explanation says. “The side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving.”

Biotechnology Innovation Organization (BIO) member Moderna’s chief executive Stephane Bancel said in a statement that the company’s next-generation COVID-19 vaccine Spikevax Bivalent Original/Omicron (mRNA-1273.214) “has consistently shown a superior breadth of immune response over mRNA-1273 in clinical trials.” He predicts the shot will have “an important role to play in protecting people in the UK from COVID-19 as we enter the winter months.”

COVID-19 booster tweaking

Back in January 2021, Science magazine quoted Moderna’s announcement of clinical trials of two booster strategies, in one of which “the mRNA has been tweaked to incorporate B.1.351’s mutations.”

The ‘tweaking’ approach, as 9News pointed out, “is used with flu shots, which are adjusted each year depending on the variants that are circulating and can protect against four influenza strains.”

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has yet “advise on how this vaccine should be offered as part of the deployment program.” British health officials have not yet decided “whether or not the tweaked vaccine will be used in its fall strategy.”

The US Food and Drug Administration (FDA) said back in June that its “advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.”

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