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British drug regulators have become the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that aims to protect against the original virus and the omicron variant.

In a statement on Monday, the Medicines and Healthcare Regulatory Agency said it had given the green light to Moderna’s combination “bivalent” vaccine, which will be used as an adult booster shot.

Each dose of the booster shot will target both the original COVID-19 virus that was first detected in 2020 and the omicron BA.1 variant that was first picked up in November. British regulators said the side effects were similar to those seen for Moderna’s original booster shot and were typically “mild and self-resolving.”

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“What this (combination) vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve,” said Dr June Raine, the head of Britain’s health care and medicines regulator.

British drug regulators have become the first to approve an updated version of Moderna’s COVID vaccine. (AP Photo/Jenny Kane)

Such an approach is used with flu shots, which are adjusted each year depending on the variants that are circulating and can protect against four influenza strains.

Stephane Bancel, Moderna’s Chief Executive, said in a statement that it was the first regulatory authorization for a vaccine aiming to fight the omicron variant, predicting the booster would have an “important role” to play in protecting people against COVID-19 in the winter.

Britain’s health officials have not yet decided whether or not the tweaked vaccine will be used in its fall strategy. In July, the government said everyone 50 and over would get a COVID booster in the fall.

On Friday, Germany’s health minister said the European Medicines Agency might clear tweaked COVID-19 boosters next month.

In June, the U.S. Food and Drug Administration told vaccine makers that any booster shots tweaked for the fall would have to include protection against the newest omicron variants, meaning BA.4 and BA.5 , not the BA.1 subvariant included in Moderna’s latest shot.

Last month, the FDA said it was no longer considering authorizing a second COVID-19 booster for all adults but would instead focus on revamped vaccines for the autumn that target the newest viral subvariants.

Both Moderna and Pfizer are currently brewing updated versions of their vaccine to include BA.5 in addition to the original COVID-19 virus.

According to the World Health Organization , the latest global surge of COVID-19 has been driven by omicron subvariant BA.5, which is responsible about 70% of the virus samples shared with the world’s largest public virus database. The subvariant BA.5 is even more infectious than the original version of omicron and has some genetic differences that earlier vaccines might not address.

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Scientists have warned that the continued genetic evolution of COVID-19 means drugmakers will likely be one step behind the virus in their efforts to tailor their vaccines.

“The virus is unlikely to stand still and Omicron-targeted immunity, might push the virus down other evolutionary paths,” warned Jonathan Ball, a professor of virology at Britain’s University of Nottingham. Still, he said the new Moderna vaccine would likely still be protective.

“Unless there is a major shift in the virus, immunity will continue to protect the vast majority from serious disease caused by emerging variants,” he said in a statement.

The UK medicines regulator ( MHRA ) approved the so-called bivalent vaccine made by U.S. drug company Moderna as a booster for adults.

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

The MHRA also cited an exploratory analysis in which the shot was found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5.

No serious safety concerns were identified with this new formulation, the agency added.

Now approval has been secured, Britain’s Joint Committee on Vaccination and Immunisation (JCVI) will advise on how the vaccine should be deployed in the country.

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

“The first generation of COVID-19 vaccines being 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 sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.”

European Medicines Agency (EMA) officials expect COVID variant-adapted vaccines to be approved in the European Union by September, and have signalled the regulator is open to using shots targeting the older BA.1 variant this autumn, given those specifically targeting newer subvariants are further behind in clinical development.

In contrast, the U.S. Food and Drug Administration (FDA) has said it will seek the specific inclusion of the newer BA.4 and BA.5 offshoots of Omicron in any new shots used domestically.

Apart from Moderna, partners Pfizer Inc and BioNTech have also been testing versions of their mRNA vaccine modified to combat Omicron variants.

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

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Fox News Flash top headlines for August 15

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All adults in the United Kingdom will be offered a COVID-19 booster starting from September, health officials said, hours after the country became the first in the world to approve an Omicron-adapted shot.

The preference is to deploy what is known as a bivalent vaccine that targets both the original virus and the Omicron variant through the autumn campaign, but that will depend on the UK health regulator (MHRA) approving such shots and the state of vaccine supplies.

Previously, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) had advised boosters should be given to over 50s, individuals in clinical risk groups, frontline workers and care-home staff ahead of the winter, when respiratory viruses are typically at their peak.

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Around 26 million people in Britain are estimated to be eligible for an autumn COVID-19 booster having had at least two COVID vaccine doses already, a UK Health Security Agency (UKHSA) spokesperson said.

On Monday, the MHRA gave Moderna’s bivalent shot conditional approval.

The endorsement of the vaccine is based on data that showed it produced a marginally better immune response against some Omicron variants , versus the original novel coronavirus – although whether that translates into stronger protection against serious disease is unclear.

The UK plans on offering COVID booster shots to all adults starting in September 2022. Pictured: A nurse administers a COVID-19 vaccine to a patient at a vaccination center in Ancenis-Saint-Gereon, France, on Nov. 17, 2021. (REUTERS/Stephane Mahe/File Photo/File Photo)

UK contracts with Moderna and Pfizer-BioNTech – the partnership behind the other mRNA vaccine that has been tailored to also target Omicron – dictate that supply will switch to bivalent shots upon MHRA approval.

A UKHSA spokesperson declined to provide details on how much supply the country has of the Moderna bivalent shot.

“Where feasible, it would be preferable for a single type of booster vaccine to be offered throughout the duration of the autumn programme for simplicity of deployment,” the JCVI said in a statement on Monday.

At the same time, the JCVI also advised that the original Moderna vaccine , the original Pfizer-BioNTech vaccine, and the Novavax shot – for certain patients – can be used in the autumn booster campaign.

“It is important that everyone who is eligible takes up a booster this autumn, whichever vaccine is on offer,” Wei Shen Lim, chair of COVID-19 immunisation on the JCVI, said in a statement.

Lost Momentum

While the original COVID-19 vaccines continue to provide good protection against hospitalisation and death, vaccines have become less effective as the virus has evolved.

Britain was the first to approve COVID vaccinations in 2020, but has since lost momentum and is now in such a vulnerable position “any booster programme is to be warmly welcomed,” Danny Altmann, professor of immunology at Imperial College, London, told Reuters.

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The debate about the nuances of which booster is tricky – the bivalent booster may offer some additional benefit against the BA.5 variant now dominant in Britain, although this may not be substantial, Altmann said.

“Still, the benefit coming into a difficult winter will be palpable if we can really encourage large-scale uptake,” he said.

In the week ending Aug. 5, more than 800 deaths were registered within 28 days of positive COVID test in England, data https://coronavirus.data.gov.uk published by the UK government showed.