UK authorises 'next generation' omicron booster vaccine in world first
The UK is the first country in the world to authorise an omicron-specific booster vaccination, with an updated version of the Moderna jab set to be available in time for an autumn campaign.
Covid vaccines - SEBASTIEN BOZON/AFP
The US-based company's so-called bivalent vaccine combines both the original form of the Covid vaccine, with a version tailored for omicron, currently the dominant strain.
Data published in June shows the two-in-one vaccine gives just as good protection against omicron as the first jab did against the original strain of SARS-CoV-2.
Half of the dose is the original (25 micrograms) and the other half is the genetic code to target omicron, providing protection against both.
On Monday, the Medicines and Healthcare Products Regulatory Agency (MHRA) authorised the new Covid vaccine for use in the UK, making Britain the first country in the world to give the green light to an updated, omicron-specific jab.
"We are delighted with the MHRA’s authorisation of Spikevax Bivalent Original/Omicron, our next-generation Covid-19 vaccine," said Stéphane Bancel, the chief executive of Moderna.
"This represents the first authorisation of an omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the Covid-19 pandemic."
'Superior breadth of immune response'
He added that the new guise of the mRNA vaccine "has consistently shown superior breadth of immune response" when compared to the original form of the vaccine first made in 2020.
"This bivalent vaccine has an important role to play in protecting people in the UK from Covid-19 as we enter the winter months," he said.
The UK ordered 29 million doses of vaccine from Moderna in 2022, with an undisclosed number already delivered. The remainder of the order is set to be fulfilled with the new jab, The Telegraph understands.
"It's great news for the British public that the first bivalent Covid vaccine is now available," Darius Hughes, UK General Manager at Moderna, told The Telegraph.
"We'll be shipping it in the next couple of weeks and it will be available for the autumn-winter booster campaign.
"We will be working now with the vaccines taskforce (VTF) and with UK Health Security Agency (UKHSA) and with our NHS partners so that we can begin deliveries of this new bivalent vaccine within the next couple of weeks so that the NHS has it available to give to the UK public some time beginning-mid September, depending on when they choose to deploy."
Moderna data show that people boosted with the omicron vaccine had high levels of antibodies in their blood, recording a geometric mean titre (GMT) score of 941.
Moderna’s original vaccine produced about 1,000 units against the wild form of the virus, and anything above 400 "we consider gives good protection", Dr Paul Burton, Moderna’s chief medical officer, said in June.
There is no evidence yet that the vaccine will be any more or less effective at stopping transmission.
The JCVI announced in July that a Covid booster jab will be offered to all over-50s, as well as care home staff and residents, frontline healthcare workers, and vulnerable under-50s.
It will operate in tandem with the seasonal flu jab rollout, which has been brought forward this year to get ahead of what is expected to be a particularly bad winter for respiratory viruses.
Several hundred million doses of the bivalent vaccine have already been stockpiled by Moderna, ready for delivery, with the company pivoting its entire operation to the new product and betting on widespread authorisation.
It is also hoping to have a Covid-flu combined vaccine ready by next winter, as well as a triple-threat jab combining Covid and flu with respiratory syncytial virus (RSV) by the winter of 2024-25.
Mr Hughes added that the omicron jab contains the genetic code for the original form of omicron, BA.1, which also works well against BA.4 and BA.5, the currently circulating sub-lineages of omicron.
He said that the design of the mRNA vaccine means the company could add other strains into the dose, if needed.
"Our lipid nanoparticle design allows us to put more than one strain inside, in fact, we have put up to six in the same lipid particle so we can keep the original strain, we could keep an omicron strain, and we could add another strain. We can be very flexible in the way that we approach it," Mr Hughes revealed.
A BA.4 and BA.5 bivalent vaccine, combining the currently dominant strains of omicron with the original variant, is also being developed and data on this will be sent to MHRA next month, Mr Hughes told The Telegraph.
'Sharpened tool in our armoury'
Dr June Raine, the chief executive of the MHRA, said: "I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the omicron BA.1 variant as well as the original 2020 strain.
"The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives. 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.
"We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this will include the vaccine approved today."
Reference: The Telegraph: Joe Pinkstone
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