Moderna’s updated Omicron vaccine will be offered as part of the autumn Covid booster programme, the Government has announced.
The new bivalent vaccine, which targets both the original virus from 2020 and the Omicron variant, was today approved for delivery by the UK medicines regulator.
Now the health secretary has accepted advice from the Joint Committee on Vaccination and Immunisation (JCVI) to offer it as part of the upcoming autumn rollout.
Health secretary Steve Barclay said: ‘I have accepted the independent advice of the Joint Committee on Vaccination and Immunisation (JCVI) on which vaccines should be offered in this autumn’s booster programme.
‘This includes a Moderna bivalent vaccine which will target two different variants – the Omicron and original strain of Covid.’
He added: ‘Vaccines remain our best defence against Covid and this safe and effective vaccine will broaden immunity and potentially improve protections against some variants as we learn to live with this virus.
‘We will begin to contact those eligible from early September and I would urge people to come forward as soon as they are invited so together we can keep each safe and protect our NHS.’
The Department of Health and Social Care (DHSC) added that the NHS will outline further deployment details in due course.
Half of each vaccine dose (25 micrograms) targets the original 2020 virus strain and the other half (25 micrograms) targets the Omicron variant in the new booster.
The Medicines and Healthcare products Regulatory Agency (MHRA) today announced that it had granted approval for the bivalent vaccine ‘for adult booster doses’ after it ‘was found to meet the UK regulator’s standards of safety, quality and effectiveness’.
It said: ‘The decision to grant approval for this booster vaccine in the UK was endorsed by the Government’s independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence.’
It added that its decision is ‘based on data from a clinical trial which showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain’.
Side effects observed in safety monitoring were the same as those seen for the original Moderna booster dose and were ‘typically mild and self-resolving’ with ‘no serious safety concerns’ identified, the MHRA said.
MHRA chief executive Dr June Raine 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.’
Professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine Professor Stephen Evans said that the ‘similarity’ of the new component targeting the Omicron variant to the original Moderna vaccine ‘has allowed the MHRA to authorise the vaccine based on its antibody response rather than demonstrating it prevents infections’.
He said: ‘We now know from many studies that this antibody response (neutralising antibodies) is to a degree predictive of the clinical effect in prevention of infection and hence admission to hospital or death.
‘It would take very much larger trials to show such effects conclusively, but we can be confident it is likely to show better clinical efficacy against the Omicron variants than the original vaccine alone.’
Moderna announced last month that it had ‘completed regulatory submissions’ for its new Omicron Covid vaccine and said that it could be used for autumn boosters in the UK if approved by the MHRA.
It followed clinical trials showing that the company’s updated Covid vaccine generates a strong immune response against the Omicron BA.4 and BA.5 variants.
Covid booster vaccines will be extended to people aged 50 and over this autumn alongside other at-risk groups, following a final recommendation from the JCVI last month.
This story first appeared on our sister title, Pulse.