A “next generation” Covid-19 booster jab which is the first to target two strains of the virus has been approved for use in adults in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Moderna’s bivalent vaccine, which targets both the original Covid strain and the Omicron variant.
Known as mRNA-1273.214, the dose is an updated version of the Moderna vaccine which is already in use for first, second and booster doses.
The UK is the first nation to approve the jab, and it could be used in the booster programme.
This bivalent vaccine has an important role to play in protecting people in the UK from Covid-19 as we enter the winter months.— Stephane Bancel, chief executive officer at Moderna
Moderna’s chief medical officer, Dr Paul Burton, previously said that the new jab can boost a person’s antibodies to such high levels that it may only be needed annually.
Stephane Bancel, chief executive officer at Moderna, described it as a “next generation Covid-19 vaccine” which will play an “important role in protecting people in the UK from Covid-19” over the winter.
Mr Bancel said: “We are delighted with the MHRA’s authorisation of Spikevax Bivalent Original/Omicron, our next generation Covid-19 vaccine.
“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.
“This bivalent vaccine has an important role to play in protecting people in the UK from Covid-19 as we enter the winter months.”
Mr Bancel added that the jab has “consistently shown superior breadth of immune response” over alternatives in clinical trials.
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.— Dr June Raine, MHRA chief executive
The MHRA said that the vaccine’s side effects are the same as those seen in the original Moderna booster dose and were typically mild.
Its chief executive, Dr June Raine, described the new booster as “a sharpened tool in our armoury” to protect the UK against Covid-19.
Dr 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.
“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.”
Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, an independent body sponsored by the DHSC to advise ministers on the safety, efficacy and quality of medicinal products, said the vaccine was safe to use.
Prof Pirmohamed said: “The Commission on Human Medicines and its Covid-19 Vaccines Expert Working Group has independently reviewed the data on safety, quality and effectiveness and agrees with the MHRA’s decision.”
He added that since coronavirus is “continually evolving in order to evade the immunity provided by vaccines” constant updates to the jabs are needed.
Prof Pirmohamed said that a recent paper in the Lancet medical journal suggested that coronavirus vaccines have prevented up to 20 million deaths in their first year of use.
Whether the jab is used in the UK booster programme will depend on factors including cost and clinical efficacy estimates, according to Professor Stephen Evans.
The Professor of Pharmacoepidemiology at London School of Hygiene and Tropical Medicine added that the jab is based on the original Moderna jab, developed to target Omicron.
Prof Evans said: “This vaccine contains two components; the first is the original Moderna Covid vaccine for which there is both very large clinical trial data and massive experience following its introduction in many countries including the UK.
“The second is a modification of that original vaccine targeted at the Omicron variant of SARS-CoV-2 which is a new component.
“The similarity of that new component to the original has allowed the MHRA to authorise the vaccine based on its antibody response rather than demonstrating it prevents infections.
“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.”
Moderna said it has also completed its applications for regulatory approval of the booster in Australia, Canada, and the EU.
