UK first to approve Moderna's Omicron booster jab
The UK has become the first country in the world to authorise an updated COVID-19 booster vaccine directed at the Omicron variant, giving a green light to Moderna's mRNA-1273.214 shot.
The new vaccine is an updated version of Moderna's widely-use Spikevax vaccine, which includes sequences from the original Wuhan strain of SARS-CoV-2, as well as from the Omicron BA.1 subvariant.
While BA.1 has been displaced by subvariants BA.4 and BA.5, the new vaccine retains activity against the newer strains, so could have "an important role to play in protecting people in the UK from COVID-19 as we enter the winter months," according to Moderna's chief executive Stéphane Bancel.
The new version – dubbed Spikevax Bivalent Original/Omicron – has been given conditional authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) based on phase 2/3 trial data, which showed it was better at stimulating neutralising antibodies against BA.1 than the original Spikevax.
The 437-patient study – reported in June – compared a 50 µg booster dose of both vaccines on antibody levels one month after administration, with the new version outperforming Spikevax in seronegative and seronegative patients, with an eight-fold increase in antibodies against Omicron.
Follow-up data looking specifically at BA.4 and BA.5 found that it stimulated a greater than five-fold increase in neutralising antibodies against Omicron BA.4 and BA.5 subvariants, regardless of whether the recipient had been previously infected with COVID-19.
The response against BA4 and BA.5 was three times weaker than for the original Omicron strain BA.1, but should provide "lasting protection," said Moderna at the time.
The biotech is also working on a version of the vaccine specifically directed at BA.5/BA.5 – mRNA-1273.222 – which is in clinical testing.
The UK authorisation activates a 66 million-dose order for the updated shot from the UK government under the terms of a deal announced earlier this year, at the same time as Moderna said it would build a research and manufacturing facility in the UK to produce COVID and other mRNA jabs.
Last week, the European Commission expanded its order for Moderna's Omicron-targeted vaccine by 15 million, whilst agreeing to set back delivery times from this summer to September and into next year.
At the moment, there is no information on how quickly the new vaccine will become available for immunisation. The UK is due to start offering second boosters to the over-50s and vulnerable people from next month.
"Moderna is working with The Vaccine Taskforce, UK Health Security Agency, and NHS to make Spikevax Bivalent Original/Omicron available to the UK public," said Moderna in a statement.
The company added that it has completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the EU and expects further authorisation decisions "in the coming weeks."
"The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," said MHRA CEO Dr June Raine.
"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."
The approval keeps Moderna a step ahead of Pfizer/BioNTech, its main rivals in the mRNA COVID-19 vaccine category, which filed their updated Omicron BA.1 candidate to regulators in Europe last month.