An Omicron-targeting COVID-19 booster vaccine can be rolled out in the United Kingdom after receiving approval from the country’s therapeutics regulator.
The mRNA-1273.214 vaccine (known commercially as Spikevax Bivalent Original/Omicron) developed by Moderna is ‘bivalent’, meaning it targets two variants of a disease – in this case both the original SARA-CoV-2 and Omicron (BA.1) strains.
Data from Moderna’s clinical trial for the booster found an eight-fold increase in Omicron-neutralising antibodies over a baseline comparison.
The world-first approval for an Omicron-targeting vaccine was made by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), which also reported a good immune response against the current circulating BA.4 and BA.5 subvariants.
Professor Sir Munir Pirmohamed chairs the UK’s Commission on Human Medicines, which provides independent scientific advice to the British government on new medications. He says the approval of bivalent vaccines represents the ‘next step’ in disease prevention.
“The virus, SARS-CoV-2, is continually evolving in order to evade the immunity provided by vaccines,” he says.
“This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine.”
The Therapeutic Goods Administration (TGA) – Australia’s equivalent to the MHRA – has granted provisional determinations to both Pfizer and Moderna for bivalent mRNA vaccines. Provisional determination is one of the first steps towards registering a new medicine for use, but the TGA notes that approval is not guaranteed.
MHRA chief executive Dr June Raine says the regulator has “a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this will include the vaccine approved.”