The UK has become the first nation to approve a COVID vaccine that targets the Omicron variant as well as the original strain, with claims it is eight times more effective against Omicron.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s new bivalent vaccine, which targets two separate COVID variants.
In each dose of the mRNA-based ‘Spikevax bivalent Original/Omicron’ vaccine, half the solution (25mg) is targeting the original strain while the other half targets Omicron specifically.
The approval comes after extensive clinical trials that showed the booster triggers a strong immune response against both variants. The trials also showed the vaccine generated a ‘good’ immune response against Omicron sub-variants BA.4 and BA.5.
Omicron has been the dominant variant of concern this year, blamed for infecting half of the Australian population.
CSIRO research scientist Daniel Layton said the clinical data showed the new vaccine’s immune response was eight times more effective at tackling Omicron’s original variant, BA.1, than existing vaccines.
“That’s going to translate to a really improved immune response and better protection for people when being infected with that earlier strain of Omicron,” he told SBS News.
Dr June Raine, MHRA chief executive, says the vaccine represents the next stage in the fight against COVID, after the first round of vaccines managed to steady the ship.
“The first generation of COVID-19 vaccines … continue to provide important protection against the disease and save lives,” Dr Raine says.
“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.”
Australia’s Therapeutic Goods Administration (TGA) has granted Moderna a ‘provisional determination’ for the new vaccine.
A provisional determination is essentially the first step to being approved in Australia. It means the TGA has examined preliminary medical data and is inviting Moderna to apply for provisional registration, the next step in the process.
If approved, Moderna may even manufacture the new vaccine in Australia – at least for the local market.
The pharmaceutical giant has announced a partnership with Monash University and the Victorian government to build a state-of-the-art mRNA vaccine production facility in Melbourne.
The facility will be the first mRNA production facility in the southern hemisphere and is expected to produce 100 million vaccine doses each year for COVID, influenza and respiratory syncytial virus (RSV).
“Monash is at the cutting edge of mRNA/RNA therapeutics development and we are delighted that Moderna will be joining specialists from across the university and research sector to build an Australian mRNA ecosystem right here,” says vice-chancellor Professor Margaret Gardner.
“Today’s announcement is recognition of the collaborative work between Australian and Victorian governments, other research institutions and industry partners to develop vaccines and treatments for a range of global health issues.”
Would you consider getting the new Moderna jab? Should the TGA fast-track Moderna’s application after this ruling? Let us know in the comments section below.
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