Nine months after Omicron nabbed the title of newest Covid-19 virus variant, a vaccine to battle the new, more contagious variant has received a regulatory nod. But so far, only in the UK. Moderna announced Monday that the UK signed off on its booster vaccine 1273.214, a 50 µg dose and essentially a 2-in-1. Half of the vaccine targets the original virus strain, while the other half targets Omicron (BA.1). Moderna noted that an exploratory analysis showed a “good immune response” against BA.4 and BA.5, two Omicron sub variants that have been popping up more and more frequently.
CEO Stéphane Bancel celebrated the approval, noting in a statement that it “represents the first authorization of an Omicron-containing bivalent vaccine.” Moderna’s share price $MRNA rose 2% after the approval.
MHRA chief executive June Raine said in a separate release that the bivalent vaccine, also endorsed by the UK’s scientific advisory body Commission on Human Medicines, is “a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.”
The approval was based on a successful Phase II/III study that read out in June, in which the booster met all primary endpoints, including a superior antibody response against Omicron (BA.1) when compared to baseline in participants without antibodies. Moderna execs said at the time during an investor call that vaccine durability will be something the company is watching and highlighted six months as a key durability point, which would get people through the winter months.
Moderna noted that it has already completed regulatory submissions for the booster shot in Australia, Canada and the EU, and expects to hear back on more authorization decisions in a matter of weeks. There was no mention about the booster’s regulatory status in the US.
The new development will push other Covid-19 vaccine makers in a rushed bid for second place, namely its Big Pharma competitor Pfizer, the other mRNA Covid vaccine juggernaut. Pfizer and its partner BioNTech announced just last month that they launched a Phase II study to test efficacy in their new and improved candidate, BNT162b5. As for Moderna, demand has already started, with the European Commission modifying its deal with the biotech to switch doses of Spikevax to the new version once the EMA signs off on it. Plus, the Commission is purchasing 15 million doses of the new vaccines. The US also agreed to place an order for 66 million doses of the candidate back in July in a contract worth $1.74 billion.
Covid-19 roundup: Deserted by Roche and plagued by setbacks, Atea marches on; Europe lines up order for Moderna's Omicron booster With the UK signing off on it, it’s probably just a matter of time before the rest of Europe — and countries across the Atlantic — follow suit.