The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced in August 2022 that it approved Moderna’s bivalent vaccine, Spikevax Bivalent Original/Omicron, against two forms of Covid. Dr June Raine, chief executive of the MHRA, stated that the “first generation” vaccines “continue to provide important protection against the disease”. However, the candidate presents exciting opportunities for the UK.
“What this bivalent vaccine gives us is a sharpened tool in our armoury”.
The UK is the first to approve the dual vaccine, which targets the original virus and the newer Omicron variant. It is predicted to be available during the autumn as a booster, and we can expect 13 million doses by the end of the year. Moderna will begin supplying doses in the next few weeks. The vaccine also awaits approval in Australia, Canada, and the EU.
In June 2022 Moderna announced that the vaccine was safe. It also offered a “superior antibody response” in trials. The dose “increased neutralising geometric mean titers against Omicron approximately 8-fold above baseline levels.” Furthermore, it “elicited potent neutralising antibody responses against the Omicron subvariants”.
Stephane Bancel, CEO of Moderna, is “delighted” at the approval of the vaccine.
“This represents the first authorisation of an Omicron-containing bivalent vaccine, this bivalent vaccine has an important role to play in protecting people in the UK”.
The UK government’s independent science advisory body also approved the vaccine. Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, reported that the Commission “independently reviewed the data” and agreed with the decision taken by MHRA.
“This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus”.
Moderna will partner with The Vaccine Taskforce, UKHSA, and the NHS, to make the vaccine available in the UK. However, we will need to see further action to share the vaccine more widely if it is to have a tangible effect.
To hear from speakers from Moderna at the World Vaccine Congress in Europe 2022 follow the link to get your tickets.