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Moderna’s XBB.1.5-adapted COVID-19 vaccine receives MHRA approval

The vaccine has been updated to target the currently circulating XBB.1.5 Omicron variant


Moderna’s updated COVID-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in individuals aged six months and older.

In line with previous recommendations from regulators and global public health bodies, the company’s monovalent ‘Spikevax’ vaccine has been adapted to target the XBB.1.5 Omicron variant.

In addition to XBB sublineages, the vaccine has also demonstrated an 8.7 to 11-fold increase in neutralising antibodies against other currently circulating variants, including BA.2.86, which is currently being tracked by global health authorities, and the EG.5 strain.

The approval comes shortly after Pfizer/BioNTech’s XBB.1.5-adapted COVID-19 vaccine received approval from the UK regulator, also for use in those aged six months and older.

The adapted vaccines work in the same way as their original versions by causing the immune system to produce antibodies and blood cells that work against the virus.

The US Food and Drug Administration approved both vaccines earlier this month for individuals aged 12 years and older and for emergency use in those aged six months to 11 years.

Pfizer/BioNTech’s updated vaccine is also approved in the EU, and Moderna’s has recently been recommended by the European Medicines Agency’s human medicines committee.

Stéphane Bancel, Moderna’s chief executive officer, said: "Our updated COVID-19 vaccine generates a strong human immune response against circulating variants, including BA.2.86, EG.5, and FL.1.5.1, and will be a critical tool for protection.”

Public health authorities are monitoring BA.2.86 particularly closely, with some bringing forward their COVID-19 vaccination campaigns due to its potential to break through protective immunity generated from previous COVID-19 vaccinations or infections.

The NHS recently announced that its COVID-19 and flu vaccination programme, which was due to start in October, will now offer vaccinations from this month onwards due to the risks presented by BA.2.86.

Steve Russell, NHS England chief delivery officer and national director for vaccinations, said at the time: "While we know that flu and COVID-19 usually hit hardest in December and January, the new COVID-19 variant presents a greater risk now."

Article by
Emily Kimber

18th September 2023

From: Regulatory, Healthcare



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