Pfizer and BioNTech’s Omicron XBB.1.5-adapted COVID-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in individuals aged six months and older.
The approval comes after the vaccine, known as Comirnaty Omicron XBB.1.5, met the MHRA’s standards of safety, quality and effectiveness against the currently circulating Omicron XBB.1.5 subvariant.
The vaccine also showed effectiveness against the World Health Organization’s ‘variant of interest’, EG.5.1, otherwise known as ‘Eris’.
Working in the same way as the original vaccine, the updated vaccine causes the immune system to produce antibodies and blood cells that work against the virus.
The new approval comes just days after the European Commission’s approved the updated vaccine. The EU regulator’s decision followed a positive opinion from the European Medicines Agency’s human medicines committee, which recommended marketing authorisation for use of the vaccine in eligible individuals.
The decision was based on results from pre-clinical data, which showed that the adapted vaccine generated a substantially improved response against multiple XBB sublineages of the SARS-CoV-2 virus variants in comparison to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
Albert Bourla, chairman and chief executive officer at Pfizer, said in a previous statement: “This season’s vaccine is ready to ship as soon as the final regulatory decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises.”
Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, added: “Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally.
“The updated COVID-19 vaccine aims to further improve protection against severe illness and hospitalisation.”
The companies have also filed an application with the US Food and Drug Administration (FDA) for the approval of the updated vaccine in individuals aged six months and older.
In June, the FDA’s vaccines advisory committee recommended that updated COVID-19 vaccines be developed to target the currently circulating XBB variants.
The approved adapted COVID-19 vaccines will help to improve protection from earlier doses of the vaccine and provide longer-term protection against getting seriously ill from COVID-19.
Most recently, Bavarian Nordic announced that it was no longer moving forward with its COVID-19 booster, known as ABNCoV2, after results from a phase 3 trial showed that the vaccine only showed 64% of detectable antibodies in people, compared to 84% in the original version of Pfizer and BioNTech’s Comirnaty.