The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Pfizer and BioNTech’s adapted Covid-19 vaccine (Comirnaty) targeting the Omicron XBB 1.5 subvariant.
After validating the safety, quality and effectiveness, the UK regulator approved the vaccine.
The vaccine is indicated for usage in individuals aged six months and above.
The regulator said: “The adapted vaccine works in the same way as the original vaccine by causing the immune system to produce antibodies and blood cells that work against the virus, so giving protection against Covid-19.”
All adapted Covid-19 vaccines that received approvals aid in boosting protection obtained from prior doses and also help offer extended protection from becoming extremely ill.
The latest approval obtained through the European Commission (EC) Decision Reliance Route is valid only in Great Britain.
This is due to the marketing authorisation application submitted by the companies referencing the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
In such scenarios, the UK regulator takes into consideration the application along with the EC’s approval.
MHRA approval for the vaccine comes after the EC granted clearance for the Comirnaty XBB.1.5-adapted Covid-19 vaccine on 1 September 2023.
This is the third adaptation of the vaccine targeting new variants of the SARS-CoV-2 virus and is indicated for use in adults and children aged over six months.