Pfizer and BioNTech have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a change to the licence of their Comirnaty Omicron XBB.1.5-adapted COVID-19 vaccine after meeting the UK regulator’s standards of safety, quality and effectiveness.
The COVID-19 vaccine will be available for supply to UK high street pharmacies, occupational health providers and private healthcare companies from March 2024, said a Pfizer spokesperson.
There have been more than 25 million confirmed cases of COVID-19 in the UK as of January 2023, with the nation holding the highest death toll from the virus in western Europe.
Last September, the Pfizer/BioNTech Omicron XBB.1.5-adapted monovalent COVID-19 vaccine was approved by the MHRA for use in individuals aged six months and older.
The vaccine is currently indicated for active immunisation to prevent COVID-19 in people 12 years of age and older.
Prior to this, COVID-19 vaccines in the UK have only been made available via the COVID-19 NHS national immunisation programme (NIP), to provide vaccinations for free to the groups who are at the highest risk of serious illness, as determined by the Joint Committee on Vaccination and Immunisation (JCVI).
Between 11 September 2023 and 4 February 2024, the NHS has administered over 11,000,000 individuals in England an autumn COVID-19 vaccination as part of the NIP.
As of March this year, UK individuals who are not eligible to receive the free COVID-19 vaccination through the NIP will be able to decide whether or not they would like to purchase it instead.
Dr Gillian Ellsbury, primary care medical director, Pfizer UK, said: “Vaccines remain an important pillar in helping to prevent serious illness or hospitalisation as a result of COVID-19.
“By enabling the wider availability of the Pfizer/BioNTech COVID-19 vaccine, we are facilitating choice and access for those that are not eligible to receive it through the NHS programme but want the option of a COVID-19 vaccine.”
Dr John McGinley, primary care lead, Pfizer UK, said: “Enabling the provision of our vaccine for sale to the public does not influence the scope or supply of the NHS programme but offers the public greater choice and accessibility to the same vaccine as the NHS.”