HQ Team
September 6, 2023: Britain’s Medicines and Healthcare products Regulatory Agency has cleared a vaccine made by Pfizer Inc., and its German partner BioNTech SE that targets Omicron XBB.1.5 subvariant alone.
The approval was granted for Comirnaty after it was found to meet the UK regulators’ standards of safety, quality and effectiveness, according to an MHRA statement.
The vaccine has been approved for use in individuals from six months of age.
The adapted vaccine works in the same way as the original vaccine by causing the immune system — the body’s natural defences — to produce antibodies and blood cells that work against the virus.
It gave long-term protection against getting seriously ill from COVID-19, according to the statement. The MHRA regulates medicines, medical devices and blood components for transfusion in the UK.
In June the USFDA advised manufacturers, who were updating their COVID-19 vaccines, that they should develop vaccines with a monovalent XBB 1.5 composition.
Pfizer Inc. and BioNTech SE submitted regulatory applications to the FDA for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older, for the 2023-2024 fall and winter season.
The Omicron XBB sublineages currently account for nearly all COVID-19 cases in the US and are further antigenically distant from prior circulating SARS-CoV-2 variants, including Omicron BA.4/BA.5 and the original SARS-CoV-2 strain.
Moderna and Novavax have also created monovalent vaccine versions that target the XBB.1.5 subvariant of the virus.
The COVID-19 virus has claimed the lives of nearly seven million people globally. The virus is still mutating and new variants such as BA.2.86, which is informally being termed Pirola, are emerging.
