The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the authorization of the Pfizer/BioNTech vaccine adapted to combat the omicron XBB.1.5 subvariant, which is called ‘Comirnaty Omicron XBB.1.5’ , to prevent COVID-19 in children from six months of age and adults.
The administration guidelines for this vaccine will follow the previous ones. EMA recommendations and the European Center for Disease Prevention and Control (ECDC), according to which adults and children from 5 years of age who are required to be vaccinated should receive a single dose, regardless of their vaccination history against COVID-19. . Children from 6 months to 4 years of age may receive one or three doses, depending on whether they have completed a primary vaccination cycle or have had COVID-19.
In making the decision to recommend the authorization of this drug, the CHMP has taken into account all the available data on Comirnaty and its other adapted vaccines, including the available information on safety, efficacy and immunogenicity (their efficacy in generating immune responses ).
The Committee has also evaluated new laboratory data showing a potent response of the adapted vaccine against XBB.1.5 and related strains of the SARS-CoV-2 coronavirus responsible for COVID-19. More data on emerging variants is awaited and will be evaluated by the Committee when it becomes available.
An effective vaccine against omicron XBB.1.5
COVID-19 vaccines are modified to better match circulating variants. This vaccine was developed to combat omicron XBB in accordance with the recommendations of the EMA and ECDC, as well as other international regulators and the World Health Organization.
As omicron XBB.1.5 is closely related to other variants currently in circulation, the vaccine is expected to help maintain optimal protection against COVID-19 caused by these other variants, as well as omicron XBB.1.5.
Since Comirnaty’s first authorization, the authorities have gained extensive knowledge about the safety of the vaccine. Side effects are usually mild and short-lived, the most common being headache, diarrhoea, joint and muscle pain, tiredness, chills, fever, and pain or swelling at the injection site. Rarely, more serious side effects may occur.
The EMA will now forward the CHMP recommendation to the European Commission for a legally binding decision across the European Union. As with other COVID-19 vaccines, the national authorities of the EU Member States will determine how to use this vaccine in national vaccination campaigns, taking into account factors such as infection and hospitalization rates, the risk to vulnerable people and the availability of the vaccine.
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