The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given the green light to the adapted Nuvaxovid vaccine that specifically targets the Omicron XBB.1.5 subvariant of the coronavirus, recommending its authorization. This vaccine, called Nuvaxovid XBB.1.5will be administered to adults and children over 12 years of age to protect them from COVID-19.
According to the guidelines of the EMA and the European Center for Disease Prevention and Control (ECDC), People who need to be vaccinated will receive a single dose, regardless of whether They have already been vaccinated against COVID-19 previously.
In its decision to recommend authorisation, the CHMP assessed laboratory data showing that the adapted vaccine is capable of triggering an adequate immune response against XBB.1.5.
The Committee also considered that it is expected that Nuvaxovid XBB.1.5 trigger an appropriate immune response against XBB.1.5. The most common side effects of this vaccine are pain and tenderness at the injection site, tiredness, headache, muscle pain, and general malaise.
The EMA has forwarded the CHMP recommendation to the European Commission for a legally binding decision across the EU.
Targeting Omicron XBB.1.5
COVID-19 vaccines are tailored to better match the circulating variants of the SARS-CoV-2 virus.
This vaccine was developed to target Omicron XBB in accordance with the recommendations of the EMA emergency task force (ETF), as well as other international regulators and the World Health Organization.
As Omicron XBB.1.5 is closely related to other variants that currently circulating, The vaccine is expected to help maintain optimal protection against COVID-19 caused by these other variants, as well as Omicron XBB.1.5.
As with other COVID-19 vaccines, national authorities in 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.
Nuvaxovid was first authorized in the EU in December 2021. Adapted versions of Nuvaxovid targeting the Omicron BA.5 variant were developed but were not submitted for marketing authorisation.
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2023-10-31 16:41:12
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