American company Pfizer and its German partner BioNTech announced on Thursday that they had received a positive opinion from a committee of experts of the European Medicines Agency (EMA) for a new vaccine adapted against a sub-variant of Covid-19, at a time when several European countries are experiencing an epidemic rebound.
“The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for the monovalent Covid-19 vaccine adapted (to the sub-variant) Omicron JN.1”, which can be administered to “people aged 6 months and over”, according to a joint press release from the two laboratories.
New sub-variants of the virus, all members of the Omicron JN.1 lineage, are currently spreading in several countries, including France, while an immune decline is observed in the population and existing vaccines do not provide an adequate response.
The European Commission, which is responsible for approving medicines, generally aligns with the EMA’s recommendations within two months.
Since the first wave of Covid-19 in early 2020, the German SME and the American giant have designed a vaccine based on messenger RNA, a molecule allowing the human body to create viral proteins which will trigger an immune response.
This innovative technology quickly became dominant in anti-Covid vaccination campaigns in Western countries due to their high effectiveness.
Pfizer and BioNTech say they have already started production of the vaccine against the Omicron JN.1 variant in order to be able to supply EU countries by the next autumn-winter season 2024-2025, when demand for vaccination is expected to increase.
At the same time, the two partners indicate that they have requested similar marketing authorization from the United States Food and Drug Administration (FDA).
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