Es gab von der EMA noch kein "ja, machen wir!", sondern ein "wir beobachten das weiter und bewerten bei Bedarf neu", quasi.
EMA will continue to review data on vaccine effectiveness and severity of the disease, as well as the evolving landscape in terms of circulating variants and natural exposure to Omicron, as they become available. The outcome of these assessments may impact future vaccination strategies recommended by experts in EU/EEA Member States.
https://www.ema.europa.eu/en/news/preli ... talisation
While most available data suggest that the approved COVID-19 vaccines are losing effectiveness in protecting against infection and mild disease, they continue to provide high protection against people developing severe disease and the need for hospitalisation linked to the Omicron variant.
When looking at regulatory requirements for any variant vaccine, there was broad agreement that clinical data are needed for approving a new updated vaccine.
https://www.ema.europa.eu/en/news/globa ... on-variant
"While we believe we can deliver an adapted vaccine in March 2022, we do not yet know whether this will be needed and availability will require authorization by regulatory authorities," Pfizer said.
The European Medicines Agency has so far said that there is no conclusive evidence an adapted vaccine is needed against Omicron.
https://www.reuters.com/world/europe/eu ... 021-12-17/
Und die ganzen Mitteilungen im Dezember, dass die EU bzw. die Bundesregierung ja x Millionen Dosen angepassten Impfstoff bestellt haben, waren auch etwas irreführend. Laut BioNTech:
This order would also cover potential vaccines adapted to the Omicron variant without additional costs, if a variant vaccine is determined to be needed and subsequently authorized or approved.
https://investors.biontech.de/news-rele ... 00-million
