Brussels/Amsterdam, 12 September 2022 (dpa/MIA) – The European Commission has approved another vaccine adapted to Omicron, a booster from the companies BioNTech/Pfizer directed against the current coronavirus variants, President Ursula von der Leyen announced on Twitter on Monday.
An expert committee of the European Medicines Agency (EMA) had earlier recommended the approval of the vaccine, which is adapted to the Omicron subvariants BA.4 and BA.5. A broader protection against different coronavirus variants is expected, the EMA announced.
The vaccination is recommended as a booster for people 12 years and older.
Because of its timeliness, there are no completed clinical trials for the BA.4/BA.5 vaccine yet. As the EMA explained, the expert committee took into account all available data. For example, it looked at the adapted vaccine which also targets the Omicron subvariant BA.1 and was only recently licensed in the EU. Clinical data exist for that.
The experts also reviewed data on the quality and manufacturing process, as well as the ability of the latest preparation to trigger immune responses, according to the EMA.
Commenting on the expert committee’s vote, BioNTech said that, apart from the addition of the messenger ribonucleic acid (mRNA) sequence of the spike protein of BA.4/BA.5, all other components of the vaccine remained unchanged.
According to the company’s announcement, EU citizens should have access to the Omicron-adapted vaccines “before the winter season.”
According to the EMA, the BA.4/BA.5-adapted vaccine is believed to be as comparatively safe as the BA.1-adapted booster and the original BioNTech/Pfizer vaccine, for which there is a large amount of data.
The US Food and Drug Administration (FDA) had already granted emergency approval to two BA.4/BA.5 vaccines at the end of August: from BioNTech/Pfizer and Moderna.