DThe European Commission has approved another vaccine adapted to Omicron. The booster from the companies Biontech/Pfizer is aimed against the current corona variants, President Ursula von der Leyen announced on Twitter on Monday. A committee of experts from the EU medicines agency EMA had previously recommended the approval of the vaccine adapted to the Omicron sub-lines BA.4/BA.5. Like the previous vaccines, the agent also targets the original variant of Sars-CoV-2. Federal Minister of Health Karl Lauterbach (SPD) rated the message on Twitter as good in the fight against the virus.
The EMA announced that broader protection against different corona variants is expected. The vaccination is recommended for people aged 12 and over as a booster. BA.4/BA.5 are the omicron sublines that currently cause almost all corona infections in Germany according to data from random samples.
Due to the topicality, there are no completed clinical studies for the BA.4/BA.5 vaccine. As the EMA explained, the expert committee took into account all available data – for example also on the adapted vaccine recently approved in the EU, which also targets the omicron subline BA.1. Clinical data exist for him. The delivery of this BA.1 vaccine started in Germany a few days ago.
Access to adapted vaccines before winter
According to the EMA, the experts also checked data on the quality and the manufacturing process as well as the ability of the latest preparation to trigger immune responses. Biontech said in response to the expert committee’s vote that, apart from the addition of the mRNA sequence of the BA.4/BA.5 spike protein, all other components of the vaccine remained unchanged. According to the company’s announcement, EU citizens should have access to the vaccines adapted to Omikron “before the winter season”.
According to EMA, the BA.4/BA.5-adapted vaccine is believed to be comparable in safety to the BA.1-adapted booster and the original Biontech/Pfizer vaccine, on which there is a large amount of data. The US Food and Drug Administration (FDA) had already granted emergency use authorization to two BA.4/BA.5 vaccines at the end of August: from Biontech/Pfizer and Moderna. BA.1 is no longer circulating in Germany.
So far there is no recommendation from the Standing Committee on Vaccination (Stiko) for the use of booster vaccinations adapted to Omikron. According to Minister Lauterbach, the committee is already working on recommendations. Several experts who do not belong to the Stiko recently said that the refresher with the new preparations is an option for groups for which the Stiko is already recommending a second booster vaccination. These are, for example, people over 60, groups with risk factors and healthcare workers.