Corona vaccines adapted to the Omicron variant can now also be used in the European Union. The European Medicines Agency approves vaccines from Biontech/Pfizer and Moderna. However, they are only adapted to the omicron subvariant BA.1.
The European Medicines Agency (EMA) has approved corona vaccines adapted to the omicron variant in the EU. The applications for approval for the vaccines against the omicron subtype BA.1 and the original virus strain had been submitted by the Mainz-based biotechnology company Biontech and its US partner Pfizer, as well as by the US pharmaceutical company Moderna. The EU Commission now has to formally decide on the approval. As a spokesman for the EU Commission said, the Brussels authorities will accept the EMA's decision very quickly. Whether this will happen on the same day remains to be seen.
Federal Health Minister Karl Lauterbach welcomed the EMA's green light for the new vaccines as a "quantum leap in the fight against the pandemic". Vaccination with the new vaccines could start next week, said the SPD politician. "Now is the best time to close vaccination gaps for the fall."
"Today's positive assessment from the European Medicines Agency on the first two variant-adapted mRNA vaccines from Biontech-Pfizer and Moderna is important to protect Europeans from the likely risk of autumn and winter outbreaks of infection," said Commissioner for Health Stella Kyriakides . "We will now seek accelerated approval for these vaccines to ensure they can be rolled out quickly across the EU."
In mid-August, the British Medicines Agency gave the green light for Moderna's so-called bivalent corona vaccine, which, like the Biontech vaccine, is effective against both the original coronavirus strain and the omicron subvariant BA.1. However, the latter no longer plays a role. The currently dominant subtypes of the omicron variant are BA.4 and BA.5.
In the United States, the Food and Drug Administration (FDA) on Wednesday granted emergency use authorization for two adapted vaccines by Moderna and Biontech/Pfizer targeting these subtypes. With the vaccines now approved by the EMA, however, there is hope that they will also work better against the omicron sublines currently circulating.
EMA stated that the adapted vaccines elicited strong immune responses against the omicron subline BA.1 in previously vaccinated individuals. In particular, studies have shown that they are more effective in this regard than the vaccines used to date. The side effects are comparable to those of previous vaccines and are mostly mild and short-lived.
Lauterbach explained that with the two adapted preparations there are additional reasons for corona vaccinations. "There is protection against serious illness and death, that's the most important thing," he said on ARD. "But we are now assuming again that there is protection against infection, at least for a certain period of time." The minister also announced an information campaign on this.
The Federal Ministry of Health expects around 14 million doses of the two preparations in the next two weeks. According to the National Association of Statutory Health Insurance Physicians, medical practices can request the new vaccine until next Tuesday. The first doses could then probably come on Thursday or Friday. Regular delivery is scheduled for September 12th.
"A second booster vaccination with the new preparation makes sense for the groups to which the Standing Vaccination Commission (STIKO) is already recommending this, i.e. certain groups at risk of severe courses - such as people over 60 years of age," said the Bonn virologist Hendrik Streeck . "Data to date have shown that the side effect profile is very similar to that of the original Covid-19 vaccines."
