In the fight against the corona virus, the European Medicines Agency EMA has cleared the way for two vaccines adapted to the omicron variant. This was announced by the EMA after the consultation of a committee of experts in Amsterdam. The EU Commission now has to formally decide on the approval. The two vaccines could be used as a booster vaccination for people aged 12 and over.
As a spokesman for the EU Commission told the German Press Agency, the Brussels authorities will accept the EMA’s decision very quickly. Whether this will happen on the same day remains to be seen.
Lauterbach: Quantum Leap
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.”
Vaccines against virus of origin as well as Omicron BA.1
The EMA decision affects applications from Biontech/Pfizer and the US company Moderna for approval of so-called bivalent mRNA vaccines, which are intended to offer protection against the original Sars-CoV-2 and against the omicron subline BA.1. In Germany, these viruses no longer play a role. However, the hope is that this vaccine will also work better against the Omicron sublines currently in circulation.
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 Committee (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.”