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Adapted vaccines: It could start next week (symbol image)
Photo: Jan Woitas / dpa
The European Medicines Agency Ema has approved the use of further developed corona vaccines.
The Ema announced that the recommendation applies to people over the age of 12 who already have basic immunization.
Now the EU Commission still has to formally approve Ema's decision.
The meeting of the Ema Committee for Medicinal Products for Human Use (CHMP) dealt with applications from the pharmaceutical companies Biontech/Pfizer and the US company Moderna for approval of so-called bivalent vaccines.
They should offer protection against the original Sars-CoV-2 and against the omicron subline BA.1.
In Germany, these virus variants no longer play a role.
The omicron sublines BA.4 and BA.5 are currently circulating.
However, experts assume that the adapted vaccines will also work better against the currently dominant omicron sublines.
Studies have shown that the vaccines "Comirnaty Original/Omicron BA.1" (Biontech/Pfizer) and "Spikevax Bivalent Original/Omicron BA.1" (Moderna) induce a strong immune response in people who have already been vaccinated against the Omicron variant BA.1 and could cause the wild type of the corona virus, the Ema said.
The side effects of the adapted vaccines are comparable to those of the original vaccines.
They are usually mild and short-lived.
"Adapted vaccines can extend protection against different virus variants and contribute to optimal protection against Covid-19 as the virus continues to evolve," wrote the drug agency.
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.
In the United States, the Food and Drug Administration (FDA) on Wednesday granted emergency use authorization for two adapted vaccines from Moderna and Biontech/Pfizer targeting subtypes BA.4 and BA.5.
Manufacturers in the EU have also submitted an approval for these vaccines, but no decision has yet been made on this.
The Ema announced that the applications were currently being examined.
The Federal Ministry of Health expects that these vaccines will also be available in a few weeks.
Clinical data are available for the new vaccines, and the preparations have been tested on several hundred subjects.
The antibody reactions were compared with a control group that had received the previous vaccine a fourth time, says the Secretary General of the German Society for Immunology, Carsten Watzl.
"We saw significantly more antibodies against the omicron variant in people with the adapted vaccine - in young people, old people and those who have recovered," said Watzl.
Percentages of effectiveness, as there were for the first Covid 19 vaccines, were not collected.
Data on the actual protection against symptomatic infection, serious illness and death can only be expected from use.
The aim is better protection against omicrons and above all against the disease, because protection against the infection will only be temporary after the vaccination, said Watzl.
Vaccinations are scheduled to start on September 5th
The federal government is planning to start the corona vaccinations with the advanced vaccines for newer virus variants at the beginning of September.
Around 14 million doses from Biontech/Pfizer and Moderna are expected in the two weeks beginning September 5th.
This emerges from a letter from Health Minister Karl Lauterbach (SPD).
Lauterbach recommends everyone who wants to be vaccinated in the near future to wait for the new vaccines.
"Now it really makes sense to wait a few days for the new vaccine to be available," he said on Thursday in the ARD "Morgenmagazin".
Both adapted vaccines offer "very good protection" against old and new virus variants.
Lauterbach described the fact that old vaccines are now expiring as a “luxury problem”.
Anyone can be offered a vaccination.
"First of all, I'm grateful that this enormous scientific leap forward has been achieved," said Lauterbach.
Who should get vaccinated now?
According to its own statements, Lauterbach is in discussion with the Standing Vaccination Commission (Stiko).
A week after the approval of the new vaccine, the panel will make a recommendation.
Immunologist Watzl considers a recommendation for a second booster with the new preparations only likely for certain groups - such as people over 60 years of age, with a suppressed immune system or with previous illnesses.
"I would be very surprised if the Stiko said that all adults should be vaccinated again." He didn't want to anticipate the Stiko - but above all risk patients benefited.
“This means that a serious illness is less likely.” So if you are over 60 and have so far waited with the fourth vaccination, now is the opportunity for you.
For healthy people under 60, the additional booster is usually not needed, said Watzl.
Nevertheless, he spoke out in favor of not generally denying younger people the adapted vaccine: Since the vaccines provided more protection against infection, albeit only temporarily, vaccination could make sense if someone wanted more protection because of risk patients in the family wishes.
kry/dpa/AFP
