The first vaccines, which no longer only target the so-called wild type of Sars-CoV-2, should soon be available in many places.
The European Medicines Agency EMA gave the green light on Thursday for two corona vaccines adapted to the omicron variant.
What vaccines are we talking about?
The Committee for Medicinal Products for Human Use dealt with the assessment of two so-called bivalent mRNA vaccines from the companies Biontech/Pfizer and Moderna.
Bivalent means that two components are taken into account: The preparations are adapted both to the original type of Sars-CoV-2 and to the omicron subline BA.1.
Experts assume that these vaccines also bring an advantage against the subtype BA.5, which currently dominates in Germany.
Specifically, according to the EMA, the committee examined requirements for quality, safety and effectiveness and a positive benefit-risk ratio.
How good are the new vaccines?
There is clinical data, the preparation has been tested on several hundred subjects, says the Secretary General of the German Society for Immunology, Carsten Watzl.
The antibody reactions were compared with a control group that had received the previous vaccine a fourth time.
"You saw significantly more antibodies against the omicron variant in people with the adapted vaccine - in young and old as well as in 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.
Which groups need the customized booster?
This answer would have to come from the responsible Standing Vaccination Committee (Stiko) - but there is still no recommendation for the new preparations.
This is causing criticism among general practitioners and specialists, who are now receiving many inquiries.
According to the plan, vaccination should finally start quickly in Germany - in the two weeks from September 5th, around 14 million doses of the BA.1 preparation from Biontech/Pfizer and Moderna are to come, according to a letter from Health Minister Karl Lauterbach ( SPD) emerged, which became known at the beginning of the week.
Is it foreseeable who will benefit from the new booster?
The 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 did not want to anticipate the Stiko - but above all risk patients benefited.
"A serious illness is therefore less likely." So if you are over 60 and have so far waited with the fourth vaccination, now is the opportunity for you.
What should be considered when vaccinating?
According to experts, timing is very important.
Watzl said that anyone who has already followed the existing Stiko recommendation for a fourth vaccination or has been infected with Corona in the past few months should allow at least six months to elapse before the next vaccination.
"This means that if you only got vaccinated two months ago, you should definitely wait another four months."
According to Watzl, for some risk patients it could make sense to inject the adapted vaccine earlier - this must be discussed individually with the doctor.
What about healthy people under 60?
For them, the additional booster is usually not needed, said Watzl.
Nevertheless, he spoke out in favor of not generally denying younger people the BA.1 booster: Since the vaccines, albeit only temporarily, created more protection against infection, vaccination could make sense if someone was in the hospital because of risk patients Family wants more protection from others.
BA.1 - what is it?
After the Corona variants Alpha and Delta, Omikron, a mutant with a heavily modified genetic make-up, appeared at the end of 2021.
She can better bypass the first line of defense of vaccinated and recovered.
The omicron waves were caused by different omicron sublineages: first by BA.1, later by BA.2, and in the summer months mainly by BA.5.
According to data from the Robert Koch Institute (RKI), BA.1 has not been found in random samples in Germany for a long time.
Is it worth waiting for a more recent vaccine?
A vaccine adapted to the currently circulating BA.4/BA.5 sublines is in prospect.
The US Food and Drug Administration (FDA) granted such preparations from Biontech/Pfizer and Moderna an emergency use authorization on Wednesday evening.
The EMA is also examining an application in the so-called rolling review process, as stated on request - but we are still waiting for further data.
Immunologist Watzl clearly advises those who want to be vaccinated not to wait.
"So far there is no clinical data on this vaccine candidate." One can only speculate about the benefit - also in view of the unforeseeable development of the prevailing variants in the coming months.
The modalities of approval in the EU and their timing are also open.
Experts also point out that the big jump in virus development was between wild-type and BA.1, with far fewer mutations between BA.1 and BA.4/BA.5.