They have been announced for many months: Covid-19 vaccines that also target the omicron variant. The Medicines Agency EMA has cleared the way for the first preparations and they are now in doctors’ surgeries. How good are they and who should use them?

It’s routine when it comes to flu protection: vaccines are adjusted every year because the virus is constantly changing. More than two and a half years after the start of the pandemic, the time has come for Covid-19: The first vaccines, which no longer only target the so-called wild type of Sars-CoV-2, should soon be available in many places.

On September 1, the European Medicines Agency EMA gave the green light for two corona vaccines adapted to the omicron variant. Questions and answers about the new vaccines:

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

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 checked quality, safety and effectiveness and a positive benefit-risk ratio.

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. “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 omicron – and above all against the disease. Because protection against infection will only be temporary after vaccination, explained the immunologist.

This answer would have to come from the competent Standing Vaccination Committee (Stiko) – but there has not yet been a 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.

The Omikron boosters are vaccinated in vaccination centers, by mobile vaccination teams and by general practitioners. The general practitioners have prepared their practices for vaccinations with the Omikron vaccine. The Association of Statutory Health Insurance Physicians (KBV) does not expect a rush, reports ZDF. The KBV recommends that patients call their family doctor and make an appointment.

The government will ensure sufficient vaccination options, emphasized Health Minister Stefanie Drese (SPD) for the state of Mecklenburg-Western Pomerania. In addition to general practitioners, physicians in the existing vaccination centers in the districts and independent cities would also administer the injections.

In Berlin, Brandenburg, Hamburg, Hesse and Saxony-Anhalt, the corona vaccines are primarily vaccinated via medical practices.

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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 older than 60 and have so far waited with the fourth vaccination, now is the opportunity for you.

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.

“That means that if you only got vaccinated two months ago, you should definitely wait another four months,” explains the immunologist. Another booster after too short a time does not bring any additional benefit. According to Watzl, it could make sense in some risk patients to inject the adapted vaccine earlier. This must be discussed individually with the doctor.

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.

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.

A vaccine adapted to the currently circulating BA.4/BA.5 sublines is in prospect. The US Food and Drug Administration (FDA) has already granted emergency use authorization for such preparations from Biontech/Pfizer and Moderna. The EMA also examines 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 leap in virus development was between wild-type and BA.1, with far fewer mutations between BA.1 and BA.4/BA.5.

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