Omikron gains the upper hand in Germany. In order to get through the cold season well, Federal Health Minister Karl Lauterbach would like to vaccinate 40 million Germans before winter – including with the adapted vaccine from Biontech. But then it could be too late.

In the race against the mutating coronavirus, manufacturers have presented positive clinical data on adapted vaccines from their point of view. Pfizer/Biontech and Moderna recently published results according to which their adapted boosters also stimulate an efficient immune response against the newer omicron sublines BA.4 and BA.5.

It is important to know that the new vaccines are not specially tailored to these variants, but to the sub-line BA.1, which is no longer circulating in Germany. It is now being debated whether the approval process should not be shortened so that the preparations do not lag too far behind the evolution of Sars-CoV-2.

There is evidence that infection with BA.1 does not protect well against further infection with BA.4 or BA.5. From this one could conclude that the newer sub-lines are more likely to go through the net even with a vaccine adapted to BA.1.

Adapted vaccine more protective against omicron variant BA.1

Federal Health Minister Karl Lauterbach (SPD) and the Berlin virologist Christian Drosten recently spoke out in favor of a vaccination campaign with up to 40 million vaccinated people before winter. Adapted vaccines could offer better immune protection against omicron sublines than existing preparations. At the moment nobody knows exactly which variants will dominate in winter in Germany.

The results published by Biontech/Pfizer over the weekend relate primarily to protection against BA.1. Subjects who had received an adapted vaccine as a booster showed significantly higher neutralizing antibody responses against BA.1 than with the previous Biontech/Pfizer vaccine. A total of 1234 participants aged 56 and over took part in the study.

A Biontech spokeswoman said on request that no data had yet been published on how the adapted vaccines against the currently occurring sublines such as BA.4 and BA.5 compare to the existing vaccine. However, preliminary laboratory studies have shown that both adapted vaccines are effective against BA.4 and BA.5 viruses, albeit to a lesser extent than BA.1.

Approval procedure with potential for conflict

Moderna and Biontech/Pfizer are making their new data available to the EU drug authority Ema, which is already running test procedures. So far, no vaccine adapted to variants has been approved in the EU.

The approval of such a drug is expected in September at the earliest, also because the manufacturers have to prove in studies on humans that the tailor-made vaccine brings a real advantage. Now there are discussions as to whether these studies are really necessary. The reasoning: Approval would be quicker with fewer requirements, and there would be less risk that the virus would have mutated further when the vaccination started, so that it would be easier to escape the effects of the vaccination.

Biontech boss Ugur Sahin recently spoke in the “Financial Times” for a much faster process that does not require additional clinical studies – similar to the annually adjusted flu vaccine. That can save up to four months of time.

The President of the Paul Ehrlich Institute (PEI), which is responsible for vaccines in Germany, Klaus Cichutek, sees things differently. “If we prepare for the autumn wave in peace, there is no reason at all to do without the corresponding clinical data in humans,” he told the “Welt am Sonntag”. Admission practice can be adjusted in an emergency, but that is not the case at the moment.