The coronavirus mutates and mutates. But the existing vaccines are unchanged: they target Sars-CoV-2 as it spread at the beginning of the pandemic. The first vaccines adapted to the omicron variant are in development and could be available in autumn. But the big question is whether Omikron will still set the tone at all with well-known sub-lines such as BA.1, BA.4 and BA.5. By then, an old variant could return or a new one could emerge. The horror idea: That the vaccination protection will be undermined and many more people will become seriously ill again.
In view of the race between the virus and vaccines, there is a discussion as to whether the approval process should be accelerated. Biontech boss Uğur Şahin is in favor, as he recently told the "Financial Times". He spoke of a four-month time advantage through a procedure without additional clinical studies, i.e. in humans.
Approval as with the flu vaccination?
The EMA, which is responsible for approval in Europe, signaled a few weeks ago that, depending on the data submitted, a framework similar to that of the flu vaccination could possibly be reached. No clinical data would have to be submitted before the annually updated vaccine could be approved. The expert discussion about it is in progress, it said.
"I think it's logical to come to a process like that of the flu vaccination," says Carsten Watzl, Secretary General of the German Society for Immunology. It doesn't have to be this fall. "You could use the first adapted vaccine to show that everything is going well. And then choose a faster procedure in the coming seasons."
Having clinical data available sounds nice, says Watzl, but the significance is limited. They only provided information about antibody levels and rudimentary vaccination reactions. "A protective effect cannot be derived." The data is virtually irrelevant for safety, because very rare side effects could not be detected given the low number of test subjects.
Skepticism at the Society for Virology
The President of the Society for Virology, Ralf Bartenschlager, is rather skeptical as to whether the current situation requires more speed in approval. "The vaccines that are already available protect against severe disease even with the current omicron variants, which are less pathogenic compared to previous variants." In this respect, the question arises as to whether the emergency is so great that the procedure must be shortened.
From this point of view, it makes sense to continue testing these vaccines in human studies. Tests on mice, for example on immune responses, are no substitute for this. "In particular, thorough security data is necessary," says Bartenschlager. For the adaptation to Omikron quite a lot of building blocks would have to be changed. "One should also examine how the new vaccine antigens behave in vaccinated and recovered individuals with the adapted Omicron vaccines. Any new antigen could, to a certain extent, cause unexpected reactions such as an excessive immune response."
In principle, Watzl agrees with this consideration, but he qualifies: Such unexpected reactions are rare and would never be noticed in clinical studies because of the small number of test subjects. In addition, the virus itself would then have to cause excessive immune responses, because it has the same spike protein as the adapted vaccine. "If that were to happen, we would have a completely different problem."
One thing is clear: If the approval procedure were to be simplified, experts consider a good communication strategy to be essential. In view of the ongoing debate about vaccination reactions and side effects, Bartenschlager sees the danger that approval without submission of clinical studies would be viewed even more critically by the public - it could possibly be perceived as giving in to the pharmaceutical industry.
Expert: People mainly pay attention to Stiko recommendation
On the other hand, Markus Schäfer, an expert in health communication from the University of Mainz, does not expect that a simplified approval process would have a significant impact on the acceptance of the Covid 19 vaccines. "You have to reckon with the fact that some media will scandalize such a step, if it comes to pass. However, surveys suggest that most people do not inform themselves in great detail about complex relationships such as an approval procedure." What most people value are the recommendations of the Standing Vaccination Commission (Stiko).
Immunologist Watzl addresses another concern: While the US regulatory authority FDA has already made it clear that adapted vaccines should also take into account the omicron sublines BA.4 and BA.5, which were widespread this summer, the EMA has not yet made a decision. "In the worst case, it could happen that we still get the BA.1 vaccines that have already been developed in Europe, while the more current sublines are already being considered in the USA. That would then be a two-class society."
