Status: 24.03.2021 8:44 a.m.
Virus mutations are driving the third corona wave in Germany – and making it difficult for vaccine developers. The EMA requires CureVac & Co. to provide accurate data on efficacy in mutants.
In spring 2020, the nervousness can be felt in Tübingen: Strangers are already being intercepted by a private security service in the visitor parking lot of the vaccine manufacturer CureVac. A few days ago the rumor got around that US President Donald Trump wanted to bind the German biotech company exclusively to the USA. There is talk of a billion dollars in media reports. From one day to the next, CureVac becomes known worldwide, stands for hope in the fight against the still largely unexplored corona virus.
“In the rolling approval process”
A year later, the former hopefuls from southern Germany became quiet. There was no exclusive collaboration with the USA – maybe also because Trump’s takeover interest was just a rumor? CureVac, at least, never tires of denying that there was a US offer.
Instead of the USA, the German state is now investing millions in CureVac. But while competitors from Mainz, Great Britain and the USA have already launched their vaccines and vaccinated millions of times, in Tübingen they are still working on approval.
The company headquarters in Tübingen are making good progress these days. Most of the 36,000 test subjects for the approval-relevant phase 2b / 3 have now been recruited – in Europe and Latin America. “We are already in a rolling approval process with the European approval authority EMA,” it says at the request of tagesschau.de from a CureVac spokesperson, “and [wir] intend to submit the final data package in the second quarter of this year. “The vaccine called” CVnCoV “could be approved in the EU in June – around six months after the first vaccinations with the BioNTech / Pfizer vaccine.
Did CureVac overestimate itself?
But how did it happen that the former German pioneer and inventor of mRNA technology lost the boat in the race for a corona vaccine? “At the beginning of the vaccine development, CureVac was not that well positioned in management,” Wolf-Dieter Ludwig is convinced. The physician is chairman of the drug commission of the German medical profession. Ludwig believes that competitor BioNTech from Mainz dealt better with the sudden pressure of expectations: “BioNTech benefited from the cooperation with Pfizer early on.”
CureVac, on the other hand, only signed a cooperation agreement with Bayer AG in Leverkusen in January. The pharmaceutical giant supports the newcomer, among other things, in conducting studies and in the approval process. Because cooperation with EU regulators is new territory for Tübingen.
EMA adapts approval requirements
Bayer’s experience could particularly pay off for CureVac these days. Because with the resounding power of virus mutations, the pandemic has also changed. The original virus, known by scientists as the “Wuhan virus”, is being pushed back, and more contagious mutants are rampant.
The European Medicines Agency (EMA) has now adjusted the requirements for vaccine approval. In a written statement to tagesschau.de it says: “The agency has asked all vaccine developers to investigate whether their vaccine can offer protection against new virus variants.” The companies are also asked to submit relevant data.
The Chairman of the Medicines Commission, Ludwig, sees this as a stumbling block: “The increase in vaccine-resistant virus mutants could reduce the effectiveness of the CureVac vaccine. For CureVac this could mean that the effectiveness would be worse than that of the vaccines that have already been approved.”
More vaccinated people, fewer subjects
In practice, the EMA’s decision means that CureVac has to collect even more data. Any Covid-19 disease that occurs during clinical trials must be carefully examined and the virus sequenced. CureVac announces: “To evaluate our study and assess the effectiveness of our vaccine, we need a certain number of infections for each virus type in order to achieve a statistically relevant order of magnitude. To do this, we need to know which virus we are dealing with – that’s why we do the sequencing. ”
The fact that the pathogens now also have to be sequenced is not a disadvantage, emphasizes the study director for the CureVac vaccine, Peter Kremsner from the University Hospital in Tübingen: “I share the assessment that we need longer because our studies are more strongly influenced by virus variants Not.” What is noticeable, however, is the fact that more and more approved vaccines are available and more and more – vaccinated – people are dropping out as potential test subjects.
Grace of late admission?
If everything goes according to plan from now on, the first patients could be vaccinated with the CureVac vaccine this summer. Late, but not necessarily too late. After all, by then CVnCoV could show with a large database how effectively the vaccine can work against mutants. CureVac presented its first success this week: The latest studies in mice have already shown that CVnCoV also effectively protects against the South African virus variant, the company said.