The Mainz-based pharmaceutical company BioNTech announced at its annual general meeting that the first results of the studies of an adapted omicron vaccine would be available in the coming weeks at the earliest. This means that the required approval will be delayed until late summer or autumn.
by Bernhard Loyen
The Mainz-based company BioNTech, which was completely unknown until 2020, surprised the world with the impressively fast development of a new type of vaccine for the corona virus variant B.1.1.7, also called SARS-CoV-2 variant. In cooperation with the US pharmaceutical giant Pfizer, a first COVID vaccine could be offered and delivered worldwide after a few months.
At the annual general meeting of BioNTech on June 1, 2022, CEO Uğur Şahin had to personally address the audience communicatethat the company cannot yet announce a breakthrough in the further development of its corona vaccine. The first study results are loud SWR news to be expected “in the coming weeks” at the earliest. Hawk will with the words quoted:
“Depending on the authorities’ decision, an adapted vaccine could be approved in August, September or autumn.”
As late as January, BioNTech left promising to announce:
“The Mainz-based pharmaceutical company and its US partner announced about two weeks ago that they had already started production of a corona vaccine adapted to the omicron variant for later commercial use. BioNTech had stated that the two companies ‘by March ready to supply the market once regulatory approvals are in place’.”
Now, at the end of June, a meeting is planned between BioNTech and the US Food and Drug Administration FDA, “at which specifications are to be made as to what the authority expects from the vaccines adapted to the omicron variant,” according to the website Stock exchange online. Şahin therefore expects an appointment with the European Medicines Agency EMA.
In January this year started the first clinical trials by BioNTech and Pfizer to develop a modified COVID vaccine that efficiently targets the currently dominant omicron variant. That medical journal explained:
“The study will include up to 1,420 test subjects, who will be divided into three groups. The first group includes a good 600 participants who have already received two doses of the previous vaccine between 90 and 180 days before the start of the study and are now receiving one or two doses of the The second group, almost as large, consists of boosted people who receive an additional dose of the conventional vaccine or a dose of the Omicron vaccine.The third group of around 200 test persons consists of unvaccinated people who have not yet had COVID -19 sick people together, who then get three doses of the omicron vaccine.”
In November 2020, the companies Pfizer and BioNTech shared the details of the first “phase 3 study” in a joint publication press statement with: “A total of 43,000 subjects took part in the study”. The number of subjects in the ongoing follow-up study of a modified active ingredient is just 3.3 percent of the original size.
In the meantime, however, the next so-called BA.5 omicron variant has manifested itself in southern Europe, especially in Portugal. This leads to a greater increase in respiratory diseases, which in turn worries experts, as Portugal has one of the highest vaccination rates in Europe. Die Quote is 87.2 percent of fully vaccinated citizens, that of the once or twice vaccinated even 95.5 percent.
This reality contradicts the announcements or the perception of Uğur Şahin, who in January after the start of the latest study communicate let:
“The study is part of our scientific approach to develop a variant-based vaccine that offers protection against omicron similar to that we have observed with previous variants, but at the same time lasts longer.”
In the meantime, however, it has turned out that more and more citizens in Germany who have been fully vaccinated three or four times have to go through a first or repeated corona infection due to the lack of “protection”. The most prominent case study at the moment is the musician Herbert Grönemeyer, who, like his team, recently canceled his entire anniversary tour due to multiple infections among the tour crew:
Herbert @greenmeyer has canceled its anniversary tour “20 Years Man”. According to management, “unfortunately, the corona virus infected employees, band members and Herbert”. Appearances in Hanover, Gelsenkirchen, Berlin, Leipzig, Hamburg and Munich have been cancelled.
— WDR current (@WDRaktuell) May 25, 2022
Grönemeyer himself commented his disbelief in a personal Instagram post:
“As a band, we were spared the virus for two and a half years, we isolated ourselves in the run-up to the tour, we’ve all been vaccinated several times, we’ve been continuously tested, and yet it hit us just now, harsh, and we can only wait. That’s great bitter.”
Health Minister Lauterbach, just one day after BioNTech’s annual general meeting and the knowledge that was certainly available about the delays, nevertheless confirmed his confidence that everything would continue to be done strategically. in the ZDF Today Journal he let to know:
“Everyone wants us to be well prepared in the fall and we have already done a lot together… For example, we ordered vaccines that work for very different variants, we have already continued to finance the vaccination centers… The preparation is running at full speed and will be good too…”
Vaccines “that work for very different variants”? Is he talking about the COVID vaccine that exists but increasingly seems to have only a limited effect on citizens, or about the vaccine that does not yet exist or has not yet been approved? Only the company BioNTech knows why it is taking so long. Reasons for the delays were not given at the AGM. Uğur Şahin has to be measured against the one he has not denied headline from December 2020:
“The vaccine, which studies have shown to be 95% effective, was developed by BioNTech co-founder Ugur Sahin in one day: January 25.”
In March of 2021, the company’s CEO explained in a Interview:
“The development of a vaccine normally takes a good ten years. When we started work, we therefore considered how we could speed up this process — without taking shortcuts. In the meantime, with our mRNA technology, on which our developed vaccine is based , the possibility of developing a vaccine within a few weeks and producing it for testing.”
According to the Robert Koch Institute (RKI), the omicron subvariant BA.5 is not very common in Germany. According to the most recent RKI weekly report from May 23, their share of infections nationwide in mid-May was 2.5 percent. You don’t really want to be in the shoes of Uğur Şahin now. The pressure, the expectations are increasing daily for the “People of the Year 2020“.
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