Corona vaccine: Biontech and Pfizer awaken hope – health

It should have been the first of September. Then they switched to October. By then, those responsible for Biontech and Pfizer hoped that the first data from the decisive effectiveness studies could be presented on a new type of vaccine against the Covid-19 pathogen that was developed in a few months. In October it was finally said that the first results were not expected until mid-November. Early media warned against relying too much on a vaccine that will soon be available in the fight against Corona.

But now the big time has arrived, a few days earlier than the middle of the month, and it is not without good reason that it is fueling new hope. On Monday, the German biotech company Biontech and the US pharmaceutical manufacturer Pfizer announced that the vaccine with the strange name “BNT162 b2” exceeded all previous expectations about the efficacy of a potential corona vaccine. Consequently, after two injections, it appears to protect more than 90 percent from Covid 19 disease. According to the FDA, vaccines that prevent 50 percent of diseases are considered effective. The interim analysis was carried out after some of the subjects were vaccinated and then Covid diseases were tracked among the 40,000 study participants. In total, there were 94 confirmed cases of Covid-19, more than 90 percent of which occurred among unvaccinated participants.

The interim results that have now been submitted could allow the vaccine to gain emergency approval in the US before the turn of the year. Although Biontech and Pfizer have to wait for two-month data on immunization side effects, it is expected in the third week of November and is a prerequisite for early approval to be considered. But the application is firmly planned according to Biontech. And so far, in contrast to some incidents in other studies, the Biontech vaccine apparently, if anything, only resulted in usual vaccination reactions like fever and pain. According to Pfizer Senior Vice President William Gruber on the science portal Statnews These reactions are likely to be slightly more severe than after the annual flu vaccination. Gruber, who has been active in vaccine research for 35 years, described the rapid development of such an effective vaccine as “extraordinary.”

“I find the results presented very encouraging”

Meanwhile, immunologists and virologists around the world have been cautiously optimistic about the news from Biontech and Pfizer. “I think the results presented are very encouraging,” says Stephan Becker, who heads the Institute of Virology at the University of Marburg. The number of cases that occurred in the study was relatively low, 94, and the full data would certainly have to be awaited. “But for me this is a very positive result,” says the virologist. According to Becker and many of his colleagues, a more accurate assessment is currently not possible. “We still don’t have the primary data,” says Leif-Erik Sanders of the Berlin Charité, referring to the limited information provided by the two companies. According to the companies, there were no safety-relevant side effects. “However, it should be noted that the observation period for relevant vaccine side effects is still too short.” WHO recommends at least three months of observation, so far it is almost half in the ongoing study. The effectiveness data also comes from a period of just one week.

The immunologist and vaccine expert Sanders also loses another piece of information that is crucial in the current crisis: “It remains to be seen if the vaccine is also effective in different population groups, especially in risk groups such as the elderly.” Many other professionals see this information gap as well. In fact, many vaccines do not work equally well in all age groups; especially in older people, the immune response to a vaccine is usually significantly weaker than in younger vaccinated people. Add to this the fact that in the event of an emergency approval, according to Pfizer and Biontech, only 50 million doses of vaccines will be available by the end of the year. Only in the next year will production be increased to amounts that make vaccination possible in larger population groups. The EU is still in negotiations with Biontech and Pfizer, and there is currently no contract for the delivery of vaccine doses. And last but not least, there are the logistical issues: the Biontech vaccine is a new type of RNA vaccine that must be stored at minus 70 degrees Celsius until it is used.

And so experienced Covid-19 physician Clemens Wendtner of Munich’s Schwabing Clinic sees cause for optimism, but not euphoria: “These early data are silver lights on the otherwise bleak horizon,” he said. Wendtner on Monday. It will be months before the ray of light turns into a true hope in which there is no alternative to the previous measures to contain the pandemic.