Corona vaccine ahead of the trailer: these questions are still open – Coronavirus Vienna

The fact that the information about the efficacy of the corona vaccine BNT162b2 from the German company Biontech and the American pharmaceutical company Pfizer only came from a press release makes experts somewhat skeptical.

With all the joy at the first results, it was also said that a comprehensive evaluation based on the available information would be difficult. I look forward to more dates. Therefore, some questions remain:

According to information from the company, which has not yet been published in a scientific article that has not yet been peer-reviewed, the vaccine’s efficacy rate exceeds 90 percent seven days after the second dose is administered. According to this, protection would accumulate only 28 days after the start of vaccination. If the trend towards this high efficacy is confirmed, “it would be an unexpectedly high vaccination efficacy,” Leif-Erik Sander of the Berlin Charite told the German Science Media Center (SMC). Many routine vaccinations did not reach such high levels. “This is even more astonishing given that no vaccine with mRNA technology has ever been approved.”

Clemens Wendtner from Munich Clinic Schwabing was also surprised by the high level of effectiveness: “This is remarkable because many ongoing vaccination studies on Covid-19 currently only require a success rate of at least 50 percent.” The United States FDA had set 50 percent effectiveness as the minimum value for possible approval. Although the effectiveness may turn out a little lower later, the director of the Scripps Research Translational Institute in La Jolla, USA, Eric Topol, believes that it will not fall below 50 percent, he said on the magazine’s website. specialized “Nature”.

Austrian virologist Florian Krammer noted that “of course it would be better to see age-specific data, but I suspect this will be published soon.” Marylyn Addo, from the Hamburg-Eppendorf University Medical Center, also takes the same line: “Currently, there are few details about the exact dates, for example regarding the different age groups and in which groups the 94 cases occurred.” According to some experts, of course, little can be said about the longer-term duration of protection by vaccination. “For me the main question is what is it six or three months later,” said Rafi Ahmed of Emory University in Atlanta, USA.

Sander emphasized that due to the available data, not much can be said about the possible side effects. According to the company, “no serious safety issues were reported” in the full study. As planned, more data will be collected and discussed with regulators around the world, he said. Sander notes that “the observation period for relevant vaccine side effects is still too short.”

“The follow-up period is still very short, but the 60 days after the second dose of vaccination required by the FDA will be reached shortly, that is, in the third week of November,” Wendtner explained. In addition to the long-term effects desired to protect against infection, “long-term side effects must also remain on the radar screen in the long term. This vaccine was very safe at least for a short time,” the expert explained. Heidemarie Holzmann from the Vienna University of Medicine (Meduni) spoke to the APA in favor of “accurate monitoring.”

He hoped “that large quantities of the vaccine will be available quickly,” said Gerd Fätkenheuer of the Cologne University Hospital. “All in all, we can assume that an emergency approval application will be submitted through the FDA in the current month of November. If this step is taken, a wave of vaccinations could begin in late 2020 and, according to the manufacturer, already 50 million doses will be available. ” says Wendtner.

The EU Commission already announced on Tuesday that they had negotiated a contract with Biontech and Pfizer for the delivery of the promising vaccine. A few weeks ago, Krammer stated in a general article in the journal “Nature” that many fundamental questions remain open about the global distribution of vaccines as a whole and about the significant vaccination strategies in different countries.

Since RNA vaccines such as BNT162b2 must be stored frozen, distribution itself poses a certain problem, especially in economically less developed countries, where ensuring the cold chain is a special challenge. Since RNA technology is completely new, it is not yet clear how well the production of large quantities of such vaccines works, Krammer wrote.

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