The start of vaccinations against the SARS-CoV-2 virus is within reach. However, people in Germany are still reluctant when it comes to willingness to actually be administered one of the drugs. According to a Forsa survey published last week, for example, 50 percent of respondents probably want to wait and see, 43 percent want to be vaccinated and seven percent refuse to be administered a drug. “One reason for this reluctance is likely to be the unusually short time in which the vaccine candidates were developed, tested and submitted to the regulatory authorities for approval,” says Noushin Irani, fund manager at DWS Biotech. According to the World Health Organization, 52 candidates are currently (as of December 10, 2020) in clinical trials, 13 of them in phase III. Another 162 candidates are still in the pre-clinical investigation.
30,000 to 60,000 subjects in each study
At the end of November, Biontech and Pfizer submitted their candidate to the European Medicines Agency (EMA) for approval. According to the EMA, the result of the test should be available by December 29th. In the US, Biontech and Pfizer had already applied for an emergency approval on November 20, and at the end of last week the US Food and Drug Administration (FDA) approved the vaccine for people aged 16 and over. The drug was approved in Great Britain on December 2nd and has been administered to people at a particularly high risk of the disease for a few days. The test procedure is already running for the candidate from Moderna. The EMA’s decision is expected on January 12th, and the FDA has scheduled an advisory committee meeting on December 17th to discuss the application.
“Finding a vaccine is generally very time-consuming. In the past, it often took more than ten years from analysis of the pathogen to approval. The agents against SARS-CoV-2 have therefore been developed at a historically unprecedented pace, “says Irani. But this record was not achieved through softened standards. The number of subjects in each study was between 30,000 and 60,000. At the same time, Biontech and Pfizer had assured that the candidate did not cause any serious side effects for at least eight weeks after the test subjects were given the last dose of vaccine. “As a rule, most of the side effects actually become visible in the first two months after the vaccination,” says the biotechnologist.
Parallel instead of sequential processes at your own risk
According to Irani, there are several reasons for this high pace of development and testing. First of all, the SARS-CoV-2 vaccine was given top priority for all those involved at all stages of the process. “It was worked under high pressure seven days a week, 24 hours a day,” she says. In addition, many processes were carried out in parallel during development that would otherwise only take place sequentially after the previous step had been successfully completed. “So a lot has already been tested or manufactured at your own risk in the knowledge that it may have to be discarded,” says Irani. And finally, the so-called rolling review process was used, in which the pharmaceutical companies could provide data on safety and efficacy before the complete application for approval in order to accelerate approval. “Figuratively speaking, you can say that the route was not shortened during development, but that everyone ran much faster,” says the fund manager.
Livestream on December 14th, 2020 from 6 p.m .:
With Hans-Werner Sinn, former President of the Ifo Institute: Corona and the miraculous increase in money in Europe
– Here is the stream! –