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The Pfizer and Biontech vaccine is said to protect nine out of ten vaccinated people against infection. This was the result of an interim analysis of a global study. Experts hope that the vaccine will be approved soon.
Blood samples from subjects in a clinical vaccine trial in the USA.
The race for the first properly approved vaccine against the new coronavirus, Sars-CoV-2, is entering the home stretch. In a press release on Monday, the US company Pfizer and Biontech of Mainz, Germany, announced for the first time efficacy data from a phase 3 clinical approval study. According to the report, its vaccine candidate BNT162b2 achieved efficacy of more 90 percent in an interim analysis.
The international study with the mRNA-based vaccine, a ribonucleic acid (RNA) -based genetic vaccine, began in late July and has recruited more than 43,000 test subjects to date. Most of them received two doses of the vaccine three weeks apart and a smaller proportion received a placebo vaccine. Neither the subjects nor the clinicians knew who was using the correct vaccine. This “blinding” of information should only be lifted after 94 confirmed cases of Sars-CoV-2 infections in the subjects in question, according to the study protocol.
Protective effect established after one month.
Analysis of the “unblinded” data now shows, according to the company, that the tested vaccine protected nine out of 10 vaccinated people from infection. This protective effect was already achieved one week after the second vaccination dose, that is, one month after the start of vaccination. In addition to the efficacy information, the external and independent Data Monitoring Committee also reviewed the vaccine safety data in its interim review. So far, no serious security issues have been observed, according to the company’s announcement to investors and the media.
The phase 3 study will continue even after the success of the interim analysis. With this, the companies want to collect even more data on the effectiveness and safety of vaccination. It should also answer other questions: Does the vaccine also protect against a second virus infection? And does it prevent serious diseases?
As soon as 164 confirmed corona infections have occurred in subjects, the final analysis should be performed. It should then be published in a specialized magazine. Furthermore, Pfizer and Biontech want to apply for emergency approval from the US FDA as soon as the safety milestones prescribed in the study are reached. According to the companies, this should already be the case in the next week.
Pfizer and Biontech are also confident and ambitious about the production and distribution of the vaccine. This year, 50 million doses of vaccines could be distributed worldwide; and in 2021 the quantity produced can be increased to 1,300 million cans.
Independent scientists are also excited
“Today is a good day for science and humanity,” Albert Bourla, chairman of the board of directors and chief executive officer of Pfizer, was quoted in the press release. The interim results presented are an important step on the way to ending the global health crisis.
Interim analysis shows that vaccination could prevent Covid-19, says Ugur Sahin, co-founder and CEO of Biontech, according to the announcement. “This is a victory for innovation, science and global cooperation.”
Many scientists seem to see it in a similar way. Contrary to their sober ways, they also use a lot of superlatives in their evaluations. There is talk of “great and promising data” as well as “fantastic” and “outstanding” results. For one researcher, the information from Pfizer and Biontech is the best news he has heard since the pandemic began. That will have a decisive influence on how we deal with the pandemic. Many hope that the mRNA vaccine will be approved soon.
The same applies to Munich-based infectologist and Covid-19 researcher Clemens Wendtner. It describes the reported effectiveness data as a “ray of light” on the otherwise gloomy Corona horizon. In a statement to the German Science Media Center (SMC), it describes the 90 percent effectiveness as even more remarkable, as many of the ongoing vaccination studies on Covid-19 only require a 50 percent success rate.
No knowledge of the raw data
Marylyn Addo, a specialist in tropical medicine at the Eppendorf University Medical Center in Hamburg, assesses the interim results presented somewhat more critically: “These are interesting early signs,” she told SMC. He complained that the results were only disclosed in a press release and that no primary data was available. Addo would also like to know how good the protective effect of vaccination was in different age groups.
It is clear to all specialists: the results of the most recent studies are preliminary efficacy data. These may still change after a longer observation period by the test persons. Therefore, it is important, as Wendtner emphasizes, that long-term effects and long-term side effects remain on the radar screen even after the vaccine has been approved.
