Preliminary results of the first human clinical trials of a possible vaccine for the new coronavirus developed by the German BioNTech and the American pharmacist Pfizer are encouraging: it generated an immune response in healthy people, without dangerous adverse effects. However, much more data and research is required.
“These early results from clinical trials show that the vaccine offers immune activity and generates a strong immune response,” BiNTech co-founder Ugur Sahin told StatNews.
“We still have a long way to go and we are testing other candidates. However, what we can say at this point is that it is a viable candidate based on immunogenicity and on tolerance and safety data, “said Philip Dormitzer, spokesperson for Pfizer.
The clinical data was published in a preprint that is being reviewed for publication in a scientific journal, but was greatly appreciated by the medical community, which had criticized the lack of transparency of the modern biotechnology company, which released the results of Evidence of his covid-19 vaccine was released in a statement, but not by publishing the study as such.
“It is the first positive data that I see coming out of Operation Maximum Speed. I am glad that Pfizer took the initiative to publish it when others have not. I think we should see more of this, ”tweeted Peter Jay Hotez, dean of Baylor University School of Tropical Medicine.
This Pfizer and BionTech vaccine, named BNT162b1, is just 1 of 17 being tested in humans and, according to Reuters news agency, the fourth to show promising results in them, along with those of Moderna, CanSino Biologics and Inovio. Pharmaceuticals.
45 people aged between 18 and 55 years participated in the study: 12 received a dose of 10 micrograms, 12 of 30 micrograms, 12 of 100 micrograms and 9 placebo.
More than half of the participants who received one of the doses reported some type of adverse effect that is usually seen with some vaccines, such as fever, pain in the prick area or sleep problems, but none considered serious.
In all the participants, the vaccine generated antibodies against SARS-CoV-2, some of them neutralizing and at levels between two and three times higher than those detected in patients recovered from covid-19. For this response to be generated, a second dose was required, delivered about three weeks apart.
With this information, it will be determined which dose to use to conduct a much larger clinical trial, involving about 30,000 people, and which would begin in late July, according to a Pfizer statement.
If the next clinical trials are successful and the vaccine is approved, BioNtech and Pfizer hope to manufacture up to 100 million doses by the end of 2020 and more than 1.2 billion doses by the end of 2021.
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