The side effects that appeared in a large, late-stage trial of a COVID-19 vaccine candidate from Pfizer Inc. and BioNTech SE are in line with those seen in early, smaller studies, a positive sign for one of the pioneers of the race. for a blow.
The partners did not have to stop their late stage study on the security issues, BioNTech chief executive Ugur Sahin said in an interview. They are sticking to their previously announced goal of being able to show as early as this month whether the vaccine is working.
This would put Pfizer and BioNTech on track to potentially be the first to show the effectiveness of a COVID-19 vaccine, in an environment of scrutiny for all possible complications. This week, Eli Lilly & Co. and Johnson & Johnson both said they had to halt research into potential therapies or injections for safety concerns. Meanwhile, US President Donald Trump has touted unproven treatments and pushed for faster regulatory review.
Pauses in other studies show “that there is no room to ignore the facts,” Sahin said. “If there is a problem, the process stops. No one turns a blind eye, and that should give people confidence that if a vaccine survives the development process and is approved, it should be considered safe.
Pfizer and BioNTech chose their candidate from a list of four candidates, all of which relied on messenger RNA technology designed to teach cells in the body to become full-fledged vaccine factories.
In what Sahin said was an unusual step, Pfizer and BioNTech on Wednesday published some of the data they used to narrow the field in the New England Journal of Medicine. Results show that people who took the investigational vaccine they chose had fewer so-called systemic side effects – things like fever, chills, and fatigue – than those who received another blow in the wallet. partners.
Due to the structure of the trial, BioNTech and Pfizer first disclosed the first results of another vaccine candidate, BNT162b1, in July. Investors were already optimistic about the outlook for BNT162b1, but after comparing the data, the companies instead decided to pursue another candidate, BNT162b2, Sahin said. This performed equally well in the elderly in the study as it did in the younger participants, he said, an important consideration for a vaccine against the coronavirus.
With only 195 participants, the first study was too small to show the real safety implications of experimental shooting. Yet the side effects that have appeared so far in the late-stage trial of 44,000 people are similar to those seen in those early studies, Sahin said.
Safety is a key consideration for any potential vaccine, as vaccines will be widely administered to healthy people. The Food and Drug Administration said it would take two months of safety data before it would consider any emergency clearance requests for a vaccine.
Collecting additional safety data is unlikely to cause much delay once the vaccine efficacy reading becomes available, Sahin said.
“Waiting a few more weeks to complete the safety data shouldn’t be a problem,” he said.