The side effects that have emerged 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 smaller initial studies, a positive sign for one of the pioneers in the career. for a drink.
The partners have not had to halt their late-stage study due to safety concerns, BioNTech CEO Ugur Sahin said in an interview. They are meeting their previously announced goal of being able to show as soon as this month if the vaccine works.
That would put Pfizer and BioNTech on track to potentially be the first to show the efficacy of a Covid-19 vaccine, in an environment of intense scrutiny on every possible complication. This week, Eli Lilly & Co. and Johnson & Johnson said they had to stop research on possible therapies or vaccines due to safety concerns. Meanwhile, US President Donald Trump has touted unproven treatments and pushed for a faster regulatory review.
The pauses in other studies show that “there is no place to ignore the facts,” Sahin said. “If there is a concern, the process stops. Nobody closes their eyes and it 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 contenders, all of which were based on messenger RNA technology designed to teach the body’s cells to become vaccine factories in their own right.
In what Sahin said is an unusual step, Pfizer and BioNTech published some of the data they used to narrow the field in the New England Journal of Medicine on Wednesday. The results show that the people who took the experimental injection of their choice had fewer systemic side effects (such as fever, chills and fatigue) than those who took another hit to the partner’s portfolio.
Due to the structure of the trial, BioNTech and Pfizer had first disclosed the first results of another candidate vaccine, BNT162b1, in July. Investors were already optimistic about the prospects for BNT162b1, but after comparing data, the companies decided instead to look for another candidate, BNT162b2, Sahin said. That worked just as well in the study’s older people as it did in the younger participants, he said, an important consideration for a coronavirus vaccine.
Similar effects
With only 195 participants, the first study was too small to show the real safety implications of the experimental injection. Still, the side effects that have emerged so far in the late-stage trial of 44,000 people are similar to those seen in these early studies, Sahin said.
Safety is a key factor for any potential vaccine because the injections will be widely administered to healthy people. The Food and Drug Administration has said it will require two months of safety data before reviewing any request for emergency authorization for a vaccine.
Collecting the additional safety data probably won’t cause much of a delay once the reading on the effectiveness of the vaccine is available, Sahin said.
“Waiting a couple more weeks to complete the safety data shouldn’t be a concern,” he said.
.
