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 early studies, a positive sign for one of the front-runners in the race for a shot.
The partners haven’t had to stop their late-stage study over safety concerns, BioNTech Chief Executive Officer Ugur Sahin said in an interview. They’re sticking with their previously announced target of being able to provide preliminary data on whether the vaccine works as soon as this month, if a threshold for infections is reached; if so, any submissions for regulatory approval would come later.
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 over every possible complication. This week, Eli Lilly & Co. and Johnson & Johnson both said they had to pause research on potential therapies or shots because of safety concerns. Meanwhile, U.S. President Donald Trump has touted unproven treatments and pushed for more rapid regulatory review.
The pauses in other studies show “there is no room for ignoring facts,” Sahin said. “If there is a concern, the process stops. No one closes their eyes, and it should give people confidence that if a vaccine survives the development process and is approved, it should be regarded as safe.”
With just 195 participants, the early study was too small to show the real safety implications of the experimental shot. Still, the side effects that have emerged so far in the 44,000-person late-stage trial are similar to those seen in these early studies, Sahin said.
Safety is a key factor for any potential vaccine because the shots will be given widely to healthy people. The Food and Drug Administration has said it will require two months of safety data before reviewing any application for emergency authorization for a vaccine.
Collecting the extra safety data probably won’t cause much of a delay once readout on the vaccine’s effectiveness is available, Sahin said.
“Waiting another couple of weeks to complete the safety data should not be a concern,” he said.
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