NEW YORK, Feb 18 (Reuters) – A top Pfizer Incscientist said on Thursday the company is in intensivediscussions with regulators to test a booster shot version ofits coronavirus vaccine specifically targeted for a highlycontagious variant that is spreading widely in South Africa andelsewhere.
Phil Dormitzer, one of Pfizer’s top viral vaccinescientists, said in an interview that he believes the currentvaccine – developed with Germany’s BioNTech SE – ishighly likely to still protect against the concerning variantfirst discovered in South Africa.
“We’re not doing that primarily because we think that thatmeans that we’re going to need to change that vaccine,” he said.”It’s primarily to learn how to change strain, both in terms ofwhat we do at the manufacturing level, and especially what theclinical results are.
“So if a variant comes along for which there is clinicalevidence of escape, we’re ready to respond very quickly,”Dormitzer added.
Dormitzer, chief scientific officer of viral vaccines atPfizer Vaccines Research and Development, said the company hasalready made a DNA template for a prototype vaccine and plans tomanufacture a batch of that prototype.
The company is proposing to do a Phase I clinical trial of abooster shot of that prototype vaccine that it would testagainst a booster for the current vaccine.
“This will be a immunogenicity study where you look at theimmune response. And those studies are much, much smaller thanthe giant efficacy studies,” Dormitzer said.
“In immunogenicity studies you can look at the immuneresponse of every person in the study. So that enables you tohave much smaller, easier studies to run. It’s not as definitiveas efficacy data, for sure. But it can be gathered much morequickly,” he explained.
The U.S. Food and Drug Administration has not yet released aroadmap for how companies should design trials of booster shots.
A laboratory study released on Wednesday suggested that theSouth African variant of the coronavirus may reduce protectiveantibodies elicited by the Pfizer/BioNTech vaccine bytwo-thirds, but it is not clear how much that reduces the shot’seffectiveness against the variant.(Reporting by Michael ErmanEditing by Caroline Humer and Bill Berkrot)