“I fear this vaccine is being oversold,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, in an interview. “We have data in mice. We need human data. I don’t think that’s asking too much.”
Authorization of the bivalent formulations mirrors how the agency has historically assessed changes for the annual influenza vaccine, FDA officials said Wednesday on a press call. While there is no human data showing the effectiveness of these updated vaccines, earlier boosters from both Pfizer and Moderna have shown safety and effectiveness in a large number of people, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“We have those data from humans, plus we have non-clinical data -- data from animal experiments -- that help bolster our impression that this should produce a better response,” Marks said. “That’s our expectation for these and we’ll see whether that’s borne out”
White House chief medical adviser Anthony Fauci said he agreed with the FDA’s decision. Clinical experience with the earlier BA.1 variant isn’t very different from BA.4 and BA.5, he said.
“I think you can make a reasonable assumption that the immunogenicity of the BA.4/5 will be rather similar to, if not closely matched, to what we’ve seen,” he said in an interview.
Human data are preferable, but the results in animals are strong, said Fauci, who also directs the National Institute of Allergy and Infectious Diseases. “Although you can understand why some people may want more data to it, I’m actually comfortable with that decision,” he said.
--With assistance from Robert Langreth, Riley Griffin, Celine Castronuovo and Jeannie Baumann.
This article was provided by Bloomberg News.