James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Law Pharmaceutical & Life Sciences News, in “Botched Covid Plasma Announcement Clouds FDA’s Vaccine Process,” by Jeannie Baumann.
Following is an excerpt:
Overblown claims about antibodies harvested from infected Covid-19 patients’ blood threaten to undermine public faith in future FDA approvals of therapies or even vaccines. …
James A. Boiani, an attorney with Epstein Becker Green, said any vaccine that the FDA approves will be safe and reasonably effective.
“There will be judgment baked into the approval—like every approval—and some people will question whatever happens,” he said. “But I have confidence that FDA will make a reasonable decision. The stakes are too big for them as an agency, and as public health officials, to do anything else.”