Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in The New York Times, in “Kennedy Issues Demands for Vaccine Approvals That Could Affect Fall Covid Boosters,” by Christina Robles and Sheryl Gay Stolberg. (Read the full version – subscription required.)
Following is an excerpt:
Health Secretary Robert F. Kennedy Jr. on Thursday announced plans to require all new vaccines to be tested against placebos and to develop new vaccines without using mRNA technology, moves that extend his reach deep into vaccine development and raise questions about whether Covid boosters will be available in the fall.
A spokesman for the Department of Health and Human Services called the requirement for placebo testing “a radical departure” from existing standards. But that will depend on how the department defines “new,” because most new vaccines are already tested either against placebos — inert substances — or, in some cases, against vaccines for other diseases….
The agency was expected to issue a decision on April 1 regarding whether to issue a full approval of the more traditional protein-based Novavax Covid shot, which had been used under emergency authorization. The F.D.A. delayed the decision, though, asking the company to conduct additional research.
“I’m curious if this administration actually intends to just obliterate the Covid vaccine,” said Richard Hughes, a lawyer with the law firm Epstein Becker Green who represents some vaccine makers. ...
