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 Axios, in “RFK Jr.’s Latest Vaccine Plan Threatens Future of Shots, Experts Say,” by Tina Reed and Maya Goldman.
Following is an excerpt:
A major change in the way HHS plans to evaluate vaccine safety is raising fears that approvals will become unnecessarily onerous and make shots for COVID-19 and other viruses scarcer.
Why it matters: The change under Secretary Robert F. Kennedy Jr. could result in a slow-walking of innovative technologies for future vaccines and runs counter to long-held ethical and scientific standards for ensuring vaccines are safe and effective.
"It's going to do some damage to the speed at which we get new vaccines, and just the basic availability of new vaccines to prevent diseases," said Richard Hughes, a partner at law firm Epstein, Becker & Green and former vice president of public policy at Moderna. …
Of note: HHS announced on Thursday that it plans to invest $500 million into new research around a universal vaccine for pandemic-prone vaccine production.
The agency said it would use an inactivated, whole-virus platform, a move met with skepticism by Rasmussen and some other scientists.
What to watch: The policy shift to require placebo-controlled trials could delay new COVID-19 vaccines and updated boosters in particular, Hughes said. ...