SAN FRANCISCO (KCBS RADIO) – U.S. Health and Human Services Secretary Robert F. Kennedy Jr. is known for his skeptical stance regarding vaccines, and a new plan for them from the department has some experts concerned. William Schaffner, professor of preventive medicine and health policy at Vanderbilt University Medical Center joined Audacy this week to explain why.
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This Thursday, The Washington Post reported that Kennedy planned to order new placebo testing for all new vaccines. While this type of testing is common for some vaccines, there are reasons why other methods are sometimes used.
“What it means is that before a vaccine is licensed, in order to test how well it works and how safe it is, you do what we call a clinical trial,” Schaffner explained. “You get a whole lot of volunteers, thousands of them, and half the volunteers get the vaccine, the other half get what’s called a placebo, salt solution.”
Both groups are followed, sometimes for multiple years, to determine the efficacy and safety of the vaccines. Schaffner said that placebo trials have been done for at least the first version all of the vaccines currently in use.
“Here’s where the problem comes up,” he told KCBS Radio. “Suppose we develop a new – and we hope a better – vaccine against a disease for which we already have a vaccine.”
Schaffner used whooping cough as an example, since there is an “imperfect” vaccine for the disease. If researchers developed an improved vaccine, they wouldn’t be able to do a large placebo trial.
Why?
“It would be unethical to withhold the whooping cough vaccine from half the population,” Schaffner said. “So, going forward, developing improved vaccines for the ones we already use will be very difficult. You can’t do that in a placebo-controlled trial.”
His main concern is that the new placebo trial requirement will discourage researchers from trying to make these improved vaccines, since it will likely be difficult to license them.
“We’ll have to see how exactly it’s implemented,” said the professor. “Will it be sufficiently flexible so that we can improve our vaccines as well as develop vaccines that are new against diseases against which we don't have already got a vaccine?”
It might also affect vaccines such as COVID-19 and flu vaccines that require annual updates due to how fast those viruses mutate. Schaffner said subsequent placebo trials for those vaccines would be nearly impossible since they are recommended for nearly all Americans and because the vaccine would be out of date by the time the trial is completed.
“We have other means of determining the effectiveness of vaccines when we can't do a placebo controls trial,” Schaffner said.
According to The Washington Post’s report, the HHS said its new approach to vaccine testing requirements are intended to “increase transparency.” In a Thursday press release, the HHS also announced “the development of the next-generation, universal vaccine platform, Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated, whole-virus platform,” along with the National Institutes for Health.
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