RFK Jr. wants placebo testing for ‘new' vaccines, experts say it's unethical
In a statement to the Washington Post this week, a spokesperson for the Department of Health and Human Services (HHS) said, 'All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices.'
If implemented, the new regulations would require some test subjects to receive vaccine doses, while others would be injected with a non-reactive substance.
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Vaccines that target new infectious agents are often tested using the placebo method, but for well-known and researched diseases, health experts say using a placebo poses ethical issues because the group receiving it will not know if they are actually protected against the illness.
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The health department did not provide details on how the proposed changes will be enforced or to which vaccine trials they will apply. It also did not define what it meant by 'new vaccine,' though it said the policy would not include the flu shot, which is updated yearly.
Health experts have argued that updated COVID-19 vaccines may be included, which they say could delay access.
Peter Lurie, a former Food and Drug Administration (FDA) official, told the BBC, 'It's hard to tell exactly what is being proposed.'
'But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point.'
An HHS spokesperson also told the BBC that Kennedy's goal is to achieve 'radical transparency,' which means 'being honest and straightforward about what we know—and what we don't know—about medical products, including vaccines.'
The statement went on to claim that none of the vaccines recommended for children in the U.S., except the COVID-19 shot, had gone through placebo testing, which the health department says leaves it knowing 'very little about the actual risk profiles of these products.'
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However, health experts warn that the statement is misleading because vaccines administered to children, including for hepatitis A and B, polio, and mumps, were all tested against a placebo during their development stages.
The BBC adds that all new immunizations go through a type of random testing where one test group receives the vaccine and the other is given a placebo.
But in the new system proposed by HHS, experts say vaccines under testing may not undergo the same randomized process, because it is unethical to withhold an injection that is known to be safe from a particular group, and because shots that are updated yearly go through minimal alterations.
For example, the COVID-19 vaccine has endured scrupulous testing for years, and all of that is necessary to update it for a different Omicron variant than the one used the year prior, Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told the BBC.
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Nevertheless, an HHS spokesperson said that 'significant updates to existing vaccines' could be seen as 'new products,' which could necessitate additional trials.
'A four-year-old trial is also not a blank cheque for new vaccines each year without clinical trial data, unlike the flu shot, which has been tried and tested for more than 80 years,' the spokesperson told the BBC.
Meanwhile, Lurie says requiring placebo tests for basic updates to existing vaccines that are proven to work would be expensive and could lead to drug companies opting not to upgrade them altogether.
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Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. SUBSCRIBE TO UNLOCK MORE ARTICLES Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. REGISTER / SIGN IN TO UNLOCK MORE ARTICLES Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account. Share your thoughts and join the conversation in the comments. Enjoy additional articles per month. Get email updates from your favourite authors. THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK. Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account Share your thoughts and join the conversation in the comments Enjoy additional articles per month Get email updates from your favourite authors Don't have an account? Create Account Some public health care workers say the shooting that killed a police officer and rattled the CDC campus shouldn't be surprising in the face of ongoing misinformation and animosity about the safety of immunizations. 'All of us, anybody who stands up for science or vaccines, will at some level get hate mail or a phone call that's unnerving or a death threat,' said Paul Offit, the co-inventor of a rotavirus vaccine. 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Winnipeg Free Press
9 hours ago
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'One of the things that we saw during COVID is that the government was overreaching in its efforts to persuade the public to get vaccinated, and they were saying things that are not always true,' Kennedy said during a television interview with Scripps News later in the day. A spokesperson for Kennedy blasted any notion that blamed vaccine misinformation for Friday's attack. 'This narrative is pure fiction, built on anonymous complaints and a willful disregard for the facts,' said Andrew Nixon of the U.S. Department of Health and Human Services. 'Secretary Kennedy is not advancing an 'anti-vaccine agenda' — he is advancing a pro-safety, pro-transparency, and pro-accountability agenda.' Authorities have said that 30-year-old Patrick Joseph White had written about his discontent with the COVID-19 vaccine before he opened fire on the CDC. White also had verbalized thoughts of suicide, which led to law enforcement being contacted several weeks before the shooting, according to the Georgia Bureau of Investigation. White died at the scene of a self-inflicted gunshot wound on Friday after killing DeKalb County Police Officer David Rose. Shooting rattles CDC campus Following the attack, CDC employees were asked to scrape off old CDC parking decals from their vehicles. But even before that, some workers had taken steps to become less visible, including not wearing their public health service uniform, said Yolanda Jacobs, a union leader who represents some CDC workers. The CDC's new director told employees this week that no act of violence can diminish their mission to protect public health. 'We know that misinformation can be dangerous. 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'Because he basically told them that those are the people you should hurt.' ___ Hollingsworth reported from Kansas City, Missouri, and Seewer reported from Toledo, Ohio.
