RFK Jr.'s effort to undermine COVID boosters is unethical
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'At this point in time, our standard of care has been placebo-controlled trials,' said Jodie Guest, professor and senior vice chair of the department of epidemiology at the Rollins School of Public Health at Emory University.
The concern is over how Kennedy will define 'new.' It's not clear if the requirement would apply to updates of existing vaccines. For example, the pneumococcal, Hib, and measles vaccines have all been improved over the years. Most urgently, there are two vaccines — against flu and COVID — that are updated annually. The basic platform of the vaccine remains the same, but the vaccine is changed slightly to better match the strains of illness expected to be circulating in the upcoming season.
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The original COVID vaccines were tested in clinical trials against placebos. But the annual COVID booster shots, similar to flu shots, are tested by giving the shots to a test population then drawing blood and measuring antibody levels, which are correlated to how much protection the person has against disease. That type of testing involves fewer people and far less time than placebo testing.
Kennedy's proposal to potentially require placebo studies for COVID boosters is neither ethical nor effective. As laid out by
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Guest said requiring new placebo-based clinical trials of COVID-19 boosters would also probably take so long that it would be impossible to release annual updates — which, of course, may be exactly what Kennedy intended.
To be sure, scientists and public health officials should continue studying COVID boosters over the long term to ensure they are safe and effective. Scientists should be measuring the shots' impact on illness transmission and severity among different populations, from children to the elderly, and making recommendations accordingly. They should be monitoring reports of side effects to the national Vaccine Adverse Event Reporting System and claims made to the National Vaccine Injury Compensation Fund, along with relevant research by other government-based projects that monitor and research vaccine safety.
There may certainly be ways to improve safety monitoring for all vaccines — for example, making it easy for vaccine recipients to report side effects via mobile app or structuring databases so researchers can easily search for trends. With any vaccine, doctors should be honest about the risks and benefits so patients and families can make educated decisions.
As the Trump administration slashes government budgets, the best way to ensure vaccines remain safe and effective is by keeping in place the staff and infrastructure needed to develop, monitor, and approve vaccines. This means maintaining the databases and
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But adding testing requirements that aren't science-based will only harm Americans' ability to choose the health care that's right for them.
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