New vaccines and placebo controls

I was a subject in the Moderna Phase III trial for the COVID-19 mRNA vaccine. It was a placebo-controlled trial: of the 30,000 people enrolled, half received the vaccine and half got the saline control. I ended up breaking the blind by having myself tested independently. I was positive for spike protein antibody, which was what the vaccine was designed against, but I was negative for nucleocapsid antibody, so it wasn’t a natural infection. 

An HHS spokesperson recently told The Washington Post that "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure -- a radical departure from past practices."

“The statement confused experts who said that vaccines aimed at new pathogens have always been tested this way.

"That has been true of every new vaccine, ever," Paul Offit, MD, of Children's Hospital Philadelphia, told MedPage Today. "I can't think of a single vaccine in the United States that was truly a new vaccine -- not an improvement on an existing vaccine, in which case you have to test it against the existing vaccine -- that has not been subjected to placebo control."

“Some examples of newer vaccines evaluated in placebo-controlled trials include the respiratory syncytial virus vaccine (Abrysvo, Arexvy, mResvia), shingles vaccine (Shingrix), the pneumococcal vaccine (Prevnar13), and the human papillomavirus vaccine (Gardasil). Notably, the world watched as novel COVID-19 vaccines were evaluated against placebos.

 

“Experts say it's generally unethical to do placebo-controlled studies when improving on vaccines that already exist, because that would deny control patients protection against preventable illness -- though certain exceptions can be made.”

I don’t know who that HHS spokesperson was, but it reminded me of the old saying: “There’s something about the sound of a clock striking thirteen that calls into doubt everything that came before.”

https://www.medpagetoday.com/special-reports/features/115588?xid=nl_mpt_DHE_2025-05-14&mh=eb71348a5ff6ae370cc6759bc5dc3300&zdee=gAAAAABm4u1YoCP4y5SBTJUyUyqo9KxZhft26L1xeGdP0BzzQQN1Pb_ifR6vFqhFh-3U6Q_nU7DbA-EawzzXKxSRhMOwjrOGuOKbf7OE641eN0HfnK6eObE%3D&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Evening%20-%20Randomized%202025-05-14&utm_term=NL_Daily_DHE_dual-gmail-definition

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