AARON SIRI: The first Hep A vaccine ever licensed in the U.S. (and still used) did not use a placebo in its trial (instead, its control was Engerix-B, licensed for children based on a trial with 4 days of safety monitoring after injection).

Don’t be fooled by claims that earlier vaccines were licensed based on long-term placebo-controlled trials. For example:

The first Hep A vaccine ever licensed in the U.S. (and still used) did not use a placebo in its trial (instead, its control was Engerix-B, licensed for…

— Aaron Siri (@AaronSiriSG) July 29, 2024

Don’t be fooled by claims that earlier vaccines were licensed based on long-term placebo-controlled trials. For example: The first Hep A vaccine ever licensed in the U.S. (and still used) did not use a placebo in its trial (instead, its control was Engerix-B, licensed for children based on a trial with 4 days of safety monitoring after injection). The first chickenpox vaccine licensed in the U.S. (and still used) did not use a placebo in its trial (instead, its control was an injection of neomycin, an antibiotic). Prevnar 13 was licensed for babies based on a trial in which Prevnar 7 was used as a control, and Prevnar 7 was licensed based on a trial in which another experimental vaccine, an "Investigational meningococcal group C conjugate vaccine,” was used as a control – again, not a placebo. The current polio vaccine was licensed in the U.S. without a placebo (and only three days of safety monitoring) and the very first polio vaccine (the Salk vaccine) was licensed in 1955 without a placebo. In fact, Dr. Paul Offit attacked me claiming “200,000 were inoculated with salt water” in the Salk polio vaccine trials to “prove” a placebo was used. He is wrong. The official Salk trial report, page 51, describes precisely what these 200,000 children received: an injection that included, among other things, “199 solution” (a synthetic tissue culture medium and ethanol) “phenol red,” “antibiotics,” and “formalin.” In other words, not a placebo. After being called out on the above, Dr. Offit then oddly argued a “placebo” doesn’t mean a saline injection but rather something that is “immunologically inert.” But even under Dr. Offit’s revised definition that would still mean all the controls above were not “placebos” since other vaccines or injections of antibiotics are not immunologically inert. The reality is that the trials the FDA relied upon to license a vaccine as safe are contained in Section 6.1 of the package insert for each vaccine and the hard-cold-reality is right there in black-and-white for the world to see: http://icandecide.org/no-placebo Join the Spaces event discussing this chart tomorrow, on Tuesday (7/30) at noon Eastern: https://x.com/i/spaces/1ynjo/i/spaces/1ynJODQVbDXxR… (See chart in link above and prior Twitter/Stack exchanges with Dr. Offit for sources for all above.)