For a Pivotal Vaccine: Trial, Error, and Two Young Lives

October 11, 2023

(Undark) – What has been lost amid these medical milestones are the stories of the dozens of children who suffered severe bouts of illness in the early days of RSV research, after receiving an experimental vaccine that, rather than offering protection, worsened symptoms during an initial RSV infection.

Today’s vaccines are a far cry from the experimental shot that debuted in the 1960s: They’ve been rigorously tested in animals, and then vetted in phased human trials designed to catch all but the most elusive side effects. But troubling questions linger about the clinical trials that helped launch the RSV vaccine research program. The first, and youngest, children to get the vaccine were mostly Black and poor. Some were enrolled in foster care. Clinical research was largely unregulated in those days, and archival documents housed at the NIH suggest that parents did not give informed consent — or in some cases, any consent at all — for their children to receive the largely untested shot. (Read More)