Pfizer failed to inform pregnant women participating in its RSV vaccine trial of potential risks.
Some of the risks included preterm birth and neonatal death.
The information was discovered in an investigation by the British Medical Journal (BMJ).
“Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” bioethics professor at Western University in London, Canada, Charles Weijer told BMJ.
The BMJ said they contacted “governmental health authorities in all 18 countries where Pfizer had trial sites, as well as more than 80 trial investigators,” but none said they had informed expectant mothers of the risks presented in the vaccine.
Consent forms for the vaccine trial reportedly held contradictory information, according tot eh BMJ.
Some. stated that the vaccine may have “life threatening” effects on the baby, while others said, “The risks associated with the study vaccine (RSVpreF or placebo) may be experienced by you, but not your baby, since your baby will not receive the study vaccine or placebo directly.”
“Knowing what we know now, the statement in question is irresponsible and, given the benefit of hindsight, is actually factually incorrect,” said Rose Bernabe, a professor of research ethics and research integrity at the University of Oslo. “The statement gives the false sense of security that the fetus or neonate will not be exposed to any risk or inconvenience. Considering the gravity of the risk that this irresponsible statement veils, this misleading statement should be a ground for questioning the validity of the consent process.”
American Faith reported in August that the Centers for Disease Control and Prevention (CDC) recommended an RSV drug for babies as young as 8 months old.
According to the updated guidelines, the drug, developed by AstraZeneca and Sanofi, will be added to the CDC’s childhood immunization schedule.
“We had a terribly bad RSV season last year and I’m thrilled that we have a new tool to protect our infants,” CDC director Dr. Mandy Cohen said.