Drug regulators around the world are facing fresh questions after documents examined by MD Reports revealed serious compliance failures at a research site in Argentina involved in Pfizer’s pivotal maternal RSV vaccine trial.
The trial, known as MATISSE, provided the principal clinical evidence supporting approval of Abrysvo, a vaccine administered during pregnancy to protect newborn babies against respiratory syncytial virus (RSV).
Its findings were published in the New England Journal of Medicine and later in Obstetrics & Gynecology.
Argentina’s drug regulator, ANMAT, documented 32 findings of non-compliance during its inspection, including deficient medical records, failures in reporting serious adverse events involving newborns, and significant shortcomings in trial oversight.
It later concluded that serious violations had affected the quality of clinical data and safety reporting collected at the research centre.
Yet Abrysvo secured approval in the United States, European Union, United Kingdom, Canada and Australia — as well as Argentina itself — before the enforcement proceedings against Pfizer were concluded.
The question is what those regulators knew of the violations — and whether they adequately investigated them before approving the vaccine.