FDA Approves Pfizer's Maternal RSV Vaccine Despite Trial Safety Signals Of Increased Premature Birth

A recent article published in The British Medical Journal details the debate that has broken out over whether Pfizer should have told pregnant women participating in its trial of maternal respiratory syncytial virus vaccination that a trial of GSK's similar vaccine was halted over a safety signal around pre-term birth.

Hana El Sahly, professor of molecular virology and microbiology at Baylor College of Medicine and committee chairwoman, said that the signal of increased preterm births connected to the Pfizer vaccine was "Significant in the phase 2, in the phase 3, and in a very similar product," adding that failing to design the Pfizer phase 3 study to deliver clarity was a "Big missed opportunity."

Did Pfizer Afford Pregnant Women in its Trial Informed Consent? After GSK's trial was halted, opinion was split among clinical trial ethicists and some vaccine researchers over whether Pfizer should have informed all women participating in its trial about the potential risk or updated its consent forms.

The BMJ contacted governmental health authorities in all 18 countries where Pfizer had trial sites, as well as more than 80 trial investigators, and none answered saying that it had. Some confirmed that Pfizer continued to enrol and vaccinate women for months after the news of the potential risk of preterm birth in GSK's vaccine trial was made public.

Clinical trial ethicists and some other experts think that Pfizer should have made pregnant women in its trial aware of the potential preterm risk; some trial investigators and health authorities disagree.

"Once the results of the GSK trial on premature births became public, RSV vaccine studies in pregnant women should be updated to include this possible preterm risk," said Klaus Überla, director of the Institute of Clinical and Molecular Virology of the University Hospital Erlangen and a member of the German RSV working group of the standing committee on vaccination.

Beate Kampmann, director of the Centre for Global Health at Charite University Hospital Berlin, one of the lead authors of Pfizer's phase 3 trial publication, and who was responsible for a trial site in the Gambia, told The BMJ that GSK's results weren't relevant to her trial participants "As most participants were already in follow-up" and the Pfizer vaccine was not the same as the GSK product. 

https://expose-news.com/2023/11/28/fda-approves-pfizers-maternal-rsv-vaccine/