Michael Nevradakis found possibly the most important chart from yesterday’s VRBPAC meeting yesterday.
I missed it, because Dr. Munjal was flipping through her slides so fast I could not read them. Now I know why she did that. It was to avoid discussing these data while still claiming she presented them. The FDA speakers did not discuss this either, nor did the members. One member, Dr. Pergam I think, wanted to know more about maternal safety, but was blown off. He had probably seen this slide in the briefing documents, which perhaps few of the others had read. I had not.
As Michael noted in his Defender article:
Data reported by Pfizer to the CDC indicated that 14% of pregnant women who participated in Pfizer’s trial sustained an adverse event, with 4.2% sustaining a “serious” adverse event, 1.7% experiencing a “severe” adverse event and 0.5% suffering a “life-threatening” adverse event.
Similarly, the same data showed that 37.1% of infants whose mothers received the experimental Pfizer vaccine experienced adverse events within one month of birth — with 15.5% classified as “serious,” 4.5% as “severe” and 1% as “life-threatening,” while efficacy waned within months of vaccination.
If I understand this correctly, using Pfizer’s numbers below, to possibly save the lives of 20 babies a year (80% efficacy x 25 baby RSV deaths/year) or 1 in 200,000 babies born—you are going to cause 1 in 200 mothers to have a serious adverse event , 1 in 250 to have a severe adverse event (the difference between serious and severe is unknown) and 1 in 500 to have a life-threatening event.
