Members of the Vaccine Advisory Committee and invited presenters.
Brace yourselves. My comments will not be in the tone of this meeting’s rush to distribute experimental gene therapy as a vaccine.
I signed up for public comment in the event that the Vaccine Science Advisory Workgroup or others missed the opportunity to discuss the emergency authorization reports recently made available by the FDA. As you might imagine, the Phase III studies, rushed as they were, do give rise to concerns.
For instance, in the Pfizer study, 371 study participants were excluded from results – 311 in the vaccine arm & only 60 in the placebo arm – this was for “important protocol violations on or prior to 7 days after dose 2”. What were the violations? and why were 5 times as many from the vaccine group excluded? When you’re embarking on a mass vaccination program, one would think this would deserve an explanation.
In terms of potential conflicts of interest, Moderna used university-affiliated physicians to adjudicate test results and inclusion/exclusion, while Pfizer used 3 employees. This is certainly a red flag if transparency was supposed to be a key tenet of the rush to market.
Another concern about transparency: Pfizer and Moderna were able to secure government funded development, production and delivery of their products, while raw data is only available upon request and most are saying it won’t be available for two years. What are they doing with the raw data?
Perhaps most concerning is how Pfizer touted early efficacy results of 95% prior to the EUA based on 170 PCR confirmed cases, while it has now been revealed that 3,410 suspected but unconfirmed cases (1,594 vaccine / 1,816 placebo) were not addressed in the efficacy estimates. Such a large group, whether positive or negative PCR (we now know those tests have poor sensitivity) should not have been ignored in any claims of efficacy. If the “Suspected COVID-19” subjects were included, the efficacy of Pfizer’s mRNA drops to 19-29%, far below the so-called science-based 50% target threshold. Now, I didn’t directly perform review and analysis of the 400 pages of data that was recently made available. An editor at the British Medical Journal did. Peter Doshi published his concerns in a BMJ opinion piece on January 4th. Now, I’ll trust that you will read the same article and follow up on the concerns to inform your enthusiasm for these experimental vaccines. Mr. Doshi’s concerns should be considered in an abundance of caution. And please ask the State to join a call to the pharmaceutical companies to “Show us the Data.”