Wednesday, November 25, 2020

FDA Citizen's Petition and Request for Stay of Decision on Covid vaccines--until accurate tests are used to determine actual number of cases and non-cases in Pfizer vaccine clinical trial

Dr. Sin Hang Lee and the Informed Consent Action Network (ICAN), through attorneys Aaron Siri and Elizabeth Brehm, have requested that FDA require accurate counts of Covid cases in the Pfizer/BioNTech Covid-19 mRNA vaccine trial and other Covid vaccine trials. 

Furthermore, until an accurate number of Covid-19 cases in the vaccinated and placebo groups has been determined, FDA is asked to withhold an Emergency Use Authorization for this and other vaccines.

The Pfizer Phase 2/3 clinical trial was designed for haste:  in other words, to accumulate as many "cases" as possible in the shortest time, in order to speed approval and use.

To do so, only one symptom was required for a "case," and almost any  nonspecific symptom, such as a sore throat, fever, a cough or an episode of vomiting or diarrhea would do.  Patients with a nonspecific symptom were then given a PCR test.  Most PCR tests used the Cepheid XpertXpress system, which is known to have a high false positive rate. Cycle thresholds of 35 and over were used, even though Anthony Fauci and the NY Times have both noted such high cycle  thresholds lead to false positives.

Thus, both required elements of the case definition (a nonspecific symptom and an inaccurate PCR test result) lacked precision, and allowed for the inclusion of false positives.

It would have been easy to establish that PCR positive subjects were truly positive by using the gold standard of Sanger sequencing. This verifies whether the PCR product really represents the SARS-Cov-2 virus. It is a standard procedure in many labs. Sequencing would probably have slowed the collection of Covid cases, thereby slowing FDA approval... and it was not performed.

FDA is being asked in the Petition to assure that PCR positive products are sequenced, so that accurate data on efficacy of the vaccine become available.  Because Pfizer asked FDA to issue an Emergency Use Authorization for the vaccine using much less safety and efficacy data than are required to apply for a full license, imposing a requirement to assure accuracy of the limited data available is a no-brainer. 

FDA is also being asked to withhold its decision on the EUA until such time as confirmed case numbers become available.

The Petition was filed on Nov 23, and the request for a Stay was filed on November 25.  The 2 documents are similar.

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