Dr. Jeyanthi Kunadhasan On Pfizer Delaying The Announcement Of Its Covid Vaccine Until Six Days After The 2020 U.S. Presidential Election
Dr. Jeyanthi Kunadhasan of the DailyClout team joins ITN to discuss her team’s latest findings that Pfizer had completed what it considered a successful vaccine trial but waited until six days after the 2020 U.S. Presidential Election to make the announcement.
- On July 21, 2020, the United States (U.S.) government, Pfizer, and BioNTech signed a contract, known as a Statement of Work (SOW), for the rapid development of and obtaining regulatory licensure for a COVID-19 vaccine by October 31, 2020, a few days prior to the November 3, 2020, U.S. Presidential election. Regulatory licensure was to be based on approval by the U.S. Food and Drug Administration (FDA) or authorization based on demonstration of efficacy. (https://www.hhs.gov/sites/default/files/pfizer-inc-covid-19-vaccine-contract.pdf)
- The July 2020 SOW states, “…if FDA approval or authorization was not issued by October 31, 2020…and Pfizer expects it will be unable to timely complete performance, then the Parties will discuss in good faith a contract modification to shift forward the estimated delivery schedule to reflect the difference in time period between October 31, 2020, and the date of actual regulatory approval or authorization.” In the SOW, Pfizer committed to notify the Government “of any event, risk, formal or informal FDA communication, or any other issue that would be reasonably expected to materially change the anticipated schedule by one week or more.” (https://www.hhs.gov/sites/default/files/pfizer-inc-covid-19-vaccine-contract.pdf, pp. 13-14.)
- On the date of Pfizer Protocol Amendment 9, October 29, 2020, Pfizer already had more than 62 evaluable efficacy cases diagnosed, as required in that exact amendment. (“125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf,” https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf, p. 935)
- On November 9, 2020, Pfizer announced that its BNT162b2 vaccine candidate was >90% effective based on a November 8, 2020, interim analysis of partial data from its Phase 3 clinical trial. (“Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.” Retrieved June 19, 2023, from https://www.businesswire.com/news/home/20201109005539/en/.)
- Despite Pfizer not making its vaccine efficacy announcement until November 9, 2020 (https://www.keionline.org/misc-docs/FOIA/DoD-Pfizer-Contract-W15QKN21C0012-22Dec2020.pdf, p. 3), more than one week after the October 31, 2020, SOW commitment date, there is no evidence that Pfizer notified the Government, as required, of a greater than one-week change in schedule. (Department of Defense (DOD)-Pfizer Contract W15QKN21C0012 (includes Modification 310). December 22, 2020. (n.d.). Retrieved from https://www.keionline.org/misc-docs/FOIA/DoD-Pfizer-Contract-W15QKN21C0012-22Dec2020.pdf, p. 3.) (“Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.” Retrieved June 19, 2023, from https://www.businesswire.com/news/home/20201109005539/en/.)
- On November 18, 2020, Pfizer reported 95% effectiveness based on analysis of a larger dataset that included 170 patients (162 in the placebo group and 8 in the vaccinated group). Based on the strength of that data, Pfizer formally requested Emergency Use Authorization (EUA) from the US Food and Drug Administration.” (Department of Defense (DOD)-Pfizer Contract W15QKN21C0012 (includes Modification 310). December 22, 2020. (n.d.). Retrieved from https://www.keionline.org/misc-docs/FOIA/DoD-Pfizer-Contract-W15QKN21C0012-22Dec2020.pdf, p. 3.)
- The FDA then authorized the EUA for Pfizer’s COVID-19 vaccine on December 11, 2020. (https://www.fda.gov/media/144416/download)
- From the analysis of the 170 patients found in the FDA-released Pfizer clinical trial documents (https://phmpt.org/pfizer-16-plus-documents/), there is evidence that Pfizer had the data needed for its interim analysis of the “evaluable efficacy” in October 2020, when the various accrual thresholds of evaluable efficacy cases (i.e., the total number of COVID-19-positive patients that Pfizer counted to prove “efficacy”) were reached. Therefore, an announcement of vaccine efficacy could have been made in October 2020, before the U.S. 2020 presidential election. When you read on, you will likely have the same question we do: Was this unnecessarily delayed announcement an effort to negatively impact one candidate’s chances of winning the U.S. Presidential election?