Pfizer's vaccine trial questioned over data integrity, regulatory oversight

Source: Xinhua| 2021-11-07 15:09:23|Editor: huaxia

People wait in line to receive the Pfizer/BioNTech COVID-19 vaccine at a mobile vaccine clinic in the Brooklyn borough of New York, United States, Aug. 23, 2021. (Photo by Michael Nagle/Xinhua)

Pfizer "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in its pivotal phase III trial," a former regional director at the Texas-based research organization Ventavia Research Group, which managed Pfizer vaccine trial sites, was quoted as saying.

WASHINGTON, Nov. 7 (Xinhua) -- U.S. multinational pharmaceutical corporation Pfizer has come under pressure over alleged data fraud suspicion in its COVID-19 clinical trials, according to British medical journal The BMJ.

Pfizer "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in its pivotal phase III trial," an article published Wednesday in the The BMJ said, quoting a former regional director at the Texas-based research organization Ventavia Research Group, which managed Pfizer vaccine trial sites.

Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding, the article added.

Vials of the Pfizer-BioNTech vaccine are seen in Ankara, Turkey, on March 31, 2021. (Photo by Mustafa Kaya/Xinhua)

Before she blew the whistle to the journal, the former regional director, with more than 15 years of experience in clinical research coordination and management, was fired for repeatedly reporting massive clinical trial violations of Pfizer, including having emailed a complaint to the U.S. Food and Drug Administration.

While verifying her statements and the information provided, The BMJ received more evidence confirming that the vaccine trials did not meet the standards declared by Pfizer, including improper storage of jabs, violations of the norms of blind testing, frequent data errors and slow response to side effects complaints, the article said.

KEY WORDS: U.S.,Pfizer,COVID,19 Vaccine
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