Pathologist Petitions FDA to Stay Phase III trial of Pfizer COVID-19 vaccine

Dr. Sin Hang Lees has filed a citizen petition with the FDA to pause the Pfizer’s Phase III trial of their COVID-19 experimental mRNA vaccine BNT162 until its study design is amended to accurately assess efficacy. Dr. Lee explains his concerns in detail. His filing states:

“Furthermore, if the vaccine is approved without an appropriate and accurate review of efficacy, then any potential acceptance or mandate of these vaccines is likely to be based on inaccurate evidence regarding the vaccine, namely that it will stop transmission of the virus from the vaccine recipient to others and/or that it will reduce severe COVID-19 disease and deaths. The Pfizer trial protocol is currently not designed to determine whether either of those objectives can be met; and even if it was, if cases cannot be reliably identified, neither objective could be reliably met.”

About Sin Hang Lee, MD, F.R.C.P. (C) Pathologist

“Dr. Sin Lee is a pathologist who has been practicing for more than 40 years: as an attending Pathologist at Yale-affiliated teaching hospitals from 1973 to 2003. He was the Director of the Molecular Diagnostic Section at Milford Hospital Laboratory from 2004 to 2015. Since 2015, he is the Director of the Milford Molecular Diagnostics Laboratory.

Dr. Lee was born in Hong Kong, and received his medical degree from Tongji-Wuhan Medical University in China. He is a naturalized U.S. citizen, and a licensed medical doctor in in DC, New York, and Connecticut, in Canada. He is a board certified pathologist by the American Board of Pathology, and is a Certificated Specialist and is a fellow of the Royal College of Physicians and Surgeons of Canada.  Dr. Lee is a qualified medical practitioner registered at the General Medical Council in London. His expertise includes General pathology, surgical pathology, clinical microbiology and molecular diagnostics by PCR/direct DNA sequencing.”