Judicial Watch announced today that it received 2369 pages of records from the National Institutes of Health (NIH) revealing over two dozen cases where research involving recombinant or synthetic nucleic acid (r/sNA) molecules was conducted in America without proper approval and in violation of NIH guidelines.
Recombinant or synthetic nucleic acid (r/sNA) molecules are constructed outside of living cells. The molecules are made by joining DNA or RNA segments (natural or synthetic) to DNA or RNA molecules that can replicate within a living cell. They may also result from replication of previously constructed recombinant molecules.
NIH guidelines detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules – including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. These guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses be reported to NIH within 30 days.
The documents further showed that the research, which occurred at Biosafety Level 1/2/3 laboratories, led to dozens of dangerous mishaps, accidents, and spills.
Judicial Watch obtained the records in response to a Freedom of Information Act (FOIA) request to NIH asking for:
Any and all records maintained by the National Institutes of Health including memoranda, draft memoranda, reports, email communications, email chains, data compilation, and other communications regarding or documenting accidents, incidents, illnesses and hazards identified concerning (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, organisms, and viruses containing such molecules research which was conducted at Biosafety Level (BSL) 2, BSL 3 or BSL 4 laboratories, including government owned facilities, hospitals, pharmaceutical companies, biotechnology firms, private laboratories, university laboratories, international laboratories and State public health laboratories.
Nearly 100 r/sNA incidents were reported to the NIH through their email system, the following are incidents that were reported with the subject line, “NIH Guidelines.”
In an email on February 12, 2020, Biosafety Officer for the University of Nebraska – Lincoln Dr. Matt Anderson reports an incident that began in March 2018 wherein Dr. Shi-Hua Xiang created an HIV pseudo virus containing Marburg glycoprotein M78 in a university Biosafety Level 2 laboratory, for which he did not have authorization.
The incident was discovered during a pathogen inventory, and Xiang was told to cease any further work. During the investigation, it was determined that Xiang was assisted by student researchers and that the experiment had continued until enough virions were created to complete the experiments that were testing novel peptide inhibitors of viral entry. The report states that Xiang completed NIH Guidelines training in 2012, 2018 and 2019 on responsibilities of obtaining approval prior to engaging in these types of experiments. This research was funded by NIH under contract 1R2 1AI126299-01A1.
In an email on April 19, 2020, Chairman of the Institutional Biosafety Committee of the Memorial Sloan Kettering Cancer Center in New York, NY, Dr. Michael Glickman reports an incident at his facility where an investigator was conducting unauthorized research constructing recombinant Modified Vaccinia Ankara (MVA) expressing spike proteins from SARS-COV-2 in violation of NIH Guidelines.
Upon discovery, the investigator was ordered to immediately halt the unapproved research. It was determined during the investigation that recombinant viruses had been generated and must be destroyed immediately. The report did not mention the Biosafety Level of the laboratory involved.
In an email on April 22, 2020, the Biosafety Officer for the University of North Carolina, Chapel Hill, Dr. Garry Coulson reports an incident directly to Kathryn Harris of the NIH Office of Science Policy.
Coulson states that a researcher who was working in a Biosafety Level 3 laboratory was bitten by a mouse infected with SARS COV-2 2AA. The incident occurred on April 21, 2020, and the researcher was placed on a mandatory fourteen-day quarantine and monitored for COVID symptoms. The research was funded by NIH under grants U19AI100625 / U19AI142759 and contract HHSN27220170036.
In an email on May 19, 2020, the Associate Director of the Office of Research, Office of Responsible Research Practices at The Ohio State University Helen O’Meara reports an incident where Dr. Shan-Lu Liu had conducted unauthorized research in a Biosafety Level 2 laboratory developing a pseudo typed lentivirus containing the gene encoding for the SARS-COV-2 S protein. This research was in violation of NIH Guidelines.
In an email on October 16, 2020, the IBC Chair of the New York Medical College in Valhalla, NY, Dr. Paul Arnaboldi reports an incident discovered during an April 2019 Biosafety compliance investigation wherein Petra Rocic had submitted false reports to the Institutional Biosafety Committee indicating experiments that were actually conducted did not occur.
Rocic was approved to inject mice with Adenoviral vectors containing EGFP, Adenoviral vectors containing micro-RNA-145, and lentiviral vectors containing GPR-shRNA. After injection, the mice were to remain in a Biosafety Level 2 laboratory for a minimum of 48 hours due to the potential for shedding the virus. During the investigation, it was determined that the mice were immediately returned to only a Biosafety Level 1 laboratory. The investigation revealed these experiments took place in April 2014 and September 2017 and were funded under NIH Grant R01HL093052. It should be noted that the security and safety precautions of a Biosafety Level 2 laboratory are much more stringent than a Biosafety Level 1 laboratory.
In an email on October 23, 2020, Biological Safety Officer for the University of Central Florida, Dr. Don Sibley reported an incident that occurred from September 17, 2018, to September 23, 2020 in a Biosafety Level 2 incubatory facility at the university. Dr. Hao Yu, President & CEO of OncoTroy, was operating a private laboratory inside the University of Central Florida Biosafety Level 2 incubator facility and was conducting recombinant DNA experiments that he had not obtained Institutional Biosafety Committee approval for, a violation of NIH Guidelines.
On June 8, 2020, Dr. Garry Coulson, Biosafety Officer, University of North Carolina, Chapel Hill, NC, sent an email to “NIH Guidelines” and other NIH officials, titled “NIH Incident Report” reporting a researcher who spilled recombinant SARS COV-2 NanoLuc virus while working with the virus inside a Biosafety Level 3 laboratory. The researcher was placed on mandatory 14 days quarantine and monitored for COVID symptoms. The research was funded by NIH under grants U19AI100625 / U19AI142759 and contract HHSN27220170036I.
“Americans deserve to know just how much illegal research is being conducted in their country without any government oversight whatsoever,” said Judicial Watch President Tom Fitton. “These records appear to show that viruses that are potentially worse than COVID-19 are being illegally created in labs in our own country.”
On October 29, 2021, the U.S. Director of National Intelligence released a declassified report on the origins of COVID-19. The report acknowledges that, “the first human infection with SARS-CoV-2 most likely was the result of a laboratory-associated incident, probably involving experimentation, animal handling, or sampling by the Wuhan Institute of Virology.”
Through FOIA requests and lawsuits, Judicial Watch has uncovered a substantial amount of information surrounding COVID-19, to include the communications of Anthony Fauci and other U.S. officials, as well as biosafety issues here in the United States. The findings include:
- May 2022: Galveston National Laboratory at the University of Texas Medical Branch (UTMB) records showed that former director Dr. James W. Le Duc warned Chinese researchers at the Wuhan Institute of Virology of potential investigations into the COVID issue by Congress.
- May 2022: HHS records regarding biodistribution studies and related data for the COVID-19 vaccines show a key component of the vaccines developed by Pfizer/BioNTech, lipid nanoparticles (LNPs), were found outside the injection site, mainly the liver, adrenal glands, spleen and ovaries of test animals, eight to 48 hours after injection.
- April 2022: Records from the Federal Select Agent Program (FSAP) reveal safety lapses and violations at U.S. biosafety laboratories that conduct research on dangerous agents and toxins.
- March 2022: HHS records include emails between National Institutes of Health (NIH) then-Director Francis Collins and Anthony Fauci, the director of National Institute of Allergy and Infectious Diseases (NIAID), about hydroxychloroquine and COVID-19.
- March 2022: HHS records show the State Department and NIAID knew immediately in January 2020 that China was withholding COVID data, which was hindering risk assessment and response by public health officials.
- December 2021: HHS records include a grant application for research involving the coronavirus that appears to describe “gain of function” research involving RNA extractions from bats, experiments on viruses, attempts to develop a chimeric virus and efforts to genetically manipulate the full-length bat SARSr-CoV WIV1 strain molecular clone.
- August 2021: HHS records include an “urgent for Dr. Fauci ” email chain, citing ties between the Wuhan lab and the taxpayer-funded EcoHealth Alliance. The government emails also report that the foundation of U.S. billionaire Bill Gates worked closely with the Chinese government to pave the way for Chinese-produced medications to be sold outside China and help “raise China’s voice of governance by placing representatives from China on important international counsels as high level commitment from China.”
- July 2021: NIAID records reveal that it gave nine China-related grants to EcoHealth Alliance to research coronavirus emergence in bats and was the NIH’s top issuer of grants to the Wuhan lab itself. The records also include an email from the vice director of the Wuhan Lab asking an NIH official for help finding disinfectants for decontamination of airtight suits and indoor surfaces.
- June 2021: HHS records reveal that from 2014 to 2019, $826,277 was given to the Wuhan Institute of Virology for bat coronavirus research by the NIAID.
- March 2021: HHS records show that NIH officials tailored confidentiality forms to China’s terms and that the World Health Organization (WHO) conducted an unreleased, “strictly confidential” COVID-19 epidemiological analysis in January 2020.
- October 2020: Fauci emails include his approval of a press release supportive of China’s response to the 2019 novel coronavirus.