Research Ethics/Article Retraction

Johnson & Johnson

Scientific American, by William Petri, The Conversation US 4/13/2021

New York Times, by Noah Weiland, Sharon LaFraniere and Carl Zimmer, published 4/13/2021, updated 10/15/2021

New York Times, By Rebecca Robbins, Stephanie Nolen, Sharon LaFraniere and Noah Weiland, 2/8/2022

"Dr. Gili Regev-Yochay, an infectious disease expert...concluded that a fourth dose restores some protection lost after a third shot but 'doesn't boost immunity beyond that.' 'Not a third dose, not a fourth dose, not a fifth dose will do anything to stop infections [long term],' Regev-Yochay told NPR." -- Dailymail.co.uk, by Reuters and Ronny Reyes 3/17/2022

"Generally, the only thing that changes from one potential mRNA medicine to another is the coding region – the actual genetic code that instructs ribosomes to make protein. Utilizing these instruction sets gives our investigational mRNA medicines a software-like quality. We also have the ability to combine different mRNA sequences encoding for different proteins in a single mRNA investigational medicine." -- Moderna website

StatNews.com, by Damian Garde, 1/10/2017

ClinicalTrials.gov Identifier: NCT04283461

BMJ 2021;375:n2477

CNBC.com, by Chloe Taylor, published 10/8/2021, updated 10/12/2021

Forbes.com,by Robert Hart, 11/10/2021

AstraZeneca, published 11 January 2016

StatNews.com, by Damian Garde, 9/13/2016

Research not fit to print. Nat Biotechnol 34, 115 (2016). https://doi.org/10.1038/nbt.3488

CBS News, by Alexander Tin, 11/15/2021

Fox Business with Maria Bartiromo, 2/24/2022. Interview with Moderna CEO Stephane Bancel.

Ken Paxton, Attorney General of Texas

FDA is reissuing the June 17, 2022 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA."

Question posed to Pfizer's president of international developed markets Janine Small, in a COVID hearing at the European Parliament by Rob Roos, Member of the European Parliament, JA21 - Vice Chairman ECR. The answer in essence, the vaccine was not tested before the public rollout to determine whether it stopped transmission of COVID.

FDA.gov

Reuters, by Manas Mishra and Michael Erman, 6/30/2022

ProjectVeritas.com, 2023

Townhall.com, Leah Barkoukis, 1/26/2023

"Officials from Argentina and the other Latin American country, which cannot be named as it has signed a confidentiality agreement with Pfizer, said the company’s negotiators demanded more than the usual indemnity against civil claims filed by citizens who suffer serious adverse events after being inoculated. They said Pfizer also insisted the governments cover the potential costs of civil cases brought as a result of Pfizer’s own acts of negligence, fraud, or malice." -- Stat News, By Madlen Davies, Ivan Ruiz, Jill Langlois and Rosa Furneaux and Madlen Davies, 2/23/2021

Sivan Gazit, Roei Shlezinger, Galit Perez, Roni Lotan, Asaf Peretz, Amir Ben-Tov, Dani Cohen, Khitam Muhsen, Gabriel Chodick, Tal Patalon
medRxiv 2021.08.24.21262415; doi: https://doi.org/10.1101/2021.08.24.21262415

"People given both doses of the Pfizer-BioNTech vaccine were almost six-fold more likely to contract a delta infection and seven-fold more likely to have symptomatic disease than those who recovered." -- Bloomberg.com, by Michelle Fay Cortez, 8/27/2021

Pfizer

Trialsitenews.com, Sonia Elijah, 7/26/2022

(Alternative title: How to evaluate Pfizer's claim its booster works against omicron) QZ.com (Quartz), by Annalisa Merelli, 12/9/2021

"The second booster’s protection against infection dwindled after four weeks, Israeli researchers showed in their study published on Tuesday in the New England Journal of Medicine." -- New York Post, Reuters, 4/7/2022

"Third shots of the coronavirus vaccines become significantly less likely to protect against serious illness after about four months, according to a new study released Friday." -- New York Post, by Mark Lungariello, 2/11/2022

"It is necessary, a fourth booster right now. The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, and doesn’t last very long.” -- Pfizer CEO Albert Bourla.

Washington Post, by Andrew Jeong and Adela Suliman, 12/9/2021

"The best way to see it is the virus is the enemy. We want to protect ourselves. We build a wall. The first dose builds a wall, but it’s not very high,” Bourla explained on CNBC’s “Squawk Box. He continued, “The third dose takes the wall very high and should expect to stop the Omicron." -- Breitbart.com

CNBC.com, Spencer Kimball, 12/8/2021

Pfizer news release, Wednesday, December 08, 2021

Ky3.com, Associated Press, 9/26/2022

News Medical Life Sciences, by Sally Robertson, 5/10/2021

"Little is known about the broad effects of the new class of mRNA vaccines...Intriguingly, the BNT162b2 vaccine induces reprogramming of innate immune responses as well, and this needs to be taken into account: in combination with strong adaptive immune responses, this could contribute to a more balanced inflammatory reaction during COVID-19 infection, or it may contribute to a diminished innate immune response towards the virus." -- Domínguez-Andrés J, et al. The BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and innate immune responses. medRxiv, 2021. doi: https://doi.org/10.1101/2021.05.03.21256520, https://www.medrxiv.org/content/10.1101/2021.05.03.21256520v1

Sara Y Tartof, Jeff M Slezak, Heidi Fischer, Vennis Hong, Bradley K Ackerson, Omesh N Ranasinghe, Timothy B Frankland, Oluwaseye A Ogun, Joann M Zamparo, Sharon Gray, Srinivas R Valluri, Kaije Pan, Frederick J Angulo, Luis Jodar, John M McLaughlin, Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study, The Lancet, Volume 398, Issue 10309, 2021, Pages 1407-1416, ISSN 0140-6736, https://doi.org/10.1016/S0140-6736(21)02183-8. (https://www.sciencedirect.com/science/article/pii/S0140673621021838)

Reuters.com, by Manas Mishra, 10/5/2021

FDA, 11/19/2021

ir.novavax.com, 6/7/2022

FDA

BMJ 2021;375:n2965

NEW YORK (WABC) Eyewitness News, 11/9/2021

AOL.com, by Anjalee Khemlani, 11/10/2021

Drugs.com, updated by Judith Stewart, 9/12/2021

Reuters.com, by Carl O'Donnell and Dania Nadeem, 11/1/2021

Novavax.com, 9/17/2021

CDC.gov. Slideshow, AstraZeneca,Tonya Villanfana, VP Global Franchise Head, Infection

"The COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. The manufacturer URL for this document will be provided once that is available." -- CDC website

Project Veritas

Project Veritas YouTube video, AstraZeneca CEO Pascal Soriot discussing antibody treatment

reuters.com, 12/8/2021

BMJ 2021;372:n743

DailyMail.com, by Connor Boyd, 6/21/2022

Sputnikvaccine.com

Sputnik V COVID-19 vaccine candidate appears safe and effective Jones, Ian et al. The Lancet, Volume 397, Issue 10275, 642 - 643

ClinicalTrials.gov Identifier: NCT04871841

Carnegie Endowment for International Peace, Paul Stronski, 11/15/2021

"The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection." -- Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database of Systematic Reviews 2023, Issue 1. Art. No.: CD006207. DOI: 10.1002/14651858.CD006207.pub6. Accessed 06 February 2023.

"These FAQs are intended to clarify that medical consent is not required by federal law for COVID-19 vaccination in the United States." -- CDC.gov

Cardozo, T., & Veazey, R. (2021). Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease. International Journal of Clinical Practice, 75(3), e13795. https://doi.org/10.1111/ijcp.13795

" Based on more recent risk-benefit calculations, pregnant people are now authorized to receive the vaccine from their physicians or other health care professionals but without the benefit of evidence that has been provided for nonpregnant patients. " -- Bianchi DW, Kaeser L, Cernich AN. Involving Pregnant Individuals in Clinical Research on COVID-19 Vaccines. JAMA. 2021;325(11):1041–1042. doi:10.1001/jama.2021.1865

CDC.gov

"8.3.5.1. Exposure During Pregnancy An EDP occurs if: ...A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception. • A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy:• A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact. PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 68 • A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception. The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred."

Bramstedt KA. The carnage of substandard research during the COVID-19 pandemic: a call for quality. Journal of Medical Ethics Published Online First: 01 October 2020. doi: 10.1136/medethics-2020-106494

Motonori Takahashi, Takeshi Kondo, Gentaro Yamasaki, Marie Sugimoto, Migiwa Asano, Yasuhiro Ueno, Yasushi Nagasaki,
An autopsy case report of aortic dissection complicated with histiolymphocytic pericarditis and aortic inflammation after mRNA COVID-19 vaccination, Legal Medicine, Volume 59, 2022,

Ricardo Jorge Dinis-Oliveira (2020) COVID-19 research: pandemic versus “paperdemic”, integrity, values and risks of the “speed science”, Forensic Sciences Research, DOI: 10.1080/20961790.2020.1767754

PLOS ECR (Early Career Research) Community, blog post by Meredith Wright Whitaker, 1/29/2021

Bardosh, Kevin and Krug, Allison and Jamrozik, Euzebiusz and Lemmens, Trudo and Keshavjee, Salmaan and Prasad, Vinay and Makary, Martin A. and Baral, Stefan and Høeg, Tracy Beth, COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities (August 31, 2022). Available at SSRN: https://ssrn.com/abstract=4206070 or http://dx.doi.org/10.2139/ssrn.4206070

Maissa Safieddine, Radwan Kassir, BJS Society, Research letter, 9/16/2020 https://doi.org/10.1002/bjs.11966

N Engl J Med 2022; 386:933-941
DOI: 10.1056/NEJMoa2117128

DOI: 10.1056/NEJMc2209371

BMJ 2021;372:n627 doi: https://doi.org/10.1136/bmj.n627

Science.org, by Jocelyn Kaiser, 1/25/2023

Boetto E, Golinelli D, Carullo G, et al Frauds in scientific research and how to possibly overcome them Journal of Medical Ethics Published Online First: 06 October 2020. doi: 10.1136/medethics-2020-106639

LA Times column, By MICHAEL HILTZIK, 6/8/2020

Jamieson, K.H. How conspiracists exploited COVID-19 science. Nat Hum Behav (2021). https://doi.org/10.1038/s41562-021-01217-2

LSE Impact Blog, Serge Horbach, 2/10/2020

Ai-ris Collier, Jessica Miller, Nicole Hachmann, Katherine McMahan, Jinyan Liu, Esther Bondzie, Lydia Gallup, Marjorie Rowe, Eleanor Shonberg, Siline Thai, Julia Barrett, Erica Borducchi, Emily Bouffard, Catherine Jacob-Dolan, Camille Mazurek, Audrey Mutoni, Olivia Powers, Michaela Sciacca, Nehalee Surve, Haley VanWyk, Cindy Wu, Dan Barouch bioRxiv 2022.10.24.513619; doi: https://doi.org/10.1101/2022.10.24.513619

"The retraction process is inconsistent and often ambiguous, with more than half of retracted Covid-19 research articles remaining available, unmarked, from a wide range of online sources" -- excerpt, Frampton, Geoff, et al. “Inconsistent and Incomplete Retraction of Published Research: A Cross-Sectional Study on Covid-19 Retractions and Recommendations to Mitigate Risks for Research, Policy and Practice.” PLoS ONE, vol. 16, no. 10, Oct. 2021, pp. 1–22. EBSCOhost, doi:10.1371/journal.pone.0258935.

Ontario Civil Liberties Association

Caroline Stein, Hasan Nassereldine, Reed J D Sorensen, Joanne O Amlag, Catherine Bisignano, Sam Byrne, Emma Castro, Kaleb Coberly, James K Collins, Jeremy Dalos, Farah Daoud, Amanda Deen, Emmanuela Gakidou, John R Giles, Erin N Hulland, Bethany M Huntley, Kasey E Kinzel, Rafael Lozano, Ali H Mokdad, Tom Pham, David M Pigott, Robert C Reiner Jr., Theo Vos, Simon I Hay, Christopher J L Murray, Stephen S Lim,
Past SARS-CoV-2 infection protection against re-infection: a systematic review and meta-analysis, The Lancet, 2023,
ISSN 0140-6736, https://doi.org/10.1016/S0140-6736(22)02465-5.
(https://www.sciencedirect.com/science/article/pii/S0140673622024655)

YouTube interview with Ivan Oransky. A session from the 2021 Researcher to Reader Conference - R2R 2021 - 05, posted 5/9/2021. Alternative title from PowerPoint presentation: From Cancer to COVID-19, Does Science Self-Correct?

Vaccine, Volume 40, Issue 40, 22 September 2022, Pages 5798-5805

(Alternative title: How to evaluate Pfizer's claim its booster works against omicron) QZ.com (Quartz), by Annalisa Merelli, 12/9/2021

Retraction Watch, by Anna Abalkina, 8/16/2021

Disinformation Chronicle, Paul D. Thacker, 1/11/2022

Wall Street Journal, by Liz Essley Whyte, posted 8/28/2022

DailyMail.com, Luke Andrews, 4/27/2022

New York Post, by Marty Makary, 2/27/2022

"But it doesn’t sound like they actually want to do a study. They just want to vaccinate these people—
if I am reading this correctly." -- Philip Krause

Smith-Schoenwalder, C. (2021). Concerns, Questions Cloud Quickly Approaching COVID-19 Booster Plan. U.S. News & World Report - The Report, C8–C11.

Fox News, by Kayla Rivas.

NBC News, by Sara G. Miller, Reynolds Lewis & Erika Edwards, 9/17/2021

Armour, S., & Hopkins, J. S. (2022, Feb 19). FDA eyes second covid-19 booster shot; agency has begun reviewing data that could lead to clearing a second booster dose of the pfizer, moderna vaccines in the fall. Wall Street Journal (Online) Retrieved from https://www.proquest.com/newspapers/fda-eyes-second-covid-19-booster-shot-agency-has/docview/2630513490/se-2?accountid=14196

FDA (U.S. Food & Drug Administration). Information regarding warning letters to firms for selling fraudulent products such as essential oils, colloidal silver products, etc. purported to treat COVID-19.

"GOP lawmakers on Tuesday asked the Food and Drug Administration (FDA) for answers as to why the top agency did not rely on its typical committee approval process before authorizing a third Pfizer COVID shot for children ages 12-15." -- Fox News, by Caitlin McFall, 01/18/2022

Healthline.com, written by George Citroner on October 28, 2021 — Fact checked by Dana K. Cassell "The CDC has found reduced vaccine effectiveness in people who are immunocompromised compared with people who are not. It now advises that certain people who are immunocompromised can get a fourth vaccine dose. One reason for these new guidelines is that vaccine efficacy has been shown to drop over time, placing certain groups at increased risk."

Fox News, Julia Musto, 3/4/2022

KY3.com. Washington (AP) By Lauran Neergaard and Matthew Perrone,Oct. 12, 2021

Walker, J., Kostov, N., & Bertrand, B. (2022, Feb 11). Robust covid-19 booster protection wanes after four months, CDC says; CDC study assessing effectiveness against the omicron and delta variants underscored generally strong protection for authorized mRNA vaccines. Wall Street Journal (Online) Retrieved from https://www.proquest.com/newspapers/robust-covid-19-booster-protection-wanes-after/docview/2627421417/se-2?accountid=14196

Bramstedt, K.A. Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00224-1

Daily Mail, By Mansur Shaheen, 3/25/2022

According to Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, "Unless there's clear evidence something is of value, don't give it," -- ABC News, by Sony Salzman, 3/24/2022

Bloomberglaw.com, 1/18/2022

FDANews.com PDF of the United States District Court for the Northern District of Texas Fort Worth Division decision

MedPage Today, by Amanda D'Ambrosio, 3/7/2022

"Big pharma is the least trusted industry. At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars. One pleaded guilty to fraud." -- BMJ 2022;376:o102 published 1/19/2022

New York Post, by Marty Makary, 2/27/2022

Research not fit to print. Nat Biotechnol 34, 115 (2016). https://doi.org/10.1038/nbt.3488

AMA

VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), agencies of the U.S. Department of Health and Human Services (HHS)

VAERS Team Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention

Trialsitenews.com, Sonia Elijah, 7/26/2022

CDC, updated 2/3/2022

Letter to Senator Ron Johnson from Rochelle P. Walensky, CDC Director "regarding the Centers for Disease Control and Prevention's (CDC) tracking of reports of coronavirus disease 2019 (COVID-19) vaccine adverse events." -- https://www.documentcloud.org/documents/22309653-walensky-letter

A Letter from Senator Ron Johnson requesting answers to discrepancies in CDC covid-19 adverse reactions data collection.

Oversight.gov

Senator Johnson's letter states that his office "recently received data from a Department of Defense (DoD) whistleblower showing an increase in disease and injuries in pilots across the DoD in years 2020-2022 compared to years 2016-2019.16 Based on data from the Defense Medical
Epidemiology Database, the whistleblower reported that the total number of disease and injuries in pilots across DoD was 265 in 2016; 252 in 2017; 164 in 2018; 223 in 2019; 2,194 in 2020; 2,861 in 2021; and 4,059 in 2022.17 These increases in disease and injuries in pilots across the DoD over the last three years, and particularly over the last year, raise questions as to whether FAA has seen similar increases in disease and injuries in individuals in the aviation industry." -- letter dated 1/27/2023

BMJ 2021;372:n627 doi: https://doi.org/10.1136/bmj.n627

Seneff, S., & Nigh, G. (2021). Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19. International Journal of Vaccine Theory, Practice, and Research, 2(1), 38–79. https://doi.org/10.56098/ijvtpr.v2i1.23 (Original work published May 10, 2021)

PHE.gov

LifeSite

Cardozo, T., & Veazey, R. (2021). Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease. International Journal of Clinical Practice, 75(3), e13795. https://doi.org/10.1111/ijcp.13795

National Law Review, 1/24/2022

Congressional Research Service Legal Sidebar, updated 1/13/2022

Public Health Emergency, U.S. Department of Health & Human Services

"Bottom line: The FDA, Centers for Disease Control, Pfizer, and Moderna knew about myocarditis and pericarditis risks from the mRNA vaccines since day one, yet made no formal warnings to Americans in the form of recommending labeling changes or any other warnings, such as letters to warn physicians, pharmacists, or the American public."-- Federalist.com, by DAVID GORTLER 3/25/2022 (Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and health policy fellow at the Ethics and Public Policy Center. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethicist Center, and was an FDA medical officer who was later appointed by the White House as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs.) -- article

"Under the PREP Act, companies like Pfizer and Moderna have total immunity from liability if something unintentionally goes wrong with their vaccines." -- CNBC, MacKenzie Sigalos, 12/17/2020

Jenna Schauer, Sujatha Buddhe, Avanti Gulhane, Eyal Sagiv, Matthew Studer, Jessica Colyer, Sathish Mallenahalli Chikkabyrappa, Yuk Law, Michael A. Portman, Persistent Cardiac MRI Findings in a Cohort of Adolescents with post COVID-19 mRNA vaccine myopericarditis, The Journal of Pediatrics, 2022, ISSN 0022-3476, https://doi.org/10.1016/j.jpeds.2022.03.032. (https://www.sciencedirect.com/science/article/pii/S0022347622002827)

Gibson, John, (2022), The Rollout of COVID-19 Booster Vaccines is Associated With Rising Excess Mortality in New Zealand, Working Papers in Economics, University of Waikato.

"In this cohort study of 23.1 million Nordic residents aged 12 years or older, the risk of myocarditis was higher within 28 days of vaccination with both BNT162b2 and mRNA-1273 compared with being unvaccinated, and higher after the second dose of vaccine than the first dose. The risk was more pronounced after the second dose of mRNA-1273 than after the second dose of BNT162b2, and the risk was highest among males aged 16 to 24 years." -- Karlstad Ø, Hovi P, Husby A, et al. SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents. JAMA Cardiol. Published online April 20, 2022. doi:10.1001/jamacardio.2022.0583

Firece Pharma, by Zoey Becker, 8/26/2022

" The two top manufacturers of COVID-19 vaccines in the U.S. are each facing a lawsuit alleging they infringed another company's copyright in the development of their Covid vaccines .. Moderna is also facing a lawsuit from the National Institutes of Health (NIH) and by two small Vancouver-based biotechnology firms." -- Dailymail.co.uk, by Mansur Shaheen, 3/17/2022

"DR. FAUCI: One of the things that's clear from the data [is] that even though vaccines - because of the high degree of transmissibility of this virus - don't protect overly well, as it were, against infection, they protect quite well against severe disease leading to hospitalization and death." -- Fox News, 7/12/2022

YouTube video, speech by Stefan Oelrich to the World Heath Summit. At 8:31 Oelrich says, "If we had surveyed two years ago if people were willing to take gene or cell therapy and inject it into your body we would have probably had a 95% refusal rate" -- Stefan Oelrich is on the Board of Management of Bayer AG and head of the Pharmaceuticals Division.

Dolgin, E. (2021). The tangled history of mRNA vaccines. Nature, 597(7876), 318.

By MANSUR SHAHEEN U.S. DEPUTY HEALTH EDITOR FOR DAILYMAIL.COM, 11/16/2021

OxFam International, 11/16/2021

sharylattkisson.com, by Sharyl Attkisson, 3/27/2024