Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports
In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1
But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.
Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.
Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.
In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”
Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”
Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.
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LBC presenter Maajid Nawaz discusses major concerns around vaccine mandates with Consultant Cardiologist Dr Aseem Malhotra who says the corporate capture of public health is at the root of the healthcare crisis
A Graceful Watchman – William Cooper – British Israelism – The “Christian” Identity
TheTruthIsFullOfLies, when you find the truth, you will also find a lot of lies. I am going to do this until you either wake up or I die a martyr. If you don’t wake up then I would rather be killed as this world will not be worth living in… http://thetruthquotes.webs.com/ Back up channel Subscribe! http://www.youtube.com/user/TruthFull… “The truth is extreme, to make it moderate is to lie.” – Aaron Hawkins Matthew 5:11-12 “Blessed are ye, when men shall revile you, and persecute you, and shall say all manner of evil against you falsely, for my sake. Rejoice, and be exceeding glad: for great is your reward in heaven: for so persecuted they the prophets which were before you.” “If you’re not outraged, you’re not paying attention.” – Anonymous “Humankind has not woven the web of life. We are but one thread within it. Whatever we do to the web, we do to ourselves. All things are bound together. All things connect.” – Chief Seattle “Anybody listening to me will realize that these are indeed Historic Broadcast’s and by making them I have sealed my fate” – Bill Cooper Universal Law Trumps all others. 1. No man or woman, in or out of government shall initiate force, threat of force or fraud against my life and property and, any and all contracts I’m a party to, not giving full disclosure to me, whether signed by me or not are void at my discretion. 2. I may use force in self-defense against anyone that violates Law 1. 3. There shall be no exceptions to Laws 1 and 2 TURN OFF YOUR TELEVISION!
Duane L. Pierson,1 Satish K. Mehta,2 Don Gilden,corresponding author4,5 Randall J. Cohrs,4 Maria A. Nagel,4 D. Scott Schmid,6 and Stephen K. Tyring3
1 Space Life Sciences, NASA, Lyndon B. Johnson Space Center
2 Enterprise Advisory Services, Inc
3 University of Texas Health Science Center, Houston, Texas
4 Department of Neurology
5 Microbiology, University of Colorado School of Medicine, Aurora
6 National VZV Laboratory, Centers for Disease Control and Prevention, Atlanta, Georgia
Correspondence: Don Gilden, MD, Department of Neurology, University of Colorado School of Medicine, 12700 E 19th Ave, Box B182, Aurora, CO 80045 (ude.revnedcu@nedlig.nod).
Abstract
Analysis of 36 individuals over age 60 years who were immunized with Zostavax revealed varicella zoster virus (VZV) DNA in swabs of skin inoculation sites obtained immediately after immunization in 18 (50%) of 36 subjects (copy number per nanogram of total DNA, 28 to 2.1 × 106) and in saliva collected over 28 days in 21 (58%) of 36 subjects (copy number, 20 to 248). Genotypic analysis of DNA extracted from 9 random saliva samples identified vaccine virus in all instances. In some immunized individuals over age 60, vaccine virus DNA is shed in saliva up to 4 weeks.
Varicella zoster virus (VZV) is a neurotropic alphaherpesvirus. Primary infection usually causes varicella (chicken pox) in children. Airborne VZV enters the nasopharynx and replicates in tonsillar T cells followed by viremia and skin lesions [1, 2]. After primary infection, VZV becomes latent in neurons of cranial nerve ganglia, dorsal root ganglia, and autonomic ganglia along the entire neuraxis. Decades later, VZV reactivates in elderly and immunocompromised individuals to produce zoster (shingles), a syndrome characterized by pain and a vesicular rash on an erythematous base in 1–3 dermatomes. Zoster is common, with ∼1,000,000 cases annually in the United States. Importantly, zoster is often followed by chronic pain (postherpetic neuralgia [PHN]) as well as by meningoencephalitis, cerebellitis, cranial nerve palsies, vasculopathy, myelopathy, and multiple inflammatory diseases of the eye [3].
To prevent zoster and its attendant neurological complications, Zostavax vaccine (Merck) was approved by the Food and Drug Administration for use in individuals at least 60 years of age. Over a 3-year period, Zostavax effectively reduced the risk of zoster by 51% and PHN by 66% in nearly 20,000 healthy adults age 60 years or older [4]. Zostavax contains live attenuated VZV, and the package insert warns newly vaccinated individuals to avoid contact for an unspecified time with newborn infants, immunosuppressed individuals, and pregnant women who have not had chicken pox or have not been immunized for chicken pox. Because VZV DNA is present in saliva of zoster patients for at least 2 weeks [5] and VZV in saliva can also be infectious [6], we examined the inoculation site and saliva of Zostavax-vaccinated subjects for the presence of VZV DNA for 4 weeks after immunization.
US National Library of Medicine
National Institutes of Health – 1980
SIR,-The recommendations and medicolegal implications of smallpox vaccination have been discussed in these columns on several occasions
(11 October 1980, p 1004; 25 October, pp 1141 and 1142).
Although vaccination for the public is no longer necessary it is worth noting, as Minerva pointed out (4 April, p 1163), that it continues to be offered to the British Army (both regular and reserve). The risk of transmission of vaccinia by recently vaccinated soldiers to their close and immediate susceptible contacts therefore is likely to increase. This has been illustrated in the following case. A 23-year-old Scottish housewife was referred to the gynaecology department of this hospital on 17 December from the local family planning clinic for confirmation of diagnosis of presumed genital herpes simplex infection. The patient had developed painful itchy lesions on the vulva one week previously and she had also noticed similar lesions on her left loin and ear lobe. On examination she had large moist umbilicated vesicles on the vulva as well as on her left hip and left ear lobe. A clinical diagnosis of vaccinia was confirmed at the regional virus laboratory, Ruchill Hospital, by electron microscopy, and vaccinia virus was isolated in cell culture. These lesions rapidly regress,.d and healed with local application of betadine paint. The history of contact with a vaccinated person was not volunteered; but on close questioning it was revealed that the patient’s husband, who had joined the Royal Air Force, had been vaccinated three weeks previously and had been home at weekends. The patient herself had not been vaccinated in the past. In 1980, of six reported incidents of contact vaccinia received by the Communicable Disease Surveillance Centre,1 one was almost identical to our own case: a young woman whose soldier husband had been vaccinated three weeks previously developed genital vaccinia. Another case was in a soldier who had taken part in a boxing match and may have been infected by a colleague. The immediate and obvious question that arises is whether vaccination in the armed Forces is justifiable when there is no valid medical reason for it, and it is no longer necessary for international travel (except to Chad and democratic Kampuchea). The policy of smallpox vaccination has been discussed in a recent editorial of the Jrournal of the Royal Army Medical Corps2 and the main argument for vaccination seems to be to protect the Forces against the possible use of smallpox virus by an enemy as an agent of biological warfare. If the vaccination of the army personnel should continue because of this unlikely but perfectly feasible threat of germ warfare, one can only endorse the view that “Continued education of service personnel and their contacts about the risk and its prevention is now, therefore, even more essential than before.”3 Otherwise we might see more cases of genital vaccinia in women transmitted from recently vaccinated young, healthy, virile British soldiers.
US National Library of Medicine
National Institutes of Health – Feb 2012
Wertheimer ER, Olive DS, Brundage JF, Clark LL.
Author information
Armed Forces Health Surveillance Center, 11800 Tech Road, Suite 220, Silver Spring, MD 20904, USA. ellen.wertheimer@us.army.mil
Abstract
Since 2002, approximately 40,000 US civilians and 2.1 million military personnel have been vaccinated against smallpox. The vaccine contains live vaccinia virus that can be transferred through physical contact. This report summarizes numbers, rates, and characteristics of contact vaccinia cases that presented between December 2002 and March 2011. Cases were identified from reports in adverse event reporting systems and peer-reviewed literature. One hundred fifteen cases of vaccinia transmission through contact were identified (5.4 per 100,000 vaccinees); 52 reports (45%) noted laboratory confirmation. Three-quarters of vaccinees, but fewer than 8% of contact vaccinia cases, were described as military members. Most cases were household or intimate contacts (n=86, 75%) or wrestling partners (n=18, 16%) of vaccinees. Nearly all cases manifested mild, local skin reactions; of 14 hospitalized cases, one was life-threatening. Vaccinia transmission from vaccinees is relatively infrequent. Continued attention to both vaccinee education and screening for contraindications to vaccination is appropriate.
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1 Corinthians 15 Authorized (King James) Version (AKJV)
1 Moreover, brethren, I declare unto you the gospel which I preached unto you, which also ye have received, and wherein ye stand;
2 by which also ye are saved, if ye keep in memory what I preached unto you, unless ye have believed in vain.
3 For I delivered unto you first of all that which I also received, how that Christ died for our sins according to the scriptures;
4 and that he was buried, and that he rose again the third day according to the scriptures:
Hebrews 6 Authorized (King James) Version (AKJV)
1 Therefore leaving the principles of the doctrine of Christ, let us go on unto perfection; not laying again the foundation of repentance from dead works, and of faith toward God,
2 of the doctrine of baptisms, and of laying on of hands, and of resurrection of the dead, and of eternal judgment.
3 And this will we do, if God permit.
4 For it is impossible for those who were once enlightened, and have tasted of the heavenly gift, and were made partakers of the Holy Ghost,
5 and have tasted the good word of God, and the powers of the world to come,
6 if they shall fall away, to renew them again unto repentance; seeing they crucify to themselves the Son of God afresh, and put him to an open shame.
7 For the earth which drinketh in the rain that cometh oft upon it, and bringeth forth herbs meet for them by whom it is dressed, receiveth blessing from God:
8 but that which beareth thorns and briers is rejected, and is nigh unto cursing; whose end is to be burned.
1 Who hath believed our report? and to whom is the arm of the Lord revealed?
2 For he shall grow up before him as a tender plant,and as a root out of a dry ground:he hath no form nor comeliness;and when we shall see him,there is no beauty that we should desire him.
3 He is despised and rejected of men;a man of sorrows, and acquainted with grief:and we hid as it were our faces from him;he was despised, and we esteemed him not.
4 Surely he hath borne our griefs,and carried our sorrows:yet we did esteem him stricken,smitten of God, and afflicted.
5 But he was wounded for our transgressions,he was bruised for our iniquities:the chastisement of our peace was upon him;and with his stripes we are healed.
6 All we like sheep have gone astray;we have turned every one to his own way;and the Lord hath laid on him the iniquity of us all.
7 He was oppressed, and he was afflicted,yet he opened not his mouth:he is brought as a lamb to the slaughter,and as a sheep before her shearers is dumb,so he openeth not his mouth.
8 He was taken from prison and from judgment:and who shall declare his generation? for he was cut off out of the land of the living:for the transgression of my people was he stricken.
9 And he made his grave with the wicked,and with the rich in his death;because he had done no violence,neither was any deceit in his mouth.
10 Yet it pleased the Lord to bruise him;he hath put him to grief:when thou shalt make his soul an offering for sin,he shall see his seed, he shall prolong his days,and the pleasure of the Lord shall prosper in his hand.
11 He shall see of the travail of his soul, and shall be satisfied:by his knowledge shall my righteous servant justify many;for he shall bear their iniquities.
12 Therefore will I divide him a portion with the great,and he shall divide the spoil with the strong;because he hath poured out his soul unto death:and he was numbered with the transgressors;and he bare the sin of many,and made intercession for the transgressors.
M Murti – 1, M Krajden – 2, M Petric – 2, J Hiebert – 3, F Hemming – 1, B Hefford – 4, M Bigham – 1, P Van Buynder – 1
Author Affiliations:
1 Fraser Health Authority, Surrey, British Columbia, Canada
2 Public Health Microbiology and Reference Laboratory British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada
3 National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada
4 1-1400 George St., White Rock, British Columbia, Canada
Case report
We describe a case of vaccine-associated measles in a two-year-old patient from British Columbia, Canada, in October 2013, who received her first dose of measles-containing vaccine 37 days prior to onset of prodromal symptoms. Identification of this delayed vaccine-associated case occurred in the context of an outbreak investigation of a measles cluster.
In this report we describe a case of measles-mumps-rubella (MMR) vaccine-associated measles illness that was positive by both PCR and IgM, five weeks after administration of the MMR vaccine. Based on our literature review, we believe this is the first such case report which has implications for both public health follow-up of measles cases and vaccine safety surveillance.
Between 29 August and 2 September 2013, three unlinked persons from across the Fraser Valley, British Columbia, Canada, presented with rash illness consistent with clinical measles [1]. Based on the outbreak investigation by the local health authority, none of the three cases had an identified exposure to a measles case or travel history outside of Canada during the incubation period, and a source case was never identified. All three cases had the same measles genotype B3 sequence type (MVs/British Columbia.CAN/34.13, MeaNS id 39928, GenBank accession numbers KF704002 and KF704001). Measles genotype B3 is endemic in the World Health Organization’s African and Eastern Mediterranean regions [2]. Two additional cases of measles due to secondary transmission from one of the above cases were identified in British Columbia in the third week of September.
US National Library of Medicine
National Institutes of Health – 1987
Authors
Carra L – 1, Dumbell KR.
Author information
Department of Medical Microbiology, University of Cape Town.
Abstract
An orthopoxvirus was isolated from the vesicular rash of a man in Natal who died in coma and who had not been vaccinated. Analysis of the viral DNA showed that it was a vaccinia virus, more closely related to the virus of South African smallpox vaccine than to other vaccinia viruses. DNA analysis also showed that an orthopoxvirus isolated from a sporadic case of severe pustular rash in Nigeria was a vaccinia virus closely related to the smallpox vaccine virus used there. Minor biological differences between the viruses isolated and the corresponding vaccine strains suggested that some natural transmission of the virus had occurred, but the results of DNA analysis implied that they originated from the use of smallpox vaccine. No similar cases have been detected since smallpox vaccination was discontinued.
US National Library of Medicine
National Institutes of Health – 1989
Derenne F – 1, Vanderheyden JE, Bain H, Jocquet P, Jacquy J, Yane F, Druyts-Voets E, Lamy ME, Vanhaeverbeek M.
Author information
Service de Médecine Interne, C.H.U. André Vésale, U.L.B., Montigny-le-Tilleul.
Abstract
The authors report the case of a 26 year old woman with acute anterior poliomyelitis contracted during the vaccination of her baby. Despite having been herself vaccinated in infancy she was not protected against the poliovirus. The clinical interest of this uncommon case is a severe paralytic state with definitive paraplegia. The authors suggest serologic testing of patients born before 1967 especially if they are at risk of encountering the virus.
1 Corinthians 15 Authorized (King James) Version (AKJV)
1 Moreover, brethren, I declare unto you the gospel which I preached unto you, which also ye have received, and wherein ye stand;
2 by which also ye are saved, if ye keep in memory what I preached unto you, unless ye have believed in vain.
3 For I delivered unto you first of all that which I also received, how that Christ died for our sins according to the scriptures;
4 and that he was buried, and that he rose again the third day according to the scriptures:
Hebrews 6 Authorized (King James) Version (AKJV)
1 Therefore leaving the principles of the doctrine of Christ, let us go on unto perfection; not laying again the foundation of repentance from dead works, and of faith toward God,
2 of the doctrine of baptisms, and of laying on of hands, and of resurrection of the dead, and of eternal judgment.
3 And this will we do, if God permit.
4 For it is impossible for those who were once enlightened, and have tasted of the heavenly gift, and were made partakers of the Holy Ghost,
5 and have tasted the good word of God, and the powers of the world to come,
6 if they shall fall away, to renew them again unto repentance; seeing they crucify to themselves the Son of God afresh, and put him to an open shame.
7 For the earth which drinketh in the rain that cometh oft upon it, and bringeth forth herbs meet for them by whom it is dressed, receiveth blessing from God:
8 but that which beareth thorns and briers is rejected, and is nigh unto cursing; whose end is to be burned.
1 Who hath believed our report? and to whom is the arm of the Lord revealed?
2 For he shall grow up before him as a tender plant,and as a root out of a dry ground:he hath no form nor comeliness;and when we shall see him,there is no beauty that we should desire him.
3 He is despised and rejected of men;a man of sorrows, and acquainted with grief:and we hid as it were our faces from him;he was despised, and we esteemed him not.
4 Surely he hath borne our griefs,and carried our sorrows:yet we did esteem him stricken,smitten of God, and afflicted.
5 But he was wounded for our transgressions,he was bruised for our iniquities:the chastisement of our peace was upon him;and with his stripes we are healed.
6 All we like sheep have gone astray;we have turned every one to his own way;and the Lord hath laid on him the iniquity of us all.
7 He was oppressed, and he was afflicted,yet he opened not his mouth:he is brought as a lamb to the slaughter,and as a sheep before her shearers is dumb,so he openeth not his mouth.
8 He was taken from prison and from judgment:and who shall declare his generation? for he was cut off out of the land of the living:for the transgression of my people was he stricken.
9 And he made his grave with the wicked,and with the rich in his death;because he had done no violence,neither was any deceit in his mouth.
10 Yet it pleased the Lord to bruise him;he hath put him to grief:when thou shalt make his soul an offering for sin,he shall see his seed, he shall prolong his days,and the pleasure of the Lord shall prosper in his hand.
11 He shall see of the travail of his soul, and shall be satisfied:by his knowledge shall my righteous servant justify many;for he shall bear their iniquities.
12 Therefore will I divide him a portion with the great,and he shall divide the spoil with the strong;because he hath poured out his soul unto death:and he was numbered with the transgressors;and he bare the sin of many,and made intercession for the transgressors.
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