Published on 6 March 2019, by Jim Meehan, MD
Clinical Trials on Vaccines : the Revelations of a Doctor
Meehan MD on the poor science of the recent Danish MMR Autism Study
Tag: Vaccines
Vaxxed: From Cover-Up to Catastrophe
Doctor behind film that links autism to vaccines speaks out featuring Dr. Andrew Wakefield & Polly Tommey
A 2016 American film alleging a cover-up by the Centers for Disease Control and Prevention (CDC) of a purported link between the MMR vaccine and autism.
One particular flu vaccine linked with early miscarriages
Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010–11 and 2011–12
A study, funded by the Centers for Disease Control and Prevention, found that women who had received an influenza vaccine containing the 2009 pandemic strain pH1N1 and who were also vaccinated in the next flu season had a statistically significant, 7.7-fold higher odds of spontaneous abortion within 28 days of the second vaccination. Image credit @rich_hurley.
2017 Study Abstract
Introduction
Inactivated influenza vaccine is recommended in any stage of pregnancy, but evidence of safety in early pregnancy is limited, including for vaccines containing A/H1N1pdm2009 (pH1N1) antigen. We sought to determine if receipt of vaccine containing pH1N1 was associated with spontaneous abortion (SAB).
Methods
We conducted a case-control study over two influenza seasons (2010–11, 2011–12) in the Vaccine Safety Datalink. Cases had SAB and controls had live births or stillbirths and were matched on site, date of last menstrual period, and age. Of 919 potential cases identified using diagnosis codes, 485 were eligible and confirmed by medical record review. Exposure was defined as vaccination with inactivated influenza vaccine before the SAB date; the primary exposure window was the 1–28 days before the SAB.
Results
The overall adjusted odds ratio (aOR) was 2.0 (95% CI, 1.1–3.6) for vaccine receipt in the 28-day exposure window; there was no association in other exposure windows. In season-specific analyses, the aOR in the 1–28 days was 3.7 (95% CI 1.4–9.4) in 2010–11 and 1.4 (95% CI 0.6–3.3) in 2011–12. The association was modified by influenza vaccination in the prior season (post hoc analysis). Among women who received pH1N1-containing vaccine in the previous influenza season, the aOR in the 1–28 days was 7.7 (95% CI 2.2–27.3); the aOR was 1.3 (95% CI 0.7–2.7) among women not vaccinated in the previous season. This effect modification was observed in each season.
Conclusion
SAB was associated with influenza vaccination in the preceding 28 days. The association was significant only among women vaccinated in the previous influenza season with pH1N1-containing vaccine. This study does not and cannot establish a causal relationship between repeated influenza vaccination and SAB, but further research is warranted.
Controversial trial of a tuberculosis vaccine on African babies
Oxford University scientists gave babies trial TB vaccine ‘that did not work on monkeys’
- Professor Peter Beverley, a former principal research fellow at Oxford University, made the claim
- A “monkey study” began in November 2006. Scientists ignored worrying data, collected by Government officials, that showed primates given the booster jab seemed to “die rather rapidly”.
- Oxford researchers applied for funding 18 months later, for a clinical trial on 2,800 babies, but Professor Beverley said that regulators weren’t given the results of the study.
- The “baby trial” began in July 2009 ; in 2013 the results indicated that the new vaccine offered no extra protection.
- Oxford university has since denied the claim and an inquiry found no wrongdoing.
Press Releases
- Babies were given a trial TB vaccine ‘that did not work on monkeys by Oxford University scientists’, former academic at the institution claims, dailymail, 5 September 2017.
- Oxford University scientists gave babies trial TB vaccine ‘that did not work on monkeys’, telegraph, 3 SEPTEMBER 2017.
- Oxford University scientists gave hundreds of babies a trial TB vaccine that ‘did not work on monkeys’, independent, 4 September 2017.
- TB vaccine administered to African children, despite fatalities in monkeys, today.mims, 11 Sep 2017.
- Featured image credit File on 4.
There is no such thing as “free” vaccines…
Why Médecins Sans Frontières (MSF) rejected Pfizer’s donation offer of pneumonia vaccine (PCV) doses for the children they serve
Abstract
… “Free is not always better.
Donations often involve numerous conditions and strings attached, including restrictions on which patient populations and what geographic areas are allowed to receive the benefits. This process can delay starting vaccination campaigns, which would be an untenable situation in emergency settings, or grossly limit who you’re able to reach with the vaccine.
Donations can also undermine long-term efforts to increase access to affordable vaccines and medicines. They remove incentives for new manufacturers to enter a market when it’s absorbed through a donation arrangement. We need competition from new companies to bring down prices overall — something we don’t have currently for the pneumonia vaccine.
Donations are often used as a way to make others ‘pay up.’ By giving the pneumonia vaccine away for free, pharmaceutical corporations can use this as justification for why prices remain high for others, including other humanitarian organizations and developing countries that also can’t afford the vaccine. Countries, which continue to voice their frustration at being unable to afford new and costly vaccines such as PCV, need lower prices as well to protect children’s health.
Critically, donation offers can disappear as quickly as they come. The donor has ultimate control over when and how they choose to give their products away, risking interruption of programs should the company decide it’s no longer to their advantage. For example, Uganda is now facing a nationwide shortage of Diflucan, an essential crytpococcal meningitis drug, in spite of Pfizer’s commitment to donate the drugs to the government. There are other similar examples of companies’ donation programs leaving governments and health organizations in a lurch without the medical tools they need to treat patients.” …
… Read the full paper – There is no such thing as “free” vaccines: Why we rejected Pfizer’s donation offer of pneumonia vaccines, by Jason Cone, Executive Director of Doctors Without Borders in the United States, on medium.
- More about the MSF Access Campaign, “pushing for access to & the development of life-saving and life prolonging medicines, diagnostic tests & vaccines for patients in MSF programmes and beyond“.
- The Needle image by ps_sahana.
Ovarian failure caused by Gardasil HPV vaccine ?
2012-2014 studies on the association between human papillomavirus vaccine and adolescent primary ovarian failure
Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination
2014 Study Abstract
Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination, National Institutes of Health, NCBI pmc/articles/PMC4528880/, 2014 Oct-Dec.
Three young women who developed premature ovarian insufficiency following quadrivalent human papillomavirus (HPV) vaccination presented to a general practitioner in rural New South Wales, Australia. The unrelated girls were aged 16, 16, and 18 years at diagnosis. Each had received HPV vaccinations prior to the onset of ovarian decline. Vaccinations had been administered in different regions of the state of New South Wales and the 3 girls lived in different towns in that state. Each had been prescribed the oral contraceptive pill to treat menstrual cycle abnormalities prior to investigation and diagnosis. Vaccine research does not present an ovary histology report of tested rats but does present a testicular histology report. Enduring ovarian capacity and duration of function following vaccination is unresearched in preclinical studies, clinical and postlicensure studies. Postmarketing surveillance does not accurately represent diagnoses in adverse event notifications and can neither represent unnotified cases nor compare incident statistics with vaccine course administration rates. The potential significance of a case series of adolescents with idiopathic premature ovarian insufficiency following HPV vaccination presenting to a general practice warrants further research. Preservation of reproductive health is a primary concern in the recipient target group. Since this group includes all prepubertal and pubertal young women, demonstration of ongoing, uncompromised safety for the ovary is urgently required. This matter needs to be resolved for the purposes of population health and public vaccine confidence.
Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants
2013 Study Abstract
Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants, American journal of reproductive immunology New York, NCBI pubmed/23902317, 2013 Jul 31.
PROBLEM:
Post-vaccination autoimmune phenomena are a major facet of the autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and different vaccines, including HPV, have been identified as possible causes.
METHOD OF STUDY:
The medical history of three young women who presented with secondary amenorrhea following HPV vaccination was collected. Data regarding type of vaccine, number of vaccination, personal, clinical and serological features, as well as response to treatments were analyzed.
RESULTS:
All three patients developed secondary amenorrhea following HPV vaccinations, which did not resolve upon treatment with hormone replacement therapies. In all three cases sexual development was normal and genetic screen revealed no pertinent abnormalities (i.e., Turner’s syndrome, Fragile X test were all negative). Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (antiovarian and anti thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.
CONCLUSION:
We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.
Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination
2012 Study Abstract
Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination, BMJ Case Report, NCBI pmc/articles/PMC4543769, 2012 Sep 30.
Premature ovarian failure in a well adolescent is a rare event. Its occurrence raises important questions about causation, which may signal other systemic concerns. This patient presented with amenorrhoea after identifying a change from her regular cycle to irregular and scant periods following vaccinations against human papillomavirus. She declined the oral contraceptives initially prescribed for amenorrhoea. The diagnostic tasks were to determine the reason for her secondary amenorrhoea and then to investigate for possible causes of the premature ovarian failure identified. Although the cause is unknown in 90% of cases, the remaining chief identifiable causes of this condition were excluded. Premature ovarian failure was then notified as a possible adverse event following this vaccination. The young woman was counselled regarding preservation of bone density, reproductive implications and relevant follow-up. This event could hold potential implications for population health and prompts further inquiry.
2017 Update
Premature Ovarian Insufficiency – an update on recent advances in understanding and management
2017 Study Abstract
Premature ovarian insufficiency is a complex and relatively poorly understood entity with a myriad of etiologies and multisystem sequelae that stem from premature deprivation of ovarian sex hormones. Timely diagnosis with a clear understanding of the various comorbidities that can arise from estrogen deficiency is vital to appropriately counsel and treat these patients. Prompt initiation of hormone therapy is critical to control the unsolicited menopausal symptoms that many women experience and to prevent long-term health complications. Despite ongoing efforts at improving our understanding of the mechanisms involved, any advancement in the field in recent decades has been modest at best and researchers remain thwarted by the complexity and heterogeneity of the underpinnings of this entity. In contrast, the practice of clinical medicine has made meaningful strides in providing assurance to the women with premature ovarian insufficiency that their quality of life as well as long-term health can be optimized through timely intervention. Ongoing research is clearly needed to allow pre-emptive identification of the at-risk population and to identify mechanisms that if addressed in a timely manner, can prolong ovarian function and physiology.
Read the full study (free access) on the NCI PubMed, PMCID: PMC5710309.
Whooping cough: hybrid vaccination protocol would make sense
Old Vaccine, New Tricks: Revive Early Pertussis Shot, Study Says
Hybrid vaccination protocol could cut whooping cough cases by 95 percent, Santa Fe Institute, March 29, 2016.
Whooping cough is making a major comeback in the United States right now, and public health officials are struggling with what to do about it. Now, two SFI researchers have a surprising proposal: go back to an old vaccine—one that was largely abandoned 25 years ago because of relatively minor side effects—but do it for just the first of the usual five doses. Doing so, they says, could cut pertussis cases by 95 percent and save $142 million per year.
Abstract
Epidemiological and Economic Effects of Priming With the Whole-Cell Bordetella pertussis Vaccine, JAMA Pediatrics, March 28, 2016.
Importance
Current acellular pertussis vaccines may not protect against transmission of Bordetella pertussis.
Objective
To assess whether a priming dose of whole-cell pertussis (wP) vaccine is cost-effective at reducing pertussis infection in infants.
Design, Setting, and Participants
Mathematical model of pertussis transmission fit to US incidence data in a simulation of the US population. In this simulation study conducted from June 2014 to May 2015, the population was divided into 9 age groups corresponding to the current pertussis vaccination schedule and fit to 2012 pertussis incidence.
Interventions
Inclusion of a priming dose of wP vaccine into the current acellular pertussis vaccination schedule.
Main Outcomes and Measures
Reductions in symptomatic pertussis incidence by age group, increases in wP vaccine–related adverse effects, and quality-adjusted life-years owing to changing vaccine schedule.
Old Vaccine, New Tricks: Revive Early Pertussis Shot, Study Says, livescience, March 28, 2016.
Results
Switching to a wP-priming vaccination strategy could reduce whooping cough incidence by up to 95% (95% CI, 91-98), including 96% (95% CI, 92-98) fewer infections in neonates. Although there may be an increase in the number of vaccine adverse effects, we nonetheless estimate a 95% reduction in quality-adjusted life-years lost with a switch to the combined strategy and a cost reduction of 94% (95% CI, 91-97), saving more than $142 million annually.
Conclusions and Relevance
Our results suggest that an alternative vaccination schedule including 1 dose of wP vaccine may be highly cost-effective and ethically preferred until next-generation pertussis vaccines become available.
What if some Vaccines were Really about Profit?
A former Merck sales rep reveals
WAVE 2016 video published by LearntheRisk channel.
Brandy Vaughan is a former sales rep for Merck & Co. – a vaccine maker – and she details how vaccine companies are using vaccines as a vehicle for massive profit and not public health…
More Information
- learntherisk.
- Our posts tagged Merckx and vaccination.
- Our video playlist about Big Pharma.
Pharmaceutical, Biotechnology and Diagnostics Industries Declaration on Combating Antimicrobial Resistance
More than 80 pharmaceutical companies have called on governments to develop new ways of paying them to develop antibiotics
More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections – socalled ‘superbugs’ – with a joint declaration launched today at the World Economic Forum in Davos, Switzerland. The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance.
The Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance – drafted and signed by 85 companies and nine industry associations across 18 countries – represents a major milestone in the global response to these challenges, with commercial drug and diagnostic developers for the first time agreeing on a common set of principles for global action to support antibiotic conservation and the development of new drugs, diagnostics, and vaccines. The industry is calling on governments around the world to now go beyond existing statements of intent and take concrete action, in collaboration with companies, to support investment in the development of antibiotics, diagnostics, vaccines, and other products vital for the prevention and treatment of drug-resistant infections.
In particular, the Declaration supports a continuation of efforts towards improved conservation of antibiotics, including a call for improved uptake of rapid point-of-care diagnostics to improve how antibiotics are prescribed, and changes to incentive structures within health systems that directly reward doctors, pharmacists and veterinarians for prescribing antibiotics in greater volumes.
In what the Review on Antimicrobial Resistance recognises to be a notable step for the industry, the signatory companies call on governments to work with them to develop new and alternative market structures that provide more dependable and sustainable market models for antibiotics, and to commit the funds needed to implement them. These mechanisms are needed to provide appropriate incentives (coupled with safeguards to support antibiotic conservation) for companies to invest in R&D to overcome the formidable technical and scientific challenges of antibiotic discovery and development. These include mechanisms to ensure that, where appropriate, the pricing of antibiotics more adequately reflects the benefits they bring; and novel payment models that reduce the link between the profitability of an antibiotic and the volume sold. An integral part of these models is a reduced need for promotional activity by companies.
As well as calling for continued progress by governments on these fronts, the Declaration sets out a commitment to further action on drug resistance by its signatories, which the Review warmly welcomes. These span across three broad areas:
- Reducing the development of drug resistance
The companies commit to encouraging better and more appropriate use of new and existing antibiotics, including through work that supports the antibiotic stewardship principles set out by the World Health Organization (WHO) Global Action Plan on antimicrobial resistance (AMR), and via improved education of clinicians. This support extends to promoting more judicious use of antibiotics in livestock, as part of a ‘one health’ approach. - Increasing investment in R&D that meets global public health needs
Recognising the need to increase research into new antibiotics, diagnostics, vaccines and other alternative treatments, the companies commit to a continuation and extension of collaborative initiatives between industry, academia and public bodies to improve how R&D in the field is done and provide greater opportunities for the scientific barriers to antibiotic discovery to be overcome. - Improve access to high-quality antibiotics for all
In light of the gaps that remain in global access to our existing antibiotics and vaccines, and the importance of ensuring that new generations of products are available to all those who need them, the signatories commit to supporting initiatives aimed at ensuring affordable access to antibiotics in all parts of the world, at all levels of income.
By bringing together such a wide range of companies in this unprecedented way, the Declaration provides a valuable roadmap to guide further collaborative efforts between industry, governments and NGOs in the global fightback against AMR. The Review will continue to work to drive progress towards a series of key international milestones in 2016 – including likely discussions on AMR at the UN General Assembly and as part of China’s G20 programme in the autumn – and in support of progress against the WHO Global Action Plan on AMR.
The Declaration will be updated every two years, to take account of the evolving global landscape of AMR and changing challenges and priorities. It remains open to accept new signatory companies and bodies at any time, with a complete list maintained on the Review on AMR’s website.
European Medicines Agency started reviewing HPV vaccines safety
EMA confirmed evidence does not support that HPV vaccines cause CRPS or POTS… but the Nordic Cochrane Center said their report is flawed…
July 2015
The European Medicines Agency (EMA) started a review of HPV vaccines to further clarify aspects of their safety profile.
The review looked at available data with a focus on rare reports of two conditions:
- complex regional pain syndrome (CRPS)
a chronic pain condition affecting the limbs, - postural orthostatic tachycardia syndrome (POTS)
a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness.
In its review the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) considered the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee decided whether to recommend any changes to product information to better inform patients and healthcare professionals.
- EMA to further clarify safety profile of human papillomavirus (HPV) vaccines, ema press release, 13/07/2015.
- EMA information on Cervarix, Gardasil, Gardasil 9, Silgard vaccines.
November 2015
EMA concluded this review : HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS.
- EMA press release and full PDF, 12 January 2016.
Summer 2016
An official complaint has been filed by the Nordic Cochrane Center against the European Medicines Agency (EMA) over its handling of safety issues concerning human papillomavirus (HPV) vaccines.
In the complaint, which runs to 19 pages, the Nordic group says that the official EMA report is flawed.
- Complaint to the European Medicines Agency (EMA) over maladministration at the EM, Nordic Cochrane Centre, 26 May 2016.
- Complaint Filed Over EMA’s Handling of HPV Vaccine Safety Issues, Medscape Medical News, July 05, 2016.