All UK spontaneous reports received between 04/01/21 and 05/04/21 for COVID-19 vaccine Oxford University/AstraZeneca
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All UK spontaneous reports received between 9/12/20 and 05/04/21 for COVID-19 vaccine mRNA Pfizer/BioNTech vaccine analysis print
Published 9 September 2009
WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.
Nevertheless, what I am currently struggling with is the failure to report the reality of the morbidity caused by our current vaccination program within the health service and staff population. The levels of sickness after vaccination is unprecedented and staff are getting very sick and some with neurological symptoms which is having a huge impact on the health service function. Even the young and healthy are off for days, some for weeks, and some requiring medical treatment. Whole teams are being taken out as they went to get vaccinated together.
Conclusions: The majority of studies report identification of SARS-CoV-2 RNA on inanimate surfaces; however, there is a lack of evidence demonstrating the recovery of viable virus. Lack of positive viral cultures suggests that the risk of transmission of SARS-CoV-2 through fomites is low. Heterogeneity in study designs and methodology prevents comparisons of findings across studies. Standardized guidelines for conducting and reporting research on fomite transmission is warranted.
We identified virtually no evidence for mass screening of asymptomatic individuals using rapid antigen tests in people with no known exposure. A small study screening travellers returning from high‐risk countries (Cerutti 2020), identified only five SARS‐CoV‐2 infections (prevalence of 3%) with a reported sensitivity of antigen testing for detecting infection of 40%. However, important larger studies have been published since the end of our search, as mentioned above.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013705.pub2/full
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine
QCovid is an evidence-based model that uses a range of factors such as age, sex, ethnicity and existing medical conditions to predict risk of death or hospitalisation from COVID-19.
It provides nuanced information on people’s risk of serious illness due to COVID-19 and has the potential to help patients and doctors reach a shared understanding of risk.
It is a ‘living’ risk prediction model which will be updated regularly as our understanding of COVID-19 increases and more data become available.
The risk calculator can be found at the link below. You will be asked to accept the license terms but it does not ask for any personally identifiable information.
COVID-19 vaccines do not contain fetal cells. However, some COVID-19 vaccines use a historic fetal cell line in
production and manufacturing.
• Johnson & Johnson (Janssen) COVID-19 vaccine used a
fetal cell line to produce and manufacture their vaccine.
• Pfizer and Moderna COVID-19 vaccine did not use a fetal
cell line to produce and manufacture their vaccine.
However, a fetal cell line was used in a very early phase to
confirm efficacy prior to production and manufacturing.
In conclusion, the observed safety profile is considered favourable. Longer term safety data is awaited
from the ongoing clinical trials.
There are very limited data on the use of the vaccine in immunocompromised individuals and on use in pregnancy and breastfeeding. No data was generated with mRNA-1273 when administered concomitantly with other vaccines.
The CHMP considers the following measures necessary to address the missing safety data in the
context of a conditional MA:The final clinical study report will be submitted no later than December 2022 and is subject to a specific obligation laid down in the MA. This will provide long-term data.
The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.
EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed.
https://archive.today/2022.12.06-175136/https://www.bmj.com/content/372/bmj.n627
Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari
Wikipedia snapshot from 9 March 2021:
| Year | Company | Settlement | Violation(s) | Product(s) | Laws allegedly violated (if applicable) |
|---|---|---|---|---|---|
| 2012 | GlaxoSmithKline[1][6] | $3 billion ($1B criminal, $2B civil) | Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program | Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex | False Claims Act, FDCA |
| 2009 | Pfizer[2] | $2.3 billion | Off-label promotion, kickbacks | Bextra, Geodon, Zyvox, Lyrica | False Claims Act, FDCA |
| 2013 | Johnson & Johnson[7] | $2.2 billion | Off-label promotion, kickbacks | Risperdal, Invega, Nesiritide | False Claims Act, FDCA |
| 2012 | Abbott Laboratories[8] | $1.5 billion | Off-label promotion | Depakote | False Claims Act, FDCA |
| 2009 | Eli Lilly[9] | $1.4 billion | Off-label promotion | Zyprexa | False Claims Act, FDCA |
| 2001 | TAP Pharmaceutical Products[10] | $875 million | Medicare fraud, kickbacks | Lupron | False Claims Act, Prescription Drug Marketing Act |
| 2012 | Amgen[11] | $762 million | Off-label promotion, kickbacks | Aranesp | False Claims Act, FDCA |
| 2010 | GlaxoSmithKline[12] | $750 million | Poor manufacturing practices | Kytril, Bactroban, Paxil CR, Avandamet | False Claims Act, FDCA |
| 2005 | Serono[13] | $704 million | Off-label promotion, kickbacks, monopolistic practices | Serostim | False Claims Act |
| 2008 | Merck[14] | $650 million | Medicare fraud, kickbacks | Zocor, Vioxx, Pepsid | False Claims Act, Medicaid Rebate Statute |
| 2007 | Purdue Pharma[15] | $601 million | Off-label promotion | Oxycontin | False Claims Act |
| 2010 | Allergan[16] | $600 million | Off-label promotion | Botox | False Claims Act, FDCA |
| 2010 | AstraZeneca[17] | $520 million | Off-label promotion, kickbacks | Seroquel | False Claims Act |
| 2007 | Bristol-Myers Squibb[18] | $515 million | Off-label promotion, kickbacks, Medicare fraud | Abilify, Serzone | False Claims Act, FDCA |
| 2002 | Schering-Plough[19] | $500 million | Poor manufacturing practices | Claritin | FDA Current Good Manufacturing Practices |
| 2006 | Mylan[20] | $465 million | Misclassification under the Medicaid Drug Rebate Program | EpiPen (epinephrine) | False Claims Act |
| 2006 | Schering-Plough[21] | $435 million | Off-label promotion, kickbacks, Medicare fraud | Temodar, Intron A, K-Dur, Claritin RediTabs | False Claims Act, FDCA |
| 2004[22] | Pfizer | $430 million | Off-label promotion | Neurontin | False Claims Act, FDCA |
| 2008 | Cephalon[23] | $425 million | Off-label promotion[23] | Actiq, Gabitril, Provigil | False Claims Act, FDCA |
| 2010 | Novartis[24] | $423 million | Off-label promotion, kickbacks | Trileptal | False Claims Act, FDCA |
| 2003 | AstraZeneca[25] | $355 million | Medicare fraud | Zoladex | Prescription Drug Marketing Act |
| 2004 | Schering-Plough[26] | $345 million | Medicare fraud, kickbacks | Claritin | False Claims Act, Anti-Kickback Statute |
No pupil or student should be denied education on the grounds that they are not wearing a face covering.
The NHS’s London regional team has told its integrated care systems to draw up plans for ‘another possible [covid-19] surge later in 2021’, HSJ has learned.
We note that a wide range of side effects is being reported following vaccination of previously healthy younger individuals with the gene-based COVID-19 vaccines. Moreover, there have been numerous media reports from around the world of care homes being struck by COVID-19 within days of vaccination of residents. While we recognise that these occurrences might, every one of them, have been unfortunate coincidences, we are concerned that there has been and there continues to be inadequate scrutiny of the possible causes of illness or death under these circumstances, and especially so in the absence of post-mortems examinations.
Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech’s proposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for our investigational COVID-19 Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to this request, and specifically, the following request from the Agency.
The download link is available from Public Health and Medical Professionals for Transparency.
Important points from this report include:
- A seven-year-old experienced a stroke.
- One child and one infant suffered facial paralysis.
- One infant had a kidney adverse event, either kidney injury or failure.
- Of the 34 cases, 24 (71%) were classified as serious.
- Predominantly female patients were affected — at least 25 of 34 (73.5%) patients.
- Table 6 reports 34 cases of use in pediatric individuals. However, 28 additional cases were excluded because details such as height and weight were “not consistent with pediatric subjects.”
- Ages ranged from two months to nine years, with median 4.0 years, which means half the children were under four years of age.
- 132 adverse events were reported in the 34 children – i.e., an average of 3.88 AEs per child.
Summary from Daily Clout journalists:
Abstract
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.
Conclusions
A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents. As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.
In considering this subject, we must be clear about the distinction between the political objective and military objective.
The two are different but not separate. For nations do not wage war for war’s sake, but in the pursuance of policy. The military objective is only the means to a political end.
https://www.jstor.org/stable/45104543
http://archive.today/2022.02.23-164110/https://www.jstor.org/stable/45104543
Some 8.8 million schoolchildren in the UK have experienced severe disruption to their education, with prolonged school closures and national exams cancelled for two consecutive years. School closures have been implemented internationally1 with insufficient evidence for their role in minimising covid-19 transmission and insufficient consideration of the harms to children.