New Zealand regulator ignored vaccine risks
The life of Ray Avery, a New Zealand-based scientist could come right out of a Hollywood screenplay. It is a rags to global influencer story. Known as “Sir Ray,” he heads the Sir Ray Foundation. The author of two books including the bestselling autobiography “Rebel with Cause", chronicling his life from orphaned and homeless street-kid in England to actual Kiwi Knighthood.
The scientist, social activist, inventor and much more, Sir Ray founded Medicine Mondial, an independent agency focused on improving the lives of impoverished people around the world via distribution of high quality healthcare technology. In 2011, Sir Ray was honored as a Knight Grand Companion of the New Zealand Order of Merit by governor-general Sir Anand Satyanand.
Recently TrialSite featured Sir Ray’s thoughts on the World Health Organization (WHO), and how it was never really possible to think the non-governmental organization funded by governments and wealthy donors could contain a global pandemic.
Now Sir Ray goes on the record, in the professional network LinkedIn to remind all that side effects linked to the COVID-19 vaccine are systematically ignored according to a response from the New Zealand Ministry of Health’s Medsafe (New Zealand Medicines and Medical Devices Safety Authority).
Reminding all about the role and importance of post marketing surveillance and ongoing monitoring of medicinal products once they reach the market after clinical trials. This includes the ongoing evaluation of vaccines for example, taken by individuals under a wide range of circumstances over an extended period of time.
According to Sir Ray, such surveillance “must be conducted in perpetuum by the vaccine manufacturer to determine any long term adverse clinical effects due to the medicine and above all to validate the long-term safety and efficacy of the medicine.”
It is an important topic given rare but real side effects such as the incident with 26-year-old male Rory Nairn who died after receiving the Pfizer mRNA-based BNT162b2 COVID-19 vaccine. This incident was reported in the Kiwi mainstream media such as 1 News.
In New Zealand, where Sir Ray resides, such tragic adverse event reports and records derive from The New Zealand Medsafe. The website states:
“Anyone living in New Zealand who thinks they may have experienced an adverse reaction due to a medicine or vaccine can report it. You do not need to be a healthcare professional to report an adverse reaction.”
According to Sir Ray, “Medsafe collects and processes suspected adverse reaction reports and the physicians at the Centre for Adverse Reactions Monitoring (CARM) medically assess non-routine reports.”
According to Medsafe’s website on the topic of Post-marketing surveillance:
“Post-marketing surveillance monitors the safety of medicines and medical devices in use. Products shown to be unsafe are removed from use, and prescribers are advised about new safety information for products. Post-marketing surveillance is achieved through activities such as:
monitoring adverse reactions to medicines used in New Zealand and monitoring the international literature and other information sources.
testing marketed medicines against product quality standards.
handling complaints and investigations; and
auditing and licensing medicine manufacturers.
Filing for OIA Request: Are they doing their job?
Under the Official Information Act (OIA) request, Sir Ray requested Medsafe to provide the number of adverse clinical events recorded for each Batch of Pfizer vaccine administered in NZ.
The New Zealand Government’s official response:
“Medsafe does not hold information on all recorded adverse events for medicines as these may be recorded in a patient’s notes but not reported to CARM, and the batch may not be recorded. Therefore, this part of your request is refused under section 18(g)(i) of the Act, as the information requested is not held by the Ministry and there are no grounds for believing it is held by another agency subject to the Act.
What?
Sir Ray informs, “So, in plain English, no one in Medsafe or any medical related agency in NZ is monitoring and recording all serious adverse effects to individual Pfizer vaccine batches in NZ and many patient notes are not routinely reported to CARM – the Medsafe Adverse Drug reactions database.”
Truly Troubling if True Reality
It is a troubling finding to say the least if fully verified. Sir Ray learns that since adverse clinical reactions in the original Pfizer trial were only followed up for two months, and as a consequence of that fact, post marketing surveillance of any serious adverse reactions to the vaccine becomes absolutely vital to demonstrate the long-term clinical safety and efficacy of the Pfizer vaccine, BNT162b2, developed in partnership with BioNTech from Germany.
Yet what Sir Ray has learned is that the New Zealand Government is failing to follow decades of obligation to ensure patient safety, not systematically monitoring recording all Kiwi-related serious adverse effects to individual Pfizer vaccine batches, plus the many patient notes are not routinely reported to CARM – the Medsafe Adverse Drug reactions database.
According to Sir Ray, “If you don’t measure it, you don’t know it is safe.”
TrialSite has sent an email request to the Group Manager via multiple email contact addresses for clarification from the agency’s point of view.
A Message to New Zealand Ministry of Health
The health-related activist, philanthropist and entrepreneur has a serious message for the New Zealand government agencies responsible for this terrible gap in responsibility:
“I urge Medsafe and the MOH to put in place an effective post marketing surveillance system to record ALL batch related adverse clinical effects due to the Pfizer Covid Vaccination.”
Sir Ray’s request in actuality represents a mandatory requirement for a pharmaceutical companies to gain and maintain ISO 13485 Certification to ensure the safety of the products that they manufacture, but they can only act of the feedback from Medsafe and New Zealand’s Ministry of Health.
More on Medsafe
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.
With 60 operating staff and 2 offices according to the agency’s website, their mission is “To enhance the health of New Zealanders by regulating medicines and medical devices to maximise safety and benefit.”
It would appear the agency falls short of their responsibility and their mission based on Sir Ray’s investigational probing.
Who is running this agency?
Although the agency makes it very difficult to find what individuals actually fill the roles in the org chart below, TrialSite found that Christopher James runs Medsafe as Group Manager. A pediatric pharmacist by training, according to Mr. James’ own LinkedIn profile he has spent 17.5 years at the Ministry of Health New Zealand, serving as Group Manager for MedSafe Group Manager since 2015.
TrialSite reached out to Christopher James requesting that he respond and clarify on Sir Ray’s allegations. Any response will contribute to an updated article.
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Does COVID-19 Vaccination Lower the Risk of Long-COVID?
The global healthcare system has faced numerous challenges due to the COVID-19 pandemic, with long COVID emerging as a major concern—the enduring, long-term effects of COVID-19 infection. Despite these challenges, Scientific American reported that the impact would have been more severe without vaccines. A consensus is emerging that individuals receiving higher doses of COVID-19 vaccines prior to infection experience a reduced risk of developing long COVID. This article will analyze this claim. TrialSite previously reported on the findings of a Nature article which purportedly provided evidence that COVID-19 vaccines reduce the risk of long-COVID in children and adolescents.
Long-COVID, also called post-COVID-19 conditions (PCC), is a condition in which individuals continue to experience a range of symptoms over an extended period after their initial COVID-19 infection. These can affect various parts of the body and can last for months and even years. Common symptoms of long COVID include fatigue, headache, shortness of breath, cough, chest pain, depression, and anxiety. According to an article by The Lancet, over 200 million people will develop the condition worldwide.
Vaccines may reduce the risk of long COVID
Studies highlighted by Scientific American shed light on the intricate interplay between vaccination and long COVID.
One was an observational cohort study published by JAMA in July 2022. The study included 2560 participants out of which 29% experienced COVID-19 and about 31% of those experienced long-COVID. Among unvaccinated individuals, the prevalence of long-COVID was 41.8%, while in vaccinated individuals, it was 30% with one dose, 17.4% with two doses, and 16% with three doses. Importantly limitations accompany this study, and the observational study cannot prove causation.
A systematic literature review published in Cambridge University Press in December 2022 concluded that receiving COVID-19 vaccination before or after getting an infection plays a major role in reducing post-COVID-19 conditions. This evaluation was based on ten studies with over 1.6M individuals. The vaccine efficacy in preventing long-COVID was 35.3% among individuals who received vaccination before infection and 27.4% among those who received vaccines after getting infected with SARS-CoV-2.
A meta-analysis published in the same journal in October 2023 was performed to investigate the long-term effects of vaccines on individuals. This analysis was based on 24 articles. The efficacy of vaccines against long-COVID was 36.9% among those individuals who received two doses before COVID-19 infection and 68.7% among those who received three doses before getting the infection. However, the analysis indicated that the vaccines did not protect from long-COVID symptoms for those who received vaccination after getting the infection. Ironically, some studies show that a combination of infection plus full vaccination (hybrid immunity) represents the strongest protection against future symptomatic COVID-19.
Another population-based cohort study was published in November 2023 by BMJ. This study was based on almost 600,000 individuals split into two approximately equal groups: one set that got vaccinated before getting an infection and the other that was unvaccinated at the time of infection. People who received one dose of the COVID-19 vaccine were 21% less likely to develop long-COVID symptoms. Having two and three doses of vaccine reduced the risk by 59% and 73% respectively. Based on the study results which are associated with its own limitations, the involved researchers suggest the more vaccine doses an individual gets, the more protection from long-COVID symptoms is observed.
Mixed effects of vaccines on long COVID symptoms
In addition to the peer-reviewed articles and meta-analyses looking at the incidence of long COVID, several studies have examined the effect of vaccines on the symptoms experienced by patients.
A study published in 2021 in the journal Vaccines was based on a survey of 396 patients who received at least one dose of vaccine within a year of becoming infected with COVID-19. Persistent symptoms at the time of vaccination were reported in 380 patients. After vaccination, 201 patients reported a change in their symptoms: 21.8% experienced improvement while 31% experienced worsening of symptoms, regardless of the vaccine type used.
Another study, published in the Journal of Medical Virology in 2022, investigated the changes in long COVID symptoms in COVID-19 patients after getting vaccinated. It reported a different conclusion. They evaluated the symptoms of 42 patients before and 14–21 days after their first dose of the vaccine. Results showed that the symptoms in 61.9% of patients remained unchanged, improved in 16.7%, and worsened in 21.4%. Importantly, the group that experienced worsening symptoms had higher antibody levels. The authors suggested that the vaccine might trigger an overly strong immune response that leads to the worsening of symptoms in long-COVID patients. They concluded that there is a need for careful monitoring to handle the additional concerns that may arise.
An observational study published by JIM in July 2023 aimed to examine the COVID-19 vaccine's potential to change the clinical presentation of long COVID. This study involved 477 individuals, of whom 245 were vaccinated. The results indicated that vaccinated people experienced fewer symptoms compared to unvaccinated individuals. The symptoms reduced with vaccination included abdominal pain, anosmia (loss of sense of smell), parosmia (distorted sense of smell), chest pain, dyspnea (shortness of breath), numbness, dizziness, and weakness.
https://www.trialsitenews.com/a/does-covid-19-vaccination-lower-the-risk-of-long-covid-59aeb9de
*************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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