Health Alert on mRNA COVID-19 Vaccine Safety was reported 15^th February 2023. Referencing the Communications Office of News Media# Glorida Health Government. The State Surgeon General notified the Health Care Sector and the public of substantial increase of Vax Adverse Event reporting (VAERS) in Florida after the COVID-19 Vax rollout.

In Florida alone there was a 1,700% increase in VAERS reports after the rollout of COVID19 jabs, compared to an increase of 400% in overall vaccine administration for the same period. The reporting of life threatening conditions increased over 4,400%. This is a novel increase and was not seen during the 2009 H1N1 Vax campaign. The State Surgeon General states’ there is a need for additions unbiased research to better understand the COVID-19 vax short and long term effects.

The findings in Florida are reported to be consistent with various other studies that continue to uncover such risks. After evaluating this the State Surgeon General wrote a letter to FDA and CDC illustrating the risk factors associated with the mRNA COVID-10 vaccines, emphasizing the need for additional transparency.

The State Surgeon General referred to a number of studies associated with an excess risk of serious adverse events, including coagulation disorders, acute cardiac arrests, other cardias acute events, Bells Palsy and encephalitis In one of the studies the risk was 1 in 550 individuals, which is much higher than in other vaccines.

Another study found increased acute cardiac arrests and other acute cardiac events following the COVID jab. A third study related to COVID19 vax, found preliminary evidence of increased risk of both coronary disease and cardiovascular disease.

The CDC had already identified safety signal for stroke among individuals over 65 years of age and older following the bivalent booster administration, referring to a need for further assessments and research regarding safety of ALL mRNA COVID-19 Vax’s. The State Of Florida remined health care providers to accurately communicate the risks and benefits of all clinical interventions to their patients, including those associated with COVID-19 and other public health concerns. To promote importance of treatment and promoting prevention through healthy habits, encouraging health care providers to do the same.

To support transparency including those associated with COVID19 Vax as additional risks continue to be identified and disclosed to the public. To support transparency, the State of Florida reminds health care providers to accurately communicate the risks and benefits of all clinical interventions to their patients, including those associated with the COVID-19 vaccine as additional risks continue to be identified and disclosed to the public.

The State of Florida in the department that is nationally accredited by the Public Health Accreditation Board, works to protect, promote and improve health of all people in Florida through integrated state, county and community efforts

LINKS:

https://www.floridahealth.gov/newsroom/2023/02/20230215-updated-health-alert.pr.html#:~:text=2022%2C%20mRNA%20COVID%2D19%20vaccines,much%20higher%20than%20other%20vaccines.&text=Sun%20CLF%20et%20al%2C%20Sci%20Rep.

Reference  Communications Office  [email protected]  (850) 245-4111

According to a study, Fraiman J et al, Vaccine. 2022,

A second study, Sun CLF et al, Sci Rep. 2022, found

Additionally, Dag Berild J et al, JAMA Netw Open. 2022, assessed the risk of thromboembolic and thrombocytopenic events

Public Health Accreditation Board, works to protect, promote and improve the health of all people in Florida

Florida Department of Health  www.FloridaHealth.gov.

 

Researched by Carol Sakey

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CORRUPTION GLOBALLY AT WORLD HEALTH ORGANIZATION (UN) REQUEST … At WHO (UN) request countries around the world have changed the way they report COVID19 deaths. All deaths where a person has had a Positive COVID19 test, if they die for any reason whatsoever within 28 days is classed as a COVID19 death, there is also an available window to extend the 28 days to a loner period. In the UK it is between 28 days and can be extended to 60 days.

To bring NZ inline with other countries and the WHO (UN) request this classification for deaths was adopted by NZ on 10^th March 2022. NZ Govt Health NZ reported “this ensures that all COVID19 cases are formerly recorded to help provide accuracy, accurate assessments of the impact of ”this can range from death not related for instance with COVID 19 someone for example who dies in a motor vehicle accident but has been tested positive for COVID-19.

It can also be some-one who dies from an existing health condition, hence this would be a COVID death. This could also apply to suicides and post  vaccine related deaths all hidden in this classification of counting COVID19 deaths.  NZ Herald reported 19^th July 2022 Ashley way of reporting COVID19 deaths, this can boost compliance. Fast track  Bloomfield “The way we analyze how many people have died from COVID19 in NZ is more accurate and informative, it’s a useful tool for NZs management of COVID19”

In the same article a marketing expert reported “this is a more transparent  way of reporting COVI deaths, this can boost compliance , fast tracking all deaths associated with a positive COVID19 test. 19/7/2022 NZ Herald reported  “yesterday NZ registered 1900 COVID deaths (1870). The new system is a better measure of COVID19 burden on society.  This approach is consistent with UK, Australia and US. The change in classification of COVID19 deaths was at the request of the World Health Org (UN)

Michael Baker, University Of Otago who collaborates with Arderns Govt and authors articles in main stream media said “All health agencies and researchers want health stats that are valid ie “that measure what they intend to measure- therefore the change in classification of COVID19 deaths will  increase the confidence we have that death attributed to COVID19 is valid” Saying “reporting of deaths of COVID19 could convince anti-vaxxers and boost overall compliance. Marketing expert Dr. Bode Lang reported “he believes this could help shift anti-vax sentiment in NZ communities and those that are less likely to follow the govt’s control measures would take the control measures seriously”. This will also address criticisms  from anti-vaxxers and COVID19 doubters how many deaths are really caused by COVID19, and would then make people more likely to follow govts guidelines.

The news article also reported ‘Lang’ said “the improvement of traditionally opaque COVID19 death reporting could shore up compliance measures. However, he also said that the opposite could occur if new data found that COVID19 had been largely unrelated to previous linked deaths. On the 10^th March 2022 Newshub reported ‘the actual number of COVID19 deaths revealed as government changes their approach. Dr Ashley Bloomfield Director General of Health revealed changes in the approach of reporting COVID19 deaths saying .“The Ministry Of Health from now on report COVID19 related deaths as “those that die within 28days of testing positive for COVID19 will be classed as a COVID19 death-other countries are using this for official reporting to the WHO (UN)

Bloomfield also stated “As for hospitalizations reported it is possible that about 566 or 75% are seeking treatment for the virus, this is based on trends in Auckland” However the Minister Of Health commented in Newshub “while it is not clear exactly how many cases are actually hospitalized for COVID19, it is estimated as ¾. We are developing a way to collect and report this data- estimates were from proportions reported from a US hospital study”. Bloomfield also said “Its difficult to obtain data, as patients admissions to hospital are recorded when patients are discharged”. We all know that as soon as anyone enters through that hospital door symptoms, health issues are reported. This is a lame excuse- a lie. Chris Hipkins told the AM show “the government did not have data on how many COVID19 related patients were in hospital for virus related systems or other health issues”

.Change of reporting of COVID19 deaths are rising reported RNZ on 25/3/2022. What should we know? RNZ report. How are they being measured? And points out how measurements from 10^th March 2022 had changed thus driving death rates much higher. That some deaths will be included outside the 28day window.

Michael Baker said “there is a problem with assessing COVID19 deaths as to an underlying illness. “Its worth having a healthy suspicion for every bit of data” Michael Plank another Govt COVID modeler reported “people who have died within 28days of a COVID19 positive test is a  number that’s easily counted and can be provided quickly”

And added “Yes, and that means that people who died during that 28 days of COVID19 positive test may have actually be unrelated to COVID19” Michael Baker added “simple count data is important because events mean something, particularly when it comes to deaths of family and friends” and this can be expressed in different ways” That “a simple death count is a key indicator that a disease is having an impact on mortality rates

Pharmasols.Com website ‘The Destination for your next clinical trial’ Sites for clinical trials in Australia and New Zealand are ready to conduct your research. A billion dollar industry, every year a thousand clinical trials are run across the region. With a diverse population, world class research units. Low transmission rates of COVID19 in Australia and NZ are ideal regions to conduct your clinical studies. In NZ and Australia clinical trials are classed as an essential service, sites have tele-medicine, virtual, remote capabilities.  Remote monitoring to ensure study continuity and compliance. Population distribution and geography of Australia and NZ allows for effective regional rather than nationwide lockdowns. (yes we have regional locks in NZ).

NZ and Australia provide one of the fastest regulatory approval environments in the world. Thus less likely a clinical trial delays. Is cost effective- cheaper. There is a clinical cost to delays when trial budgets feel the sting.

 In Australia and NZ it is highly regarded there is successful patient recruitment. NZ first to see the dawn is a great asset and a small population with a great variation of cultural, ethnic groups which is very important for clinical trials. In NZ there is no requirement for US Pre Investigational New Drug submission to initiate first in human trials.  WEALTH N OT HEALTH.

NZ’s diverse population is ideal for clinical trial location. The government is supportive of clinical trial research initiatives and actively encourage the conducting of clinical trials. Many drugs that are not subsidized by the Govt are unaffordable to most New Zealanders. Hence adds to the human guineapig pool

Increase COVID19 reporting of deaths will increase fear and anxiety hence this will also add to the guineapig pool, and the scaremongering mainstream media, global, national that inflicts this false increased number of COVID deaths to add to the number of guineapigs seeking a cure for what is seen as a huge increase in death rates of COVID19. As the government keeps the public on COVID alert for the next variant, and the next, and the next and Variant X that they don’t even know what Variant X is. Wake Up NZ to a COVID Compliance Governance to control all humanity worldwide.

To track, trace, identify, stalk and control you. And to keep the population fearful. Which will make you sick effect your overall health and wellbeing if you buy into this. The people are the solution, more people need to speak out publicly to report this corrupt authoritarian regime that demands compliance from NZ Citizens. Expose the Truth Now.

https://www.rnz.co.nz/news/national/463975/measuring-and-reporting-covid-19-deaths-what-you-need-to-know

https://www.nzherald.co.nz/nz/covid-19-coronavirus-why-the-counting-of-covid-deaths-is-changing/SiFM474YIR2B54AVZ52XWR7HUQIY/

https://pharmasols.com/how-we-deliver/your-go-to-region

PLEASE CLICK ON THE IMAGE ABOVE WHICH WILL TAKE YOU TO MY VIDEO

 

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Conflicts Of Interest In Clinical Trial: 

References Clinical Trial 30^th December 2020. Efficacy and Safety of the mRNA Sars Cov-2 Vaccine.  Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19.

The Conflict Of Interest Statement Kicks In: However the researchers then stated serious adverse events were rare as to the conclusion of their study. However it is important to note that there was a conflict of interest statement the researched study was funded by the NHI to conduct clinical trials in collaboration with Janssen and Moderna. Receiving grant support from Pfizer, Merck, Pasteur, Eli Lilly. Consulting fees were funded by Horizon Pharma and GSK for fees on data monitoring,. Dr Bennet who was involved in the study owning stock and stock options in Moderna, Dr, Pajor another person involved in research owing stocked and being employed by Moderna, other doctors working in the research study too owned stock in Moderna and employed by Moderna.

Research finds COVID-19 Spike Protein binds to cells in the heart and couls help explain some effects of severe infection (28/08/2021). The Spike Protein found on the surface of COVID 19 virus cells causes damage to cells in the small blood vessels of the heart, according to early findings presented at the European Society of Cardiology Congress.

Researchers from the University of Bristol have found that, in cells in a dish in the lab, the spike protein binds to cells called pericytes which line the small vessels of the heart. This binding triggers a cascade of changes which disrupt normal cell function, and can lead to the release of chemicals that cause inflammation. This happened even when the protein was no longer attached to the virus. There is some previous evidence to suggest that following Covid-19 illness, the spike protein can remain in the bloodstream after the virus has gone and travel far from the site of infection. This research could help explain and ultimately treat some of the effects of severe Covid-19 infection, where levels of the virus are particularly high.

Research has shown that vaccination is a safe and effective way of reducing your risk of severe Covid infection, so is the best thing you can do to reduce your risk of Covid-19 complications, including heart damage. Researchers took small vessel cells from the heart and exposed them to the spike protein. They found that the spike protein alone was enough to disrupt normal cell function, and lead to the release of chemicals that cause inflammation.

They then blocked the CD147 receptor and found that this prevented the spike protein from causing some of the changes to the cells. However, the inflammation continued. Now the researchers hope to find out if a drug blocking CD147 in humans can help to protect people from some of the complications arising from Covid-19. Professor James Leiper, Associate Medical Director at British Heart Foundation, which funded the research, said: “Covid-19 has presented an unprecedented challenge for the cardiovascular research community. There is still a lot that is unknown relating to how the virus can impact our health in the long term

PLEASE  CLICK ON THE LINK PROVIDED WITHIN THE IMAGE ABOVE TO VIEW MY RUMBLE VIDEO ‘ NZ GOVERNMENT WAS PUT ON NOTICE ‘HOMICIDE’ AND IGNORES THE CRIMES ACT 158′

https://pubmed.ncbi.nlm.nih.gov/33378609/

https://www.bhf.org.uk/what-we-do/news-from-the-bhf/news-archive/2021/august/covid-19-spike-protein-binds-to-and-changes-cells-in-the-heart

 

 

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VAERS is a passive reporting system, (meaning it relies on individuals to send in reports of their experiences to CDC and FDA). Passive surveillance of adverse events following immunization (AEFI) is a spontaneous reporting system, affected by under-reporting limitations  (Carol Sakey)

ORIGINAL RESEARCH:  FREQUENCY & ASSOCIATIONS OF ADVERSE REACTIONS OF COVID-19 VACCINES REPORTED IN THE EUROPEAN UNION AND THE US. 3rd February 2022 – Sec. Infectious Diseases – Surveillance, Prevention and Treatment.  (Department Of Population- Based Medicine. Institute of Health Sciences, University of Tubingen, Germany)

This study aims to provide a risk assessment of the adverse reactions related to COVID19 vax’s manufactured by AstraZeneca, Janssen, Moderna and Pfizer BioNTech which have been in used since Dec 2020 and Oct 2021 in the European Union and the US.

Data from the European Database of Suspected Adverse Drug Reaction (EudraVigliance) and the Vaccine Averse Events Reporting System (VAERS) FROM 2020 TO October 2021 as analysed. There were more than 7.8 millions adverse reaction of about 1.6 millions persons are included in the study. The COVID19 Vax Adverse reaction was compared to the adverse reaction to the influenza vaccine exposures.

There was a higher risk of reporting serious adverse reactions for COVID 19 Vax’s in comparison to influenza vaccines. Individuals over the age of 65years were associated with a nigher frequency of death, hospitalisation and life threatening reactions than younger individuals. The onset of serious adverse reactions occurred within the first 7 days after vaccination in 77.6 -89.1% of cases. The largest risks observed were allergic, constitutional reactions, dermatological, gastrointestinal, neurological reactions. The largest  relative risks between COVID19 vs Influenza vaccines observed were allergic reactions, arrhythmia, general cardiovasula events, coagulation, haemorrages, gastrointestinal;, ocular, sexual organs reactions and thrombosis.

CLASSIFICATION OF ADVERSE REACTIONS: There is different MedDRA Coding levels used in VAERS and EudraVigiliance therefore allow a relatively detailed description in particular medical conditions mentioned in the reports. It is necessary to take into account the different biological pathways linking vaccine expose and adverse reaction.  The medical conditions coded in VAERS are classified in 17 event categories following the Common Toxicity Criteria (CTC) developed by the National Cancer Institute in the US, this is one of the oldest and most common used classification systems of adverse reactions in clinical trials

STATISICAL ANALYSIS: One of the major drawbacks of spontaneous reports of adverse reactions is the fact that the calculation of risk differences needed in causal influence is not straightforward due to under or over reporting of adverse reactions, uncertaintities regarding to the number of individuals exposed to the vaccines. In the case of COV ID19 vax programmes in the EU and US risk estimators of adverse reactions for the COVID19 vs Influenza vaccines, namely the number of individuals exposed to the COVID19 vaccines and the age distribution are known and used as the denominator to calculate the risk estimates for COVID19 vaccines

COVID-19 vaccines are associated with higher absolute risks of serious adverse outcomes in comparison to influenza vaccines used in 2020 and 2021.  In comparison of the reported adverse reaction reported across vaccine types it suggests a substantial agreement between reporting between EudraVigilance and VAERS studies, with dyspnoea, respiratory arrest, pulmonary embolism, myocardial infarction, thrombosis, cerebral haemorrhages, and pneumonia being the adverse reactions most frequently mentioned in the death reports.

The risk estimates of adverse reactions by vaccine type and CTC category were largest for the Pfizer-BioNTech vaccine in both EudraVigilance and VAERS, followed by the vaccines of AstraZeneca and Moderna. mRNA and chimeric virus vaccines were obtained from pre-clinical trials assessing their effects in treatment of various cancer types such as melanoma, renal cancer, prostrate cancer, leukaemia, lung cancer. Previous research concerning the use of nucleic-acid based technology, in particular for the mRNA platform is much more limited. Only previous research on cancer immunotherapy, the spike S protein of SARS-COV-2 and the nanoparticles, the biological plausibility of the adverse reactions following COVID19 vaccination can be summarized by the action of at least three major pathophysiological mechanisms.

mRNA USED FOR IMMOTHERAPY FOR CANCER: First of all the strong immune responses must be the feature of both cancer immunotherapy and prophylactic vaccination, since their effect is basically due to the building up of a specific antigen-antibody production targeting the destruction of tumour cells in cancer immunotherapy and the induction of immunisation against viral infections in prophylactic vaccination, respectively.

Hence the nucleic-acid-based pharmaceutical technology on which the COVID-19 vaccines are based upon elicits potent immune responses via Toll-like receptos (TLR), interleukins (IL) IL-6, IL-12, interferon type 1 (IFN-1), tumour necrosis factor α (TNFα), pattern recognition receptors, dendritic cell maturation, induction of CD4+ and CD8+ T cell responses, among others  At the same time, however, such potent immune reactions may also increase the risks of pathophysiological mechanisms related, for instance, to tissue and organ lesions and thromboembolic events

At least for the adenovirus-vector technology, results from clinical trials indicated that adenovirus proteins may elicit acute-phase immune responses involving the release of IL-6 and TNFα and activation of innate immunity cells such as mast cells and neutrophils . In some instances, this may result in an increased likelihood of an acute shock-syndrome due to a cytokine cascade leading to disseminated intravascular coagulation, acute respiratory distress and multiorgan failure . In addition, by mechanisms which have not been fully explained so far, the pro-inflammatory environment related to the interactions between nucleic acids, TNFα, matured dendritic cells (DC) and the receptors TLR3 and TLR7 has been associated with disease progression of autoimmune diseases such as lupus erythematosus and rheumatoid arthritis

Despite the advances made in the reduction of the pro inflammatory risks of mRNA and vectorised pharmaceutical platforms, the induction of severe immune induced reactions such as thrombocytopenia and human erythrocyte agglutination has been previously documented with adenovirus-vectorised therapies . The present investigation suggests that all four nucleic-acid-based COVID-19 vaccines are associated with increased risks of thromboembolic events

Endotheliopathy and Coagulopathy had been observed also for all types of COVID-19 vaccines . ( Endotheliopathy, or endothelial dysfunction, is emerging as an important pathological feature in COVID-19. Transmission electron microscopy of blood vessels from autopsy specimens from patients with COVID-19 has revealed the presence of endothelial cell damage and apoptosis)   (Coagulopathy (also called a bleeding disorder) is a condition in which the blood’s ability to coagulate (form clots) is impaired.)

From this perspective it is reported that recently proposed vaccine induced immune thrombotic (VITT) maybe actually be a severe manifestation in a continuum of vaccine induced coagulopathy affecting vaccinated individuals. In particular the high frequency of adverse reactions following COVID19 vaccines than for influenza vaccines

The pathogenicity of the Spike -S of SARS-COV-2 which has been involved in the  endotheliopathy and coagulopathy(as described above) . The  spike S protein, expressed in both nucleic acid technologies of the COVID-19 vaccines reviewed here, is not only a potent activator  which may contribute to  endothelial damage, but also an enhancer of platelet aggregation and thrombus formation . In addition, the spike subunit S1 can cross the blood-brain barrier and is taken up by the neural cells, the lung, liver, kidney and spleen  Hence, it is likely that the cleaved spike protein subunit in itself has the ability to cross other types of blood endothelial barriers surrounding immune privileged organs such as the spinal cord, ovaries, testes, pregnant uterus, placenta, and eyes , potentially inducing innate immune responses.

Moreover, whereas adenovirus serotype 5 have been found to cross the blood brain barrier in the murine model, the nanolipid-complexed mRNA vaccine platform is optimised to diffuse across non-fenestrated endothelial blood barriers and, thus, due to the immune responses mentioned above, both vaccine platforms may induce in some cases a pro-inflammatory environment in the immune privileged organs. To some extent, this pathophysiological pathway involving transduction across blood barriers and subsequent immune response may partly explain some of the neurological and inflammatory reactions reported to VAERS and EudraVigilance affecting the central nervous system and the sexual organs.

Concerning the mRNA platform, a third pathway is related to the role of the lipid nanoparticles themselves used to complex the naked synthetic mRNA. Even though there have been advances to reduce the immunostimulation of lipid nanoparticles (e.g., by increasing the density of polyethylene glycol in the lipid nanoparticles , they still may elicit pathogenic anaphylactoid reactions by complement activation and enhanced platelet aggregation  (An anaphylactoid reaction is a severe, potentially life threatening allergic reaction, it can occur in minutes of expose )

The Nanoparticle realted adverse reactions may contribute to the pro inflamatory host responses and consequently increase risks of thromboembolic or anaphylactoid outcomes. In particular, the complexed mRNA will tend to bio-accumulate in the adrenal and seminal vesicle wall, liver and spleen due to the normal lipid metabolism, bloodstream distribution and the permeability of the fenestrated endothelium to the lipid nanoparticles and, hence, these organs may become target organs of toxicity (72, 73). In fact, previous pharmacokinetic findings on the biodistribution of nanolipid, encapsulated nucleic-acid drugs revealed that the nanolipid vehicle prevents the nucleic-acid from being metabolised and, thus, blood and plasma concentrations of the nucleic-acid components are determined by the pharmacokinetics of the nanolipid vehicle   ( Thromboembolism is the name for when a blood clot (thrombus) that forms in a blood vessel breaks loose, is carried by the bloodstream, and blocks another blood vessel. This is a dangerous condition that can affect multiple organs, causing organ damage and even death.  As such, it requires immediate treatment.)

The adverse reactions commonly mentioned in the death reports such as  pulmonary embolism, thrombosis, cerebral haemorrhage, myocardial infarction, cerebral venous sinus thrombosis are in agreement with the findings of previous autopsy studies which have identified several causal mechanisms linking COVID-19 vaccination and a lethal outcome. Of particular importance are strong immune-related life-threatening conditions involving antibody-mediated platelet activation in VITT cases (platelet factor 4) neutrophil and histiocyte infiltrates in myocarditis (and reactive astrocytes, microglia, and foamy macrophaghes in cases of acute disseminated encephalomyelitis (neuro-inflammation)

As for the deaths, hospitalisation of those people over 65 years of age as to COVID19 Vaccines, these age-dependent alterations of the inflammatory response, vascular function and haemostasis may pre-dispose older individuals to an exacerbated inflammatory response, thrombus formation and endotheliopathy following COVID-19 vaccination which ultimately lead to the increased frequency of lethal outcomes, hospitalisations and life-threatening reactions among older individuals.

STRATEGIES AND LIMITATIONS: Major strengths of this study is the availability of the number of individuals exposed to the new COV ID19 and Influenza Vaccines in the US and EU populations during 2020 and 2021, allowing a more accurate reporting of adverse reactions. COVID19 Vaccine exposures 451 million as opposed to 437 influenza vaccine exposures, and the populations are practically the same in 2020 and 2021 (ie., almost the same individuals and demographic structure)Also varying sensitivity of the passive reporting systems can be ruled out as a major explanatory factor of the frequency observed.

This is an important strength of the present study in view of the rapidly increasing vaccine coverage rates against SARS-CoV-2 which will limit the availability of appropriate control groups made up of individuals without COVID-19 vaccine exposure. In addition, the present analyses are based on some of the largest datasets publicly available worldwide on vaccine-related adverse reactions containing approximately 7.8 million adverse reactions of 1.6 million individuals.

FUTURE RESEARCH: The results of the present investigation in this study may provide avenues for future clinical research in several area’s, whereas passive or spontaneous reporting systems suffer from serious under-estimation of adverse reactions. This is important as it is a drawback as to the magnitude of under-reporting of non serious and serious adverse reactions . Spontaneous report systems has been estimated to lie in the range

Finally, the results of the present investigation may provide avenues for future clinical research on several areas. First, passive or spontaneous report systems suffer from serious under-estimation of adverse reactions. This is an important drawback, as the magnitude of under-reporting of non-serious and serious adverse reactions to spontaneous report systems . It cannot be ruled out that the reporting rates of COVID19 vaccines may be to some extent much higher than for influenza vaccines because of the major limitations of passive reporting systems, under reporting rather than over reporting.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. Passive surveillance of adverse events following immunization (AEFI) is a spontaneous reporting system, affected by under-reporting limitations. https://academic.oup.com/eurpub/article/25/suppl_3/ckv175.042/2578461

It is noted that future research should assess the magnitude of under estimation and coverage of adverse reactions in VAERS in order to obtain more accurate risk estimates. At the same time, additional autopsy studies may clarify the pathogenic mechanism potentially accounting for the reported death cases and/ or life threatening conditioning as to COVID19 vaccines.

In the present investigation a higher risk of reporting serious adverse outcomes was observed for the COVID-19 vaccines in comparison to influenza vaccines deployed during 2020 and 2021. Individuals age 65 and older were associated with a higher frequency of death, hospitalisations, and life-threatening reactions than individuals age 18–64 years .

The largest relative risks between COVID-19 vs. influenza vaccines were observed for allergic reactions, arrhythmia, general cardiovascular events, coagulation, haemorrhages, constitutional, gastrointestinal, ocular, sexual organs reactions, and, in particular, thromboembolic events. Further clinical investigations are needed to identify both specific and common biological pathophysiological mechanisms across the different vaccine platforms, and to assess the relative safety between the different COVID-19 vaccines currently being deployed.

Funding and publishing of this study is by Open Access Publishing Fund of University of Tubingen, Germany.  The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

https://www.frontiersin.org/articles/10.3389/fpubh.2021.756633/full

Data Availability Statement

Data of Eudra Vigilance are publicly available as CSV files at https://www.adrreports.eu/ under the line listings view of the corresponding vaccine type. Data on vaccination coverage in the EU are available at https://www.ecdc.europa.eu/en/publications-data/data-covid-19-vaccination-eu-eea (download 26.10.2021). Data on population for the EU are available from Eurostat’s database at https://ec.europa.eu/eurostat/web/main/data/database in the table population on 1 January by age, sex and educational attainment level (demo_pjanedu). Data on US vaccination coverage are available at https://data.cdc.gov/Vaccinations/COVID-19-Vaccinations-in-the-United-States-Jurisdi/unsk-b7fc (download 27.10.2021). Data of VAERS are publicly available as ZIP files for each reporting year at https://vaers.hhs.gov/data.html. Data on US annual resident population by age groups from 2010 to 2019 are available from the US Census Bureau at https://www.census.gov/en.html (table NC-EST2019).

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fpubh.2021.756633/full#supplementary-material

REFERENCES:

1. Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization. Silver Spring: US Department of Health and Human Services, Food and Drug Administration, 2020.
2. Food and Drug Administration. Moderna COVID-19 Vaccine Emergency Use Authorization. Silver Spring: US Department of Health and Human Services, Food and Drug Administration, 2020.
3. Commission E. Commission Implementing Decision of 6.1.2021 Granting a Conditional Marketing Authorisation Under Regulation (EC) No 726/2004 of the European Parliament and of the Council for “COVID-19 Vaccine Moderna – COVID-19 mRNA Vaccine (Nucleoside Modified),” a Medicinal Product for Human Use. Brussels: European Commission, 2021.
4. Commission E. Commission Implementing Decision of 21.12.2020 Granting a Conditional Marketing Authorisation Under Regulation (EC) No 726/2004 of the European Parliament and of the Council for “Comirnaty – COVID-19 mRNA Vaccine (Nucleoside Modified),” a Medicinal Product for Human Use. Brussels: European Commission, 2020.

 

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