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Tuesday, June 14, 2022

Covid-19 Vaccine Pharmacovigilance Report - June 2022 (World Council for Health)

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Covid-19 Vaccine Pharmacovigilance Report

My Post June 11, 2022 / WCH Updated on June 12, 2022 / WCH Updated November 3, 2023

World Council For Health

Read the entire report here including references.  A synopsis is below:

 

Report prepared by the World Council of Health to determine whether sufficient pharmacovigilance data exits on WHO VigiAccess, CDC VAERS, EudraVigilance, and UK Yellow Card Scheme to establish a safety signal on Covid-19 vaccines.   

This report collates adverse event data on COVID-19 vaccines from the following pharmacovigilance databases:   

This is an informational report created by World Council for Health to aid healthcare practitioners, scientists, and individual citizens in making informed decisions about Covid-19 vaccines. It examines the parameters by which other vaccines and drugs have been recalled in the past.

Reports made on pharmacovigilance databases do not establish causation. One important part of the science of drug safety is a process known as 'Signal Detection' in which a variety of techniques are employed to determine if reports point to a possible causal relationship between the product and the adverse events being reported.  A possible causal relationship established through this process is known as a 'signal'.  If a signal is detected, further in-depth investigation is required.   

 

VigiAcess Data

 

The tuberculosis vaccine has been administered to the highest percentage of the world's population, more than any other vaccine.  88% of 1 year-olds have been immunized against tuberculosis.  Some 4 billion individuals have received the vaccine.  VigiAccess reports around 37,000 adverse events reports relating to the tuberculosis vaccine.  

At least one dose of the Covid-19 vaccine has been administered to 65.7% of the world’s population or approximately 5.1 billion individuals. VigiAccess reports around 3.8 million adverse events reports relating to the Covid-19 vaccine.

For common vaccines that have been distributed to the vast majority of the world’s population we see a range of adverse event reports reports numbering between 2000 and 100,000 on VigiAccess.

 

 VigiAccess shows a number of adverse events that is unprecedented on the database for any other pharmaceutical product or vaccine. The total reports of adverse event reports cannot be compared directly because of the lack of contextual data discussed earlier. However, given that other similar products have been widely distributed on a global scale in comparable numbers, the magnitude of disparity is cause for grave concern. This data is particularly relevant given that Covid-19 vaccines are being widely distributed, are still in clinical trials, and must be scrutinized using all available evidence.

CDC VAERS

Over 50% of total adverse event reports made on VAERS, that is reports made for ALL vaccines since 1990, are attributed to COVID19 vaccines. 

VAERS data shows an overwhelmingly large proportion of adverse events reports relating to the Covid-19 vaccine with over 50% of total reports since 1990 being attributed to the vaccine. Though, for many reasons, the adverse event reports of individual vaccines cannot be compared directly, the magnitude of the disparity in adverse events and deaths is indicative of a cause for concern. As shown in Table 3, we see a 10 fold difference in the number of adverse event reports for the MMR vaccine and the Covid-19 vaccine. In addition there is a 169 fold increase in reported deaths to VAERS after Covid-19 vaccination when compared to the flu vaccine and a 56 fold increase in adverse event reports on VAERS after Covid-19 vaccination when compared to the flu vaccine. Most deaths and adverse events occurred days after vaccination, making a causal relationship more likely. Given that Covid-19 vaccines are novel and still in clinical trials, VAERS data is sufficient to establish a concerning safety signal.

EudraVigilance Data

The total number of individual adverse event cases identified in EudraVigilance are as follows: Covid-19 MRNA Vaccine Moderna – 294,772; Covid-19 MRNA Vaccine Pfizer-BioNTech (Tozinameran) – 956,913; Covid-19 Vaccine Astrazeneca – 488,769; Covid-19 Vaccine Janssen – 59,751; Covid-19 Vaccine Novavax – 756. The total number of individual adverse events cases identified for all Covid-19 vaccines on EudraVigilance is over 1.8 million.

The total number of people vaccinated in EU/EEA countries is 341,628,772 or approximately 75.4% of the population. 

On the EudraVigilance database, the total number of individual adverse event reports are as follows: Measles, Mumps and Rubella Vaccine (LIVE) – 36,947; Measles Vaccine (LIVE) – 592; Measles and Rubella Vaccine (LIVE) – 116; Measles, Mumps, Rubella and Varicella Vaccine (LIVE) – 11,258. The total number of adverse events potentially relating to a vaccine containing a measles inoculation on EudraVigilance is 48,913

In 2018, around 90% of European children were vaccinated for measles as part of measles, mumps, rubella vaccine.

Given that other similar products have been similarly widely distributed across Europe, the magnitude of the disparity in total individual case reports for Covid-19 vaccines on EudraVigilance is cause for grave concern

UK Yellow Card Data

In the UK, over 53 million individuals have received at least one dose of the Covid-19 vaccine. The UK Yellow Card scheme currently documents over 450 000 reports of adverse reactions. 

Yellow Card data for other vaccines is currently not available on the Yellow Card Website. 

The Yellow Card Scheme shows over 450,000 yellow card reports related to the Covid-19 vaccines. Though the data for other vaccines is not available on the website, the data for paracetamol, a medication in widespread use for several decades in the UK, shows only a fraction of the reports (~25 000 since 1968) on the Yellow Card Scheme. Though these cannot be used in direct comparison, the magnitude of the disparity is cause for concern. Given that the Covid-19 products are still in clinical trials, all evidence should be used to assess their safety. The UK Yellow Card data is sufficient to establish a safety signal for these products. 

Major Drug and Vaccine Recalls in History

When a concerning number of adverse events or deaths is noticed in pharmacovigilance reports, governing bodies may recall a previously authorized or approved product. The following graph shows the number of deaths reported to VAERS or FAERS before a product was recalled.

The Polio Vaccine was recalled in less than 1 year after 10 reported deaths, the Swine Flu Vaccine was recalled in less than 1 year after 53 reported deaths. The Covid-19 vaccine, with over 28 000 associated reports of death, has not been recalled.

Signal Detected



Across all databases, Covid-19 vaccines show an alarming number of adverse events and death reports when compared to other commonly administered vaccines.




Conclusion

This report sought to look at pharmacovigilance data from VigiAcess, VAERS, EudraVigilance, and UK Yellow Card for Covid-19 vaccines. The aim was to determine if the data on these databases was sufficient to establish a safety signal about these products. We conclude the following:

Data from Pharmacovigilance Databases about Covid-19 Vaccines vs. Other Commonly Administered Vaccines and Pharmaceutical Products

  • All pharmacovigilance databases examined in this report reveal a number of adverse events reports linked to Covid-19 vaccines that are between ten times and 169 times more than what is observed in other commonly administered products
  • There are several thousand reports of adverse events in children for whom the Covid-19 product has not been approved

There is sufficient evidence on all pharmacovigilance databases examined in this report to establish a concerning safety signal about Covid-19 vaccines.

Data about the Types of Adverse Reaction Reports Linked to Covid-19 Vaccines

  • Data from WHO VigiAccess, EudraVigilance, and UK Yellow Card Scheme reveal that the majority of adverse events reports related to Covid-19 vaccines are: Nervous System Disorders, Musculoskeletal and Connective Tissue Disorders and Gastrointestinal Disorders
  • Data from VAERS reveal that the majority of adverse event reports related to Covid-19 vaccines are: Arthritis and Arthraligia, Anaphylaxis, Venous Thromboembolism, Myocarditis/Pericarditis, Stroke, and Convulsions/Seizures
  • Eudravigilance reports 1200 deaths linked to Covid-19 vaccines. UK Yellow Card reports 2100 deaths linked to Covid-19 vaccines. VAERS reports 28 000 deaths linked to Covid-19 vaccines

The types of adverse reaction reports linked to Covid-19 products are serious in nature. 

Data about the Rate of Adverse Events that is Sufficient for Product Recall

  • Pharmacovigilance databases, such as those examined in this report, rely on passive surveillance. Adverse events are underreported 
  • Covid-19 products are unique in that they were developed quickly and administered to large populations while still in Phase 3 clinical trials
  • In 1967, the American government rushed a mass vaccination campaign for swine flu. Information emerged about the nature of the virus and adverse reactions linked to the vaccine, and the campaign was halted in less than a year
  • Data from VAERS and FAERS reveals that The Polio Vaccine was recalled in less than 1 year after 10 reported deaths, the Swine Flu Vaccine was recalled in less than 1 year after 53 reported deaths. The Covid-19 vaccine, with over 28,000 associated reports of death, has not been recalled after two years

There is sufficient evidence of adverse events relating to Covid-19 vaccines to indicate that a product recall is immediately necessary.


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