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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:
- The World Health Organization
(WHO) – VigiAccess
- The US
Center for Disease Control (CDC) – Vaccine Adverse Events Reporting
System (VAERS)
- EudraVigilance – European
Database of Suspected Adverse Drug Reaction Reports
- Medicines
& Healthcare products Regulatory Agency – UK Yellow Card Reporting
Site
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.
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.
