COVID-19 Vaccines/AEFI

Adverse Events Following Immunisation (AEFI)

25 June 2021
The ... COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19.
There is no FDA-approved vaccine to prevent COVID-19.

Source: FDA (USA) (emphasis added)

13 July 2021

Millions of People Have Safely Received a COVID-19 Vaccine

Over 334 million doses of COVID-19 vaccine have been given in the United States from December 14, 2020, through July 12, 2021.

COVID-19 vaccines are safe and effective. COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines met the Food and Drug Administration’s (FDA) rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA). Learn more about EUAs in this video.

Millions of people in the United States have received COVID-19 vaccines since they were authorized for emergency use by FDA. These vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history. This monitoring includes using both established and new safety monitoring systems to make sure that COVID-19 vaccines are safe.

Source: CDC (USA)

SARS-CoV-2 is a dangerous virus. By mid-2021 over 190 million people globally have had the virus and over four million people have died.

The roll-out of vaccines provides a hope of protection from the virus and a return to a more normal way of life; a Covid-normal.

Any individual receiving one or more doses of an approved vaccine could reasonably expect that, apart from some mild reactions perhaps, the vaccine would guarantee a high level of immunity to the coronavirus. Anyone looking forward to the benefit of a vaccine would not be anticipating a shorter life or a significant loss of quality of life. That is not a rational expectation. To be more specific, people aged under 70 generally have an optimistic view of their life expectancy and the younger they are the longer they expect to live. Right? And their present health is a guide to the health they would expect to have for their immediate future, hopefully longer. Right again? So is it acceptable that many people have died within a short period after being vaccinated; or developed a serious illness; or developed neurological conditions; or become permanently disabled?

This is not fake news, misinformation or alarmist anti-vax propaganda. The statistics are publicly available; the evidence is hidden in plain sight. You only need to access the data, interpret it correctly and make a value judgement.

Emergency Use Approval (EUA)

As at July 2021 all of the millions of people who have received one or more doses of a Covid vaccine are not guaranteed the same level of safety as a vaccine which has been given marketing authorisation, or full FDA registration or approval. The current situation is like a continuation and expansion of Stage III trials.

The UK was the first country to approve a coronavirus vaccine. This was developed by Oxford University and AstraZeneca. The approval states:

This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation of individuals aged 18 years and older for the prevention of coronavirus disease 2019 (COVID-19).

Covid-19 vaccines developed in the U.S. during 2020 were fast-tracked through a Trump era initiative called Operation Warp Speed. Candidate vaccines were short-listed and those which continued development through trials were approved for emergency use by the FDA. The mRNA vaccines produced by Pfizer-BioNTech and Moderna were the first to be granted Emergency Use Approval (EUA), followed by a Janssen vaccine. Each vaccine given emergency use approval is described in terms similar to this:-

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 12 years of age and older under an Emergency Use Authorization (EUA).

Similar emergency approvals have been granted in the European Union and other countries throughout the world. In addition, other vaccines have been developed, for example the Sputnik vaccine in Russia and the Sinopharm in China, but these are not covered here.

Vaccine Documentation

There are at least three levels of information available publicly for each vaccine. These are:-

1. Information for recipients
   This is usually a short document provided to a person receiving their injection, contains a short description of the vaccine and most common side effects, and instructions on what to do or who to contact if any severe reaction occurs.
2. Information for Health Professionals and Caregivers
   Since health care professionals can understand medical terminology this document usually contains more detailed information, specifics about common side effects, notes about possible allergic reactions, advice for people with diabetes and other health conditions, information for pregnant women, and may also include the full text of the relevant EUA for reference.
3. Emergency Use Authority or Approval
   This document is usually long, detailed, full of medical and statistical terms, and contains summary results of the trials. If adverse events have occurred during the trial they will be noted, compared with the placebo group and perhaps the incidence in a normal population.

Actual trial data would be a fourth level but such information is not readily available.

To be fair to each of the government agencies which review documentation provided by the pharmaceutical companies and subsequently made the approvals, the documents are regularly updated as new information about adverse events is obtained. When referring to an EUA, for example, it is relevant to note the date and to recognise that amendments are, or have been, frequently made.

However, as the roll-out of vaccines progresses globally the number of recipients will grow to billions of people and the incidence of adverse events will increase. If the number of people who die, for example, following vaccination is significantly less than the number of lives potentially saved then the relevant EUA will be updated to reflect the acknowledged risk, but if public health officials believe that the benefits outweigh the risk the product will not be withdrawn and the roll-out will not stop.

Adverse Events

To discuss adverse events following immunisation, usually abbreviated AEFI, we need to know some definitions and terminology. The first is that, for most people, the words immunisation and vaccination are generally interchangeable. So I will use the word vaccine. This article is about vaccines for COVID-19 which claim to provide some immunity to the SARS-CoV-2 virus, so I will just call them Covid vaccines.

All of the Covid vaccines are new. Some of them also use new technology and are described as mRNA vaccines. Some people dispute that these really are a vaccine because they work differently from what we are used to, but if they do the same job and the experts and officials call them vaccines then that is what they are.

In Australia the Federal Government has published The Australian Immunisation Handbook online, and it includes this definition of an adverse event:-

What is an adverse event following immunisation?

An adverse event following immunisation (AEFI) is any untoward medical occurrence that follows immunisation. It does not necessarily have a causal relationship with the vaccine.

The adverse event may be any:

• unfavourable or unintended sign
• unfavourable or unintended symptom
• disease
• abnormal laboratory finding

These events may be caused by the vaccine(s) or may occur by chance (that is, the event would have occurred regardless of vaccination).

This definition is taken from a 198-page document titled Definition and Application of Terms for Vaccine Pharmacovigilance produced by the Council for International Organizations of Medical Sciences (CIOMS) for the World Health Organization in 2012.

While the definition of an AEFI seems vague, the CIOMS document is incredibly detailed, beyond the level of this article.

The biggest issue with the definition, and the recording of adverse events in official databases, is that any post-vaccine event can be reported as an AEFI, but the event may (or may not) have been caused by the vaccine.

So, when we look at the data the numbers alone do not tell the story. A couple of examples show what I mean...

1. Imagine a middle-aged couple downsizing from the family home to a retirement villa. Their bucket-list included a tour through South America, so with the funds now available they make their booking. Their travel adviser recommends vaccination against diseases they may encounter during the trip which they arrange through their family doctor. Sadly however, three days after getting the shot, the lady has a heart attack. This could be recorded as an Adverse Event Following Immunisation. But the family doctor observed that the couple experienced a high level of stress with the move, plus some anxiety prior to the trip, and was aware of her age; no other patients have reacted like that after the same vaccine; so the doctor is confident that the event (the heart attack) would have occurred regardless of the vaccination.

   I based this example on a couple who were neighbours of mine. Between selling their house and moving into a unit the wife had a heart attack and died! It was sad but these things do happen.




2. This next example is based on a real event but the details have been altered to make it less specific.

   A middle-aged lady in good health received one of the Covid vaccines and shortly afterward was admitted to hospital with a blood disorder but tragically, she died. The government's independent panel of experts investigated the woman's death and decided that the vaccination was the likely cause. This conclusion was based on 'a strong lack of evidence for other causes and the timeframe within which she died after taking the vaccine'.

   It is rare for such a statement to be made as it is usual to say that no causal link could be established.

Data Sources

Records of adverse events following immunisation are publicly accessible from online databases. A few prominent ones are listed below. Each item is linked to a sub-page which provides a description, links to the appropriate webpages, and helpful comments. More sources may be added, but most countries should have a similar system so it will just be a matter searching for it.

1. United States
   Vaccine Adverse Event Reporting System (VAERS)
   This article also includes links to the OpenVAERS website which is easier to use.


2. European Economic Area (EEA)
   EudraVigilance


3. Yellow Card Scheme (UK)
   This article provides links to weekly reports for COVID-19 vaccines, and an analysis by a group known as the UKFreedomProject.

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adverse event following immunisation

CoronaVirus Disease 2019 (caused by SARS-CoV-2)

Food and Drug Administration (USA)

Emergency Use Authorization (USA)

Centers for Disease Control and Prevention (U.S)

Severe Acute Respiratory Syndrome CoronaVirus 2

messenger RiboNucleic Acid

European Economic Area (EEA)

World Health Organization