Nowadays it is challenging to discuss vaccine safety openly. It is easy to overlook that vaccines, like other medications, can have side effects — some very serious. However, the way vaccines are treated and regulated differs significantly from standard drugs. Before 1986, only two primary vaccines were widely used in the United States: MMR (measles, mumps, and rubella) and DTP (diphtheria, tetanus, and pertussis). In the years leading up to 1986, there was a surge in lawsuits for vaccine injuries and deaths, especially concerning the DTP vaccine.

What happened in 1986 that completely changed things?

In response to this surge in lawsuits, after establishing that vaccines are “unavoidably unsafe”, US Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986. Under this law, a no-fault compensation program; the National Vaccine Injury Compensation Program (NVICP), was put in place to handle claims of vaccine-related injury or death. Hearings are generally closed to the public with no judge or jury; all compensation and legal expenses awarded are funded by taxpayers.

This blanket immunity from liability for vaccine manufacturers has created a highly lucrative business model. It started a surge in the vaccine market which is projected to reach $159 billion by 2032, with many more vaccines in the pipeline. it is worth considering that many vaccine manufacturers have paid substantial fines for other medicines that were linked to severe adverse effects so this compensation programme represented a golden ticket.

As of the start of 2024, the compensation programme had paid out over $5 billion in compensation for childhood vaccine injuries and deaths and $67 million in legal expenses . Although manufacturers in Ireland enjoy the same immunity, no similar program exists, making it difficult for those affected by vaccine injuries to seek redress .

Does industry funding represent a conflict of interest?

Substantial funding and advertising spend often compromise the objectivity of the media, influential institutions and medical journals. Another significant concern is that regulatory agencies’ budgets receive the majority of their funding from the industry they are suppose to oversee.

What is the industry currently saying about vaccine safety?

A recent (2024) study by Dr Stanley Plotkin, the “Godfather of Vaccines”, suggests that vaccine safety for all vaccines needs to be improved in order to restore public confidence damaged by the roll out of the recent COVID-19 emergency use authorised vaccine.

Why do clinical trials for vaccines differ from standard drugs?

There are two main differences between vaccine clinical trials and those of standard drugs: duration and placebo.

With immunity from product liability, there is a clear loss of incentive to guarantee the safety of vaccines routinely recommended for infants and children. Common medications such as Lipitor and Eliquis, which are not immune to liability, undergo testing for several years . Vaccines, however, often undergo testing for a short period – sometimes just a few days – despite many being intended for newborns, the most vulnerable in our society. European Medicines Agency (EMA) guidelines in January 2023 confirms this in their guidelines:

“Since most adverse reactions to vaccines occur within the first few days after each dose, it is common practise that solicited local and systemic symptoms are collected for approximately 5-7 days after each dose. A longer post-dose period of collection of solicited symptoms may be applicable for replication-competent live vaccines (e.g. 10-14 days or sometimes more), depending on what is known about the duration of shedding of the vaccine(s)”

The double blind, placebo-control study, considered the gold standard for drug safety testing, is not required for vaccines . A double-blind, placebo-controlled study is when no one knows who gets the treatment or the inert placebo. In vaccine trials, an older version of the vaccine can be used as the control instead of an inert placebo. Using an active control instead of an inert placebo can obscure the true effects and side effects of the vaccine, making it difficult to accurately assess its safety and efficacy. The EMA confirms the use of vaccines as placebos in their clinical evaluation of vaccines guidelines (section 5.2):

“If a placebo control is considered inappropriate..a licensed vaccine without an effect on the disease to be prevented by the candidate vaccine could be administered to the control group”.

Clinical trials for Infanrix Hexa (6-in-1) vaccine and the MMR vaccine, none of which used a placebo, are listed here.

Once the vaccine is introduced to the market it is deemed unethical to leave any child in the “control group” unvaccinated. As a result, all individuals in the control group are given the latest vaccine. This practice makes it nearly impossible to compare long-term health outcomes between vaccinated and unvaccinated populations.

Where can I find vaccine adverse events?

Every medicine comes with a patient information leaflet (PIL). Section 4 of the PIL documents all side effects observed during clinical trials, for example:

What happens if you or your child suspect an adverse reaction?

Patients and health professionals are encouraged to log adverse events as they happen. These are referred to as post marketing adverse events.

• IRELAND : Side effects from vaccines in Ireland should be reported to the HPRA which are in turn fed into the Eudravigilance. (https://www.hpra.ie/homepage/about-us/report-an-issue)
• EUROPE WIDE : Eudravigilance – the European Medicine Agency (EMA). (https://www.adrreports.eu/en/disclaimer.html)
• USA : VAERS – US Centre for Disease Control (CDC) (https://openvaers.com)
• WORLD HEALTH ORGANISATION : Vigiaccess – World Health Organisation (www.vigiaccess.org)

Note : Information in these databases relates to potential side effects observed following the use of a medicinal product once it has been authorised for use on the market, but which may or may not be related to or caused by that product.

Do all suspected adverse events get reported?

Many parents are unaware of the full range of possible side effects, so when their child becomes ill after vaccination, they often don’t make the connection. Even when parents suspect a link, confirming that a vaccine caused a side effect is nearly impossible.

The US government funded a study carried out by Harvard Pilgrim Health Care that concluded that less than 1% of adverse reactions are reported to the US Vaccine Adverse Event Reporting System (VAERS). The HSE also refers to this lack of reporting in a 2016 presentation on Adverse Events following immunisation.

Informed consent

Vaccination is not compulsory. Ensure you have all the information on risks of the intervention and of the disease to empower you to make the best decision possible for you or your child:

• Informed consent must be obtained prior to vaccination. The person providing consent to a vaccination should be offered as much information as they need to make their decision as per the latest HSE National Consent Policy.
• Section 13 of the Irish Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners 9th Edition 2024 states: “In order to come to a decision about whether to proceed with any proposed treatment, patients must be sufficiently informed about the treatment options and the nature, risks and benefits of such treatment options (Section 13.3)”
• The Code of Professional Conduct and Ethics for Nurses and Midwives 2021 Principal 1, Standard 11 states; “you are responsible for seeking the patients consent to nursing and midwifery treatment and care. Never presume a patient’s consent….”