Protection from liability
To begin to answer the question of whether vaccines are safe, one needs to delve a little into the history of vaccines. In the US, after establishing that vaccines are “unavoidably unsafe” the National Childhood Vaccine Injury Act of 1986 granted immunity from liability to all vaccine manufacturers and established the Vaccine Injury Compensation Program (VICP). In America, anyone sustaining an injury from a vaccine must seek redress directly from the VICP. No other product or medicine has ever enjoyed this level of immunity. See the Compensation Scheme information below for the legal situation in Ireland.
This came about because the liability for the vaccines on the market before 1986 were exceeding revenue for the manufacturers and they threatened to stop making vaccines altogether.
These favourable market conditions have led to a booming vaccine market currently worth in excess of $60bn and projected to grow to $125bn by 2028. Government lobbying, large scale funding and advertising spend means that media, influential institutions and medical journals cannot be objective. In addition, large portions of regulatory agencies’ budgets are funded by the industry they are supposed to regulate:
Data source: Extract from table 1 – From FDA to MHRA: are drug regulators for hire?
Clinical trials and placebos
Although most vaccines are for children and newborns, they undergo much shorter clinical trials and safety review periods than regular drugs. Standard drugs, such as Lipitor (for cholesterol) and Eliquis (a blood thinner), that are not protected from liability, are tested for several years. Vaccines on the other hand are tested for a very short timeframe. The Guideline on clinical evaluation of vaccines published by the European Medicines Agency (EMA) in Jan 2023 states the following:
“Some additional considerations for the assessment of vaccine safety in clinical trials follows. 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 (with an inert placebo) which is the gold standard of drug safety testing required for all other drugs, is not required for vaccines. Instead, other vaccines or biologically reactive solutions are used in place of placebos which obscure safety issues with the new vaccine being tested. The EMA confirms in their guideline on vaccine trials (section 5.2) that other licenced vaccines can be used in place of a placebo.
“If a placebo control is considered inappropriate (e.g. because investigators and/or participants/care-givers would reject the possibility of randomisation to multiple placebo injections), a licensed vaccine without an effect on the disease to be prevented by the candidate vaccine could be administered to the control group.”
Once the vaccine is launched on the market it is considered unethical to leave any child in the “control group” unvaccinated, so all controls are vaccinated with the latest vaccine. This practice renders comparison of the longer term health outcomes of vaccinated and unvaccinated population essentially impossible.
See our table of completed studies from clinicaltrials.gov showing how long general serious side effects were monitored and the number of participants in each.
Vaccine injury compensation programmes
The Vaccine Injury Compensation Program (VICP) emerged as a solution to the granting of protection from liability under the US National Childhood Vaccine Injury Act of 1986. At the start of 2023, the programme had paid out in excess of $4.5 billion in childhood vaccine injury claims. A similar programme in the UK paid out €86 million between 1979 and 2019. This is despite the fact that the UK scheme requires that claimants are severely disabled and caps awards at £120,000. Since the scheme began in 1979 until May 2017, 79% of claims were rejected based on the claimants’ inability to prove causation.
An overview of a number of such schemes published on oireachtas.ie highlights that they “require standards of proof showing a causal link between vaccination and injury, although this has often led to overly strict standards of proof”. Although there are numerous problems with VICPs, depending on how they are designed, as discussed in the Oireachtas overview, they should in theory make it more affordable and easier for parents whose child has been injured or killed by vaccines to be compensated as it is not normally required to pay legal fees. A detailed review of the different schemes carried by the Health Research Board (HRB) in Ireland sums it up as follows:
“The purpose of compensation schemes is to provide an alternative option to civil litigation. This is achieved by lessening the stringency around the standard of proof; crucially however, the compensation on offer is typically available more quickly, but the amount is usually lower than what a vaccine-injured individual may receive through litigation.”
However, there is no such compensation scheme in Ireland at present. This is the case even though the Oireachtas Joint Committee on Health and Children recommended that a vaccine damage compensation scheme be set up at the earliest possible date in 2001 according to the HRB. The Oireachtas overview which was published in April 2021 notes that the issue has taken on increased significance now due to the fact that the manufacturers of the covid vaccines are being given “legal indemnity through purchase agreements which means that they cannot be pursued for compensation for vaccine-related harm”. The HRB review, says the urgency in introducing a VICP scheme is increasing since claims are being taken against the Minister for Health, the HSE and GlaxoSmithKline by individuals claiming that they developed narcolepsy after getting the H1N1 (swine flu) vaccine. According to the review, this will result in exposure of the State to a large number of claims.
The lack of a VICP scheme in Ireland means that the only avenue open to parents is taking legal action against the state. The HRB review points out the problems with this:
“However, a more strict form of causation applies in tort law, so mounting a successful case is more difficult and often more time-consuming and costly, restricting access to litigation to those with adequate resources.”
Proving causation is also hampered by the fact that adverse reactions listed in manufacturers leaflets are not accepted as causing the reaction when it comes to getting compensation. This is evident given that claimants have to prove that their child’s adverse reaction was due to the vaccine even with the VICP schemes which should have a lower standard of proof.
Reporting adverse events (side effects)
The Health Services Executive (HSE) in Ireland states:
The vaccines used in Ireland are safe. All medicines can cause side effects, but with vaccines these are usually mild, like a sore arm or leg or a slight fever. Serious side effects to vaccines are extremely rare.
The Centre for Disease Control (CDC) in the US states:
As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.”
There are a number of systems that healthcare practitioners and the general public can use to report any adverse effects they may have with any vaccine once they have been launched on the market (post marketing adverse events).
- VigiAccess – World Health Organisation platform
- VAERS – US system managed by the Center for Disease Control (CDC)
- Eudravigilance – EU system managed by the European Medicines Agency (EMA)
Side effects to vaccines and other drugs in Ireland can be reported to the HPRA which is in turn added to the Eudravigilance database. The systems listed above are all passive reporting systems relying on voluntary rather than mandatory reporting.
The US government funded a study – carried out by Harvard Pilgrim Health Care – that found that less than 1% of adverse reactions are reported to VAERS. In this study, data on vaccines was collected over 3 years on 1.4 million doses given to 376,452 individuals. The study cost over 1 million dollars. Another study on the Italian reporting system, which is also a passive system, found a huge disparity in the numbers of Adverse Effects Following Immunisation (AEFIs) between passive and active reporting systems and said that “passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs “.
What Parents Say
“Advice to new parents- research vaccines from sources not receiving payments for administering vaccines as much as you likely researched baby products you purchased. What I wish I had known – the ingredients. ALL the potential side effects (not just the 5 the HSE informed me about), the frequency at which side effects happen”More from parents
Join the parents support group to continue the discussion and learn from the experience of others.
Health Freedom Ireland – Aluminium in Vaccines
Health Freedom Ireland – Childhood Vaccines
Health Freedom Ireland – Pregnancy Vaccines
Health Freedom Ireland – The Vaccine Booklet (a comprehensive overview of pregnancy and childhood vaccines in Ireland)