In this, the third part of her report, Paula Jardine relates how Immunisation Information Systems (IIS) were introduced to ensure maximum vaccination coverage while no concomitant safety monitoring was deployed.
THE World Health Organisation’s Global Vaccine Action Plan (GVAP) was developed to help GAVI (the Global Alliance for Vaccines and Immunisation) achieve its ‘decade of vaccines’ from 2010, helping ‘all individuals and communities enjoy lives free from vaccine-preventable diseases’.
All countries were to make immunisation a strategic priority, requiring more surveillance to ‘strengthen national capacity to formulate evidence-based policies’. There was no aversion to financially incentivising either individuals or healthcare workers to encourage vaccination, despite the potential for conflict of interest.
The primary success metric in the GVAP was that by 2020 there should be at least 90 per cent national vaccination coverage ‘with at least 80 per cent vaccination coverage in every administrative unit for all vaccines in the national immunisation programme’ for the target populations.
Immunisation Information Systems (IIS), national registries to record the who, what and when of vaccination, were established.
The European Centre for Disease Control (ECDC) led a scoping exercise for this in 2016. Systems which would be interoperable with other databases were to be formulated with ‘a heavy design emphasis on generating evidence to support decisions that need to be made at the population level’.
Vaccination coverage is mentioned 81 times in the ECDC report, twice as many times as vaccine safety. The ECDC claims that ‘IIS can help mitigate potential rumours and unfounded concerns through the provision of evidence, including on adverse events following immunisation’.
That may be so, but the only safety signal likely to emerge from an IIS is evidence of secondary vaccine failure – that is, breakthrough disease outbreaks amongst those inoculated against a given disease, requiring a booster vaccination campaign.
The IIS do not exist for safety monitoring (the technical term for which is pharmacovigilance) of the vaccines once they are deployed on the population at large. Pharmacovigilance is the remit of the regulators who license them, not of the public health authorities who monitor vaccination coverage.
In fact, only seven European countries record adverse events to vaccines in their IIS. The UK is not amongst them. Of the seven that do, only Sweden automatically reports them to the regulator who has the power to withdraw unsafe products from use.
Dr David Sencer is the former director of the US government agency the Centres for Disease Control and Prevention (CDC), who lost his job after America’s ill-fated 1976 swine flu vaccination campaign.
He has pointed out that some adverse effects from vaccines become apparent only once the clinical trials conclude and after the vaccine is administered to very large numbers of people.
Sencer’s swine flu program had an active surveillance system for adverse events which he later called a trojan horse as the scale of death and injury led to the vaccination campaign being terminated after three months. Having indemnified the manufacturers because their insurers balked at covering them, the US government paid $135m for swine flu vaccines and an additional $90m in compensation for death or injury – almost as much in compensation over the swine flu vaccine programme as it did rolling it out.
The size of the US government’s 1976 compensation bill perhaps explains why no pharmaceutical regulator in the world has a system that actively monitors for post authorisation adverse events. Instead all regulators rely on passive surveillance through voluntary reports to systems like the Yellow Card system operated by the Medicines and Health Care Products Regulatory Authority (MHRA) in the UK.
A vaccine is deemed safe if it passes Phase 1 clinical trials without any ‘unscheduled’ animal deaths or untimely deaths of human subjects and effective if it passes Phase 2 clinical trials.
Products such as the ill-fated Pandemrix flu vaccine – hit by adverse effects in 2009 – may on occasion be withdrawn after licensing. But as a rule, regulators make no active effort to protect consumers at large that might necessitate a product being withdrawn once it is in use.
To facilitate GAVI’s efforts to monitor vaccination coverage rates reliably, the GVAP asks for each individual to be assigned a unique identification number so that the respective health authority can ensure everyone gets every vaccine in ‘time-monitored’ adherence with the vaccine schedules.
In 2013, the Bill and Melinda Gates Foundation (BMGF) funded a fingerprint identification system to track vaccinated children in Africa. GAVI, the Rockefeller Foundation and Microsoft subsequently formed the ID2020 alliance in 2016 to promote the global need for secure digital identity.
‘We are currently in the middle of a global identity crisis: Tens of millions of children – especially those living in most remote, impoverished communities – have no formal record of their existence,’ said Dr Seth Berkley, associate director of health sciences at the Rockefeller Foundation, and one of the instigators of GAVI.
‘That represents an enormous impediment to GAVI’s mission of ensuring that every child worldwide receives the essential vaccines they need to survive and thrive.’
He said the pacesetters of GAVI’s initiative called INFUSE (Uptake, Scale and Equity in Immunisation) ‘are on the cutting edge of technologies that might help us overcome that challenge’.
Covid-19 has presented another opportunity to fulfil GAVI’s vaccination monitoring mission. Dr Rebecca Weintraub, a board member of Simprints, one of the companies working with it to develop biometric identification solutions for immunisation registries, said: ‘We have a narrow opportunity to set the stage for such fair and sustainable infrastructure across the globe. If done well, we can ensure the promise of the Covid-19 vaccine portfolio leads to future widespread vaccination – and protection – for global populations.’ https://gatesopenresearch.org/articles/4-182/v2
However, biometric identification for developing immunisation registries is beginning to morph into something else. The Ada Lovelace Institute, which was set up by partners including the Wellcome Trust in 2018 to ‘ensure that data and AI work for people and society’, calls vaccine passports and Covid status apps ‘systems for verifiably sharing private health data relevant to Covid-19 which could be used to stream society and impose differential lockdown restrictions.
‘This might mean limiting individual access to work, insurance, hospitality and leisure, and other parts of life, based on an individual’s health or risk of Covid-19 infection or transmission.’ In other words, universal vaccination means universal control.
Covid-19 may have brought these passports to public attention, but the idea is not new. In December 2017, the European Commission published a Roadmap on Vaccination.
The first action on the roadmap is to ‘examine the feasibility of developing a common vaccination card/passport for EU citizens (that takes into account potentially different national vaccination schedules and) that is compatible with electronic immunisation information systems and recognised for use across borders, without duplicating work at national level.’
In 2018, the European Health Parliament, a lobby organisation that develops health policy recommendations to ‘rethink European health care’ and whose sponsors include Johnson & Johnson and Pfizer, recommended that electronic vaccination passports be established in order to ‘ensure people know and act in their best interests on vaccination’.
The very day the MHRA authorised the use of the Pfizer-BioNTech vaccine, the WHO put out a call for experts to develop a so-called Smart Vaccine Certificate programme.
Pharmaceutical revenue growth has been stimulated not only by measures to increase inoculation coverage, but by raising the number of vaccines put on national immunisation schedules.
The ‘child survival revolution’ promoted by the United Nations agency UNICEF began in 1982 with six vaccines. At the time of the first GAVI board meeting in 1999, there were 11 routinely recommended vaccines on the US national immunisation schedule.
GAVI immediately identified a vaccine gap that the developing world needed to close, and its ambition is for immunisation schedules around the world to mirror that of the US.
The goalposts keep moving. When it was updated again in 2013, the US immunisation schedule comprised a total of 52 injections of 17 different vaccines over the course of a person’s lifetime.
Gone are the days when the promise made to parents was that with a single injection their children could avoid infections and be protected for life. The number of boosters continues to increase and now includes a recommendation for adults to have an additional measles, mumps and rubella (MMR) vaccine.
A footnote to the MMR recommendation says: ‘Documentation of (healthcare) provider-diagnosed disease is not considered acceptable evidence of immunity for measles, mumps or rubella.’
The very idea that someone might have acquired lifelong immunity after recovering from an infectious disease is now anathema, unless proven by a laboratory test.
The current UK immunisation schedule is marginally more conservative, both in terms of the total number of vaccines recommended and the number of doses. The most recently updated version, as of November 23, 2021, appeared on the website of the Oxford Vaccine Knowledge Project.
It recommends only three vaccines for adults – flu, pneumococcal and shingles. The three are recommended by Public Health England only for over-65s, or 70 in the case of the shingles vaccine. Despite the controversial mandate for NHS staff to have the Covid-19 vaccine – now withdrawn – the jab is not listed on the schedule.
The Oxford Vaccine Knowledge Project’s medical information is reviewed by Professor Andrew Pollard, chair of the UK’s Joint Committee on Vaccination and Immunisation, and a member of the WHO’s Scientific Advisory Group of Experts Committee.