by Senta Depuydt
Little publicity has been made about the event but the opportunity deserves a lot of attention. On Thursday Feb. 25th, the European Parliament is finally getting the opportunity to question Stella Kyriakides the Commissioner of DG Health and Thierry Breton of DG Inner Market along with the CEO’s of vaccine producers on the current Covid-19 vaccination campaign.
The session is an extraordinary joint public hearing of the ENVI (Environment, Public Health and Food Safety) and ITRE (Industry, Research and Innovation) parliamentary committees titled “How to increase the capacity of Covid 19 vaccine production and improve delivery”.
The CEO’s of AstraZeneca Pascal Soriot, Moderna Stéphane Bancel, Novavax Stan Erck and CureVac Franz-Werner Haas have confirmed their attendance and they might be joined by those of Sanofi, Johnson & Johnson and Pfizer.
The EU commission has recently been under fierce critics of the EU parliament for the way it has led its vaccination strategy. In April last year, the EU passed the Accelerator Act that enabled fast tracking and fast and massive financing of emergency responses in particular a Covid-19 vaccination campaign. Pressured into an attitude of blind faith in the middle of the unfolding crisis, the Parliament signed numerous bills and loans and agreed to anticipated down payments for confidential vaccine procurement deals negotiated by the EU Commission.
Following the approval of the first vaccines by the EMA at the end of December, several members of the EU parliament thought it was finally high time to obtain more information on the specific terms of the vaccine contracts. How much will each vaccine cost? Where will it be produced? What guarantees are there in terms of delivery? Who is liable for vaccine injury?
This is the less than minimal information for the Parliament to do its job. After all, the vaccination campaign uses gigantic amounts of taxpayers’ money and most of the European population is supposed to receive one of the shots.
Amazingly the Commission kept denying access to the contracts secured with the manufacturers arguing that there had been no other choice than to accept opacity in order to close the deals. After much insistance, some members of the Parliament were finally allowed to read one of the contracts, or rather as it then turned out, the few lines that had not been redacted. The fact that they couldn’t see any information on pricing, productions sites or even liability terms simply left them furious.
To add to their frustration, the speed of delivery of the vaccines has been far from what they had expected and the roll out of the campaign was slowed down by complex logistic issues (for ex. Moderna and Pfizer vaccines need to be transported and stored at very low temperatures which requires the use of specific containers) and in some countries growing vaccine hesitancy of the general public and even doctors.
Keeping the same pace, the EU as a whole would not meet its target of vaccinating 70% of its adult population before March 2024. In sharp contrast, the UK which has led its own strategy and negociations as a consequence of the Brexit plans to get a vaccine coverage of 83% by the end of this summer.
Manufacturers boasted strong and reassuring claims about efficacy and safety but, looking at the number of cases and deaths in the countries that have vaccinated the most, a clear positive impact has yet to be demonstrated.
The current situation demands that a first real risk benefit assessment of the Covid-19 vaccination campaign be done.
Here are several questions that members of the EU committees should ask:
1. Assessing the efficiency of the campaigns
Vaccine manufacturers advertised amazingly high efficacy rates to rush the approval of their products but several scientist like Peter Doshi question the validity of their analysis and how it was reported and request more raw data.And there is also a difference between measuring efficacy in terms of an antibody response and assessing the impact of a vaccination campaign at population level. On worldometer graphs, countries such as the UK, the USA, Canada or Israel all had a sharp increase in the number of cases and fatalities after an aggressive vaccination round while in countries with a low uptake such as Belgium or France (under 5%) numbers have remained at a stable and lower threshold.This can be explained by different factors BUT it should be reminded that, in its January public conference on the roll out of the vaccination campaign, the EMA had clearly stated that there is simply no data available to affirm that the current vaccines would have an impact on the transmission of the disease.
While final evaluation is planned for the end of the clinical trials in a couple of years, a preliminary impact study is highly advised and the comparison between several vaccines needs to be done.
2. The impact of vaccines on coronavirus mutations
Experts tell us there would be around 4,000 different variant strains of coronaviruses. Many new variants have emerged and their predominance is different from one country to another. Just as for flu viruses, it will likely be very hard to predict which viral strains will be in a few months or not and which vaccines would be efficient or not. Additionally, some researchers expressed their concerns over the fact that certain drugs like Remdesivir or certain vaccines could provoke mutations. Vaccine critics are pointing to the crisis in the UK where cases have surged and a new variant has imposed itself after mass vaccination started.
On the other hand some manufacturers claim that their vaccine will likely protect against the new strains. Bill Gates’ most recent warning suggested a “third dose of the vaccine,” boosters, or a “tuned vaccine” may be needed to combat coronavirus variants.
A study to determine whether vaccines can help or on the contrary aggravate the situation should be run in full transparency and with independent funding.
(The Gates foundation is controlling the manufacturing and distribution of the AstraZeneca COVID vaccine through GAVI and CEPI having provided millions to the Serum Institute of India to manufacture the vaccine, and funded the “safety and efficacy” studies of the AstraZeneca COVID vaccine in Brazil and South Africa).
If new vaccines and more doses would be the option recommended by the commission, how many would need to be developed and administered and would this cost still be viable in a public policy approach? The Union and its members states cannot endlessly purchase more vaccines and other structural approaches need to be considered.
If on the contrary it turns out that vaccines ordered would be useless against the new strains, what are the terms to end contracts and cancel orders placed?
3. Global cost of the Covid-19 vaccination campaign
The parliament and the public needs to have a clear view on how much the global cost of the Covid-19 vaccination will add to at European level and at country level. This includes the financial cost
– The price of each vaccines X doses ordered for the EU market
– The cost of allocations for research and development and follow up studies
– The cost of pharmacovigilance
– Consultancy fees
– Allocations to EU administration and task forces involved in vaccination
– The cost of promoting the vaccines
– The cost of vaccine injury
– The media campaigns
– The cost of centralizing data
– The cost of developing and implementing vaccination passports
There also need to be an impact study on privacy, data protection and possible discrimination.
4. Reevaluate the need for vaccination in the light of other options: testing new treatments and reinforcing hospital capacities
The Emergency authorization of Covid-19 vaccines is conditional in the absence of conventional treatment options. In a hearing before the US Senate on December 8th 2020, Dr. Pierre Kory reported on experiences gained by FLCCC Alliance (a not for profit organisation by Frontline Critical Care Doctors treating Covid-19) on the use of Ivermectin in combination with other compunds (MATH+ Protocol). These results were published in a number of scientific studies that were assessed and by Dr. Tess Lawrie, director of Evidence Based Medical Consultancy, a NHS and WHO sub-contractor from Bath.What is known to the Commission on Ivermectin as treatment for Covid-19? Does the Commission intend to boost research of this conventional treatment option in order to ease the burden of death from Covid-19 in the absence of safe and effective vaccines that may not stop infection and thus contribute to development of more severe forms of the SARS-CoV-2 virus?
5. Deaths and adverse reactions following vaccination
Several outbreaks and deaths in nursing homes following vaccination have been reported in European countries. In Cadiz, 46 seniors out of 145 residents died within one month of receiving the Pfizer vaccine. In Novo Sancti Petri, 22 died and 103 were contaminated by the virus. Another 29 died in a nursing home in Norway. 23 out of 40 residents in Germany and similar facts are reported in Italy, the UK and other countries. According to the American CDC, one-third of deaths following vaccination are reported within 48 hours and some reactions point to specific cardiac-related risks. This is what many scientists would call an alarm signal. Some studies suggest that COVID vaccines may trigger antibody-dependent enhancement in some people, a condition that could cause them to develop more severe symptoms when exposed to the wild virus than if they hadn’t been vaccinated. An in-depth investigation is needed to assess the risk of ADE (Antibody Dependent Enhancement) or the overreaction of the immune system that can lead to fatal consequences.
Also most vaccines have been tested on healthy people during clinical trials but not on the elderly population while it is considered to be the n°1 priority group to receive the vaccine.
There should also be a reevaluation of the interest of vaccinating the older age group.
6. Vaccine quality control and manufacturer liability
These reports of multiple deaths in the same setting after vaccination also raise the question of the control of vaccine quality lots. There should be an independent investigation into these deaths as the manufacturers remains liable in case of product default resulting from deficient manufacturing practice. The ‘leaked emails between the EMA and the Commission’ revealed pressures to fast-track the approval of some vaccines while differences in quality between the products used in clinical trials and the commercial vaccines had been found. The importance of regular, independent quality checks of the vaccine lot cannot be underestimated. Recently a public prosecutor in Rome ordered to proceed with analysis to verify the quality of several pediatric vaccines after an independent analysis revealed the presence of toxic residues and biological contaminations in several lots. Given the evidence exhibited, the court said there was a need to provide scientific answers and not get away with legal arguments. While quality issues can be raised with vaccines who have been tested and manufactured for several years this should call to extra cautious when it comes to new vaccine technologies developed and produced at extra speed. What actions are taken to guarantee a strict and transparent quality control as to reassure the public and investigate adverse outcomes?
7. mRNA vaccines and gene technology risk assessment
In the rush to develop Covid-19 vaccines, the Parliament accepted to vote a waiver for ‘GMO risk evaluation’ in clinical trials allowing the use of genetic technologies never used before such as the mRNA based vaccines. Scientists, doctors and an important part of the public are hesitant regarding these new technologies and reject their use. Understandably, they worry over possible mutagenic effects and long term consequences on their genetic makeup. Immunologist Bart Classen estimates that there are also risks of developing chronic conditions such as type 1 and 2 diabetes or prion diseases years after vaccination. In France, geneticists such as Alexandra Henrion Caude, who has directed research at INSERM, or Christian Vélot, Vice-President of CRIIGEN, have clearly exposed the possibility of carcinogenic and mutagenic risks. Several organizations have asked an annulment of the parliament’s decision in the European Court of Justice asking that the principle of precaution be respected when using completely novel technologies. When and how does the Commission plan to proceed with this specific risk evaluation? Will there also be a discussion of the bioethical implications of these new technologies?
8. What is the need to vaccinate children?
Covid poses almost no risk for children. 99,997 % survive the disease and contamination to adults seems very limited. What is the justification of planning to vaccinate children? Can the commission explain why it wants to spend time and money and take the risks of using products that have only received a conditional approval and have not completed clinical trials? If public health leaders say that parents must “vaccinate the young to protect the old”, it seems clear that officials expect children to shoulder 100% of the risks of COVID vaccination in exchange for zero benefit.
9. Vaccination passports
Why are we contemplating an international system of vaccine passport controls when there is presently no strong evidence that vaccines can do more than inhibit the severity of symptoms? As previously mentioned there is no proof that these vaccines would limit the spreading of the viruses and current observations might indicate the opposite. Vaccination may well stimulate the emergence of new variants possibly due to a phenomenon called ‘pathogenic priming’. We also have no data on long term immunity induced by the vaccines but first estimates and literature on coronaviruses would not indicate more than six months to a year. Would not a more cautious, simpler, cost efficient and democratic approach be rational in these circumstances?
At first sight, it seems the EU was the big loser of the so-called vaccine race, but what if things were not going according to plan and if the immunisation campaign was not delivering the expected results? While the EU needs guarantees from the drug companies that products ordered will be delivered in due time and people who volunteer can be vaccinated as soon as possible, the parliament should also stress the importance of answering the questions we mentioned before putting more money, efforts or even force into the Covid-19 vaccination programme.
The EU doesn’t have a Donald Trump to blame if its ‘Operation Warp speed’ were to turn into a Mad Max disaster.