Viewpoint. The introduction of the vaccine pass is not based on any scientific basis, explains Héla Saïdi, doctor in immunology*. It is mainly explained by a lack of response to the lack of means at the hospital and to avoid some people losing face when considering the number of doses of vaccines ordered.
This is not to question the effectiveness of vaccines
Vaccines are incredible tools, since a single vaccination can protect for years.
However, vaccination is not a harmless act.
Even if they remain exceptional, adverse effects do exist. This is why there is monitoring of these signals for all COVID vaccines, which is called pharmacovigilance. It is important to emphasize that this monitoring is not specific to these vaccines but to any medication and that each patient himself can report his effects on the website of the National Agency for the Safety of Medicines and Health Products (ANSM)
A delicate balance
The more people are vaccinated, the greater the probability of the occurrence of these undesirable effects. Given that the risk of developing the severe form is not the same according to age and the presence or absence of co-morbidity, it is easy to understand that the vaccination of all people increases the risk of adverse events appearing in part of the population without any benefit from the vaccine.
From an immunological point of view, how can we explain the appearance of these undesirable effects ?
Vaccinating a person activates his or her immunity and there is a balance between the benefits and risks of this activation. It is a fragile balance that cannot be totally controlled. For the benefit-risk balance to remain favorable to the vaccine, the immune balance must be respected.
Why?
When a person is infected with a virus, a race begins between the multiplication of white blood cells to stop the virus and the multiplication of the virus. The virus will enter our cells and use them to produce new viruses that will in turn infect new cells in our body. To prevent the virus from multiplying, some white blood cells will start to produce antibodies to block the virus from entering the cells and others will start to destroy the infected cells.
With Sars-CoV-2, the disease progresses to a severe form when the white blood cells start to destroy “too much” (wrongly) of our cells even when they are healthy, especially the cells of the lung. This is when the immune system goes into overdrive and becomes deleterious to the point of destroying the lung cells, which leads to the patient being admitted to the intensive care unit.
Fortunately, for the majority of patients infected with Sars-CoV-2, the immune system does not overreact and is able to control the replication of the virus without causing damage.
Too much activation of the immune system can cause damage and when patients infected with COVID-19 arrive in the ICU, corticosteroid therapy (anti-inflammatory treatment) is recommended to calm the immune system.
The treatment of the disease therefore includes an anti-inflammatory drug that reduces the activation of the immune system.
But what is a vaccination?
A vaccine is an activation of the immune system. This activation is necessary and important to prepare the immune system to react quickly against the virus when it enters our body and thus win the race against the virus!
The vaccine is not intended to prevent the virus from entering the body. In fact, it is in the mucous membranes of the upper airways (nasopharyngeal mucous membranes) that the virus chooses to hide to escape the immune system.
Vaccines, on the other hand, accelerate the immune response, allowing our bodies to prevent the virus from spreading throughout the body by awakening so-called memory cells.
Vaccines thus enable the activation of a so-called memory response that will be set up quickly and catch the virus off guard as soon as it appears. However, vaccines and even natural immunity cannot block the infection in the mucous membranes.
Vaccines do not prevent the transmission of the virus
This is what prompted the World Health Organization (WHO) on January 20, 2022, as cases of Omicron continue to increase around the world, to rule against the ban on international travel and mandatory vaccination to enter countries, citing the ineffectiveness of such measures to stop the spread of the variant Omicron.
In France, it can also be seen that neither the health pass nor the barrier measures and vaccination have prevented the spread of the virus and the December 2021 wave.
So why vaccinate ?
Once we understand the principle of vaccination, we also understand why vaccinating recovered people is useless and potentially dangerous since these people are naturally “vaccinated”. Furthermore, if there is residual infection, their symptoms may be exacerbated or worsened. Vaccination can alter the immune balance they have acquired by reactivating the immune system, which can go into overdrive if there is any virus left. For this reason, some people who have recovered from or are suffering from long-standing COVID have experienced the same symptoms after vaccination as they did when they were ill with COVID-19 and are therefore reluctant to take their second or third booster dose.
What about booster doses?
The introduction of the vaccine pass obliges recovered people to be vaccinated even though the long-term effect of booster doses is still unknown and the benefits of vaccinating recovered people have not been studied. The lack of scientific basis has led Israel and other countries to suspend the 4th booster dose for all and reserve it for at-risk populations such as people with impaired immunity.
On December 22, 2021, Tedros Adhanom Ghebreyesus, the WHO Director-General, said during a press briefing in Geneva a few days before Christmas “No country will be able to get out of the pandemic with booster doses, and boosters are not a green light to celebrate as we had planned.”
For the WHO Director General, the Covid-19 vaccine booster campaigns were not a miracle solution, and might even accelerate the mutations of the virus. Indeed, as we have seen previously, vaccines are in no way intended to limit the transmission or spread of the virus.
The morbidity and mortality curve for COVID-19 shows an increase with age, particularly in the elderly. Since the vaccine has de facto risks and new treatments are coming on the market, it would be more judicious to limit the total number of people vaccinated by restricting vaccination to those at risk.
This is the choice made by Italy, which recently made vaccination mandatory for the elderly population.
A patient/physician dialogue
It is important to note that this choice to defer the vaccination of All has the virtue of improving the safety and efficacy of these multi-dose vaccines and of specifying by protocols the number of doses required for each age group. It is important to remember that the anti-COVID vaccines are conditionally marketed and that clinical trials to demonstrate their efficacy and safety are still underway.
Concerning the rest of the population, in the light of the development of personalized medicine (modern medicine announced as a priority area of investment in tomorrow’s health by President Macron [Innovation santé 2030 – Faire de la France la 1ère nation européenne innovante et souveraine en santé – June 29, 2021]), the choice of vaccination could be the result of a shared decision, resulting from exchanges between the patient and his or her doctor; as specifically provided for in the law of 4 March 2002 on patients’ rights and the quality of the health system, known as the “Kouchner law” [Patient and health professionals : Deciding together Concept, aids for patients and impact of shared medical decision – High Authority for Health – October 2013].
Moreover, pediatricians and general practitioners advise that they should be “the privileged interlocutors of families and children to offer information and exchanges in full transparency and to reach a shared medical decision in a context of uncertainty on several important points of the pandemic (diffusion of the omicron variant, duration of immunity…)” [INFOVAC France, communiqué maj of December 24, 2021].
Precautionary principle for children
Regarding children aged 5 to 11 years, pediatricians, represented by the learned societies of pediatrics, admit that data are still limited and that there are uncertainties [INFOVAC France, communiqué maj of December 24, 2021]. This report explains that their vaccination is not mandatory and that it is recommended in priority to children with chronic diseases at risk of severe forms of COVID19 or living in contact with immunocompromised persons (who do not respond effectively to vaccination).
It is unfortunate that the same precautionary principle is not applied to children/adolescents aged 12-18 years. Indeed, for this age group, the disease is also less serious than for adults and their vaccination does not prevent them from contracting it and transmitting it to their entourage. Similarly to adults without comorbidities, the benefit-risk balance of vaccination is not favorable.
Limited clinical data
One can only be surprised that the French National Authority for Health (HAS) justifies the approval of the use of the Pfizer Paxlovid pill by stating that it considered that there was no appropriate treatment in the indication “due to limited clinical data”, the evolution of the pandemic and the level of sensitivity of monoclonal antibodies to variants (even if we hear less about monoclonal antibodies, they are part of the strategies that can be used by physicians). The anti-COVID pill is indicated for the treatment of COVID-19 in adults who do not require oxygen therapy and are at high risk of progression to a severe form of the disease.
Is this not an admission that current treatments do not fully protect patients at high risk of progression to a severe form of the disease?
In its press release, the HAS acknowledges that the need for treatment for fragile patients “is not met”, “in the context of the predominance of the omicron variant and despite its lesser severity”. In other words, vaccination does not protect all at-risk patients from the severe form, even with a less pathogenic virus, Omicron!
Importantly, the current excess mortality due to Sars-CoV-2 is similar to that before 2020, before the epidemic. We are no longer in a health crisis situation if we take the mortality criterion.
The numbers in hospitals
As of January 21, 2022, French hospitals have 27,931 Covid-19 patients on their wards, including 3,842 in critical care (not intensive care). In critical care, we have 20,000 beds. If we take the criterion of “number of patients in critical care”, we cannot say that we are still in a health crisis situation.
In the current situation of the epidemic, where the mortality rate of COVID is 0.1%, the median age of the people who die is 85 years (i.e. 50% of the people who die are over 85 years old!) and the life expectancy in France is 82 years old, there is therefore no scientific argument that can justify this vaccination obligation for All.
Especially since the people at risk, the unvaccinated over 85 years old, are not the ones who go to restaurants in large numbers; the vaccine pass should not help to convince them to be vaccinated.
However, to rely on a collaborative and proximity work between different health professionals would have made it possible to reach these populations at risk.
Obesity, regardless of age, is also a co-morbidity to be taken into account. Today, this at-risk population is not privileged at all, whereas a prevention campaign targeting it would have been beneficial.
Tests or oximeters ?
Finally, desaturation, the lack of oxygen in the blood, is a worrying symptom that is easily detected by a simple oximeter. With an Omicron virus that is not very dangerous, making an oximeter available would be more judicious than continuing to rely on costly and useless PCR/antigenic tests, as they only serve to detect the virus in people known as “contact cases”, very often asymptomatic patients or those with mild symptoms.
In the end, all of these scientific arguments are in favor of personalized care, giving priority to the protection of people at risk in each age group. For the latter, an additional booster dose can be offered.
However, the introduction of a vaccination pass has no scientific basis and cannot be seen as a measure intended to guarantee “health protection for all” as provided for in the eleventh paragraph of the preamble to the 1946 Constitution.
Ironically, the vaccine pass is activated for people who have received the first dose and is deactivated for those who have already had two doses and without the 3rd booster dose. A lack of understanding of the measures taken that lead a good number of citizens to adopt risky behaviors, preferring to be contaminated by the virus to a vaccination.
Infantilization and injustice
Whether from a scientific or legal point of view [Contribution transmitted to the President of the Constitutional Council by the Cercle Droit et liberté, an association of students and legal professionals], the vaccine pass, implemented at the same time as the lightening of certain sanitary measures, is in the end nothing more than a sleight of hand by the government to hide a lack of response to the lack of means at the hospital and to avoid losing face when considering the number of doses of vaccine ordered.
- In spite of the infantilization, even to the point of insult,
- In spite of the injustice of such liberticidal measures, which harm the mental health and the socio-professional balance of a good number of citizens,
- In spite of the failure of our institutions and counter-powers to ensure the respect of our rights and liberties by validating the principle of the vaccine pass without really respecting the principle of the contradictory, thus blithely flouting our constitution,
- Many citizens refuse this smoke and mirrors and are impatiently waiting for the position of the presidential candidates on this crisis: diagnosis, lessons they draw from it and proposals to guarantee us in the future a protection of our rights and liberties.
*Héla Saïdi, President of France Démocrate
Doctor in Immunology, Scientific Expert