A serious accusation of WHO transparency and the handling of the Covid 19 case in relation to the reports of the Chinese government, was launched by the President of the United States Donald Trump who a few days ago announced the interruption of funding to the most powerful health body in the world (1).
Before Trump, there had already been an investigation of Senator Rick Scott (2), allegations by the Japanese deputy minister who calls the WHO "Chinese health organization" (5), the positions of Taiwan that first launched the unheard alarm (6), of the UK government that is reviewing relations with China and of numerous newspapers around the world among which Swedish ones stand out for determination with explicit accusations to Beijing for having supported lies and sidings that have contributed to the spread of the virus. (2)
Now comes the CNN complaint (3) according to which China censures the publication of a research on the origins of coronavirus and makes it disappear from the web and at the same time security protocols regarding studies on coronavirus and their diffusion are tightened .
On the other hand, the Chinese Communist Party, which isn’t transparent nor democrat, immediately hid what was happening in Wuhan by censoring and imprisoning the doctors and journalists who sounded the alarms, denying for days the human-to-human transmissibility and generating ambiguity on the first samples of the viral genome. (3)
Beijing officially released the alarm only on January 23, although there are reports that the first cases have been identified as early as November 7, 2019. (2)
Many are the rumors and doubts about the reliability of the real numbers of infections and deaths in China.
All this with the political coverage of the WHO and its general manager Tedros Ghebreyesus, whom after every step guaranteed the transparency and effectiveness of every choice and action of the Chinese government (2), making it a global model at the expense of others health approaches that have brought to even more immediate and convincing results (South Korea, Japan, Honk Kong, Taiwan). (6)
But how could the WHO have done otherwise since the Wuhan institute of virology, previously accused by the scientific community of jeopardizing public health with Gain of Function research (the "engineering" of the viruses genome present in animals in nature, with some different virus genes, in an attempt to predict future mutations and understand if they could lead to species jumps from animal to man), is an international collaboration with researchers from all over the world and under the auspices of the same WHO, funded mainly by multinational drug companies interested in these types of "creative" research? (7, 25)
As for the spread of genomic data of the SARS-CoV-2 virus, we know that the first five genomes were isolated in Wuhan on January and reported by the Chinese center for disease control and prevention (CCDC) at a short distance from the laboratories mentioned above.
• As of January 30, the number of genomes had reached 42.
• By March 4, there were 249, up to March 27 with 1,495 genomes sampled on six continents and dozens of mutations compared to a common ancestor. (8)
Given the poorly constructive premises with respect to the transparency of the Beijing government and the cover game that WHO has been carrying out since the early stages of the story, we propose some questions to the readers and at the same time to the institutions and the scientific community:
1) - How reliable are the original genomic sequences from Chinese laboratories?
- Why to date there is no transparency on the method of isolation and implementation of the sequencing provided by the Chinese government and not even on the same process carried out by the Spallanzani laboratories in Rome and by the Sacco labs in Milan?
- If the swabs were performed immediately taking as reference part of the original sequences, how did the mutations that occurred subsequently over time and in different places of propagation influence epidemiological data and health choices?
2) To date, the debate about the acquisition of immunity to SARS-CoV-2 is still underway, so much so that both the ISS and the clinical microbiologists association (among others) advise against serological research as an appropriate method and surveillance for multiple reasons, including cross reactions with other coronaviruses, responsible for widespread and benign pathologies, such as to determine falsely positive results (a problem widely attributed also to nasal-pharynx swabs) and the temporal indeterminacy for the appearance of IgM and IgG. (9)
Another aspect, far from negligible, derives from the experience acquired with other coronaviruses, among which SARS (severe acute respiratory syndrome) which showed specific IgG up to two years, resulting negative on the third year and therefore susceptible to the possibility of a new infection of the subject in the presence of the pathogen, a common characteristic for the whole coronavirus family including the common cold. (9)
Despite this, dozens of pharmaceutical companies are producing vaccines against SARS-CoV-2 starting from a sequencing with a history that is not exactly transparent and in continuous genetic evolution.
What guarantees do we have these vaccines will be effective at the time of use, when there is no certainty about a stable immunnization nor the virus’ stabilization?
How are the vaccines developers evaluating hundreds of patients (91 just in South Corea) that, after developing the pathology and being tested negative, are coming back positive again? (11)
3) One of the major risks that would unavoidably require the animal testing phase for the vaccine manufacture, is known as ADE (Antibody-Dependent Enhancement), that happens when the vaccine produced antibodies facilitate the virus entry into host cells, leading to increased infectivity when the organism encouters the wild virus. (12)
When the scientists have exposed the vaccinated animals to the wild virus, results have been , to put it mildly, terrifying. Animals have shown severe hyper-immune responses, included generalized inflamation ending with deadly lung infections.
The biggest problem is that any new vaccine against coronavirus could trigger fatal immune reactions when the vaccinated people come into contact with the wild virus!
Prof. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, for example, worked on developing a vaccine for SARS and witnessed these severe reactions.
“There is a risk of immune enhancement,” said Hotez. “The way you reduce that risk is first you show it does not occur in laboratory animals.”
For this reason too there is no vaccine for any of the new coronaviruses that have caused outbreaks in the past 20 years. (4)
How is it lawful that in mid February, during a WHO extraordinary and little known meeting, scientists representing government funded research organisations and manufacturers all over the globe came to agree that the threat was so serious to fast track the vaccine moving straight into human tests without waiting for the completion and the release of animal tests results? (4, 27)
We join with Senator Robert Kennedy Jr.'s accusation to Anthony Fauci, immunologist and current leader of the Us Emergency Task Force - the United States are the country which is highly engaged in the development of the coronavirus vaccine:
"He chose the fast-track approval process for the new vaccine. But bypassing animal testing could lead to a DISASTER. He also called for a guaranteed immunity procedure, which gives immunity from liability to the manufacturers of the COVID-19 vaccine when it causes damage. Thanks to this procedure, the pharmaceutical industry will not be interested in producing a SAFE vaccine." (13)
4) In this unwise race for the "salvation vaccine", it is necessary to make some remarks that should be agreed by the civil society and firmly submitted to political and health institutions:
a) The large family of coronaviridae, which has been known for a long time, can cause serious diseases to animals as well, including livestock. Despite decades of studies, no specific vaccine is administered to either farm or domestic animals, simply because they do not work, given the rapidity with which this viral family mutates (such capability was already noted in the viral strains that attacked human beings in the past, including SARS in 2002 and MERS in 2012, along with common colds. To date, there is no valid vaccine against any of these diseases). (14, 15)
A 2015 study (27) on the implementation of a chimeric virus against SARS-Cov1 and the subsequent in vivo testing on mice, reported that "both approaches with monoclonal antibodies and vaccines, failed to neutralize and protect against Cov infection by using the new spike protein". And even more: "the vaccine failed to protect older animals in which an autoimmune enhancement phenomenon was also observed, thus indicating the possibility that animals could be harmed by the vaccination".
How can the scientific community and in particular the developers of the SARS-CoV-2 vaccine be so convinced that this time it will be different from the SARS-Cov-1 vaccine, so much to skip fundamental research phases such as the pre-clinical animal testing?
(b) Why is the funding and the energy of researchers focused on developing a vaccine when we do not yet know the immunopathological process of the virus? (9)
c) Why do not they focus on finding a reliable antibody test capable of determining how many individuals have developed an innate immunity, thus reducing the number of people who may need the vaccine?
What if the antibody tests that are currently studied are not reliable for the detection of Covid-19?
The doubt comes from the fact that these tests do not distinguish between autoimmune and protective antibodies, given that patients with autoimmune diseases are positive in this kind of tests. (10)
d) Will we be able to distinguish the innate immunity from the adaptive immunity in order to develop the immunotherapy that has produced promising results for other coronaviruses? (16)
e) What guarantees do we currently have, for the vaccine under development and test in the next months to be effective in the event of a new wave of SARS-CoV-2, as often happens with the seasonal influenza vaccination, with mutated viral characteristics? (17)
f) Pending further explanation concerning the causes of the exceptional epidemic in the provinces of Bergamo and Brescia, where an extraordinary anti-influenza and anti-meningococcus vaccination campaign took place last autumn (18) and in the light of the announcement from Lazio region to mandate the anti-influenza vaccine for people over 65 and some categories of workers including health care professionals (19), how are the scientific studies on viral interference , namely the ability to resist the infection from a different virus, taken into account?
In one of these studies (20, 21) researchers say:
“While influenza vaccination offers protection against influenza, natural influenza infection may reduce the risk of non-influenza respiratory viruses by providing temporary, non-specific immunity against these viruses. On the other hand, recently published studies have described the phenomenon of vaccine-associated virus interference; that is, vaccinated individuals may be at increased risk for other respiratory viruses because they do not receive the non-specific immunity associated with natural infection.”
The study determines an increased risk, up to 36%, for people who received the anti-influenza vaccination to contract strains of coronavidae family virus.
g) Antigens from the viral genome of SARS-CoV cross react with more than 60 human auto-antibodies! If this applies (as would be expected) to SARS-CoV-2, could this phenomenon determin auto-immune events, as vaccination can trigger the antibody response also for these proteins that are in our organism? (29)
5) We know there are tens of private and public laboratories all over the world working at developing the anti SARS-CoV-2 vaccine. We’d like to give the example (22) of one vaccine that would be possibly distributed in Europe, and analize in depth the trial phase, highlighting the critical issues we consider more evident, however due to space limitations we will be able to discuss only some of them:
The Clinical Biomanufacturing Facility of Oxford University has drafted the new vaccine, named ChAdOx1 nCoV-19, based on an adenoviral vector which is a weakened version of a common cold virus from chimpanzees, as a carrier to the SARS-CoV-2 spike protein obtained from the first sequencing released by the Chinese government on January the 12th, 2020. It will be produced by Advent-Irbm in Pomezia and tested on over 500 volunteers recruited in the United Kingdom since April.
In the human trial information sheet (28) we read:
“this vaccine has only been tested on laboratory mice and other animal species and this is the first time that the vaccine will be given to humans”.
However neither the timeframe nor the results are defined for this trial, so it seems critical to us, given the very short time, in order to at least exclude the risk of ADE (12) we have already referred to.
“Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date, and have been shown to be safe and well tolerated, although they can cause temporary side effects”
Mentioning 320 people clearly refers to a clinical study “phase I” on selected healthy volunteers, therefore safety and tolerance relate to that first phase!
“Due to the urgent need for a vaccine against COVID-19, with agreement from the MHRA, some of the tests usually required for a newly manufactured vaccine have been modified,in order to make the vaccine available more quickly for assessment in this clinical trial. It is not anticipated that this will have an impact on the safety of the vaccine”.
…Now there’s nothing to worry about!
‘The Oxford team had exceptional experience of a rapid vaccine response, such as to the Ebola outbreak in West Africa in 2014... Professor Gilbert and team have previously developed a vaccine for another human coronavirus disease, which is Middle East Respiratory Syndrome (MERS), and this has shown promise in early clinical trials. Professor Gilbert, lead researcher of the vaccine development programme, said, ‘Since the Ebola outbreak in West Africa in 2014, my research team has been working on new approaches to vaccine development to protect the population of the world against an outbreak of infectious disease or a pandemic. We are now working with a much larger team to bring these plans to fruition.”
A number of negative experiences for the result of a vaccine stable and effective, sold as guarantee of success in the current emergency?
Finally , going into detail of human test:
“The trial, a collaboration between the University’s Jenner Institute and Oxford Vaccine Group clinical teams, will recruit up to 510 volunteers, who will receive either the ChAdOx1 nCoV-19 vaccine or a control injection for comparison.”
What is a control injection?:
“In this study we will be using a licensed vaccine against group A, C, W and Y meningococcus (MenACWY) as an ‘active control’ vaccine, to help us understand participants’ response to ChAdOx1 nCoV-19. MenACWY has been given routinely to teenagers in the UK since 2015, and protects against one of the most common causes of meningitis and sepsis. This vaccine is also given as a travel vaccine for high risk countries. We will be using one of the two licensed versions of MenACWY, either Nimenrix or Menveo. [...] It is likely that you will experience some symptoms at the vaccination site as well as general symptoms due to vaccination. It is important to remember these are vaccines in the early stage of development and the amount of safety data available are limited. For this reason, there is a chance you could experience a side effect that is more severe than what is described below, or that has not been seen before. […] Given we don’t expect MenACWY to offer any protection against COVID-19, by comparing COVID-19 disease rates, immune responses and post-vaccination symptoms between participants receiving ChAdOx1 nCoV-19 and MenACWY we will get a better understanding of how well ChAdOx1 nCoV-19 is working."
In other words they will compare ChAdOx1 nCoV-19 vaccinated people to an anti-meningococcus vaccinated cohort, not to assess the new product potential adverse reactions but to verify if it will produce the virus immunity compared to MenACWY vaccinated people (?).
Everything with only a 7 day active pharmacovigilance, followed by a 3 week passive pharmacovigilance.
In a very recent interview, prof. Gilbert, staff responsible, said that the study will begin in 2 weeks and the vaccine could be ready in September, admitting that the timing will be further cut down against the scheduled route already at a low-standard like never before to guarantee safety and effectiveness (24) as later confirmed by Pietro Di Lorenzo, CEO and chairman of Irbm . (23)
The following information is derived from the characteristics of the Nimenrix MenACWY vaccine declared by the manufacturer and confirming our doubts about using such a product as a placebo:
Syncope (fainting) may occur after, or even before, any vaccination, especially in adolescents as a psychogenic response to needle injection. It may be accompanied by several neurological signs such as transient visual disturbances, paresthesia and tonic-clonic movements of limbs during the recovery phase. It is important to establish appropriate procedures in order to prevent injury as a result of fainting.
Thrombocytopenia and clotting disorders
Nimenrix should be administered with caution to patients with thrombocytopenia or any clotting disorder because bleeding may occur after intramuscular administration.
It can be expected that patients receiving immunosuppressive treatment or patients with immunodeficiency, could not have an adequate induced immune response.
Subjects with hereditary complement deficiency (for example, C5 or C3 deficiencies) and people receiving treatments that inhibit terminal complement activation (for example, eculizumab) have an increased risk of invasive disease caused by Neisseria Meningitidis serogroup A, C, W-135 and Y, even if they develop antibodies after vaccination with Nimenrix.
The good news (luckily we preserve our sense of humor) is that these "safety standards" are common to all manufacturers involved in the research of the SARS-CoV-2 vaccine and supported by the WHO, which relies on about 80% of voluntary contributions, mainly from pharmaceutical industries. (25)
What if such an urgency result in an underestimation of the risks and zero liability of producers, as reported by Senator Robert Kennedy Jr.?
By chance, on March 31 the University of Oxford (26) published an article in which the authors claimed the need of jeopardizing the volunteers for these experiments by skipping the entire phases of control, to prevent the potential loss of up to 20 million lives caused by the current pandemic, as predicted during the event organized by the Bill and Melinda Gates Foundation on October 10, 2018 in New York.
We suggest you to carefully read the entire document, even if it shocks you as it shocked us. Here is a sample of the text, that we chose as a conclusion of our article:
"Controlled challenge clinical trials on human beings with SARS-CoV-2 vaccines could accelerate testing and potential production of effective vaccines. By replacing conventional phase 3 tests on vaccine candidates, such studies could save several months’ time for the licensing process, and effective vaccines could be available more quickly. Obviously, testing volunteers with this live virus could cause serious disease and even death. However, in our opinion such studies, by accelerating the assessment of the vaccine, could reduce the overall burden of coronavirus-related mortality and morbidity. Volunteers of such studies could authorize the risks to themselves and their net risk could be acceptable if they are healthy young adults with a relatively low risk of serious illness caused by natural infection, if they have a high baseline risk of natural infection, if they undergo frequent monitoring and, in case of any infection, they receive the best available care during the study".
Good luck to us all.
(translation by Staff traduzione Cliva)
IInteresting note added by authors on March 30, 2020:
“We understand that this article will be used as the basis for unverified theories that the new coronavirus that causes COVID-19 was designed in the laboratory. There is no clear evidence that this is true; scientists believe that an animal is the most likely source of coronavirus."
We understand that there is no evidence to the contrary, given that both the authors of this study and of the subsequent specific studies speak of "probability" for animal-human diffusion.
Excusatio non petita…?
• SíAmo Movement Health Commission
• Doctor Dario Miedico: Doctor and surgeon, specialized in Occupational Medicine, Hydrology, Climatology, Thalassotherapy, Hygiene and Epidemiology, Legal and Insurance Medicine. Vice-President SìAmo.
• Doctor Loretta Bolgan, graduated in Pharmaceutical Chemistry and Technology, PhD in Pharmaceutical Sciences.
• Stefano Scoglio, PhD, BSc, obtained his doctorate in Canada and the second degree in biomedical sciences in the UK, researcher, major expert in Klamath algae of which he holds 6 patents relating to their use, candidate for the Nobel Prize in Medicine and Physiology in 2018.
• Davide Suraci, professor of Biotechnology
• Doctor Diego Tomassone, surgeon, clinical nutritionist, specialist in Hahnemannian Homeopathy, master in complex pediatric diseases, master in PNEI, graduating student in physics and bioengineering.