ISOP ISRAEL - The Israeli Chapter of the International Society of Pharmacovigilance

Why is six feet away the right distance? (00001)

The coronavirus spreads primarily through droplets from your mouth and nose, especially when you cough or sneeze. Six feet has never been a magic number that guarantees complete protection. The C.D.C., one of the organizations using that measure, bases its recommendation on the idea that most large droplets that people expel when they cough or sneeze will fall to the ground within six feet. But some scientists have looked at studies of air flow and are concerned about smaller particles called aerosols. They suggest that people consider a number of factors, including their own vulnerability and whether they are outdoors or in an enclosed room, when deciding whether six feet is enough distance. Sneezes, for instance, can launch droplets a lot farther than six feet, according to a recent study. It's a rule of thumb: You should be safest standing six feet apart outside, especially when it's windy. But keep a mask on at all times, even when you think you’re far enough apart. Ref :
New York Times : Answers to Your Current Coronavirus Questions
Jamanetwork : Turbulent Gas Clouds and Respiratory Pathogen Emissions

Covid 19  and Pregnancy/fertility: What is currently known - Data extracted from Pfizer/BioNtech and Moderna Covid19 vaccine trials

Questions have been recently raised related to the fertility of women receiving the Covid-19 Vaccine. While some studies have attempted to address the issue of reproductive impact of patients with Covid-19 (biological and psychobehavioral)[1], we present below what is known to date...
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What is the efficacy of mRNA vaccines?

All following results on efficacy in the clinical trials have been obtained in the same level, in all groups, ethnicities, and genders. Moderna vaccine

• Moderna vaccine efficacy was tested on 30,000-person.
  Only 11 who received the vaccine developed symptoms after being infected vs. 185 in a placebo group. That is an efficacy of 94.1%!
• Moderna’s vaccine showed 100% efficacy against severe forms of the disease:
  0 such cases among those vaccinated vs. 30 in the placebo group, inc. 1 death from the disease.

Is there any other possible solution than vaccination?

• What about medication?
  As for today, some treatments and medication help in assisting COVID patients but none of them has proven full efficacy in treating patients with severe symptoms and preventing complications or death. It is therefore crucial to stop the pandemic.
  But, as for today, no treatment has been proven effective to prevent the infection.
  
• What about vaccines?
  Clinical trials of the vaccines showed vaccinated persons were protected from getting Covid with a very high efficacy (up to 95% with the Pfizer-BioNtech and Moderna vaccines) Therefore, the vaccine is the most advanced way to end the pandemic.
  
• What about the wearing of mask on mouth and nose and social distanciation*?
  Those measures help reduce our risks of being exposed to the virus or spreading it to others, But, only associated to COVID vaccination, will those measures offer the best protection from COVID,

Why are scientists not unanimous (00004)

It is the nature of science to make hypotheses and try to verify them.
“A theory that is not refutable by any conceivable event is non-scientific. Irrefutability is not a virtue of a theory (as people often think) but a vice. (...) The criterion of the scientific status of a theory lies in its falsifiability, or refutability, or testability.“ (Karl Popper)


In physics, for instance, a theory is valid as long as the results of the equations fit with the results of the experiments.
In vaccine science, a vaccine is considered legitimate if it is safe and effective. It is scientifically correct to evaluate Covid vaccines according to these criteria and then to discuss the sample size and the monitoring time allowing to include these vaccines in the therapeutic arsenal.
It is therefore normal and even recommended that scientists "argue". But it is dangerous for them to do so publicly because their field of expertise involves complex notions and a specific language that only them are able to understand. Putting up contradictory arguments is legitimate, but making it publicly invalidates public confidence.
A physician or scientist should not use social networks to express theories in conflict with Public Health decisions, especially during a global pandemic. By doing so, he or she is participating in what he or she denounces.

Is Covid-19 less dangerous than the mRNA vaccine used against it? (00005)

To this day, almost everyone knows someone who had a serious form of Covid-19 that is requiring hospitalization or even resuscitation, and many families have lost one or more loved ones. In addition, doctors have warned of the risk of collapse of the Healthcare system. In 2020, ethics and the need for care for the population do not allow us to consider this pandemic as benign. Regulatory agencies, FDA, EMA and MHRA and more agencies, have analyzed the vaccine development in real time and in an extremely rigorous manner. Efficacy results have been exceptional since the FDA required 60% efficacy and the new vaccines have demonstrated 95% efficacy with short-term safety comparable to other existing vaccines. This is a first of its kind in medicine. Of course, there are still unknowns about the long-term effects on efficacy and safety. Experts in all fields, including immunologists, hematologists and geneticists, have made the decision to give authorization to use these vaccines, weighing the benefits and the risks of the vaccine against the risk of the disease and emphasizing very close monitoring of the vaccinated individuals.

How can we assess if the occurrence of an autoimmune disease is linked to a vaccine? (00006)

The WHO Advisory Committee on Vaccine Safety has established criteria to allow an objective definition of possible associations between vaccination and adverse events. They also apply to autoimmune disorders. The assessment of autoimmune events must be accurate, based on rigorous analytical methods and sufficient data. The occurrence of an adverse event shortly after vaccination may be purely coincidental but should be investigated very thoroughly. Such adverse events should only be considered as side effects if a significant association is demonstrated in well-conducted epidemiological studies in different populations to test hypotheses which have been put forward on the basis of isolated cases. There are only two autoimmune diseases where the association with vaccines has been proven and which occur very rarely:
This is the case of Guillain-Barré syndrome (neuropathy) which is a known complication of influenza infection but occurs exceptionally after influenza vaccination. It is also the case of Idiopathic Thrombocytopenic Purpura (low blood platelets) which can be a fairly frequent complication of measles and rubella but rarely occurs after measles-mumps-rubella (MMR) Theories have circulated and are still circulating about the long-term effects of vaccines, particularly the hepatitis B or measles vaccines. All of these claims have been disproved by numerous studies. On the other hand, during the measles epidemics that broke out, serious complications and deaths were observed in children following these anti-vaccine campaigns. This is unacceptable because these tragedies could have been prevented by vaccination. Vaccination is one of the major advances of our century, preventing 2.5 million deaths worldwide every year. It has eradicated deadly and crippling diseases such as polio and smallpox. These are verifiable facts against which never-validated hypotheses have been opposed and which seriously hinder the eradication of diseases and epidemics.

Is the muscle cell transfected with the S-antigen producing mRNA endangered? (00008)

This muscle cell is not infected by a virus and therefore has no immunological reason to alert killer cells of the so-called cell-mediated immune response. It is also not a cancer cell against which immunotherapy, a somewhat different field than mRNA vaccination, would be initiated. The synthesized antibodies are not directed against a cell, which would make no sense, but against the antigenic protein S, which will only be able to alert the immune system once it has left the muscle cell. To know more see the article : about vaccines and autoimmune disease : here

Is mRNA vaccine a vaccine, or gene therapy ? (00012)

Vaccination with mRNA has nothing to do with gene therapy. Gene therapy introduces genetic material in order to correct or replace a defective gene, as a treatment of genetic disease or cancer. Pfizer vaccine mRNA enables cells to temporarily express the spike protein at their surface. It does not enter the nucleus. This limited exposure of the antigen is sufficient to trigger the immune response, without interference with cellular gene structure or function. This vaccine confers immunity by means of a single protein. It does not introduce an infectious agent, even inactivated, into the cells. This new technology therefore has definite advantages in terms of specificity and safety. Menahem Brégégère, PhD, Molecular biology & genetics
Irène Fermont, MD, Pharmacovigilance SHOW MORE

What are the mRNA vaccine site effects? (00013)

Minor to moderate secondary effects may occur after vaccination as they may occur after any vaccination; those side effects are a sign that the immune system is building up protection to the disease. They may affect your ability to do daily activities, but should resolve within a few days. The regulatory authorities in most countries have set up extensive monitoring of the vaccinated people and track continuously the eventual occurrence of rare unexpected events with COVID vaccines. READ MORE

Who should get or not get the COVID-19 vaccine ? (00014)

Most people are able to get the COVID-19 vaccine. But, a few groups of people should not get the vaccine, some should not get the vaccine for the time being and others should consult with their doctor and eventually follow special procedures.
Click to read the WHO document

THEORY The vaccines could cause illnesses. (00009)

FALSE

• No data suggests that vaccines could cause severe diseases. The vaccinated participants in the vaccine trials do not show a higher rate of severe illness compared to unvaccinated participants.
  
• The mRNA vaccines do not contain or induce the production of any pathogen substance; they do not contain any virus or any part of it and have been synthesized in laboratories or in manufacturing facilities where the virus has never been introduced.
  
• Post vaccinal follow-up is carefully monitored in order to detect the eventual occurrence of any uncommon side effect.

THEORY There are unwanted components in the vaccine (00009)

FALSE None of these unwanted components are present in the mRNA vaccines such as live viruses, inactivated viruses, gluten, egg proteins, pork products, foetal material, blood product, DNA, antibiotics, preservatives like thimerosal, adjuvants. The approval of the vaccines by Regulatory Health agencies like the FDA, the EMA etc. warrant their composition. __________________________ Sources: WHO:
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines Health Feedback independent Professors:No evidence that COVID-19 vaccines cause more severe disease; antibody-dependent enhancement has not been observed in clinical trials
https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/ Finnish Government:Vaccines and coronavirus
https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/transmission-and-protection-coronavirus/vaccines-and-coronavirus Hospital of Philadelphia:Questions and Answers about COVID-19 Vaccines
https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid?utm_source=prevent-covid&utm_medium=redirect&utm_campaign=VECCOVID

There is a connection between the 5G networks, the pandemics and the vaccines. (00009)

FALSE

• There is absolutely no way that 5G mobile phone signals could either transmit the virus or reduce our defences to it.
  Viruses cannot travel on radio waves/mobile networks. In fact, COVID is spreading in many countries that do not have 5G.
  
• There is absolutely no connection between 5G networks and vaccines. Vaccines can’t be “activated “by 5G to harm people.

Vaccines contain microchips that can track people (00009)

FALSE
The approval of the vaccines by Regulatory Health agencies like the FDA, the EMA etc. warrant their composition. _________________________ Sources: WHO:
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines Health Feedback independent Professors:No evidence that COVID-19 vaccines cause more severe disease; antibody-dependent enhancement has not been observed in clinical trials
https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/ Finnish Government:Vaccines and coronavirus
https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/transmission-and-protection-coronavirus/vaccines-and-coronavirus Hospital of Philadelphia:Questions and Answers about COVID-19 Vaccines
https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid?utm_source=prevent-covid&utm_medium=redirect&utm_campaign=VECCOVID

mRNA vaccines use a new technology and there has been no animal or clinical experimentation to test it. (00008)

FALSE Research on mRNA vaccines began in the 1990s. Over the last ten years or so, numerous animal and human trials have been carried out, particularly during epidemics of two coronaviruses, SARS-CoV (2002-2003) and MERS-CoV (2012). A large amount of data has been collected and these data demonstrated the safety and efficacy of these mRNA vaccines. TO KNOW MORE

The mRNA vaccine is a technology that has never been used in humans. (00008)

FALSE
In a review published in the journal Nature in April 2018 [1], numerous clinical trials, completed or in progress, using mRNA technology were already listed (10 trials in the framework of vaccine studies and more than fifty for the treatment of certain cancers).

In addition, studies of the mRNA-based COVID vaccine have enrolled more than 70,000 volunteers [2,3].
For the Pfizer-BioNTech vaccine alone, 43,734 volunteers were enrolled in the clinical trials: 21,937 received the vaccine and 21,797 received a placebo, providing sufficient data for Health Authorities to assess the vaccine's efficacy and safety and, following a rigorous review, to grant an Emergency Use Authorisation. ______________________________ Ref: 1-Pardi N, Hogan MJ, Porter FW, Weissman D. mRNA vaccines – a new era in vaccinology. Nat Rev Drug Discov. 2018 Apr;17(4):261-279. doi: 10.1038/nrd.2017.243. Epub 2018 Jan 12. PMID: 29326426; PMCID: PMC5906799 2-Vaccines and Related Biological Products Advisory Committee Meeting, 2-2- December 10, 2020 FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine
cf.: https://www.fda.gov/media/144245/download 3- Vaccines and Related Biological Products Advisory Committee Meeting, December 17, 2020, FDA Briefing Document Moderna COVID-19 Vaccine
cf.: https://www.fda.gov/media/144434/download

mRNA vaccines present additional potential risks (00008)

FALSE The only adverse events that occurred in the volunteers tested in the study were minor and transient effects that are usually observed with other vaccinations [1,2]. Let's clarify the terms: “Potential risk” is when an adverse reaction has occurred in animal studies BUT not in human clinical trials, or when an adverse reaction is known to be induced by a medicinal product of the same therapeutic class than the study product, BUT has not been observed in the study product (EMA, 2012 Good Pharmacovigilance Practices Annex I). A single potential risk has been identified in the Pfizer-BioNTech vaccine file: namely, an exacerbation of the disease within a very short period of time after injection. This phenomenon has been observed after the administration of other vaccines BUT has never been observed in clinical trials of COVID vaccines. Post-vaccine surveillance will, of course, monitor this potential risk very carefully. To say that mRNA vaccines pose additional potential risks (without even, defining their nature) is therefore false affirmation. These unspecified potential risks are unsubstantiated assumptions that are not supported by any information in the vaccine's license application from the U.S. FDA and European health authorities (EMA and MHRA). To know more… These hypothetical risks, not observed to date in animal or human studies, must be weighed against the verified facts:

• On the one hand, the identified, known and high risk of contamination by COVID 19, i.e. a virus responsible for 1.76 million deaths in 2020 (more than 3,527 deaths as of January 6, 2021 in Israel).

Older people were not included in the clinical trials (00008)

FALSE

• In the Pfizer-BioNTech vaccine trial mentioned in the FDA Briefing, it is stated that: 1712 patients over 75 years of age were included in the clinical trials, i.e. 4.3% of the total number (Table 4, p. 20) and that none of them subsequently contracted COVID 19 versus 5 in the placebo group (Table 9, p. 28). In addition, the Moderna group published similar results by including 1299 people over 75 years of age among its volunteers.

Mass vaccination is being carried out with experimental vaccines (00008)

• Pfizer-BioNTech and Moderna vaccines can no longer be qualified as "experimental" vaccines at this stage. They now hold an Emergency Use Authorization granted by Health Agencies after a rigorous review of basic research data, animal studies results, and clinical trials Phase 1, 2, and 3 results,involving a very large number of volunteers.

Pfizer and Moderna vaccines contain lipid nanoparticles. Do they present risks?

The liposomes in which the messenger RNA is enclosed are well tolerated by the body and used in 30% of tablet drugs, shampoos and toothpastes etc..... This is Polyethylene Glycol which is very widespread*. TO KNOW MORE Ref: * BJA. Allergic reactions to the first COVID-19 vaccine: is polyethylene glycol (PEG) the culprit?