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All our answers are based on validated references from Vaccine Safety Net,

Regulatory agencies, FDA, EMA. MHRA, WHO, Israeli Ministry of Health and scientific literature 

COVID VACCINE - QUESTIONS & ANSWERS

FAKE NEWS

THEORY 1-  The vaccines could cause illnesses.


Vaccine Safety Net Resources Author: Task Force Vaccine Published: 20/01/2021 Ref: 0016 EN 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.
_______________________ 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




THEORY 2-  There are unwanted components in the vaccine


Vaccine Safety Net Resources Author: Task Force Vaccine Published: 20/01/2021 Ref: 0013 EN 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




THEORY 3-  There is a connection between the 5G networks, the pandemics and the vaccines.


Vaccine Safety Net Resources Author: Task Force Vaccine ​​​​​​​Published: 20/01/2021 Ref: 0014 EN 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.
________________________ 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




THEORY 4- Vaccines contain microchips that can track people


Vaccine Safety Net Resources Author: Task Force Vaccine Published: 20/01/2021 Ref: 0015 EN 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




THEORY 5- mRNA vaccines use a new technology and there has been no animal or clinical experimentation to test it.


Vaccine Safety Net Resources Author: Task Force Vaccine Published: 21/01/2021 Ref: 0018 EN 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




THEORY 6- The mRNA vaccine is a technology that has never been used in humans. (00008)


Author: Task Force Vaccine Published: 20/01/2021 Ref : 0019 EN 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. ______________________________ Sources: 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




THEORY 7- mRNA vaccines present additional potential risks.


Vaccine Safety Net Resources Author: Task Force Vaccine Published: 21/01/2021 Ref: 0020 EN 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).
  • On the other hand, the efficacy and safety of the COVID vaccines that have been granted an emergency authorization by experts from Health Agencies (including those from the Food & Drug Administration, the European Medicines Agency, etc.) after an extremely rigorous analysis of the benefit/risk ratio. In addition, the efficacy and safety of these vaccines continue to be monitored by a close post-vaccination surveillance.
_Sources:______________________________________________ 1-FDA, Pfizer-BioNTech COVID-19 Vaccine,
cf.: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine 2-FDA, Moderna COVID-19 Vaccine, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine 3-European Medicines Agency, Guideline on good pharmacovigilance practices (GVP) Annex I – Definitions (Rev 4)
cf.: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-annex-i-definitions-rev-4_en.pdf




THEORY 8- Older people were not included in the clinical trials.


Vaccine Safety Net Resources Author: Task Force Vaccine Published: 18/01/2021 Ref: 0021 EN 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.
  • Although these figures are not sufficient to certify the efficacy of the vaccine on the elderly, they are encouraging and consistent with the results observed in the lower age categories [1]. It is, moreover, important to note the similarity of the results of the two clinical trials in this age category [2].
  • Even if the immune response were short, which is not proven, these vaccines could, if used quickly, save hundreds of thousands of lives before the end of the COVID 19 epidemic.
____________________ References: Vaccines and Related Biological Products Advisory Committee Meeting, December 10, 2020 FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine
cf.: https://www.fda.gov/media/144245/download 2-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




THEORY 9- Mass vaccination is being carried out with experimental vaccines


Vaccine Safety Net Resources Author: Task Force Vaccine Published: 19/01/2021 Ref: 0022 EN

  • 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.
  • There is an international consensus, adopted by a large number of countries and published on the WHO and National Health Authority websites, concerning the vaccination policy to be implemented: this consists of giving priority to those most at risk of contracting a serious form of COVID and to those most exposed to contamination. This is indeed what is done, at least in Western countries.
To know more… It is essential to remind that vaccination campaigns do not aim to immediately vaccinate the entire population (mass vaccination) but proceed with caution; the vaccination program will proceed as follows:
  • Giving priority to people at risk (elderly and/or suffering from co-morbidities, healthcare personnel, essential workers, etc.).
  • Waiting to vaccinate people whose profile has not been represented in clinical trials (children under 16 years of age, for example) and to do so only if the results of additional studies allow it.
  • And, of course, not to vaccinate people for whom vaccination is contraindicated (immunosuppressed for example) or not recommended.
Finally, pharmaceutical companies producing the COVID vaccines are required to conduct a thorough post-vaccination monitoring in order to detect the occurrence of possible adverse events (phase 4 studies). This monitoring of vaccinated individuals complements the very close and reinforced monitoring conducted by the Health Authorities as part of their Pharmacovigilance system.





SAFETY

Why is six feet away the right distance?


Author: Task Force vaccine Published: 20/01/2021 Ref: 0012 EN 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




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


Author: Ilan Bloch and Task Force Vaccine Published: January 23, 2021 Ref: 0005 EN 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 [1] T To know more: Nanoparticles" are all particles between 1 and 100 nanometers in size - this is the order of magnitude of many viruses. Tolerance to nanoparticles depends largely on their composition. Some are highly toxic, such as those from tobacco smoke or diesel engines. The lipid nanoparticles used in messenger RNA vaccines are about 80 nanometers in size and are made of lipids similar to those found in the human body; they do not contain metals (silver, titanium, gold, etc...). Swissmedic [2], the Swiss drug regulatory agency, considers these lipid nanoparticles to be well tolerated by the body, as they are already used in several drugs approved in Switzerland (including drugs used in cancer treatment). Their medicinal use in Switzerland is strictly regulated by Swissmedic. References 1-Ref: * BJA. Allergic reactions to the first COVID-19 vaccine: is polyethylene glycol (PEG) the culprit? 2- i nfovac.ch - Swiss information plateform on viruses.




Is there any other possible solution than vaccination?


Summary of the Vaccine Safety Net resources Author: Task Force vaccine Published: 19/01/2021 Ref: 0007 EN

  • 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,
*staying at least 6 feet/2 meters away from others. CDC :
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html




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


​​​​​​​ Author: Task Force on Vaccine​​​​​​​ Published: January 12, 2021 Ref: 0002 EN 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?


Author: Daniel MALLER Published: 20/01/2021 Ref: 0003 EN 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. ____________________________________ [1]US Food & Drug Administration, "What is Gene Therapy". https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy#:~:text=Human%20gene%20therapy%20seeks%20to,to%20treat%20or%20cure%20disease.&text=Replacing%20a%20disease%2Dcausing%20gene%20with%20a%20healthy%20copy%20of%20the%20gene [2]S. Brenner, F. Jacob et M. Meselson, « An unstable intermediate carrying information from genes to ribosomes for protein synthesis. », Nature, vol. 190,‎ 1961, p. 576-581. [3]National Human Genome Research Institute, "Messenger RNA". https://www.genome.gov/genetics-glossary/messenger-rna . [4]N. Pardi, M. J. Hogan, F.W. Porter, and D. Weissman, "mRNA vaccines – a new era in vaccinology". Nature Reviews Drugs Discovery, vol. 17, 2018, p. 261-279. https://www.nature.com/articles/nrd.2017.243 [5]Corum, and C. Zimmer, "How the Pfizer-BioNTech Vaccine Works". New York Times, 2020. https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html . [6]B. Dupuy, "Experts: mRNA vaccine for COVID 19 does not alter RNA". AP News, September 4, 2020. https://apnews.com/article/9340521654. [7]Cambridge Dictionary, "Vaccine". https://dictionary.cambridge.org/fr/dictionnaire/anglais/vaccine [8]Centers for Disease Control and Prevention, Definition of terms: "Vaccine". https://www.cdc.gov/vaccines/vac-gen/imz-basics.htm. [9]A. Telesnitsky, and S. P. Goff, "Reverse transcriptase and the generation of retroviral DNA". In: Retroviruses. Cold Spring Harbor (NY): Cold Spring Harbor Laboratory Press, 1997. https://www.ncbi.nlm.nih.gov/books/NBK19383/




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


Author: Task Force Vaccine Published: 20/01/2021 Ref: 0004 EN 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 a gene therapy?


Authors: Menahem Brégégère, PhD, Molecular biology & genetics Irène Fermont, MD, Pharmacovigilance Published: January 12, 2021 Ref: 0026 EN 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. SHOW MORE




What are the mRNA vaccine side effects?


Summary of the Vaccine Safety Net Resources Author: Task Force on Vaccine Published: January 12, 2021 Ref: 0008 EN NB : In February the CDC and the EMA have published a first report on spontaneous adverse events reported since the beginning of the vaccination campaign . This question is currently under revision and will be updated soon. 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. In the clinical trials, the following side effects have been described: 1- Common side effects on the arm where you got the shot

  • Pain
  • Swelling
  • Redness
2- Common side effects throughout the rest of the body
  • Fever
  • Chills
  • Tiredness
  • Headache
  • Nausea
3- Uncommon side effects
  • Malaise
  • Lymph nodes swelling
Since the start of the vaccination campaigns, moderate to severe allergic reactions have been observed and have led to Health authorities’ recommendations for the doctors to check carefully the benefit-risk for individuals, who have a history of severe allergic reaction or anaphylactic shock. For details go to the question “Who should get or not get the COVID vaccine”. TO KNOW MORE ABOUT SIDE EFFECTS References FDA: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions CDC : https://www.cdc.gov/vaccines/covid-19/hcp/prepare.html CDC: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html CanadianGovernement: https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks.html#p UKGovernment: https://extranet.who.int/pqweb/sites/default/files/documents/QA_EUL_Covid-19_July2020.pdf ScienceMag : https://blogs.sciencemag.org/pipeline/archives/2020/12/04/get-ready-for-false-side-effects Vaccines today : https://www.vaccinestoday.eu/stories/the-first-covid-19-vaccine-is-here/ Health Feedback : https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/




Who should get or not get the COVID-19 vaccine ?


Summary of the Vaccine Safety Net Resources Author: Task force Vaccine Published : January 12,2021 Updated: 31/01/2021 Ref: 0011 EN 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. 1 - People who should NOT get the vaccine: - Anyone who had a previous anaphylactic shock or a strong allergic reaction to a previous SAME vaccine (includes people who had a severe allergy to the 1st dose of the vaccines. Those people shouldn’t get the 2nd one) - Anyone with a severe allergy to any component of the COVID vaccine 2 - Persons who should NOT get the vaccine for the time being - People below 16 years of age because a too small amount of data is presently available - People isolated or with COVID symptoms; they must wait after isolation ends and/or symptoms resolve - People who recently had COVID; they-must wait until 90 days after treatment is over. NB According to the countries it may be recommended or not to vaccinate people who had COVID. Check the recommendations in your country.
- People who may get the vaccine after their doctor carefully considered their individual risks and benefit - Pregnant women and breastfeeding: due to the small amount of data during the clinical trials, it was not recommended to get the vaccine at the time of authorisation by regulatory agencies. - Then with the occurrence of several severe cases of COVID 19 in pregnant women, several countries are now recommending the vaccination in pregnancy and breastfeeding women.It is considered that pregnancy is in itself a risk of getting severe forms of COVID 19. This is the case in Israel and in the USA where the regulatory authorities recommend the vaccination after the 1st quarter of pregnancy and in breastfeeding. In France, the association of obstetricians has reached the same conclusion, but it is not yet officially recommended by the French regulatory authorities. Therefore, especially when breastfeeding or pregnant women present a high risk of getting a complicated COVID-19 either because of underlying disease or any other reason, the doctor could consider the individual benefit and risks. In addition it is admitted to consider vaccination for any pregnant woman who will desire it. According to the countries it may be possible or not to vaccinate pregnant and breastfeeding women. Check the recommendations in your country. - People with history of severe allergy (requiring medical intervention) to any vaccine or any injectable medication or non-injectable substance; they should consult their doctor prior to vaccination and remain under medical surveillance at the vaccination location for 30 min after injection - People with HIV - People with certain immune-compromising conditions - People on anticoagulants: a special procedure is described in
Sources : CDC : https://www.cdc.gov/coronavirus/2019-ncov/hcp/vaccination.html UK Government: https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a WHO : https://www.who.int/publications/m/item/who-sage-roadmap-for-prioritizing-uses-of-covid-19-vaccines-in-the-context-of-limited-supply Hospital of Philadelphia : https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid?utm_source=prevent-covid&utm_medium=redirect&utm_campaign=VECCOVID Israeli Ministry of Health French College of Obstetricians




How could COVID vaccines be developed so quickly?


Summary of the Vaccine Safety Net Resources Author: Task Force Vaccine Published: 19/01/2021 Ref: 0010 EN COVID vaccines were developed at a record speed while maintaining standards for safety and efficacy. The reasons behind this rapid progress include: 1- Research had started years ago The biggest misconception is that the work on the vaccine started when the pandemic began but research on Coronaviruses and on anti-Coronaviruses vaccines started more than a decade ago. The collected data have been used in the COVID19 vaccine development. 2- mRNA technology Technology has evolved to make development faster. Previously, viral vaccines could only be developed after growing the virus in a laboratory. Newer technologies build vaccines using the genetic code for the virus; thus, researchers could start as soon as the genome for the virus was released in January 2020. 3- Pandemic make clinical trials progress quickly Clinical trials involve the comparison of both safety and efficacy of the tested vaccine on a vaccinated group and an unvaccinated group. They progress more quickly if a disease is widespread, as is the case with COVID-19 in many countries, as a significant difference between the unvaccinated and vaccinated groups can be detected sooner than for a rare disease. 4- Parallel steps instead of sequential steps The different clinical development steps (phases 1, 2 and 3), the building of the production facilities and the production of the vaccine itself have been handled in parallel, making the process faster. In addition, the regulatory review of the data has been conducted phase by phase, without waiting for the end of the whole process. 5- Unprecedented international funding and collaboration between vaccine developers and governments around the world. Huge financial risks have been taken, such as building manufacturing facilities before a vaccine was even available and funding the research on a very large scale. Funding was coming from governments, WHO, foundations and industry. To ensure global equity to the access of the vaccine, WHO is leading COVAX, a global research platform of 75 countries, pooling international resources, accelerating development, production, and giving equitable access to tests, treatments, and vaccines. Sources WHO : https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccine-research-and-development CDC : https://www.cdc.gov/vaccines/covid-19/hcp/prepare.html Australian Government : https://www.ncirs.org.au/covid-19/covid-19-vaccine-development-landscape




Are there risks of narcolepsy with COVID-19 mRNA vaccines?


Author: Task Force Vaccine Published: 24/01/2021 Ref: 0024 EN

  • No case of narcolepsy with mRNA vaccines has been observed in clinical trials, nor has been the subject of an alert to health agencies since the start of the vaccination campaign.
  • Cases of narcolepsy were observed during the 2009-2010 H1N1 influenza epidemics following vaccination with Pandemrix® influenza vaccine. The number of cases in Europe is estimated at 650 out of 19 million people vaccinated, i.e. around 3 per 100,000. It is therefore an extremely rare phenomenon.
  • Pandemrix® influenza vaccine is an attenuated virus vaccine (fragmented virion, inactivated, with adjuvant). Its responsibility in recorded cases of narcolepsy has been much debated, particularly by the US CDC, but appears to have been confirmed primarily in children and adolescents.
We will note that these two populations are not included in the vaccine strategy of anti-COVID19 vaccines, and that the Pandemrix® vaccine is the only vaccine to have been implicated in cases of narcolepsy.
  • The risk of occurrence of narcolepsy cases being extremely low, the benefit / risk balance of vaccination with Pandemrix® was considered very favorable, compared to the annual risks of complications and death from influenza.
  • These events are unrelated to mRNA vaccine technology or to COVID, which is a disease with a higher risk of death than seasonal influenza, and has already affected many more people.
References: Nicolas Postel-Vinay, Narcolepsie post-vaccinale de type I, Société de Pneumologie de Langue Française, cf. : https://splf.fr/narcolepsie-postvaccinale-de-type-1, page consultée le 26/12/2020 Sarkanen TO, Alakuijala APE, Dauvilliers YA, Partinen MM. Incidence of narcolepsy after H1N1 influenza and vaccinations: Systematic review and meta-analysis. Sleep Med Rev. 2018 Apr;38: 177-186. doi: 10.1016/j.smrv.2017.06.006. Epub 2017 Jun 20. PMID: 28847694.0 Centers for Disease Control and Prevention, Narcolepsy Following 2009 Pandemrix Influenza Vaccination in Europe cf. : https://www.cdc.gov/vaccinesafety/concerns/history/narcolepsy-flu.html




Are there still unknown information regarding the Covid-19 mRNA vaccine?


Author: Task Force Vaccine Published: 24/01/2021 Ref: 0025 EN Health Agencies (FDA, EMA, MHRA) have decades of experience in the area of vaccine safety. These agencies have granted an Emergency Use Authorization for two vaccines that have achieved excellent results in clinical trials, both in terms of efficacy (over 90%) and in terms of safety. Some questions remain (see section For more information), and there is, as always, a low risk that in the long term, unwanted effects will appear, never before observed in animal studies or in clinical trials. However, it is crucial that this hypothetical risk, exceptionally observed with other vaccines, be weighed against the known and proven risks of mortality and morbidity, direct and indirect, linked to COVID19.

The systems for monitoring side effects (pharmacovigilance) have been greatly strengthened in most countries, and in particular in Israel, where 90% of medical data is digitized, which allows any warning signal to be detected very quickly. To date (January 8, 2021), after more than 17 millions of vaccinated patients closely monitored, COVID vaccines are estimated to be particularly safe.

It should also be noted that the rapid development of mRNA vaccines is also a major innovation that could allow:
  • The very rapid adaptation of existing vaccines when mutations emerge,
  • the development of new vaccines and new treatments for certain cancers.
  • This would thus help save millions of human lives.

For more information

Additional studies are scheduled and will allow further study of certain questions not yet fully elucidated, such as:
  • For how long does the vaccine provide immunity?
  • Can people who are vaccinated transmit the virus?
  • What categories of people not represented in clinical trials (such as children, for example), or insufficiently represented in clinical trials, can be safely vaccinated?








How does the mechanism of action of mRNA vaccines explain their safety?


Author: Task Force on Vaccine Published: 25/01/2021 Ref: 0023 EN The safety of the vaccine comes from its mechanism of action. Indeed : - The mRNA COVID19 vaccine conveys only one strand of messenger RNA, and not all of the viral RNA as in a viral infection. This mRNA encodes only one protein, the Spike protein, and this protein, which is the immunostimulant, is non-pathogenic. The extremely rare risks associated with the use of inactivated or attenuated viruses in conventional vaccines, therefore cannot occur with mRNA vaccines. The vaccine's mRNA cannot be contaminated by other elements of the virus because it was not extracted from the virus but synthesized in laboratories in which the virus itself has never been introduced. - This vaccine mRNA remains in the cytoplasm of the cell, and being very labile, it is eliminated very quickly. It does not enter the cell nucleus, is not in contact with its DNA, and does not contain any of the keys that would have allowed it to act on this DNA (and, in particular, no reverse transcriptase). This is confirmed by all regulatory agencies that have granted emergency use authorization (FDA, EMA, MHRA.): mRNA does not enter the nucleus and it cannot act on the human genome. CDC, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html





EFFICACY

What is the efficacy of mRNA vaccines?


Summary of the Vaccine Safety Net Resources Author: Task Force Vaccine Published: 18/01/2021 Ref: 0006 EN 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.
Pfizer-BioNTech vaccine
  • Pfizer vaccine was tested on 45,000-person and its efficacy was of 95%.
  • Half participants received injections and half placebo. There were 8 cases of Covid among vaccinated people vs. 162 on placebo**. 10 severe cases occurred with just 1 in the vaccinated group.
Further assessments
More CDC and manufacturers assessments will take place to better understand the protection of the vaccines under real conditions, outside of clinical trials. Many factors can affect effectiveness in real-world situations like the way a vaccine is transported and stored, the way patients are vaccinated etc... Complementary studies will help to furthermore explore questions such as:
how long will the vaccine provide protection?
can vaccinated people transmit the virus?
which categories of people among those who were not included or not well represented in the clinical trials could safely be vaccinated? FDA :
Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum
https://www.fda.gov/media/144416/download UK Government :
COVID-19: the green book, chapter 14a
https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a
New England Journal of Medicine:
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577 ScienceMag : ‘Absolutely remarkable’: No one who got Moderna’s vaccine in trial developed severe COVID-19
https://www.sciencemag.org/news/2
020/11/absolutely-remarkable-no-one-who-got-modernas-vaccine-trial-developed-severe-covid-19




Why are scientists not unanimous?


Author: Task Force Vaccine Published: 20/01/2021 Ref: 0001 EN 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 non-evidence based 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.





SPECIAL POPULATIONS

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


Author: Task Force Vaccine Published: 19/01/2021 Ref: 0017 EN 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...
READ MORE




Is there a risk for women fertility with Pfizer-Biontech vaccine?


Summary of the Vaccine Safety Net Resources Author: Task Force Vaccine Published: 24/01/2021 Ref: 0009 EN - Reports on social media have falsely asserted that the vaccine could cause infertility in women. It has been feared that this misinformation may cause women to avoid vaccination to prevent COVID-19, which is a potentially serious and life-threatening disease. - There is no scientific evidence to suggest that the vaccine could cause infertility in women. - In addition, infertility doesn’t occur as a result of COVID disease, demonstrating that immune responses to the virus, induced by infection or vaccine, cannot become a cause of infertility.
- The vaccine mechanism involves an immune reaction against the so-called Spike protein, a characteristic protein of the COVID 19. Contrary to false reports on social media, this protein to which the body opposes is not the same as any other protein involved in the formation of the placenta. Source: FDA : https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions





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