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
FAQ
Why is six feet away the right distance? (00001)
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
READ MORE
What is the efficacy of mRNA vaccines?
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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.
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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.
More CDC and manufacturers assessments will take place to better understand the protection of the vaccines under real conditions, outside of clinical trials.
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?
Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum
https://www.fda.gov/media/144416/download
COVID-19: the green book, chapter 14a
https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
https://www.sciencemag.org/news/2
020/11/absolutely-remarkable-no-one-who-got-modernas-vaccine-trial-developed-severe-covid-19
Is there any other possible solution than vaccination?
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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.
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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.
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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,
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
Why are scientists not unanimous (00004)
“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)
How can we assess if the occurrence of an autoimmune disease is linked to a vaccine? (00006)
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)
Is the muscle cell transfected with the S-antigen producing mRNA endangered? (00008)
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.
Irène Fermont, MD, Pharmacovigilance
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.
Who should get or not get the COVID-19 vaccine ? (00014)
Fake News
THEORY The vaccines could cause illnesses. (00009)
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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.
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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.
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Post vaccinal follow-up is carefully monitored in order to detect the eventual occurrence of any uncommon side effect.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines
https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/
https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/transmission-and-protection-coronavirus/vaccines-and-coronavirus
https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid?utm_source=prevent-covid&utm_medium=redirect&utm_campaign=VECCOVID
THEORY There are unwanted components in the vaccine (00009)
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines
https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/
https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/transmission-and-protection-coronavirus/vaccines-and-coronavirus
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
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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.
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There is absolutely no connection between 5G networks and vaccines. Vaccines can’t be “activated “by 5G to harm people.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines
https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/
https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/transmission-and-protection-coronavirus/vaccines-and-coronavirus
https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid?utm_source=prevent-covid&utm_medium=redirect&utm_campaign=VECCOVID
Vaccines contain microchips that can track people (00009)
The approval of the vaccines by Regulatory Health agencies like the FDA, the EMA etc. warrant their composition.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines
https://healthfeedback.org/claimreview/no-evidence-that-covid-19-vaccines-cause-more-severe-disease-antibody-dependent-enhancement-has-not-been-observed-in-clinical-trials/
https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/transmission-and-protection-coronavirus/vaccines-and-coronavirus
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
The mRNA vaccine is a technology that has never been used in humans. (00008)
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.
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
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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).
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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.
cf.: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine
cf.: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-annex-i-definitions-rev-4_en.pdf
Older people were not included in the clinical trials (00008)
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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.
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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].
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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.
cf.: https://www.fda.gov/media/144245/download
cf.: https://www.fda.gov/media/144434/download
Mass vaccination is being carried out with experimental vaccines (00008)
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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.
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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.
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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.
SAFETY
Pfizer and Moderna vaccines contain lipid nanoparticles. Do they present risks?