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Israel Society for Medication and Vaccine Safety
To Articles
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
- 01
Author: Nicole Perez Published : February 2nd ,2022 Ref: 0654 Although not as accurate as PCR, the home antigen test can achieve a relatively high level of accuracy if the instructions are carefully considered. It will be able to reveal, reliably by chemical reaction, the protein which signs the presence of the corona virus in the positive person.
1. Store test kits like medicines: in a dry place, at a temperature between 2 and 24 degrees. Indeed, poor storage conditions damage the tests.
2. Avoid disturbing the chemical reaction: Before performing the test, clean the work surface, wash your hands and put on disposable gloves if necessary.
3. Collect sample: Start the test by taking a sample from the pharynx with the swab, then use the same swab for the nostril swab. The omicron variant lodged in the pharyngeal mucosa is thus better detected.
4. Mix the swab in the tube: Mix the swab well in the tube positioned vertically and make circular movements with the swab.
5. Using developer: Run the required number of drops into the tiny window of the test plate.
6. Read the result: Wait 15 minutes (use a timer or smartphone stopwatch) to observe the result. This is the time required for the chemical reaction to occur.
Results:• Red C band: negative test• Red C and T bands: positive test• Other cases: invalid test
- 02
Summary of the Vaccine Safety Net Resources
Author:Task force
Published : January 12,2021
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.
References
- 03
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.
to read more
- 04
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
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
- 05
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.
- 06
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
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/
- 07
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 & geneticsIrène Fermont, MD, Pharmacovigilance
- 08
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.
- 09
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.
- 10
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/
- 11
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.
- 12
Authors: Daniel Maller- Task Force Vaccine
Published: 20/01/2021
Updated: 22/03/2021
Ref: 0010 EN
The WHO Vaccine Safety Advisory Committee has established criteria to allow an objective definition of associations between vaccination and adverse reactions. They also apply to autoimmunity problems.
The assessment of autoimmune events should be accurate, based on rigorous analytical methods and sufficient data. It may be a coincidence that a side effect appears soon after a vaccination.
Such undesirable events should be considered as side effects only if a significant association is demonstrated by epidemiological studies on different populations, in order to verify the hypotheses put forward on the basis of isolated cases.
There are only 3 rare autoimmune diseases for which an association with vaccines has been shown:
Guillain-Barré syndrome (neuropathy) which is a known complication of influenza, and can occur exceptionally after vaccination against influenza.
Idiopathic Thrombocytopenic Purpura (low blood platelets) which is a fairly common complication of measles and rubella, exceptionally occurring after measles-mumps-rubella (MMR) vaccination.
Narcolepsy, a sleep disorder characterized by an autoimmune attack of hypothalamic neurons, which was significantly associated with the 2009 H1N1 influenza epidemic, as a result of viral infection or vaccination with the Pandemrix vaccine.
Otherwise, theories have circulated and still circulate on the long-term effects of vaccines, especially on the vaccines against hepatitis B and measles. All of these claims have been invalidated by numerous studies.
During the measles epidemics that erupted as a result of these anti-vaccine campaigns, serious complications and children deaths have been observed. This is unacceptable because these tragedies could have been avoided by vaccination.
Vaccination is one of the major advances of our time, which prevents 2.5 million deaths worldwide each year. It has eradicated deadly and crippling diseases such as polio and smallpox. These are verifiable facts against which unconfirmed hypotheses are set, that seriously undermine the eradication of diseases and epidemics.
Références
Wraith, D.C., Goldman, M., Lambert, P.H. Vaccination and autoimmune disease: what is the evidence ? Lancet 362, 1659-1666 (2003).
Vellozzi, C., Iqbal, S., Broder, K. Guillain-Barré syndrome, influenza, and influenza vaccination: the epidemiologic evidence. Clinical Infectious diseases 58, 1149-1155 (2014).
Cecinati, V., Principi, N., Brescia, L., et al. Vaccine administration and the development of thrombocytopenic purpura in children. Human Vaccines & Immunotherapeutics 9, 1158-1162 (2013).
Partinen, M., Rahbek Kornum, B., Plazzi, G., et al. Narcolepsy as an autoimmune disease: the role of H1N1 infection and vaccination. Lancet Neurology 13, 600-613 (2014).
- 13
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
- 14
Author: Ilan Bloch and Task Force Vaccine
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]
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?
- 15
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
- 16
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
- 17
Authors: Daniel Maller- Task Force Vaccine
Published: 20/01/2021
Updated: 22/03/2021
Ref: 0004 EN
Following injection of the vaccine, a small minority of muscle cells receive, not the virus, but one of its messenger RNAs, which will direct the synthesis of the "Spike" protein.
The cells then expose this antigen on their surface and present it to the incoming immune cells, which identify it as foreign, and trigger a specific response of CD4 (helper) et CD8 (killer) T lymphocytes.
The messenger RNA is quickly degraded, which stops the expression of the Spike protein: it is not renewed on the surface of the cells, and hence disappears rapidly.
The immune response takes a few days to develop. The tiny minority of muscle cells that still display the Spike antigen on their surface are then eliminated by cytotoxic CD8 lymphocytes, and replaced according to the usual healing process.
References
Leitner, W.W., Ying, H., Restifo, N.P. DNA and RNA-based vaccines: principles, progress and prospects. Vaccine 18, 765-777 (1999).
Pardi, N., Hogan, M.J., Porter, F.W., Weissman, D. mRNA vaccines – a new area in vaccinology. Nature Reviews – Drug Discovery 17, 261-279 (2018).
Wiendl, H., Hohlfeld, R., Kieseier, B.C. Immunobiology of muscle: advances in understanding an immunological microenvironment. Trends in Immunology 26, 373-380 (2016).
- 18
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.
- 19
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
- 20
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 :
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
- 21
Author: Task Force Vaccine
Published: 24/01/2021
Update: 07/03/2021
Ref: 0024 EN
No case of narcolepsy has been observed in clinical trials with COVID-19 mRNA vaccines, nor has been subject of warning to health agencies since the vaccination campaign started.
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 appeared to be 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 that has been involved in cases of narcolepsy.
Because the occurrence of narcolepsy was extremely low, the benefit / risk balance of vaccination with Pandemrix® was considered very favorable, compared to the 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 is affecting 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
- 22
Author:Task Force Vaccine
Published: 24/01/2021
Update: 07/03/2021
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 of long-term, unwanted effects that were undetected in animal studies or in clinical trials. However, it is crucial that this potential risk, present in any vaccine or medication , be assessed in comparison with the known and proven risks of mortality and morbidity, direct and indirect, linked to COVID19.
Monitoring of side effects (pharmacovigilance) has been greatly improved in most countries, particularly in Israel where 90% of medical data are digitized, which allows a quick detection of warning signals. To date (March 3, 2021 ), after more than 300 millions of vaccines doses have been administered, patients have been closely monitored, COVID vaccines are estimated to be particularly safe.
It should also be noted that the rapid development of mRNA vaccines is a major innovation that could allow:
very rapid editing and renewal of current vaccines when mutations emerge,
development of new treatments for certain cancers.
- The mRNA technology is a historical breakthrough in the history of the medicine which opens a large field of new research . It is believed that its features may help saving millions of human lives.
For more information
Additional studies are scheduled that will allow further elucidation of certain questions, such as:
- How long does the vaccine provide immunity?
- Can vaccinated people transmit the virus?
- What categories of people that were insufficiently or not represented in clinical trials (such as children and pregnant women), should be vaccinated?
Update: The pharmaco-epidemiologic data coming from the countries where vaccination has been implemented have started to answer some of these questions and will soon bring more answers.
Israel is leading the mass vaccination and, having 90% of the medical data digitalized, has already:
- confirmed the efficacy of the clinical trials when vaccination is performed in real life
- confirmed the safety with no new signals
- started to vaccinate pregnant women and teens over 16 years of age
- observed a drastic decrease of infection in the vaccinated people
- a decrease of serious cases or mortality n the population at risks
- 23
Author:Task Force on Vaccine
Published: 25/01/2021
Update: 07/03/2021
Ref: 0023 EN
The vaccine safety derives from its mechanism of action. Indeed :
- Anti- COVID19 mRNA vaccines convey only one strand of messenger RNA instead of the whole viral RNA in a viral infection. This mRNA encodes only one protein, the Spike protein which is immunostimulant and non-pathogenic. The low risks associated with inactivated or attenuated viruses in conventional vaccines, are therefore irrelevant to these mRNA vaccines.The vaccine mRNA is free of all viral components,since it was synthesized in laboratories where the virus itself never entered.
- After cell penetration, the vaccine mRNA remains in the cytoplasm, and being very labile, it is qickly eliminated. It never enters the nucleus, has no contact with DNA, and no access to the keys that allow interaction with DNA especially reverse transcriptase. This point 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
- 24
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?
- 25
Author: Daniel Maller and Task Force
Published: 23/03/2021
Ref: 0033 EN
No.
The vaccine must be injected strictly intramuscularly. In subjects with a hemostasis or coagulation disorder, or in people on anticoagulants, the vaccination can be done in the deltoid muscle with a fine needle (ideally 25G), followed by strong and prolonged compression ( 2 minutes).
People with particularly severe hemostasis or coagulation disorder, which is a contraindication to intramuscular injection, should not be vaccinated unless the potential benefit clearly outweighs the risks associated with the injection.
References :
Lowe, D. mRNA vaccines: What happens. Science Translational Medicine (21 January 2021). https://blogs.sciencemag.org/pipeline/archives/2021/01/21/mrna-vaccines-what-happens
- 26
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