Frequently Asked Questions
What makes mRNA vaccine safe?
en-556 What makes mRNA vaccine safe?
Created on Sunday, 07 March 2021
Modified on 06 June 2021
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.
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Pfizer and Moderna vaccines contain lipid nanopart ...
en-588 Pfizer and Moderna vaccines contain lipid nanoparticles. Do they present risks
Contributor(s):Ilan Bloch
Created on Saturday, 23 January 2021
Modified on 06 June 2021
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]
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
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Can there be a causal link between vaccination and ...
en-650 Can there be a causal link between vaccination and the onset of an autoimmune disease?
Author(s):Daniel Maller
Contributor(s):Task Force
Created on Wednesday, 20 January 2021
Modified on 03 July 2021
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).
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Is there any other possible solution than vaccinat ...
en-651 Is there any other possible solution than vaccination?
Author(s):Task Force
Created on Tuesday, 12 January 2021
Modified on 03 July 2021
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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. -
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
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Who should get or not get the COVID-19 vaccine ?
en-583 Who should get or not get the COVID-19 vaccine ?
Created on Thursday, 11 February 2021
Modified on 06 June 2021
Summary of the Vaccine Safety Net Resources
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.
- 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
- Persons who should NOT get the vaccine for the time beingPeo
- 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
- 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
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