Although in rare cases the vaccine may have side effects, the probability of that side effects is lower than the probability of Covid-19 infection and consequential infecting other individuals.
However, there are certain groups that should not get vaccinated, at least for this moment. And for some of them vaccination will not be permitted.
Covid-19 vaccination is not granted for small children as there have been no clinical studies examining the impact of vaccination on children. Thus, the impact on children has not yet been documented properly. It is, therefore, possible that children may be vaccinated in the future, but this is conditioned by prior approval of the vaccine also for children by relevant EU authorities.
Vaccine by Pfizer/BioNTech is not granted for children under 16 years. Vaccine by Moderna is not granted for children under 18.
PEOPLE WITH ALLERGIC DISEASES
During real vaccination by mRNA vaccine – not in clinical studies – anaphylactic reactions have been reported. The risk of anaphylactic reaction after mRNA vaccination is negligible – one in hundred/four hundred thousand doses. The probability is higher in comparison with routine vaccines but still very low. Majority of anaphylactic reactions come within 15 minutes after vaccination and is typical for individuals diagnosed with the previous vaccine-related allergies or injection therapy allergies. These factors are not marked as a contraindication for a vaccination, but you should be careful in this case. mRNA vaccine may be used after informing the individual about the possible risk of severe allergic reaction and take this into account while weighing up risks and benefits of vaccination. Individuals with an immediate allergic reaction after the first dose of the vaccine should not be vaccinated with the second dose. Symptoms of hypersensitivity – anaphylaxis, urticaria, angioedema, respiratory distress (wheezing or stridor) – appearing within an hour of receiving the vaccine are considered to be an immediate allergic reaction.
mRNA vaccines are contraindicated for individuals having an immediate allergic reaction after any part of the vaccine. Both mRNA vaccines include only a few allergens, especially – polyethylene glycol and related molecules. Polyethylene glycol is not a part of any other registered vaccine. Reason for contraindication is also an immediate allergic reaction on the related molecule of polysorbate which is used in vaccines as a stabilizer. However, allergy to these substances is very rare. Contact dermatitis, food allergies, pollen allergies or latex allergies are not contraindications to vaccination. Vaccination centres must be equipped to cure possible anaphylactic reactions. Every staff member must be trained to recognize such a reaction and must be able to handle the situation properly. The training of the staff must be documented. Vaccination centre must dispose of at least adrenaline, a tonometer, a stethoscope, and possibly other equipment to handle the situation. Written instructions must be also well prepared for this scenario. All vaccinated people with an immediate allergic reaction on any vaccine substance must be monitored in a medical facility at least 30 minutes after vaccination, standard monitoring period is 15 minutes.
PEOPLE WITH AUTOIMMUNE DISEASES
Currently, due to lack of research knowledge, we are unable to say much about Covid-19 vaccine safety and effectiveness for individuals with autoimmune diseases despite these individuals has been found eligible to be in the sample for clinical research studies. Individuals with autoimmune diseases who participated in clinical studies and got mRNA vaccine did not statistically differ from the control group (with placebo) in terms of occurrence of symptoms typical for autoimmune diagnosis or inflammatory disorders. Thus, individuals with autoimmune diseases with no other contraindication can be vaccinated.
Amongst pregnant women, there is a higher probability of severe Covid-19 disease. There is also a greater risk of premature birth. Pregnancy was considered to be excluding factor from any study of mRNA vaccine. According to available research data, we cannot assess the effectiveness and safety of mRNA vaccines in a cohort of pregnant women. Pregnant women with another health or occupational risk are recommended to individually consider benefits and risks of vaccination (ideally with a specialist).
Vaccines do not contain live virus parts; mRNA does not interact with the nucleus and is rapidly degraded. Animal studies of developmental and reproductive toxicology have not proved any harmful effect on pregnancy. No safety signals had been detected amongst women who became pregnant during clinical trials.
For breastfeeding women, facts and recommendations are similar as for pregnant women. However, the risk of severe Covid-19 disease is not increased for breastfeeding women. Nevertheless, breastfeeding was considered to be excluding factor from any study of mRNA vaccine. Current research data do now allow us to examine the effectiveness and safety of mRNA vaccines for breastfeeding women and her child. Breastfeeding women with another health or occupational risk are recommended to individually consider benefits and risks of vaccination (ideally with a specialist). Though, vaccination is not a reason to discontinue breastfeeding.
PEOPLE WITH COMORBIDITIES
Some chronic diseases are increasing the risk of severe Covid-19 disease and subsequently the risk of death. The safety and efficacy of the vaccine have been proved in the research studies examining the impact on the cohort of people with comorbidities. The risks are comparable with the cohort of people without comorbidities. The list of chronic diseases includes hypertension, diabetes mellitus, asthma, lung, liver, and renal diseases, chronic (stabilized and well-controlled) HIV, HCV, and HBV infection. Vaccination is definitely recommended for individuals with chronic diseases.
PEOPLE WITH IMMUNODEFICIENCY
We recommend vaccination for any individual with immunodeficiency including individuals with oncological disease and individuals on immunosuppressive therapy. These individuals have increased risk of serious Covid-19 disease and consequently increased risk of death. Despite vaccine effectiveness may be lower for these individuals, expected benefits from the vaccination are considered to be higher.