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Vaccine indication for selected groups



Although in rare cases the vaccine may have side effects, the probability of those side effects is lower than the probability of Covid-19 infection and consequential infecting other individuals. 

However, certain groups should not get vaccinated, at least for now. And for some of them, vaccination will not be permitted.

Children

As there were no children participants in the very first clinical studies of Covid-19 vaccines, vaccination of children was therefore not allowed. Currently, there is a sufficient amount of relevant information for the approval of some of the children's cohorts. The European Commission approved the Comirnaty vaccine (by Pfizer/BioNTech) and Spikevax (by Moderna) based on EMA recommendations for children.

At first, using both vaccines for children 12+ was approved. As of November 26, 2021,the European Union approved the Comirnaty vaccine for children between 5 and 11 years. The Czech Vaccinology Society expressed their opinion in their report.

Dated on November 25, 2021, EMA recommended the Comirnaty vaccine for children between 5 and 11 years.

Based on the Ministry of Health decision, the Comirnaty booster dose can be administered to children over 12 as of January 24, 2022.

As of July 18, 2022, the Ministry of Health has allowed the administration of the second booster dose of mRNA vaccines to people over 18 at least 4 months after the first booster dose.

Recommendations for vaccination in individual population groups, groups in risk and contraindications

Vaccination is recommended to all people for whom the vaccine is approved by EMA (European Medicines Agency) and people with no contraindications.

For reasons of efficiency, safety and data availability, mRNA vaccines are preferred.

Age

The mRNA vaccine Comirnaty is conditionally approved for children between 5-11 years old in 10 mcg dosage and for children 12+ and adults in 30 mcg dosage.

The mRNA vaccine Spikevax is conditionally approved for for children 12+ and adults.

Vaxzevria vector vaccines and Janssen's COVID-19 Vaccine are conditionally approved only for 18+ adults.

The protein vaccine Nuvaxovid is conditionally approved only for 18+ adults.

People who have suffered from COVID-19

The vaccination is recommended to all people, including those who have already suffered from the disease. The period of post-infectious protective immunity after the COVID-19 disease is still unknown and this immunity is not induced in all people going through the infection. Vaccination reduces the risk of reinfection. Studies have shown the safety of vaccination for people who have suffered from the disease. Vaccination can be started at any time after the symptoms of acute infection have disappeared and the isolation has ended. The initiation of vaccination and the administration of any dose in immunocompetent people with a low risk of a serious course can be postponed for 3-6 months after the disease.

There are insufficient data available to vaccinate people who have suffered from multisystem inflammatory disease in children or adults. For these people, it is recommended to postpone vaccination for at least 90 days after the illness, until complete recovery, and to vaccinate based on careful consideration of the individual risk of infection and its complications. Factors that may influence this decision include age, health and immune status of the patient, and the extent of community spread of SARS-CoV-2 in the population. The administration of another dose is not recommended in case of the development of a multisystemic inflammatory disease in people who have already been vaccinated.

Vaccination can be carried out regardless of the previous application of monoclonal antibodies or convalescent plasma.

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.

Persons who have suffered from myocarditis or pericarditis

After vaccination with mRNA vaccines against the disease COVID-19, myocarditis and pericarditis occur only rarely. These cases are mild in the vast majority of cases and are more common in younger males and after second doses of mRNA vaccine.

People with a history of myocarditis or pericarditis unrelated to COVID-19 vaccination may be vaccinated with any COVID-19 vaccine.

A second dose is not recommended for people who have suffered from myocarditis or pericarditis after receiving any dose of the vaccine. By exception, it is possible to apply the next dose of the vaccine after considering the individual risk of COVID-19 disease for the vaccinated person.

Immunocompromised people

We recommend vaccination for all immunocompromised people, including peoplewith oncological diseases and people undergoing immunosuppressive therapy. These individuals are at risk of a more severe course of the COVID-19 disease, including a greater risk of death, and although the efficacy of the vaccination may be reduced, its expected benefits outweigh the possible risks.

If the patient's health allows, vaccination should be given at least 2 weeks before starting immunosuppressive therapy. If this procedure is not possible, it is possible to vaccinate during or at any interval before or after immunosuppressive therapy. Vaccination is not a reason to change therapy, but if the medical condition allows it, reducing the dose in the 14 days before and after vaccination can increase the immunogenicity of the vaccine.

Moderately and severely immunocompromised persons have an indication for additional doses (see below).

Immunocompromised people should be educated about the risk of lower vaccine efficacy and the resulting need to follow common anti-epidemic measures and the need to vaccinate their close contacts.

People with autoimmune diseases

The disease and its treatment can increase the risk of more severe course of the COVID-19 disease. The vaccination is recommended to people with autoimmune diseases.

People with neurological diseases

Some patients with neurological diseases may be at increased risk of more severe course of the COVID-19 disease and death due to respiratory and neurobehavioral comorbidities. No neurological disease is a contraindication to vaccination. Patients with multiple sclerosis, epilepsy, neurodegenerative and other neurological diseases should be vaccinated.

Cases of facial nerve paresis have occurred during clinical trials. A causal relationship of facial nerve paresis with vaccination has not been proven. A very rare occurrence of Guillain-Barré syndrome in connection with vaccination with vector vaccines is not excluded.

Dermal fillers

Individuals who have had dermal fillers may rarely experience temporary swelling in the area of ​​the filler after vaccination with mRNA vaccines. Dermal fillers are not a contraindication to mRNA vaccines.

People with thrombophilic conditions

The so-called thrombosis syndrome with thrombocytopenia (TTS) occurs very rarely after vector vaccines. This syndrome is serious and in some cases ends in death. It occurs more often in younger women. Other than age and gender, no risk factors were identified.

Due to the risk of TTS syndrome, we recommend the preferential use of mRNA vaccines.

People who have suffered from TTS after any vector vaccine have a contraindication to vector vaccines. They may be given a vaccine based on another platform.

In people with a history of heparin-induced thrombocytopenia (which is thought to have a similar mechanism to TTS), vector vaccines are contraindicated and so the people should be vaccinated with a vaccine based on another platform.

Vaxzevria vaccine is also contraindicated in people who have suffered from capillary leak syndrome.

People with a history of other thromboembolic conditions in their medical history and with thrombophilic conditions do not have an increased risk of TTS and do not have a contraindication to any vaccine.

Due to the planned vaccination, prophylactic administration of anticoagulant or antiplatelet therapy is not indicated.

People with bleeding diatheses and with anticoagulant therapy

Bleeding diathesis or anticoagulant therapy may increase the risk of bleeding after intramuscular injection. A stabilized bleeding disorder or anticoagulant therapy is not a contraindication to vaccination. Anticoagulant treatment does not need to be discontinued due to vaccination. In patients with coagulation disorders on substitution therapy, it is advisable to vaccinate shortly after its application. After vaccination, the place of injection should be compressed for at least 2 minutes and inspected before covering.

There have been very rare reports of thrombocytopenia following administration of AstraZeneca's Vaxzevria vaccine. For peoplewith immune thrombocytopenia or with a history of thrombocytopenia of unclear etiology, we recommend the application of another vaccine.

Pregnant women

Pregnant women have an increased risk of a more serious course of the COVID-19 disease, including death, compared to non-pregnant women of the same age. COVID-19 may increase the risk of preterm birth and other perinatal complications.

There are not known any specific risks of COVID-19 vaccines to a pregnant woman or her fetus. According to the available data, vaccination during pregnancy is immunogenic and effective.

Vaccination provides protection to the pregnant woman from the disease, reduces the risk of complications during pregnancy and provides protection to the fetus until the first postnatal months.

The vaccination of pregnant women is recommended. It is possible to be vaccinated at any stage of pregnancy. Pregnancy is also an indication for a booster dose (see below).

Vaccination is also recommended to women planning pregnancy. Postponing pregnancy is not necessary after vaccination. Vaccination is also possible for women undergoing infertility treatment.

According to limited data, the vaccination may cause mild temporary changes in the menstrual cycle. Vaccines have no negative effect on female or male fertility.

Breastfeeding women

Breast-feeding women do not have an increased risk of a more serious course of Covid-19 disease. It is highly unlikely that the vaccination would be considered dangerous in any way to breastfeeding women or their breastfed children. Antibodies generated after the vaccine pass into breast milk, which is beneficial for the breastfed baby. Vaccination of breastfeeding women is recommended.

After vaccination of a breastfeeding woman, no precautions are necessary in case of planned vaccinations of a breastfed child.

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. The majority of anaphylactic reactions come within 15 minutes after vaccination and are typical for individuals diagnosed with 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. Vaccines 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. No medication is given before vaccination to prevent an allergic reaction.

Available COVID-19 vaccines contain very few allergenic components, mainly polyethylene glycol (PEG) in mRNA vaccines and polysorbate in vector vaccines. Peptide vaccine Nuvaxovid contains polysorbate and Matrix-M adjuvant. Allergies to these and related molecules are very rare. PEG is not included in any other registered vaccine. Polysorbate is also used in some other vaccines as a stabilizer.

People with a history of an immediate allergic reaction to any vaccine component should be given a vaccine that does not contain that component. When vaccinating these people, it is necessary to proceed with caution and always weigh the benefit and risk of vaccination individually.

People with an immediate allergic reaction after a dose of vaccine can be given a vaccine based on a different platform as the next dose.

Symptoms of hypersensitivity - anaphylaxis, urticaria, angioedema, respiratory distress (wheezing or stridor) appearing within hours after the vaccine are considered an immediate allergic reaction.

Contact allergies, food allergies, pollen allergies, latex allergies, or other allergies are not contraindications to vaccination.

Vaccinating healthcare facilities must be equipped to treat an anaphylactic reaction. All vaccination site personnel must be trained to recognize and deal with an anaphylactic reaction. The vaccinating medical facility must be equipped with at least adrenaline, a tonometer and a stethoscope. The device can also be equipped with other means to manage an anaphylactic reaction. All people with a history of an immediate allergic reaction to any vaccine or other injectable substance must be observed at the place of vaccination for 30 minutes after administration of the vaccine; the minimum time in other cases is 15 minutes.

People with acute illness and persons in quarantine

Vaccination should be postponed for people with moderate to severe acute disease until the condition improves. Mild afebrile disease is not a contraindication to vaccination. Treatment with antibiotics is not a contraindication to vaccination. Persons in quarantine should not be vaccinated due to the risk of transmission of infection to other peopleat the vaccination center and due to the possible confusion of clinical manifestations of infection and adverse effects after vaccination.