Questions and Answers regarding the Vaccination of Children Between 5 and 11 Years of Age

Questions Answers Vaccination of children aged 5 to 11 years

Many parents in Romania have questions and answers about the vaccination of children between the ages of 5 and 11, and below you have some very good and clear information about what you should know about this process, coming directly from to the Romanian authorities.

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What do we need to know about the COVID-19 vaccines used in children ages 5 to 11?

1. Are children infected with the SARS-CoV-2 virus at risk of developing serious forms of the disease COVID-19?

A: Children between the ages of 5 and 11 who become infected with the SARS-CoV-2 virus are also at risk of severe forms of COVID-19.

It has also been observed that children, not just adults, can present persistent clinical manifestations ("Long COVID-19") after infection.

Children with comorbidities (chronic respiratory, renal, hepatic, cardiac diseases, malignancies, inflammatory bowel diseases, immunosuppression from various causes) are more at risk of developing severe forms of COVID-19 after infection with the SARS CoV-2 virus compared to healthy children.

2. Given the fact that severe forms of COVID-19 in children are rare, is vaccination justified?

A: Vaccination against COVID-19 protects children from both effects
direct, immediate effects of the disease, as well as the long-term effects. Children are protected against the risk of hospitalization or developing moderate to critical illness, as well as the occurrence of myocarditis or systemic multiinflammatory syndrome.

3. Why should children between the ages of 5 and 11 be vaccinated?

A: The main objective of vaccinating children aged 5-11 years is to protect them against SARS-CoV-2 infection and to reduce the overall burden of disease in this age group.

Children with chronic conditions should be given priority, given the increased risk of developing severe forms of the disease. The risk of developing a severe form of the disease is not negligible, however
in the case of children without chronic conditions.

4. Is it safer for my child to develop immunity by being infected with the SARS-CoV-2 virus than by vaccination?

A: First of all, we must take into account that the risk of a child developing a severe form of the disease is not negligible, even in the case of children who do not have chronic conditions. The level of natural immunity in the unvaccinated child and its duration are currently unknown and probably heterogeneous.

Vaccination against COVID-19 in children aged 5 to 11 years prevents the occurrence of severe forms of the disease and long-term complications such as myocarditis, multisystem inflammatory syndrome or persistent post-COVID-19 symptoms.

5. Should the child who is to be vaccinated against COVID-19 be consulted by a pediatrician/family doctor?

A: If the child does not have any particular medical health problem (chronic diseases, allergies, immunosuppressive treatments, etc.) he can be scheduled to be vaccinated without a prior medical consultation.

6. What type of vaccine will my child receive?

A: Comirnaty-Pfizer-BioNTech vaccine, 10 µg/dose is indicated for active immunization for the prevention of COVID-19 disease. It is a COVID-19 mRNA vaccine and is approved by the European Medicines Agency (EMA) and by the National Agency for Medicines and Medical Devices (ANMDM) for administration in the 5-11 year age group.

7. Is the vaccine against COVID-19 safe to administer to children between the ages of 5 and 11?

A: The answer is YES, vaccines are safe for children in this age group.

Studies conducted to date have reported that the safety profile of the vaccine is similar in this age group to that in adolescents.

8. What are the ingredients contained in the vaccines against COVID-19?

A: The COVID-19 vaccines currently available for adults, adolescents, and children contain active ingredients as well as inactive ingredients that vary by manufacturer. None of the vaccines contain eggs, gelatin, latex or preservatives. The vaccines against COVID-19 do not contain metals such as iron,
nickel, cobalt, lithium and alloys. They do not contain manufactured products such as
microelectronics, electrodes, carbon nanotubes or semiconductors with nanowires. There are no preservatives such as mercury/thimerosal in any of the currently available COVID-19 vaccines, including the Pfizer-BioNTech vaccine available for children ages 5 to 11.

9. Can the child be given Paracetamol or Ibuprofen before the vaccination against COVID-19 to prevent side effects?

A: The US Centers for Disease Control and Prevention (CDC) advises parents not to give their child any pain relievers before the child is vaccinated because it can reduce the immune response to the vaccine.

However, if the child has a fever or pain at the injection site after vaccination, he can receive Paracetamol or Ibuprofen in the appropriate dose, unless he has a known medical contraindication.

Aspirin is NOT recommended for use in children and adolescents under 18 years of age.

10. Is the dose of the vaccine against COVID-19 for children aged 5-11 the same as for the 12-18 age group and for adults respectively?

A: The Comirnaty-Pfizer-BioNTech Pfizer vaccine dose is 10 µg/dose for children aged 5 to 11 years, different from that for children over 12 years and adults which is 30 µg/dose.

11. How many doses of vaccine will the child aged between 5 and 11 years receive?

A: The complete vaccination schedule includes 2 doses of the Comirnaty-PfizerBioNTech vaccine, of 10 µg/dose, which will be administered intramuscularly at 21-day intervals. For a special category of children, with severe immunosuppression, the third dose can be administered at an interval of at least 28 days after the second dose.

12. Are there concerns about the occurrence of myocarditis or pericarditis after administration of a COVID-19 mRNA vaccine in children aged 5-11 years?

A: Clinical evolution of post-vaccination myocarditis, according to the data
published up to this point was favorable compared to myocarditis associated with SARS-CoV-2 infection.

SARS-CoV-2 infection is associated with a 30-fold increased risk of myocarditis in children under the age of 16, according to the US Centers for Disease Control and Prevention (CDC).

13. The child has just received another vaccine. Can he still get a COVID-19 vaccine? Can the child be vaccinated simultaneously with the flu vaccine and the vaccine against COVID-19?

A: Vaccines against COVID-19 can be administered simultaneously or at any time interval with another vaccine included in the National Vaccination Program intended for children and population groups at risk (influenza vaccination, antiHPV vaccination), tetanus prophylaxis or other vaccine products that have marketing authorization in Romania.

14. Is it indicated to vaccinate children aged between 5-11 years if they have experienced the disease?

A: Vaccination against COVID-19 is recommended for all people aged 5 years and older, regardless of whether they have historically presented an asymptomatic or symptomatic form of infection with the SARS-CoV-2 virus.

15. Can the child receive the vaccine if he has a history of food allergies, hives, anaphylactic shock?

A: The child should get the vaccine unless the child had a severe allergic reaction to a previous dose of the COVID-19 vaccine or has an allergy to one of the vaccine ingredients (eg, polyethylene glycol).

If your child has a history of a severe allergic reaction or uses an Epi-pen, please let the medical staff know on the day of the appointment.

16. In the situation where a child is diagnosed with asymptomatic or symptomatic COVID-19 after the first dose of the vaccine, can the second dose be administered?

A: The second dose of the COVID-19 vaccine can be administered after recovery from the illness and exit from the isolation period.

17. The child has a hematologic condition (eg, idiopathic thrombocytopenic purpura, hemophilia, etc.). In this situation, can the child receive a vaccine against COVID-19?

A: Having a bleeding/clotting disorder is not a reason to avoid vaccination.

Before deciding on vaccination against COVID-19, a specialist consultation (pediatric hematologist) is recommended to receive the most correct recommendations.

18. Is it true that vaccines against COVID-19 can affect fertility? Is there any evidence for this?

A: There is currently no scientific evidence to support this hypothesis.
The appointment will only be made in the vaccination centers found in
platform called P_Ped, through the accounts of parents or legal representatives. At the moment, 219 pediatric vaccination clinics are configured in the scheduling platform nationwide.

Vaccination can also be done without an appointment, through direct presentation in the offices of vaccination centers dedicated to children or in the offices of family doctors who have requested pediatric doses, throughout the working hours. Also, the National Electronic Register of Vaccinations (RENV) is optimized and allows

data processing for this category eligible for vaccination.