With the start of the Covid vaccine to children, the question of whether Biontech vaccine can be administered to children with allergic diseases such as asthma, allergic rhinitis and eczema comes to mind. Founder of Istanbul Allergy, Allergy and Asthma Association President Prof. Dr. Ahmet AKÇAY made statements on the subject. Why is the Covid vaccine so important? What is the Biontech vaccine? How do children pass the Covid infection? Why is it so important to vaccinate children and adolescents? Which Covid vaccine can be given to children? Is the Biontech vaccine approved for children? Is the Biontech vaccine effective in children? What are the Allergy Risks of the Biontech Vaccine? Which Vaccine Should Those With Allergic Diseases Get? Can People with Drug Allergies Have the BioNTech Vaccine?
Why is the COVID vaccine so important?
As of May 21, 2021, the coronavirus disease 2019 (Covid-19) pandemic has caused more than 165 million infections of all ages and more than 3.4 million deaths worldwide. Vaccination is very important to prevent deaths and ensure community immunity. The transmission of the virus in unvaccinated children and adults, the mutation of the virus puts those who are vaccinated in the future at risk.
What is the Biontech vaccine?
The Pfizer–BioNTech vaccine is a Covid-2 vaccine containing nucleoside-modified messenger RNA encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19) spike glycoprotein.
How do children get the COVID infection?
Children generally have a milder coronavirus infection than adults and have a lower risk of intensive care. Sometimes very severe reactions and fatal reactions may develop. Therefore, it is not always mild in children. It is more severe especially in children with chronic diseases and immune system problems. The main problem in children is that they can be carriers, the virus changes shape with mutations, the effectiveness of current vaccines decreases and they transmit the infection to risky groups.
Why is it so important to vaccinate children and adolescents?
The CDC recommends that everyone 12 years of age and older get the COVID-19 vaccine to help protect against COVID-19. Widespread vaccination is a critical tool to help stop the pandemic. People who are fully vaccinated can continue the activities they did before the pandemic.
Vaccination of children and adolescents is very important to ensure herd immunity rather than the risk of severe infection. Because children and adolescents do not want to stay at home. He wants to go to school more comfortably, play and travel. Due to these social activities, it is easier for them to spread the virus to the environment because they are often infected and the symptoms are not so obvious. We all know that teenagers usually don't want to listen to their parents much. They will not take the necessary protective measures. This will contribute to the spread of the disease. It also provides transmission to people in the house. This can cause risky people at home to have severe infections. Adolescents may play an important role in transmission of SARS-CoV-2. Thus, vaccines can prevent disease and contribute to herd immunity. Although children and adolescents generally have milder Covid-19 than adults, serious illness can occur in this population, especially those with underlying medical conditions.
Help Protect Your Child and Family
Getting the COVID-19 vaccine can help prevent your child from contracting COVID-19. Early information shows that vaccines could help prevent people from spreading COVID-19 to others. They can also help prevent your child from getting seriously ill, even if they contain COVID-19. Help protect your entire family by vaccinating yourself and your children aged 12 and over against COVID-19.
Which COVID vaccine can be given to children?
Biontech vaccine is the only approved vaccine after completing the phase 3 study for the COVID vaccine for children. Sinovac vaccine completed phase 13 and phase 18 studies for 1-2 years old and was found to be effective. With the completion of the phase 3 study in the near future, it seems that this vaccine will start to be given to children under the age of 18.
Is the Biontech vaccine approved for children?
In the phase 16-1 part of an ongoing global, phase 2-3-2 randomized, controlled trial involving participants aged 3 years or older, BNT162b2 had a favorable safety profile characterized by transient mild to moderate injection site pain, fatigue, headache and It was 2% effective in preventing Covid-7 19 days after the 95nd dose. Based on these findings, BNT162b2 received an emergency use authorization for Covid-19 from the Food and Drug Administration for people aged 11 years and older on December 2020, 16. Pfizer conducted a phase 3 study of the Biontech vaccine in children aged 12-15 and 16-25 years. The study was positive. On May 10, 2021, emergency use authorization was extended to persons 12 years of age or older based on the data presented in this report. Other vaccines against SARS-CoV-2 are authorized for emergency use; however, BNT162b2 is currently the only vaccine permitted for use in persons younger than 16 years of age.
Is the Biontech vaccine effective in children?
As a result of the Biontech vaccine study conducted in children and adolescents aged 12-15 and 16-25, the effectiveness of the vaccine, which was administered in two doses, was 100%. Adolescents developed antibodies at a higher rate than younger adults. Finally, the favorable safety and side-effect profile and high efficacy combined with an acceptable risk-benefit ratio in adolescents now justify vaccine evaluation in younger age groups. Immunization of adolescents is likely to provide the direct benefit of disease prevention as well as indirect benefits, including protecting the community.
What are the side effects?
Among participants aged 12-15 years, adverse events occurring up to 1 month after vaccination were reported as 3%, among those aged 16-25%, 6%. Serious adverse events were reported in 12% of 15- to 0,6-year-olds and 16% of 25- to 1,7-year-olds who received the Biontech vaccine.
Younger children have less fever, fatigue and headache side effects.
pain at the injection site
The side effect of pain at the injection site was generally mild to moderate and typically tends to resolve within 1-2 days. In the 12-15 and 16-25 age groups, pain at the injection site was the most common adverse event.
Headache and fatigue
Headache and fatigue were the most frequently reported systemic events in both age groups. While fatigue was 60% and headache 54% after the first dose, slightly more after the second dose.
While 7-10% of Biontech vaccines were after the first dose, after the second dose, fever occurred in 2% of 12-15 year olds and 20% of 16-25 year olds. In very small proportions, some enlargement of the lymph nodes has occurred. Side effects such as muscle pain, joint pain, vomiting and diarrhea can also be seen. Thrombosis (clots or hypersensitivity side effects) or vaccine-related anaphylaxis (allergic shock) were not observed.
As a result, pain at the injection site, fatigue, headache and fever are common side effects after vaccination. It usually resolves within a day or two. It may be helpful to use painkillers containing paracetamol for pain and fever.
Myocarditis and Pericarditis CDC Monitoring Reports
The CDC has received increased reports of myocarditis and pericarditis in adolescents and young adults after COVID-19 vaccination. The known and potential benefits of the COVID-19 vaccine outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis. It continues to recommend the COVID-12 vaccine to anyone aged 19 years and older.
What are the Allergy Risks of the Biontech Vaccine?
Allergic reactions to vaccines are usually due to additives and ingredients in the vaccine, such as preservatives and antibiotics, rather than the active ingredient itself. Vaccines may also contain small amounts of protein, depending on the manufacturing process.
For the BioNTech vaccine, severe allergic reactions have been observed in approximately eleven cases per million doses of vaccine. According to a report from the U.S. Centers for Disease Control and Prevention, 71% of these allergic reactions developed within 15 minutes of vaccination and mostly (81%) occurred in people with a history of an allergy or allergic reaction.
It is thought that the cause of allergic reactions to the vaccine may be due to the polyethylene glycol (PEG) substance used to prevent the degradation of the mRNA in the BioNTech vaccine and to make it dissolve in water. It is also thought that the mRNA itself may cause allergies. Although the cause of the allergy is thought to be related to the PEG substance or mRNA substance, this has not been clearly demonstrated in scientific publications. In a newly published article, in the follow-up of 4 cases reported as allergic shock, it was reported that this condition was not allergic shock, but cases mimicking allergic shock.
Which Vaccine Should Those With Allergic Diseases Get?
It is okay for people with allergic asthma, eczema, allergic rhinitis, food allergy and other allergic diseases to have the BioNTech vaccine. It would be beneficial for only those who have allergic diseases to have their vaccinations in the hospital environment and to wait under observation for 30 minutes after vaccination.
For those with drug allergies, the BioNTech vaccine has a higher risk of allergy. For this reason, it would be beneficial for those who have had an allergic reaction to the tablet form of the drugs, and those whose drug allergy has not been determined, should be evaluated by allergy specialists in terms of allergy to polyethylene glycol before receiving the BioNTech vaccine.
Classifying vaccines as low, medium and high in terms of allergy development potential may be helpful in deciding on vaccine selection.
Allergic diseases with a low risk of developing allergy to BioNTech vaccines include:
- Having a family history of allergic diseases
- Those with asthma, allergic rhinitis and eye allergies due to respiratory allergies such as house dust mite, pollen, mold,
- Those with food allergies
- Those with eczema (atopic dermatitis),
- Those who have allergy shots,
- Those who take biological therapy such as anti IgE, anti IL-5 due to asthma,
- Those who are allergic to pain relievers such as salicylic acid, ibuprofen,
- Those who have previously been allergic to certain drugs and bee venom,
- Those who have developed swelling at the vaccination site in previous vaccinations.
There is no harm in having the BioNTech vaccine for those who have the allergic disease mentioned above, and it will be sufficient to wait for 15-30 minutes under surveillance in the hospital environment after the vaccination. There is no harm in administering the BioNTech vaccine to those who have a low risk of developing allergy to vaccines.
Allergic diseases with a moderate risk of developing an allergy to the BioNTech vaccine include:
- If you are allergic to drugs and the cause of drug allergy cannot be determined, but severe allergy or allergic shock has developed against drugs (there may be a PEG allergy),
- Those who have previously developed an allergic reaction to vaccines and monoclonal antibodies such as omalizumab,
- Those with mast cell disease such as systemic mastocytosis.
In these cases, there is a risk of PEG allergy and should be examined by allergy specialists for PEG allergy. If the vaccine is to be administered, it should be waited under hospital supervision for 30 minutes after the vaccination. There is no information yet on whether it would be beneficial to use antihistamines to prevent the development of allergic reactions before treatment. The use of antihistamines before treatment may hide the first signs of allergic shock. Therefore, it is difficult to make a decision about the use of antihistamines before each vaccine.
- It would be beneficial for those with moderate allergy risk to have their vaccinations in the hospital environment and to wait at least 45 minutes after vaccination.
Allergic diseases with a high risk of developing allergy to the BioNTech vaccine include:
If an allergic reaction has developed to the Pfizer BioNTech vaccine, which was previously mRNA vaccines, the second dose of the vaccine should not be given.
Can People with Drug Allergies Have the BioNTech Vaccine?
There have been cases of allergic reactions to the BioNTech and other mRNA vaccine, the Moderna vaccine. Since it is thought that the cause of allergy to these vaccines may be related to the PEG substance, which is the preservative in the vaccine, it will be safer for those who are allergic to PEG-containing drugs not to have the BioNTech vaccine. If the cause of drug allergy is not due to a drug containing PEG, then the risk of developing an allergy will not be high. If you do not know whether the cause of your drug allergy is due to the PEG substance, it may be useful to consult your doctor and, if necessary, to do an allergy test to the PEG substance before the vaccine.
Can a Pre-Vaccine Allergy Test Detect a Vaccine Allergy Develops?
Allergy tests against PEG can be performed to predict the risk of allergy before vaccination. It may be useful to make a decision based on the test result.
How Do I Know If I Have Developed A Vaccine-induced Allergic Shock?
Allergic shock most commonly affects the skin, heart and circulatory and respiratory systems. In the case of allergic shock, the following symptoms may occur:
- Skin rash, redness, itching,
- Swelling of the tongue and lips,
- Hoarseness as a result of swelling in the larynx and narrowing of the bronchi,
- Shortness of breath and asthma,
- Lowering blood pressure as a result of affecting the heart circulation,
- heart beat fast,
- As a result of fainting, involvement of the digestive system, abdominal pain symptoms in the form of vomiting and cramps occur.
An important information to keep in mind is that allergic shock can develop without skin manifestations. This situation is especially common in older ages.
Care should be taken for early signs of allergic shock after vaccination. If symptoms such as tickling in the throat, cough, cold, sneezing, dizziness, abdominal pain developed within 30 minutes after vaccination, it would be beneficial to inform the health personnel.
What are the conditions that mimic the symptoms of allergic shock?
Allergic shock symptoms after vaccination can be seen as a result of some non-allergic reactions. These reactions may be due to fainting due to the activation of the autonomic nervous system called vasovagal syncope. Vasovagal syncope disease can occur due to anxiety, fear, pain, hot and humid environment, long standing. It is manifested by a sudden drop in blood pressure and a low heart rate.
Vocal cord spasm can cause wheezing and shortness of breath.
Psychosomatic symptoms can sometimes mimic allergic shock. As in panic attack allergic shock, sudden shortness of breath may mimic allergic shock. For example, it can cause redness in the body due to psychological stress. Sometimes it can cause a feeling of swelling in the throat and tongue. Adrenaline should not be avoided if allergic shock is suspected.
What to Do If Allergy to the Vaccine Has Developed?
Those who develop allergy to the vaccine should be treated very quickly. Life-saving adrenaline should be administered first. It is necessary to use a glucagon drug, since adrenaline will not be effective, especially in those who use beta-blocker blood pressure medication. For this reason, it is very important to have glucagon drug available in vaccination centers.
What can be done about vaccination in allergy sufferers?
-It would be more appropriate to check whether protective antibodies have developed in those who have had a reaction after the first dose, and not to apply the second dose if sufficient protective antibodies have developed.
To summarize in conclusion:
- The Biontech vaccine is the only FDA-approved vaccine between the ages of 12-18.
- Vaccination of children and adolescents is important for ensuring herd immunity and preventing transmission.
- The effectiveness of the Biontech vaccine in children is 100%.
- The most common side effects of the vaccine are pain at the injection site, fatigue, headache, and fever. In addition, vomiting, diarrhea, muscle pain, joint pain, chills can be seen as side effects.
- The side effects of the vaccine usually resolve within a day or two, and rarely severe fever and headache may develop.
- Side effects such as blood clots and allergic shock were not observed in the phase 3 study.
- If children with allergic diseases such as asthma, allergic rhinitis, eczema, food allergy, and bee allergy do not have a history of allergy to drugs containing PEG, BioNTech vaccine can be administered.
- It would be a more correct approach to make a vaccination decision by performing allergy testing against PEG substance before vaccination in children with drug allergy containing PEG.