January 17, 2022
This FAQ from American College of Allergy, Asthma and Immunology is provided to help answer patient questions about COVID-19 vaccines. These recommendations are based on best knowledge to date, but could change at any time, pending new information and further guidance from the FDA or CDC.
Originally posted September 29, 2021; Most recently updated: January 17, 2022
A: Preventing infection is essential to ending the current pandemic. A COVID-19 vaccine helps to generate immunity to the SARS-CoV-2 virus (the virus that causes COVID-19), decreasing the risk of infection with exposure.
Currently, three COVID-19 vaccines are available in the United States.
Two of the vaccines, the Pfizer/BioNTech and the Moderna, contain messenger RNA that encodes the spike protein that the SARS-CoV-2 virus uses to attach to human cells during infection. Both vaccines require two doses three or four weeks apart to achieve an optimal immune response. When muscle cells take up the mRNA and express the spike protein, it stimulates the immune system to make antibodies against it, making recipients less susceptible to contracting the SARS-CoV-2 virus.
A third vaccine for COVID-19 is made by Johnson & Johnson (J&J) and uses an adenoviral vector that cannot replicate and contains DNA for the spike protein. Then, as with the mRNA vaccines, the muscle cells produce the spike protein which stimulates the immune system to make protective antibodies. This vaccine only requires a single dose.
A: It is not possible to get COVID-19 from any of the available vaccines. The mRNA vaccines encode only the information for the spike protein of the virus. Similarly, the J&J uses an adenovirus vector which codes for the same spike protein as the mRNA vaccines. Vaccines undergo rigorous testing through clinical trials to ensure they are safe and effective for those who receive them. The COVID-19 vaccines are being held to the same rigorous safety and effectiveness standards as all other types of vaccines in the United States.
Most side effects, if any, are similar to other vaccines, including soreness at the injection site, muscle aches, fatigue, or mild fever.
A: More than 519 million doses of COVID-19 vaccines have been given in the United States through early January 2022. The vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.
The safety monitoring has identified several, yet very rare, types of health problems after vaccination including:
1. Anaphylaxis (after mRNA vaccines)
A recent study looked at 8,940 anaphylaxis cases post COVID-19 vaccination from the U.S. Vaccine Adverse Event Reporting System and the European EudraVigilance for 32 weeks ending August 8, 2021. The mean anaphylaxis rates per licensed COVID-19 vaccine were as follows:
Moderna: 8.58 cases per 10 million vaccines
Pfizer: 10.44 cases per 10 million vaccines
J&J: 7.99 cases per 10 million vaccine doses
These rates are similar to the incidence of anaphylaxis associated with other vaccines, which is 1.3 per 1 million doses.
The CDC has provided recommendations for COVID 19 vaccine providers about how to prepare for the possibility of a severe allergic reaction. All people who get a COVID 19 vaccine are required to be monitored on site. People who have a history of severe allergic reactions to vaccines or other injectable therapy are monitored for at least 30 minutes after getting the vaccine. All other people are monitored for at least 15 minutes after getting the vaccine.
2. Thrombosis with Thrombocytopenia Syndrome (TTS) – a syndrome of blood clots occurring with low platelets (after J&J)
TTS has occurred after receiving the J& J/Janssen COVID 19 vaccine and not after the mRNA vaccines at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years or older and men of all ages, this adverse event is even more rare.
3. Myocarditis and Pericarditis (mRNA vaccines)
The FDA issued a warning in June 2021 about heart inflammation. According to the CDC, as of December 16, 2021, VAERS has received 1,947 preliminary reports of myocarditis or pericarditis among people ages 30 years and younger who received COVID-19 vaccines. These reports occur more often after getting the second dose than after the first dose of one of the two mRNA vaccines. Symptoms typically occur within several days after vaccination and patients have been able to return to their normal daily activities after their symptoms improve. Because the known and potential benefits of COVID 19 vaccination outweigh the known and potential risk, including the possible risk for myocarditis or pericarditis, the CDC continues to recommend COVID-19 vaccination for everyone 5 years of age and older.
4. Guillain-Barre Syndrome
There’s a possible, but rare risk in developing Guillain-Barre syndrome after the Johnson and Johnson vaccine. According to the CDC, after more than 17.2 million J&J/Janssen COVID-19 vaccine doses were administered, there have been around 283 preliminary reports of GBS identified in VAERS as of December 16, 2021. These cases have largely been reported about 2 weeks after vaccination and mostly in men, many in those ages 50 years and older. Analysis found no increased risk of GBS after Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines).
Although these are the first mRNA vaccines licensed for use, researchers have been studying and working with mRNA vaccines for decades. mRNA vaccines have been studied for flu, Zika, rabies, and cytomegalovirus and no safety concerns were identified.
The following chart may prove helpful:
CDC note: In most situations, Pfizer-BioNTech or Moderna COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for primary and booster vaccination.
|VACCINE DEVELOPER:||PFIZER||MODERNA||JOHNSON & JOHNSON/JANSEN|
|Mechanism||Messenger RNA||Messenger RNA||Inactivated adenovirus|
|Approval date||December 11, 2020||December 18, 2020||February 27, 2021|
|Who is it approved for?||5 years and older||18 years and older||18 years and older|
|How many doses are needed?||2 doses, 3 weeks apart||2 doses, 4 weeks apart||One dose|
|When is full vaccination status achieved?||2 weeks after the 2nd dose||2 weeks after the 2nd dose||2 weeks after the dose|
|Boosters for Immunocompromised||3rd dose, at least 28 days after second dose||3rd dose, at least 28 days after second dose||Not approved|
|Boosters for Others||Everyone ages 18+ who received an original Pfizer COVID-19 vaccine series should receive a COVID-19 booster shot 5+ months after their initial series. Any of the COVID-19 vaccines authorized in the U.S. is allowed for the booster.
Teens 12–17 years old can get a Pfizer-BioNTech COVID-19 vaccine booster 5+ months after their initial series.
|Everyone ages 18+ who received an original Moderna COVID-19 vaccine series should receive a COVID-19 booster shot 5+ months after their initial series. Any of the COVID-19 vaccines authorized in the U.S. is allowed.||Everyone ages 18+ who received a J&J primary vaccine should receive a COVID-19 booster shot >= 2 months after their initial dose. Any of the COVID-19 vaccines authorized in the U.S. is allowed.|
|Are there any warnings?||The FDA issued a warning in June 2021 about heart inflammation. As of Dec. 16, 2021, there have been more than 1,900 reports of myocarditis and pericarditis..||The FDA issued a warning in June 2021 about heart inflammation. As of Dec. 16, 2021, there have been more than 1,900 reports of myocarditis and pericarditis.||In July, 2021, the FDA issued a warning about an increased risk for developing Guillain-Barre syndrome. TTS has occurred after receiving the J&J COVID-19 vaccine and not after the mRNA vaccines at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old.|
|Contraindications to getting a COVID 19 vaccination||People with a history of serious allergic reactions, anyone with a history of reactions to vaccine ingredients, including polyethylene glycol, and anyone with a history of allergic reactions to polysorbate||People with a history of serious allergic reactions, anyone with a history of reactions to vaccine ingredients, including polyethylene glycol, and anyone with a history of allergic reactions to polysorbate||Anyone who has had an allergic reaction to an ingredient in the vaccine, like polysorbate|
|Vaccine performance against emerging variants – alpha, beta, gamma, and delta||Highly effective against hospitalization and death for a variety to strains. Data suggest lower effectiveness against confirmed infection and symptomatic disease caused by the Beta, Gamma, and Delta strains compared with the Alpha variant.||Highly effective against hospitalization and death for a variety to strains. Data suggest lower effectiveness against confirmed infection and symptomatic disease caused by the Beta, Gamma, and Delta strains compared with the Alpha variant.||Effectiveness against variants currently being studied. An August 2021 study of South African health care workers showed 71% efficacy against hospitalization and 96% efficacy in preventing death from COVID-19.|
|Acquisition and transmission data for fully vaccinated people||Current evidence indicates that fully vaccinated people are less likely than unvaccinated people to acquire SARS-CoV-2 or transmit it to others.||Current evidence indicates that fully vaccinated people are less likely than unvaccinated people to acquire SARS-CoV-2 or transmit it to others.||Currently being studied.|
A: Antibody tests for COVID-19 look for the presence of antibodies made in response to a previous infection or vaccination. They are an indicator of the body’s efforts to fight off the SARS-CoV-2 virus. None of the currently authorized SARS-CoV-2 antibody tests have been validated to evaluate specific immunity or protection from SARS-CoV-2 infection.
Antibody testing is NOT currently recommended to assess:
- Immunity to COVID-19 following COVID-19 vaccination
- The need for vaccination in an unvaccinated person
There are several issues to consider when interpreting an antibody test for SARS-CoV-2 infection:
- Scientists have not yet established a serologic correlate of protection, which is the measurable threshold above which a person is protected against SARS-CoV-2 infection. This makes it difficult to interpret how laboratory results might translate to clinical protection.
- Antibody testing does not evaluate the cellular immune response, which may also play a role in vaccine-mediated protection.
- Vaccines trigger antibodies to specific viral protein targets. Currently authorized COVID-19 vaccines induce antibodies to the spike protein but not to the nucleocapsid protein, which is likely detected only after a natural infection with SARS-CoV-2. Therefore, COVID-19-vaccinated people who have not had previous natural infection will receive a negative antibody test result if the antibody test is designed to detect nucleocapsid protein.
- Antibody tests have different levels of sensitivity (i.e., the true positive rate, or ability to identify people with antibodies to SARS-CoV-2) and specificity (i.e., the true negative rate, or ability to identify those without antibodies to SARS-CoV-2).
In general, a patient is considered fully vaccinated ≥2 weeks after a 2-dose mRNA COVID-19 vaccine series or ≥2 weeks after a single dose of Janssen COVID-19 Vaccine.
CDC note: In most situations, Pfizer-BioNTech or Moderna COVID-19 vaccines are preferred over the Janssen COVID-19 Vaccine for primary and booster vaccination.
For moderately to severely immunocompromised people who originally received two mRNA COVID-19 vaccines, the CDC recommends a third mRNA COVID-19 vaccine dose. CDC recommends the third dose be administered at least four weeks after a second dose of Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine. Additionally, individuals in this group may receive a single COVID-19 booster dose (Pfizer-BioNTech, Moderna or J&J) at least 5 months after completing their third mRNA vaccine dose.
For moderately to severely immunocompromised people who originally received a single J&J vaccine, the CDC recommends a single COVID-19 booster vaccine (Pfizer-BioNTech, Moderna or J&J) at least 2 months (8 weeks) after receiving their initial J&J primary dose.
CDC recommendations apply to people who have:
- Been receiving active cancer treatment for tumors or cancers of the blood.
- Received an organ transplant and are taking medicine to suppress the immune system.
- Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system.
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome).
- Advanced or untreated HIV infection.
- Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
The CDC recommends people talk to their health care provider about their medical condition, and whether getting an additional dose is appropriate for them. The CDC has recommendations for providers to use when talking with patients who are immunocompromised about a third dose of an mRNA vaccine.
According to the CDC, individuals ages 18+ who originally received either a Pfizer-BioNTech or Moderna COVID-19 vaccine series should receive a COVID-19 booster shot (Pfizer-BioNTech, Moderna or J&J) at 5+ months after their initial series.
Additionally, teenagers ages 12-17 may get a Pfizer-BioNTech COVID-19 vaccine booster at 5+ months after their initial series.
According to the CDC, for people who received the Johnson & Johnson COVID-19 vaccine, booster shots (Pfizer-BioNTech, Moderna or J&J) are recommended for those who are 18 and older and who were vaccinated two or more months ago.
A: The CDC doesn’t consider asthma or inhaled corticosteroids for asthma as leading to an immunocompromised state. There’s no data to suggest that biologics and/or inhaled corticosteroids have any effect (good or bad) on response to a COVID vaccine including a booster injection. Only patients on daily oral corticosteroids of 20mg or more are considered immunocompromised by the CDC.
A: Herd immunity is a term used to describe when enough people have protection – either from previous infection or vaccination – that it is unlikely a virus or bacteria can spread and cause disease. As a result, everyone within the community is protected even if some people don’t have any immunity themselves. The percentage of people who need to have protection to achieve herd immunity varies by disease. Experts estimate that at least 70% of the population would need to have immunity, either through infection or vaccination, to achieve herd immunity to COVID-19. The emergence of variants with a higher transmission rate will cause the percentage of the population who need to have immunity to increase.
A: Yes, it is very important to get the influenza vaccine, particularly since influenza can cause symptoms similar to COVID-19. Reducing the number of people who get severe influenza and require hospitalization will also help ensure that the health care system, hospitals, and intensive care units will not be overwhelmed should there be an increase in COVID-19 cases during flu season. According to the CDC, COVID-19 vaccines and other vaccines may now be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccines and other vaccines on the same day, as well as coadministration within 14 days.
A: The CDC strongly recommends everyone age 5 or older get a COVID-19 vaccination as soon as possible.
The College recognizes that COVID 19 vaccines are safe and effective at preventing COVID 19 disease, especially severe illness, hospitalizations, and death. And that COVID 19 vaccines reduce the risk of people spreading the SARS CoV 2 virus. The efficacy of the vaccines clearly outweighs any risk associated with receiving the vaccines.
Getting Vaccinated and Contraindications
A: According to the CDC, people who have had an immediate allergic reaction, even if it was not severe, to a vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies [excluding subcutaneous immunotherapy for allergies , i.e. “allergy shots”] not related to a component of mRNA COVID-19 vaccines or polysorbate), should consult their physicians to determine if they should get a COVID-19 vaccine. The CDC states this is a precaution and not a contraindication.
According to the CDC, COVID-19 vaccines and other vaccines may now be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccines and other vaccines on the same day, as well as coadministration within 14 days. Following reports of a small number of patients experiencing anaphylaxis after getting an mRNA COVID-19 vaccine, the CDC issued guidance related to the mRNA COVID-19 vaccines and severe allergic reactions. ACAAI also published guidance on the risk of allergic reactions to mRNA COVID-19 vaccines.
Patients who have an immediate (<4 hours) or severe allergic reaction to the first dose of the mRNA COVID-19 vaccine should not receive the second dose.
The mRNA COVID-19 vaccines should not be administered to individuals with a known history of a severe allergic reaction to any component of the vaccine. Although the specific vaccine component causing anaphylaxis has not been identified, polyethylene glycol (PEG) is one of the ingredients in these vaccine products and has been known to cause anaphylaxis. The J&J vaccine should not be administered to individuals with an immediate allergic reaction to any ingredient in the vaccine (such as polysorbate).
Patients who have had COVID-19 and received monoclonal antibodies or convalescent serum to treat COVID-19 should wait 90 days before getting the vaccine.
A: The CDC recommends individuals discuss this with their doctor. After taking a detailed history, allergists will have a risk/benefit discussion with their patient and if the patient has no contraindications to the J&J vaccine, may recommend their patient use J&J as a booster vaccination; however, there is no current data on the efficacy or safety of using the J&J vaccine this way.
A: The Pfizer and Moderna COVID-19 vaccines require two doses. The J&J vaccine requires one dose.
A: The Pfizer COVID-19 vaccine dosing schedule recommends the second dose be given 21 days after the first dose (with a 4-day grace period). The Moderna vaccine schedule recommends the second dose be given 28 days after the first shot. If it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose.
A: The efficacy of a single dose of the approved vaccines is much lower than if a patient receives the recommended 2 injections. Protection offered by a single dose of vaccine has been estimated to be at 50%, and the second dose increases this to more than 90%.
A: Yes, if possible. According to the CDC, every effort should be made to determine which vaccine product was received as the first dose, to ensure completion of the vaccine series with the same product. In exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. If two doses of different mRNA COVID-19 vaccine products are administered, no additional doses of either product are recommended.
A: Yes, according to the CDC, COVID-19 vaccination should be offered regardless of whether an individual has already had COVID-19 infection. An antibody test is not required prior to vaccination. Current evidence suggests that reinfection with the virus that causes COVID-19 is uncommon in the 90 days after the initial infection. However, experts don’t know how long this protection lasts, and the risk of illness and death from COVID-19 far outweighs any benefits of natural immunity. It also appears that vaccination offers better protection and reduced transmission of the COVID-19 than the immunity that comes from having COVID-19 (natural immunity). However, anyone currently infected with COVID-19 should wait to get vaccinated until after their illness has resolved and after they have met the criteria to discontinue isolation.
If you were treated for COVID-19 with monoclonal antibodies or convalescent plasma, you should wait 90 days before getting a COVID-19 vaccine.
A: The COVID-19 vaccines will not influence the results of PCR or antigen testing for the disease. The vaccines generate antibodies to SARS-CoV-2, which are directed at the spike protein. Some available serologic assays test for this antibody; others do not. The manufacturers of the individual antibody tests should be able to provide this information, and it is often listed in the package insert.
A: When to get the second dose of COVID-19 vaccine is multifactorial and depends upon the medications used to treat the COVID-19 infection. This decision should be made using a shared decision-making model with a provider.
According to the CDC, prior receipt of an mRNA COVID vaccine should not affect treatment decisions including the use of monoclonal antibody therapy, convalescent plasma, antiviral treatment, or corticosteroid administration.
Currently, there are no data on the safety and efficacy of mRNA COVID-19 vaccines in people who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Based on the estimated half-life of such therapies as well as evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days, as a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses. This recommendation applies to those who receive passive antibody therapy before receiving any vaccine doses. It also applies to those who receive passive antibody therapy after the first dose but before the second dose, in which case the second dose should be deferred for at least 90 days following receipt of the antibody therapy.
If no monoclonal antibody therapy is administered, then a booster dose can be administered after recovery from COVID-19 and the isolation period has ended.
A: Having had dermal filler injections is not a contraindication for mRNA vaccine administration. People who have received dermal fillers may develop swelling at or near the site of the filler injection following administration of an mRNA COVID-19 vaccine. The symptom is temporary and treatable and has been seen with other vaccines.
A: COVID-19 vaccine may be administered to people with underlying medical conditions who have no contraindications to vaccination. In fact, clinical trials demonstrated similar safety and efficacy profiles in people with some underlying medical conditions, including those that place them at increased risk for severe COVID-19. The risks and benefits should be discussed with the individual patient depending on their underlying medical condition.
Patients with a history of Guillain-Barre syndrome within six weeks of vaccine should avoid the same vaccine. GBS not associated with a vaccine is not a contraindication nor precaution for receiving the COVID-19 vaccine. Bell’s palsy is not a contraindication to receiving the vaccine.
A: Revaccination is not currently recommended after immune competence is regained in people who received COVID-19 vaccines during chemotherapy or treatment with other immunosuppressive drugs.
A: The protection someone gains from having an infection (called natural immunity) varies depending on the disease, and it varies from person to person. Since this virus is new, we don’t know how long natural immunity might last but is variable among individuals. Some evidence suggests natural immunity can last at least 6 to 8 months and, perhaps, up to a year. There have been cases where individuals have been shown to be infected twice, but most often the second illness was mild or without any symptoms. This is what we would expect with an immune response that protects against disease but not infection.
Vaccination after recovery from a COVID infection provides up to 50 times more immunity than natural infection, so getting the vaccine is important, even if you have had the infection.
We do not know how long protection will last following vaccination in uninfected people, but early evidence suggests it lasts at least six months in most people. It may not have the same duration of benefit in certain population, such as the elderly or others with impaired immunity.
Booster shots are recommended for the immunocompromised at this time, along with certain other populations who received the Pfizer vaccines. Approval for booster shots for Moderna and Johnson & Johnson vaccines is expected in the future once additional data is available. It continues to be critically important to monitor long-term protection in various groups of people.
A: Everyone should cover their mouth and nose with a mask when around others (except those under 2 years of age or with medical conditions that prevent wearing a mask); avoid close contact with people who are sick; stay six feet away from others; avoid crowds; and wash their hands often. Get more information about these and other steps you can take to protect yourself and others from COVID-19.
A: There is no cost. The shots are free to everyone, even if you don’t have health insurance. The federal government is covering the cost.
A: According to the CDC, to maximize protection from the Delta variant and prevent possibly spreading it to others, wear a mask indoors in public if you are in an area of substantial or high transmission regardless of vaccination status. Please note that these recommendations from the CDC don’t apply to healthcare settings including doctor’s offices and hospitals; transportation hubs like airports and train stations; correctional facilities and homeless shelters. In those settings, masks should always be worn.
More information can be found at CDC: When you’ve been fully vaccinated and CDC: Interim Public Health Recommendations for Fully Vaccinated People.
A: The side effects have been similar to other routine vaccines – sore arm, redness at the site of the vaccine, fatigue, fever, chills, headache, muscle pain and joint pain. The side effects are temporary and mostly mild or moderate. Side effects may be worse after the second dose in some.
A recent study looked at 8,940 anaphylaxis cases post COVID-19 vaccination from the U.S. Vaccine Adverse Event Reporting System and the European EudraVigilance for 32 weeks ending August 8, 2021. According to the study, the mean anaphylaxis rate was estimated at 10.67 cases per 10 million doses of COVID-19 vaccines. This compares to 1 in 1,000,000, which is the incidence of anaphylaxis associated with other vaccines. At this time there is no vaccine that is preferred in a patient with a history of severe allergic reactions. The National Institutes of Health is launching a study to understand these allergic reactions better, and the FDA and CDC are also closely monitoring.
Because of reports of anaphylactic reactions in people vaccinated outside of clinical trials, the additional following guidance has been suggested by the CDC:
- A severe allergic reaction to any vaccine or injectable therapy (intramuscular, intravenous or subcutaneous) is a precaution to vaccination at this time and patients should discuss the risks and benefits with an allergist/immunologist.
- Vaccine providers should observe patients after vaccination to monitor for the occurrence of immediate adverse reactions. Anyone with a history of anaphylaxis is advised to wait 30 minutes and all others should wait at least 15 minutes.
A recent study showed that of 189 patients who had an allergic reaction to mRNA vaccine (32 or 17% with anaphylaxis), all 159 patient who received a second dose tolerated the vaccine. Sites administering the vaccine should have healthcare personnel who are trained and qualified to recognize anaphylaxis and the medications and supplies necessary to assess and manage an allergic reaction.
A: The CDC and FDA encourage the public to report possible side effects (called adverse events) to the Vaccine Adverse Event Reporting System (VAERS). This national system collects data to look for adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns of occurrence. Health care providers are required to report certain adverse events following vaccination to VAERS. Health care providers also have to adhere to any revised safety reporting requirements according to the FDA’s conditions of authorized use throughout the duration of any Emergency Use Authorization; these requirements are posted on the FDA’s website.
The CDC is also implementing a new smartphone-based tool called v-safe to check in on people’s health after they receive a COVID-19 vaccine. When you receive your vaccine, you should also receive a v-safe information sheet telling you how to enroll in v-safe. If you enroll, you will receive regular text messages directing you to surveys where you can report any problems or adverse reactions you have after receiving a COVID-19 vaccine. ACAAI recommends that patients opt into the v-safe program to help all of us understand any possible side effects from the vaccines.
A: The FDA granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people ages 16 and older. To receive full approval, the vaccine had to meet FDA standards for safety, effectiveness, and manufacturing quality. Moderna completed submission for FDA full approval in August of 2021 and is waiting for FDA approval.
The safety follow-up for COVID-19 vaccines is essentially the same as for all vaccine trials: two years of follow-up in phase 3 clinical trials. Given the importance of the vaccine in ending the current pandemic, both mRNA COVID-19 vaccines were authorized under Emergency Use Authorization by the FDA, and follow-up in the trials is ongoing.
We do not yet know the long-term safety profile of these vaccines. It is reassuring that long-term side effects with vaccines are quite rare and severe reactions typically occur within days to weeks after administration. Although this is the first time an mRNA vaccine has been used in the general population, they have been used in trials for rabies, influenza, cytomegalovirus, and Zika and no significant safety concerns were seen.
A: The CDC recommends COVID-19 vaccination for all people aged 5 years and older, including women who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. Pregnant and recently pregnant women are more likely to get severely ill with COVID-19 compared with non-pregnant women.
A: One of the reasons to perform vaccine trials in children is to make sure that they do not have any side effects that are pediatric-specific. There are also cases of multisystem inflammatory syndrome (MIS) in young adults, so ongoing vaccination in young adults may allow us to know whether this complication occurs in vaccinated individuals. Unfortunately, there is no known biomarker to predict an immune response that leads to MIS-C. It is also possible that protection from COVID-19 by vaccination will protect against its long-term effects. including MIS-C.
A: There are no data to suggest any major degree of weakening of the immune system due to inhaled corticosteroids used for asthma. It is important that your asthma is under control. There is no contraindication to receiving the COVID-19 vaccine while on inhaled corticosteroids.
A: There are no data to suggest any major degree of weakening of the immune system due to intranasal corticosteroids in use for allergic rhinitis and therefore there is no contraindication to receiving the COVID-19 vaccine while on inhaled corticosteroids.
A: There is no contraindication to receiving the COVID-19 vaccine while on oral corticosteroids. Presently we don’t know if regular oral corticosteroid use will limit the effectiveness of the COVID-19 vaccine as there is a potential for reduced immune responses to the vaccine. Much depends on the daily dose and for how long the patient has been on regular corticosteroids. Low-dose alternate day with short acting preparations such as prednisone probably have minimal if any depression of the immune system. Also, there is limited safety data with the COVID-19 vaccine with patients on regular oral corticosteroids at this time.
A: There are no data on effects of systemic corticosteroids and on immune response to COVID-19 vaccines. The optimal timing for COVID-19 vaccine following corticosteroids is unknown. mRNA vaccines such as COVID-19 vaccines do not represent a danger to immunocompromised persons and generally should be administered as recommended for healthy persons.
A: The ACAAI recommends that the COVID-19 vaccine and a biologic not be given the same day since, if there is a reaction after the second injection (vaccine or biologic) is given, it may be difficult to decide which one was the inciting agent. We suggest separating these injections by a minimum of 24 hours. There is no reason to stop a biologic until the patient completes the course of the COVID-19 vaccinations.
COVID Vaccines for Children and Teens
A. The CDC recommends everyone ages 5 and older get a COVID-19 vaccine to help protect against COVID-19.
|4 years and under||No||No||No|
|5-11 years old||Yes||No||No|
|12-17 years old||Yes||No||No|
|18 years and older||Yes||Yes||Yes|
Although children are at a lower risk of becoming severely ill with COVID-19 compared with adults, children can:
- Be infected with the virus that causes COVID-19
- Get very sick from COVID-19
- Have both short and long-term health complications from COVID-19
- Spread COVID-19 to others
Children with underlying medical conditions are more at risk for severe illness from COVID-19 compared with children without underlying medical conditions. Children who get infected with the virus that causes COVID-19 can also develop serious complications like multisystem inflammatory syndrome (MIS-C) — a condition where different body parts become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.
Getting a COVID-19 vaccine can help protect children ages 5 years and older from getting COVID-19.
- Vaccinating children can help protect family members, including siblings who are not eligible for vaccination and family members who may be at increased risk of getting very sick if they are infected.
- Vaccination can also help keep children from getting seriously sick if they do get COVID-19.
- Vaccinating children ages 5 years and older can help keep them in school and help them safely participate in sports, playdates, and other group activities.
For more information on the efficacy and safety of the COVID-19 vaccine in children, review Pfizer pediatric data in this New England Journal of Medicine article.
A. According to the CDC, the benefits of COVID-19 vaccination for children outweigh the known and potential risks.
- Serious health events after COVID-19 vaccination are rare.
- Cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been reported after Pfizer-BioNTech COVID-19 vaccination of children ages 12–17 years. These reactions are rare; in one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12–17 years.
- A severe allergic reaction, like anaphylaxis, may happen after any vaccine, including COVID-19 vaccines, but is rare.
For more information on the efficacy and safety of the COVID-19 vaccine in children, review Pfizer pediatric data in this New England Journal of Medicine article.
Allergy, Allergy Shots & Tablets (Immunotherapy), Asthma Treatment, COVID-19, Food Allergies, Severe Reactions, Anaphylaxis & Epinephrine