The COVID-19 vaccine is our best hope for ending the current pandemic. The goal is to administer vaccine to as many people as possible, as quickly as possible. As a new vaccine product, there are many questions that pediatricians and patients/families have. Below are answers to some of the most common questions.

Please note that this information will be updated regularly as data about COVID-19 vaccine becomes available.  

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COVID-19 Vaccine Recommendations

Which COVID-19 vaccines have been approved and/or authorized for use in the US?

The US has two mRNA, one viral vector, and one protein subunit COVID-19 vaccines for use in response to the pandemic. The CDC has recommended COVID-19 vaccines with a preference for people to receive an mRNA vaccine (Pfizer-BioNTech and Moderna) or the protein subunit vaccine (Novavax). Janssen (viral vector) vaccine is available for individuals who are unable to receive a different vaccine. The CDC lists the following reasons to receive the Janssen vaccine:

  • An individual has a contraindication to mRNA (i.e., Moderna, Pfizer-BioNTech) and Novavax COVID-19 vaccines (e.g., severe allergic reaction after a previous dose or to a component of an mRNA COVID-19 vaccine)
  • An individual would otherwise remain unvaccinated for COVID-19 due to limited access to other COVID-19 vaccines
  • An individual wants to receive Janssen COVID-19 Vaccine despite the safety concerns identified.

Two bivalent mRNA booster products are now available from Pfizer-BioNTech (12 years+) and Moderna (18 years+).

Pfizer-BioNTech mRNA Vaccine

Moderna mRNA Vaccine

Janssen (J&J) Viral Vector Vaccine

Novavax Protein Subunit Vaccine

FDA EUA for individuals 12 years of age and older / Fact Sheet for Healthcare Providers Administering Vaccine

Which COVID-19 vaccine should I recommend to my patients?

AAP recommends using COVID-19 vaccines that are approved through an Emergency Use Authorization (EUA) or Biologics License Application (BLA), recommended by CDC, and appropriate for your patients’ age and health status. Pediatricians should administer whichever formulation is available in their communities to achieve the highest vaccination coverage.

Children and adolescents 6 months of age and older who do not have contraindications should be vaccinated to protect them against COVID-19 as soon as possible. COVID-19 vaccines are life-saving. Delaying immunization leaves an individual vulnerable to infection for a longer period of time, placing them at greater risk of serious illness and death. AAP also supports coadministration of COVID-19 vaccines with other vaccines on the immunization schedule. See AAP policy.

Which Moderna or Pfizer-BioNTech vaccine dose should a child receive if they will have a birthday between doses in their primary series?

The size of the dose a child gets is based on how old they are on the day that they get the COVID shot. However, there are a few things to know about the COVID vaccine for kids who are crossing between age groups.

The Pfizer-BioNTech COVID vaccine and the Moderna COVID vaccine are the two products that are authorized for children ages 6 months through 12 years old. Whether they got Pfizer or Moderna first, kids should receive the same product for all doses recommended for their age in the primary series.

Pfizer-BioNTech COVID-19 Vaccine

A child turning from age 4 years to 5 years between Pfizer primary series doses can get:

  • Pfizer primary series vaccine for age 6 months through 4 years for Dose 1, either Pfizer primary series vaccine for age 6 months through 4 years or Pfizer primary series vaccine for age 5 through 11 years for Dose 2 (depending on their age), and or each of doses 2 and 3 may be with the Pfizer primary series vaccine dose for age 5 through 11 years for Dose 3 or
  • 2 doses of Pfizer vaccine for age 5 years through 11 years.

A child turning from age 11 years to 12 years between Pfizer primary series doses can get:

  • Pfizer vaccine for age 5 years through 11 years for Dose 1
  • Pfizer vaccine for age 12 years and older for Dose 2

Moderna COVID-19 Vaccine

A child turning from age 5 years to 6 years between Moderna primary series doses can get:

  • Moderna vaccine for age 6 months through 5 years for Dose 1
  • Moderna vaccine for age 6 years through 11 years for Dose 2

A child turning from age 11 years to 12 years between Moderna primary series doses can get:

  • Moderna vaccine for age 6 years through 11 years for Dose 1
  • Moderna vaccine for age 12 years through 17 years for Dose 2

Additional Resources:


What are the vaccine recommendations for children and adolescents who are moderately to severely immunocompromised?

Pediatricians who care for children and adolescents with certain immunocompromising medical conditions or who are receiving treatments that induce moderate to severe immune suppression should encourage their patients to be vaccinated with an additional dose as part of their primary series of mRNA vaccine (see CDC Clinical Considerations for a list of conditions). The recommended interval between dose 1 and dose 2 is 21 days for Pfizer-BioNTech and 28 days for Moderna. Children ages 5 years of age and older who received Pfizer-BioNTech vaccine and children ages 6 months and older who received Moderna vaccine should receive their additional dose at least 4 weeks after the 2nd dose. Infants and children 6 months through 4 years who received a Pfizer-BioNTech vaccine 3 dose series do not need an additional dose at this time. It is recommended that the same mRNA vaccine product be used for all doses in the primary series.

Patients 12 and older who receive Novavax vaccine should receive dose 2 of their primary series 3 weeks after dose 1. An additional dose is not recommended at this time.

Patients who are 5 years of age and older should also receive a Pfizer-BioNTech booster dose 3 months after their 3rd dose. Additionally, all patients 12 years of age and older should also receive one age appropriate bivalent booster dose at least 2 months following their last dose (irrespective of whether primary series or booster dose).

Prior to and following COVID-19 vaccine administration, infection prevention measures should continue such as wearing a mask, physical distancing, and avoiding crowds and poorly ventilated indoor spaces, as immunocompromised individuals may still be at increased risk for COVID-19. Close contacts of immunocompromised individuals who are eligible should receive COVID-19 vaccination (primary series and booster doses) to provide additional protection.

Information on immunization and immunocompromised children and adolescents can be found in the:

Red Book: Immunization and Other Considerations in Immunocompromised Children | Red Book® 2021 | Red Book Online | AAP Point-of-Care-Solutions

CDC Clinical Considerations: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html |CDC COVID-19 Vaccination for People Who are Moderately or Severely Immunocompromised: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#immunocompromised 

Should patients receive a booster dose of COVID-19 vaccine?

Yes. The protection COVID-19 vaccines provide decreases over time. CDC recommends the use of an mRNA booster dose for all individuals 5 years of age and older.

Children ages 5 – 11 years of age who received the Pfizer-BioNTech COVID-19 vaccine as their primary series should receive a booster dose at least five months after completion of their 2-dose primary series.

Children and adults ages 12 years and older should receive a bivalent COVID-19 vaccine booster at least 2 months after either:

  • Completion of primary vaccination series with any authorized or approved monovalent COVID-19 vaccine or
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine (irrespective of total number of boosters previously received)

The CDC offers more information about booster doses, including eligibility and answers to frequently asked questions.

Experts continue to recommend that everyone get vaccinated and boosted, regardless of whether they’ve had COVID-19 in the past. COVID-19 vaccination provides stronger and longer duration of protection against future COVID-19 disease than recovering from natural infection alone. Individuals can get COVID-19 multiple times, especially as new strains circulate in communities. As cases increase across the country, a booster dose will safely help restore and enhance protection against severe disease.

Can I administer a COVID-19 vaccine to a patient who is currently sick with COVID-19?

COVID-19 vaccination should be deferred for patients with a current SARS-CoV-2 infection until they recover from their acute illness and the criteria to discontinue isolation has been met. Patients who are asymptomatic should receive COVID-19 vaccine following their recommended isolation period. This also applies to people who become infected with COVID-19 between their first and second dose of vaccine, or those who are due for a booster.

Individuals who recently had SARS-CoV-2 infection and have concluded their isolation period may consider delaying a primary series dose or their first or second COVID-19 vaccine booster dose by 3 months from symptom onset or positive test (if infection was asymptomatic). Studies have shown that increased time between infection and vaccination may result in an improved immune response to vaccination.

What is the difference between COVID-19 mRNA, viral vector, and protein subunit vaccines?

Messenger RNA (mRNA) Vaccines

These vaccines use a newer technology where mRNA is wrapped in a coating (lipid nanoparticle) so it can enter our cells. The mRNA in the vaccine teaches our cells how to make copies of a spike protein. Once the spike protein is made, two things occur: (1) the cell breaks down the mRNA (instructions) and gets rid of them, and (2) the spike protein triggers an immune response inside of our bodies, which produces antibodies. These antibodies protect us from getting infected if the real virus enters our bodies.

Viral Vector Vaccines

Viral vector vaccines use a modified, harmless version of a different virus to deliver instructions to our cells. The virus enters the cell and teaches it how to make copies of a spike protein, which then triggers an immune response inside of our bodies. This immune response results in the production of antibodies which protect us from getting infected if the real virus enters our bodies.

Protein Subunit Vaccines

Subunit vaccines include a part (protein) of the virus that best stimulates your immune system. Once your immune system recognizes the protein subunit, it creates antibodies and defensive white blood cells. If you later become infected with the COVID-19 virus, the antibodies will fight the virus. These vaccines often include an adjuvant to increase the body’s immune response.

 

COVID-19 Vaccine Research

What is the current status of COVID-19 vaccine research in children and adolescents?

  • Novavax plans to study their vaccine in children ages 6-11 shortly.
  • Janssen and Astra Zeneca also have plans to study their vaccines in younger age groups.
  • Moderna is studying their recently authorized bivalent vaccine in children. See AAP News article

Is it safe for pregnant or lactating women to receive COVID-19 vaccine?

Safety data have showed no major concerns reported in pregnant persons. Additionally, recent studies show that vaccination during pregnancy with a 2-dose mRNA COVID-19 vaccine series may help prevent COVID-19 hospitalizations in infants < 6 months of age. The CDC has issued a Health Alert Network Advisory strongly recommending urgent action to increase COVID-19 vaccination (primary series and booster doses) before or during pregnancy as the benefits outweigh known or potential risks.

Guidance is also available from the American College of Obstetricians and Gynecologists (ACOG).

Does COVID-19 vaccine affect fertility or puberty?

Unfounded claims linking COVID-19 vaccines to infertility have been scientifically disproven. There is no evidence that the vaccine can lead to loss of fertility. While fertility was not specifically studied in the clinical trials of the vaccine, no loss of fertility has been reported among trial participants or among the millions who have received the vaccines since their authorization, and no signs of infertility appeared in animal studies. Similarly, there is no evidence that the COVID-19 vaccine affects puberty.

When is a vaccine recipient considered up to date?

An individual is up to date with their COVID-19 vaccines when they have received all doses in the primary series and all boosters recommended for them

See CDC Interim COVID-19 Immunization Schedule

 

Side Effects and Safety Monitoring

Are there any safety concerns with the new technologies (mRNA and nanotechnology) being used in the development of the Pfizer-BioNTech and Moderna COVID-19 vaccines?

There are no known additional risks of mRNA vaccines or lipid nanoparticles. Live attenuated viral vaccines, such as measles vaccine, induce an immune response that is similar to natural infection. mRNA vaccines, on the other hand, simply give the body instructions to produce one very specific part of a virus – in this case the so-called spike protein – to then induce an immune response. Because mRNA is broken down very quickly in the human body, to do its work it needs to be able to get into our cells, and so it is wrapped in a lipid nanoparticle. Once it gets into the cells to deliver the instructions, the mRNA breaks down very quickly. It does not get into the nucleus of the cell, or into our genes. Since the new mRNA vaccines have been administered, their safety profiles are reassuring.

Since April 2021, rare cases of myocarditis and pericarditis have been reported in adolescents and young adults (under 30 years of age) following receipt of mRNA vaccines – most often following the 2nd dose. COVID-19 vaccination reduces patients’ risk of myocarditis caused by getting infected with SARS-CoV-2 and developing COVID-19 disease. Studies have shown that risk of myocarditis was up to 6 times higher post SARS-CoV-2 infection than post-mRNA vaccines. Post-vaccine myocarditis is milder, requiring shorter hospital stays (1-2 days) vs. myocarditis caused by SARS-CoV-2 infection which has been more severe requiring a hospital stay of 5 days on average. Pediatricians should consider myocarditis and pericarditis in adolescents or young adults with acute chest pain, shortness of breath, or palpitations and report any suspected cases post COVID-19 vaccination to VAERS. History of myocarditis of pericarditis after a dose of an mRNA vaccine is also listed as a precaution for future doses. CDC continues to monitor the situation and has created guidance for health care providers

Clinical Considerations: Myocarditis after mRNA COVID-19 Vaccines | CDC

What side effects are noted to date with COVID-19 mRNA vaccines (Pfizer-BioNTech and Moderna)?

The side effects have been similar to other routine vaccines- sore arm, redness, fatigue, fever, chills, headache, myalgia, and arthralgia. The side effects are temporary and mostly mild or moderate. Side effects may be worse after the second dose in some individuals. Anaphylaxis has been observed following receipt of COVID-19 mRNA vaccines but this has been rare. Extremely rare cases of myocarditis or pericarditis have been reported – most often in males between 12-39 years of age – and most often following the 2nd dose. Additional information on common side effects and rare adverse reactions can be found here:

Possible Side Effects After Getting a COVID-19 Vaccine | CDC
Selected Adverse Events Reported after COVID-19 Vaccination | CDC

What side effects are noted to date with the Janssen COVID-19 viral vector vaccine? Are there any contraindications?

Common side effects post vaccination are pain, redness, and swelling in the arm where you received the shot, as well as, tiredness, headache, muscle pain, chills, fever, and nausea within the first few days.

CDC considers the following to be a contraindication to receiving Janssen COVID-19: Severe allergic reaction or immediate allergic reaction of any severity to a previous dose or component of Janssen COVID-19 vaccine. Precautions should be taken for individuals with a history of immediate allergic reaction to another vaccine or injectable therapy and those with moderate or severe acute illness.

Additionally, in December 2021, the FDA revised the EUA Fact Sheet for Janssen COVID-19 vaccine to include: (1) a contraindication for individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 vaccine or any other adenovirus-vectored COVID-19 vaccines; and (2) a warning and precaution for Thrombosis with Thrombocytopenia Syndrome (TTS) as cases of TTS following administration have been reported in males and females 18 years of age and older, with the highest rate in females aged 30-49 years. Providers should maintain a high level of suspicion for symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the Janssen COVID-19 vaccine. See CDC Health Alert Network for additional information.

On July 12, 2021, the FDA announced it is adding a warning label to the Janssen COVID-19 vaccine, due to an increased risk of a rare neurological syndrome called Guillain-Barré syndrome (GBS). The new warning label is based on preliminary data, after about 100 reports of GBS were detected in the Vaccine Adverse Event Reporting System, out of more than 12.8 million administered doses of the Janssen vaccine administered. Each year an estimated 3,000 to 6,000 people develop GBS in the US from various causes. Most people fully recover from the disorder.

The CDC has recommended COVID-19 vaccines with a preference for people to receive an mRNA vaccine (Pfizer-BioNTech and Moderna) or the protein subunit vaccine (Novavax). Janssen (viral vector) vaccine is available for individuals who are unable or unwilling to receive another vaccine and are aware of the safety profile.

What side effects are noted to date with the Novavax protein subunit vaccine? Are there any contraindications ?

Side effects similar to other vaccines, (such as fever, chills, tiredness, and headache) are more common after the second dose of the vaccine. Severe allergic reactions to vaccines are rare but can happen. Cases of myocarditis and pericarditis have been reported in people who received Novavax COVID-19 vaccine.

Novavax COVID-19 Vaccine should not be given to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Are there any contraindications to receiving COVID-19 mRNA vaccines from Pfizer-BioNTech and Moderna?

CDC considers the following to be a contraindication to vaccination with both Pfizer- BioNTech and Moderna COVID-19 vaccines: Severe allergic reaction (eg., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components, immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG]), and immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

In persons who report a history of anaphylaxis to another vaccine (i.e., any other vaccine besides the Pfizer-BioNTech and Moderna COVID-19 vaccine) or injectable therapy, a risk assessment should be conducted to determine type of reaction and certainty of information. A small number of vaccine recipients have experienced anaphylaxis following receipt of the Pfizer vaccine. Consider observing people with the following medical histories for 30 minutes after COVID-19 vaccination to monitor for allergic reactions:

Patients who experience anaphylaxis following the first dose of COVID-19 vaccine should be counseled not to receive the second dose and referred to an allergist-immunologist for appropriate follow up.

Do we need to worry about an increase in MIS-C in kids receiving COVID-19 vaccine?

To date, MIS-C has not occurred following receipt of COVID-19 vaccine without SARS-CoV-2 infection. In fact, COVID-19 vaccine offers protection against MIS-C, as a recent study demonstrated that receipt of 2 doses of Pfizer-BioNTech COVID-19 vaccine is highly effective in preventing MIS-C in persons 12-18 years of age.

What is the safety testing that has been done on COVID-19 vaccines? How do we know it is safe long-term?

The safety follow-up for COVID-19 vaccines is essentially the same that it is for all vaccine trials. All vaccines are determined to be safe and effective before they are authorized or licensed.

Pediatric vaccine studies involve very close follow up and tracking of patient’s health status and medical care post vaccination (eg. monitoring side effects, medical visits, use of new medications or changes to previous medications, and other interactions post vaccination). All reported medical events are recorded and reviewed by the study team, sponsor, an independent safety monitoring board, an ethics committee, and the FDA. Children in these studies are often followed for one to two years post vaccination and their health status is monitored for vaccine safety.

Even after authorization or licensure, safety data are collected through Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), pharmacovigilance, and, for COVID-19 vaccines, through a system called V-SAFE. These programs collect information on an even larger number of persons who get vaccinated than can be collected during clinical studies.

Safety data beyond 2 years, is captured through studies performed post licensure. No licensed vaccines have been found to have an unexpected long-term safety problem, that was found only years or decades after introduction.

What vaccine safety surveillance programs are in place?

All COVID-19 vaccines approved and/or granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and vaccines on the Recommended Child and Adolescent Immunization Schedule, including co-administered vaccines are monitored through robust FDA and CDC systems that monitor vaccine safety in the United States. This vaccine safety system includes the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Data Link (VSD), Clinical Immunization Safety Assessment (CISA), and V-SAFE, a new smartphone-based system added to the safety monitoring system specifically to monitor for side effects of the COVID-19 vaccines. These systems have proven that they work in picking up a safety signal for an extraordinarily rare complication with the Janssen COVID-19 vaccine. VAERS and VSD are specifically designed to monitor safety signals from simultaneous administration of multiple vaccines (ie co-administration). Pediatricians should share information with patients on VAERS and encourage registration in the V-SAFE program during the vaccination visit.

Ensuring COVID-19 Vaccine Safety in the US | CDC
V-safe After Vaccination Health Checker | CDC

 

Other

What do we know about the new SARS-CoV-2 variants and vaccine efficacy?

Multiple variants of SARS-CoV-2 have been documented in the United States and globally during this pandemic. Data show that vaccines may be less effective against Omicron variant in preventing infection and that effectiveness may diminish over time; however, they are still effective in preventing hospitalization and death. The AAP continues to support COVID vaccination among the population as the best way to prevent severe morbidity and mortality from SARS-CoV-2.

During Omicron variant predominance beginning in late December 2021, U.S. infants and children aged 0–4 years were hospitalized at approximately five times the rate of the previous peak during Delta variant predominance. Further, COVID-19–associated hospitalization rates in children aged 5–11 years were approximately twice as high among unvaccinated as among vaccinated children. Thus, COVID-19 vaccination should be promoted among eligible populations, including children 6 months of age and older, pregnant women, and family members/caregivers of young infants and children.

An EUA has recently been issued for bivalent COVID-19 vaccine boosters that include native strain and Omicron BA.4/5 strain. ). The Pfizer product has been authorized for adolescents 12 years of age and older, and the Moderna product has been authorized for individuals 18 years of age and older. Bivalent boosters are anticipated for younger children in the coming weeks to months. Additional information can be found in the CDC Fall Vaccination Operational Planning Guide.

New COVID-19 Variants | CDC

New England Journal of Medicine report on COVID-19 vaccine effectiveness against Omicron in Children and Adolescents BNT162b2 Protection against the Omicron Variant in Children and Adolescents | NEJM

 

Additional Resources

Last Updated

09/28/2022

Source

American Academy of Pediatrics