Read and report vaccine reactions, harassment and failures.
Contraindications
Below are the age groups authorized to receive COVID-19 vaccines, as approved or authorized by the U.S. Food and Drug Administration (FDA):
Pfizer-BioNTech/COMIRNATY
- COMIRNATY mRNA vaccine (30 mcg) is FDA approved for use in persons 12 years and older. The FDA has also determined that COMIRNATY is interchangeable with the 30mcg Pfizer-BioNTech mRNA vaccine, which also has an EUA status. This means that both vaccines can be used interchangeably in individuals 12 years and older. Persons under 12 years of age should not receive this vaccine.1
- Pfizer-BioNTech mRNA vaccine (10mcg) dose is authorized for use in children five through 11 years under EUA status. Children under five years should not receive this vaccine.2
- Pfizer-BioNTech mRNA vaccine (3mcg) dose is authorized for use in children six months through five years under EUA status. Children under six months or over four years should not receive this vaccine.3
Moderna/Spikevax
- Spikevax mRNA vaccine (100mcg) is FDA approved for persons 18 years of age and older. Persons under 18 years of age should not receive this vaccine.4
- Moderna mRNA vaccine (100mcg) is authorized for persons 12 years of age and older. Persons under 12 years of age should not receive this vaccine.5
- Moderna mRNA vaccine (50mcg) is authorized under EUA for children six through 11 years of age. Children under six years or over 11 years should not receive this vaccine.6
- Moderna mRNA vaccine (25mcg) is authorized under EUA for children six months through five years of age. Children under six months or over five years should not receive this vaccine.7
Janssen/Johnson & Johnson
- Janssen/Johnson & Johnson viral vector vaccine is authorized under EUA for persons 18 years of age and older. Persons under 18 years of age should not receive this vaccine.8
Novavax
- Novavax COVID-19 vaccine is authorized under EUA for persons 12 years of age and older. Persons under 12 years of age should not receive this vaccine.9
Vaccine Coadministration
No data is available on the safety of administering mRNA COVID-19 vaccines with other vaccines. When COVID-19 vaccines were initially authorized for use, CDC health officials recommended that COVID-19 vaccines be administered alone, and not within 14 days of receiving another vaccine.10
However, at the May 12, 2021 CDC ACIP meeting, health officials updated their guidance and stated that the COVID-19 vaccine could be co-administered with other vaccines, despite a lack of data to support this recommendation.11 12 The CDC stated that their initial guidance recommending that COVID-19 vaccines be administered alone was not based on safety immunogenicity concerns, but rather out of an abundance of caution. The CDC acknowledges that data on health outcomes and reactogenicity of coadministration of COVID-19 vaccines with other routinely administered vaccines is lacking.13
The CDC advises that young adult males who receive an orthopoxvirus (smallpox, monkeypox) vaccine such as ACAM2000 or JYNNEOS vaccine should consider delaying COVID-19 vaccination for at least four weeks due to the risk of myocarditis and pericarditis. Myocarditis and pericarditis have been associated with mRNA COVID-19 vaccines (Moderna and Pfizer-BioNTech), Novavax COVID-19 vaccine, and ACAM2000 smallpox vaccine. There is also an unknown risk of myocarditis and pericarditis with JYNNEOS vaccine. However, if orthopoxvirus vaccination is recommended due to a potential monkeypox virus exposure, the CDC does not recommend the four-week delay between COVID-19 vaccination.14
Vaccine Contraindications
According to CDC interim clinical consideration guidelines for use of COVID-19 vaccines, contraindications to receiving the Moderna, Pfizer-BioNTech, and/or Janssen/Johnson & Johnson vaccine include a history of:15
- Severe allergic reaction to any ingredient contained within the vaccine or after a previous dose of the COVID-19 vaccine;
- Immediate allergic reaction of any seriousness to any ingredient contained within the vaccine (including polyethylene glycol [PEG) or diagnosed allergy to a COVID-19 vaccine ingredient;
The CDC also states that persons that have a contraindication to one of the mRNA COVID-19 vaccines should not receive a second dose, and may be able to receive the Janssen/Johnson & Johnson COVID-19 vaccine, and vice versa, provided precautions are followed.
Persons with an allergy to polysorbate may receive mRNA COVID vaccines, though previously this was considered a contraindication due to potential cross-reactive hypersensitivity to the polyethylene glycol (PEG) contained in these vaccines. However, a polysorbate allergy remains as a contraindication to receiving the Janssen/Johnson & Johnson COVID-19 vaccine. Guidance encourages providers to make distinctions between true allergic reactions versus other types of reactions, such as syncope or other vaccine side effects, to more accurately determine if a person who has reacted should receive a second dose of an mRNA COVID-19 vaccine.16
Precautions
Individuals with a history of previously receiving dermal fillers have experienced swelling near or at the site of filler injection after mRNA COVID-19 vaccine. While a history of receipt of dermal fillers is not a contraindication to receiving mRNA COVID-19 vaccines, the CDC advises that anyone who experiences swelling after vaccination should contact their health care provider immediately.17
The CDC cautions on the use of mRNA COVID-19 vaccines in persons who have a history of immediate allergic reaction to any injectable therapy or other vaccine, and states that precautions should be considered in consultation with an allergist-immunologist as follows:18
- Persons with a contraindication to mRNA COVID-19 vaccines (including known PEG allergy) may be given to vaccination with Janssen/Johnson & Johnson COVID-19 vaccine.
- Persons who have received the first dose of an mRNA COVID-19 and who have a contraindication to the second dose, should wait at least 28 days before receiving the Janssen/Johnson & Johnson COVID-19 vaccine.
- Persons with a contraindication to Janssen/Johnson & Johnson COVID-19 vaccine (including diagnosed polysorbate allergy) may be given mRNA COVID-19 vaccines, and notes that polysorbate allergy is a precaution.
Special Populations and Conditions
Myocarditis and Pericarditis
According to the CDC, there is insufficient data on the safety or efficacy of COVID-19 vaccine in persons with a past history of myocarditis and pericarditis. The CDC, however, has stated that persons with a history of myocarditis and pericarditis that is unrelated to vaccination be vaccinated once symptoms have fully resolved. In persons who develop myocarditis or pericarditis following receipt of an mRNA or Novavax COVID-19 vaccine, the CDC recommends that the second dose be deferred.19
The CDC also states that a second dose of mRNA vaccine can be considered in certain circumstances in this population following complete resolution of symptoms. These circumstances may include risk of severe illness, community spread, person infection risk, as well as the availability of additional data on the safety and long-term health outcomes of this population.20
Immunocompromised Populations
According to the Pfizer-BioNTech, Moderna, Novavax, and Johnson & Johnson/Janssen Fact Sheet for Healthcare Providers Administering Vaccine, as well as the COMIRNATY mRNA COVID-19 vaccine and SPIKEVAX mRNA COVID-19 vaccine, individuals who are immunocompromised, including persons receiving immunosuppressive therapies, may not have an adequate immune response to vaccination. 21 22 23 24 25 26 Persons with certain immunosuppressive conditions who have previously received two doses of mRNA COVID-19 vaccines may receive a third dose of mRNA COVID-19 vaccine although it is not known whether a subsequent dose will offer any additional benefit. The third dose is recommended to be administered at least 28 days following the second dose.27 A fourth vaccine dose has also been authorized in certain immunocompromised populations, to be administered at least six months following administration of a third dose.28
A study published by the CDC in November of 2021 reported that 53 percent of immunocompromised individuals who were hospitalized with symptoms of COVID-19 vaccine were fully vaccinated. It is possible that the number of fully vaccinated may have been higher as the study excluded individuals who received a dose of the Janssen/Johnson & Johnson vaccine and those who had received their second mRNA vaccine dose less than two weeks before hospitalization.29
Previous History of Monoclonal Antibody or Convalescent Plasma Use
There is a lack of safety data on the use of mRNA COVID-19 vaccines in persons who have been treated for COVID-19 illness using monoclonal antibodies or convalescent plasma. Prior to February 11, 2022, as evidence appears to indicate that reinfection with SARS-CoV-2 virus is uncommon within 90 days of initial infection, health officials recommend that COVID-19 vaccination be deferred for at least three months following receipt of antibody therapy due to active infection.30 On February 11, 2022, the CDC updated its recommendation and stated that persons treated with monoclonal antibodies could receive a COVID-19 vaccine at any time. Persons who received tixagevimab/cilgavimab (EVUSHELD™), however, were recommended to wait at least 14 days before receiving a dose of COVID-19 vaccine.31
Pregnancy and Lactation
According to the Pfizer-BioNTech, Moderna, Novavax, and Johnson & Johnson/Janssen Fact Sheet for Healthcare Providers Administering Vaccine, as well as the COMIRNATY mRNA COVID-19 and SPIKEVAX mRNA COVID-19 vaccine package insert, there is insufficient data to determine the safety of COVID-19 vaccines in pregnant women, and it is not known whether these vaccines can cause harm to the mother or developing baby. There is also no safety data on the use of mRNA COVID-19 vaccines in lactating women, or the effects of the vaccine on the breastfed baby. 32 33 34 35 36 37
In September 2022, the Journal of American Medical Association published a research letter that reported on the presence of mRNA COVID-19 vaccine in breast milk post-vaccination. This study looked at the breast milk from 11 lactating women, six who received the Pfizer-BioNTech mRNA COVID-19 vaccine, and five who received the Moderna mRNA vaccine, and found the presence of the vaccine in seven samples taken from five women up to 45 hours post-vaccination. Researchers expressed caution in breastfeeding infants under 6 months of age within 48 hours of vaccination and called for additional studies on the effects of vaccination on the breastfeeding women.38
IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
References:
1 U.S. Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine. Mar. 16, 2023
2 U.S. Food and Drug Administration. Fact Sheet for Health Care Providers Administering Pfizer-BioNTech 5 years through 11 years of age, orange cap (must dilute). Dec. 8, 2022.
3 U.S. Food and Drug Administration. Fact Sheet for Health Care Providers Administering Pfizer-BioNTech 6 months through 4 years, maroon cap (must dilute). Mar. 14, 2023.
4 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine- Package Insert. Mar. 13, 2023.
5 U.S. Food and Drug Administration. Fact Sheet for Health Care Providers Administering Moderna Vaccine - 12 years and older (light blue border). Dec. 8, 2022.
6 U.S. Food and Drug Administration. Fact Sheet for Health Care Providers Administering Moderna Vaccine - 6 years through 11 years of age (teal & purple border). Dec. 8, 2022.
7 U.S. Food and Drug Administration. Fact Sheet for Healthcare Providers Administering Moderna Vaccine - 6 months through 5 years of age (magenta border). Dec. 8, 2022.
8 U.S. Food and Drug Administration. Fact Sheet for Healthcare Providers Administering Janssen Vaccine. Mar. 13, 2023.
9 U.S. Food and Drug Administration. Fact Sheet for Healthcare Providers Administering Novavax Vaccine. Mar. 13, 2023.
10 U.S. Centers for Disease Control and Prevention. Coadministration of COVID-19 vaccines with other vaccines. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
11 Woodworth K. Clinical Considerations for Pfizer-BioNTech COVID-19 Vaccination in Adolescents. U.S. Centers for Disease Control and Prevention May 12, 2021.
12 Jolly J. With Little Safety Data, CDC Recommends Pfizer COVID Vaccine for 12-Year-Old Children. The Vaccine Reaction May 18, 2022.
13 U.S. Centers for Disease Control and Prevention. Coadministration of COVID-19 vaccines with other vaccines. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
14 U.S. Centers for Disease Control and Prevention. Coadministration of COVID-19 vaccines with other vaccines. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
15 U.S. Centers for Disease Control and Prevention. Contraindications and precautions. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
16 U.S. Centers for Disease Control and Prevention. Contraindications and precautions. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
17 U.S. Centers for Disease Control and Prevention. Patient Counseling. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
18 U.S. Centers for Disease Control and Prevention. Contraindications and precautions. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
19 U.S. Centers for Disease Control and Prevention. Safety considerations for mRNA COVID-19 vaccines. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
20 U.S. Centers for Disease Control and Prevention. Safety considerations for mRNA COVID-19 vaccines. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
21 U.S. Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine – Fact Sheet for Healthcare Providers Administering Vaccine - 12 years of age and older, purple cap (must dilute). Dec. 22, 2022.
22 U.S. Food and Drug Administration. Package Insert – COMIRNATY (Purple Cap). July 8, 2022.
23 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (12 years and older - light blue border). Dec. 8, 2022.
24 U.S Food and Drug Administration. Janssen COVID-19 Vaccine - Fact Sheet for Healthcare Providers Administering Vaccine. Mar. 13, 2023.
25 ModernaTx, Inc. Package Insert - SPIKEVAX. U.S. Food and Drug Administration Feb. 18, 2022.
26 U.S. Centers for Disease Control and Prevention. Fact Sheet for Healthcare Providers Administering Novavax COVID-19 Vaccine, Adjuvanted. Oct. 19, 2022.
27 U.S. Centers for Disease Control and Prevention. COVID-19 vaccination guidance in people who are moderately and severely immunocompromised people. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
28 U.S. Centers for Disease Control and Prevention. COVID-19 vaccination guidance in people who are moderately and severely immunocompromised people. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023.
29 Embi PJ, Levy ME, Naleway AL, et al. Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines Against COVID-19–Associated Hospitalizations Among Immunocompromised Adults — Nine States, January–September 2021. MMWR Nov. 5, 2021;70:1553–1559.
30 U.S. Centers for Disease Control and Prevention. COVID-19 vaccination and SARS-CoV-2 infection. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Jan. 7, 2022.
31 U.S. Centers for Disease Control and Prevention. COVID-19 vaccination and SARS-CoV-2 infection. In: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Mar. 17, 2023
32 U.S. Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine – Fact Sheet for Healthcare Providers Administering Vaccine - 12 years of age and older, purple cap (must dilute). Dec. 22, 2022.
33 U.S. Food and Drug Administration. Package Insert – COMIRNATY (Purple Cap). July 8, 2022.
34 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (12 years and older - light blue border). Dec. 8, 2022.
35 U.S Food and Drug Administration. Janssen COVID-19 Vaccine - Fact Sheet for Healthcare Providers Administering Vaccine. May 5, 2022.
36 ModernaTx, Inc. Package Insert - SPIKEVAX. U.S. Food and Drug Administration Feb. 18, 2022.
37 U.S. Centers for Disease Control and Prevention. Fact Sheet for Healthcare Providers Administering Novavax COVID-19 Vaccine, Adjuvanted. Oct. 19, 2022.
38 Hanna N, Heffes-Doon A. Lin X. et al. Detection of Messenger RNA COVID-19 Vaccines in Human Breast Milk. JAMA Pediatr. Published online Sept. 26, 2022.