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Vaccine Contraindications
According to CDC’s interim clinical consideration guidelines for use of COVID-19 vaccines, contraindications to receiving the Moderna, Pfizer-BioNTech, and/or Novavax vaccine include a history of:
- 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, but may be able to receive another type of COVID-19 vaccine, provided precautions are followed.
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. Persons under 12 years of age should not receive this vaccine.
- Pfizer-BioNTech mRNA vaccine (10mcg) dose is authorized for use in children five through 11 years of age under EUA status. Children under five years of age should not receive this vaccine.
- Pfizer-BioNTech mRNA vaccine (3mcg) dose is authorized for use in children six months through five years of age under EUA status. Children under six months or over four years of age should not receive this vaccine.
Moderna/Spikevax
- Spikevax mRNA vaccine (50mcg) is FDA approved for persons 12 years of age and older. Persons under 18 years of age should not receive this vaccine.
- Moderna mRNA vaccine (25mcg) is authorized under EUA for children six months through eleven years of age. Children under six months or over eleven years should not receive this vaccine.
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.
Precautions
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. The CDC, however, states that a second dose of mRNA vaccine can be considered in certain circumstances in this population following complete resolution of symptoms as determined by the patient’s healthcare provider.
History of allergic reaction to other vaccines or injectable therapies
The CDC cautions on the use of COVID-19 vaccines in persons who have a history of immediate allergic reaction to any injectable therapy or other vaccine, but state that the benefit of vaccination outweighs the risk in most individuals. The CDC, however, reports that a risk assessment should be done prior to vaccination, and that the vaccination procedure should include a 30-minute observation period post-vaccination. Consultation with an allergist-immunologist is also advised by the CDC.
COVID-19 vaccination in person with a current or prior SARS-CoV-2 infection
Persons who have a current SARS-CoV-2 infection or those who have recently recovered from an infection are advised by the CDC to defer COVID-19 vaccination for at least 90 days from the date of the positive COVID-19 test or symptoms of illness. According to the CDC, studies have shown that an improved immune response has been found in persons who defer vaccination after SARS-CoV-2 illness. Additionally, the CDC notes that reinfection with the SARS-CoV-2 virus is uncommon in the weeks and months following SARS-CoV-2 infection.
Immunocompromised Populations
According to the Pfizer-BioNTech , Moderna , and Novavax Fact Sheet for Healthcare Providers Administering Vaccine, as well as the COMIRNATY mRNA COVID-19 vaccine and SPIKEVAX mRNA COVID-19 vaccine package inserts, individuals who are immunocompromised, including persons receiving immunosuppressive therapies, may not have an adequate immune response to vaccination.
Per the CDC’s guidelines, persons considered moderately to severely immunocompromised may receive additional COVID-19 mRNA doses and the CDC reports that “the EUAs for Moderna and Pfizer-BioNTech COVID-19 vaccines allow healthcare providers flexibility for use of vaccine products, number of doses, dosage, and intervals between doses; alternative schedules within the parameters of the EUAs may be appropriate based on individual circumstances and clinical judgement.”
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.
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 appeared to indicate that reinfection with SARS-CoV-2 virus was uncommon within 90 days of initial infection, health officials recommended that COVID-19 vaccination be deferred for at least three months following receipt of antibody therapy due to active infection. However, as of June 14, 2023, the CDC states that individuals who received monoclonal antibodies or convalescent plasma may receive COVID-19 vaccination at any time.
History of receiving dermal fillers
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.
Multisystem Inflammatory Syndrome in Children and Adults (MIS-C and MIS-A)
There is a lack of information on the effects of COVID-19 vaccine in children with a history of MIS-C, a rare condition involving a dysregulated immune response following SARS-CoV-2 infection in children. Similarly, data is also lacking on the risks of COVID-19 vaccination on adults with a history of MIS-A, a similar condition to MIS-C. Despite the lack of safety data on the use of COVID-19 vaccination in this population, the CDC reports that experts consider the benefits of vaccination to outweigh any potential risks.
The CDC, however, states that the decision to administer additional COVID-19 vaccines in children and adults who develop MIS following COVID-19 vaccination should involve consultation between the patient and/or guardian and the clinical care team or specialist. Consultation with Clinical Immunization Safety Assessment COVIDvax project may also be considered.
Pregnancy and Lactation
According to the Pfizer-BioNTech , Moderna , and Novavax Fact Sheet for Healthcare Providers Administering Vaccine, as well as the COMIRNATY mRNA COVID-19 vaccine and SPIKEVAX mRNA COVID-19 vaccine package inserts, 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.
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.
A study published in September 2023 found the presence of a trace amount of vaccine mRNA in the breastmilk of 10 of the 13 lactating women involved in the study at least 45 hours post-vaccination. Study authors reported that the trace amounts found in the breastmilk did not express the SARS-CoV-2 spike protein in the breastmilk’s extracellular vesicles and concluded that breastfeeding was safe, especially 48 hours post vaccination. Researchers, however, noted that COVID-19 vaccine mRNA does not stay at the injection site, but can spread throughout the body.
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.
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. 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. Data is lacking on the health outcomes and reactogenicity of individuals who receive COVID-19 vaccines with other routinely administered vaccines.
The CDC advises that young adult males who receive an orthopoxvirus (smallpox, monkeypox) vaccine such as ACAM2000 or JYNNEOS vaccine 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 all COVID-19 vaccines (Moderna, Pfizer-BioNTech and Novavax) 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.
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.