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COVID-19 vaccines available in the United States[1-5]

COVID-19 vaccines available in the United States[1-5]
Name Company/
developer		 Platform Indicated ages Primary series Booster dose* Common side effects Rare adverse effects
BNT162b2 Pfizer/BioNTech mRNA 6 months to 4 years Three total doses:
  • Two 3 mcg doses of monovalent vaccine 3 weeks apart
  • One 3 mcg dose of the bivalent vaccine formulation (Pfizer-BioNTech COVID-19 vaccine, bivalent) ≥8 weeks later
 Booster dose not yet authorized for this age group
  • Local injection site reactions
  • Systemic symptoms (fevers, chills, fatigue, myalgias, headache)
  • Anaphylaxis (approximately 5 per million doses)
  • Myocarditis/pericarditis (approximate risk following primary series):[6]
    • For males 12 to 16 years old: 71 cases/million doses
    • For males 16 to 17 years old: 106 cases/million doses
    • For males 18 to 24 years old: 52 cases/million doses
    • For males 25 to 29 years old: 17 cases/million doses
    • For females of the same age group: 2 to 11 cases/million doses
5 to 11 years Two 10 mcg doses 3 weeks apartΔ One 10 mcg dose of the bivalent vaccine formulation (Pfizer-BioNTech COVID-19 vaccine, bivalent) at least 2 months following the last vaccine dose
12 years and older Two 30 mcg doses 3 weeks apartΔ:
  • Healthy individuals <65 years old can extend the interval to 8 weeks◊
 One 30 mcg dose of the bivalent vaccine formulation (Pfizer-BioNTech COVID-19 vaccine, bivalent) at least 2 months following the last vaccine dose
mRNA-1273 Moderna mRNA 6 months to 5 years Two 25 mcg doses 4 weeks apartΔ One 10 mcg dose of the bivalent vaccine formulation (Moderna COVID-19 vaccine, bivalent) at least 2 months following the last vaccine dose
  • Local injection site reactions
  • Systemic symptoms (fevers, chills, fatigue, myalgias, headache)
  • Anaphylaxis (approximately 2.8 per million doses)
  • Myocarditis/pericarditis (approximate risk following primary series):[6]
    • For males 18 to 24 years old: 56 cases/million doses
    • For males 25 to 29 years old: 24 cases/million doses
    • For females of the same age group: 7 to 8 cases/million doses
6 to 11 years Two 50 mcg doses 4 weeks apartΔ One 25 mcg dose of the bivalent vaccine formulation (Moderna COVID-19 vaccine, bivalent) at least 2 months following the last vaccine dose
12 to 17 years Two 100 mcg doses 4 weeks apartΔ:
  • Healthy individuals <65 years old can extend the interval to 8 weeks◊
 One 25 mcg dose of the bivalent vaccine formulation (Moderna COVID-19 vaccine, bivalent) at least 2 months following the last vaccine dose
18 years and older Two 100 mcg doses 4 weeks apartΔ:
  • Healthy individuals <65 years old can extend the interval to 8 weeks◊
 One 50 mcg dose of the bivalent vaccine formulation (Moderna COVID-19 vaccine, bivalent) at least 2 months following the last vaccine dose
NVX-CoV2373 Novavax Recombinant protein, adjuvanted 12 years and older Two doses (5 mcg spike protein/50 mcg adjuvant) 3 weeks apart:
  • Healthy individuals <65 years of age can extend the interval to 8 weeks◊
 Use is limited to individuals 18 years and older who have not received a booster dose and are unable or unwilling to receive an mRNA vaccine§:
  • One dose (5 mcg spike protein/50 mcg adjuvant) at least 6 months after the last primary series dose
  • Local injection site reactions
  • Systemic symptoms (fevers, chills, fatigue, myalgias, headache)
  • Possible risk of myocarditis/pericarditis
Ad26.COV2.S Janssen/Johnson & Johnson Replication-incompetent adenovirus 26 vector 18 years and older One 5×1010 viral particles doseΔ Ad26.COV2.S is not authorized as a booster dose§
  • Local injection site reactions
  • Systemic symptoms (fevers, chills, fatigue, myalgias, headache)
  • Thrombotic complications associated with thrombocytopenia (approximate risk):
    • For females 30 to 39 years old: 12.4 cases/million doses
    • For females 40 to 49 years old: 9.4 cases/million doses
    • For females in other age ranges and males: 1.3 to 4.7 cases/million doses
  • Guillain-Barre syndrome (approximately 8 cases/million doses)
We recommend vaccination with one of these vaccines for eligible individuals. If availability is not an issue, we suggest an mRNA vaccine (BNT162b2 or mRNA-1273) or NVX-CoV2373. Extensive data supporting the use of mRNA vaccines have accumulated since their availability. Less data on safety and efficacy of NVX-CoV2373 are available, but it is also highly effective and may be an attractive option for individuals with concerns about the novelty of the mRNA vaccine platform. We reserve Ad26.COV2.S for those who cannot use the others, as it may be less effective against severe disease than mRNA vaccines and its associated rare adverse effects appear more severe. However, if other vaccines are not available or appropriate because of contraindications, we recommend vaccination with Ad26.COV2.S rather than forgoing COVID-19 vaccination. This approach is consistent with recommendations from the United States Centers for Disease Control and Prevention.

COVID-19: coronavirus disease 2019; CDC: Centers for Disease Control and Prevention.

* The CDC recommends a booster dose with a bivalent mRNA COVID-19 vaccine for all individuals ≥5 years old who had received a primary vaccine series (including those who had also received booster doses with the monovalent vaccine). The Pfizer-BioNTech COVID-19 vaccine, bivalent is authorized for individuals ≥5 years old, and the Moderna COVID-19 vaccine, bivalent is authorized for individuals ≥6 years old. This recommendation replaced prior recommendations regarding first and second boosters with the monovalent vaccine for these age groups. Monovalent vaccines are no longer recommended for booster doses.

¶ The formulations for children are specific to the age group and are distinct from that used in older individuals.

Δ For certain immunocompromised patients, additional doses are recommended as part of the primary series. The mRNA vaccines are given as a 3-dose series rather than a 2-dose series, with the third dose given at least 4 weeks after the second; for those who received a single dose of Ad26.COV2.S, an additional dose of an mRNA vaccine is given at least 4 weeks later. These additional doses do not replace the booster dose, which is also given for those age 5 years and older.

◊ Extending the interval to 8 weeks between vaccine doses may be preferable for adolescents and young adults (especially males age 12 to 39 years) who have no major comorbidities and do not need to maximize protection within a shorter period of time; it may be associated with a lower risk of myocarditis and slightly improved effectiveness.[6]

§ Individuals who received NVX-CoV2373 or Ad26.COV2.S for the primary series should receive a bivalent mRNA vaccine booster, either the Pfizer-BioNTech COVID-19 vaccine, bivalent (if ≥5 years old) or the Moderna COVID-19 vaccine, bivalent (if ≥6 years old).
References:
  1. US Food and Drug Administration. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. Available at: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine (Accessed on October 13, 2022).
  2. US Food and Drug Administration. Spikevax and Moderna COVID-19 Vaccine. Available at: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/spikevax-and-moderna-covid-19-vaccine (Accessed on October 13, 2022).
  3. US Food and Drug Administration. Emergency use authorization (EUA) of the Janssen COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). https://www.fda.gov/media/146304/download (Accessed on March 30, 2022).
  4. Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Available at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html (Accessed on November 1, 2022).
  5. US Food and Drug Administration. Emergency use authorization (EUA) of the Novavax COVID-19 vaccine, adjuvanted to prevent coronavirus disease 2019 (COVID-19). Available at: https://www.fda.gov/media/159897/download (Accessed on November 1, 2022).
  6. Oster ME, Shay DK, Su JR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA 2022; 327:331.
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