. 2022 Feb 1;36(2):435–479. doi: 10.1016/j.idc.2022.01.005

Table 2.

SARS-CoV-2 vaccines available in the United States

Vaccine Name	Manufacturer	Vaccine Type	Reported Vaccine Efficacy in Children	Schedule	Approval for Children	Approval Dates
BNT162b2 (Comirnaty)	Pfizer-BioNTech	mRNA (Intramuscular)	1. 100% vaccine efficacy against confirmed COVID-19 in individuals aged 12–15 y¹⁰¹ 2. 90.7% vaccine efficacy against confirmed COVID-19 in individuals aged 5–11 y¹⁰²	1. 2-dose primary series separated by 21 d 2. 1 additional primary dose in immunocompromised persons^a (≥28 d since 2nd dose) 3. Booster dose ≥5 mo after last dose in primary series	1. FDA approved for individuals ≥16 y 2. FDA EUA for individuals 5–15 y 3. Booster dose approval for individuals aged ≥12 y 4. Third primary series dose for certain immunocompromised children ≥5 y	1. December 11, 2020: FDA EUA for individuals ≥16 y⁹² 2. May 10, 2021: FDA EUA for individuals 12–15 y⁹⁴ 3. August 12, 2021: FDA EUA for third primary dose for certain immunocompromised individuals^a,²⁵⁷ 4. August 23, 2021: FDA approved for individuals ≥16 y⁹³ 5. September 22, 2021: FDA updated EUA to allow for single booster dose for high-risk populations^b aged ≥18 y administered at least 6 mo after completion of primary series²⁵⁸ 6. October 20, 2021: FDA updated EUA to allow for heterologous booster dose in eligible individuals 7. October 29, 2021: FDA EUA for individuals 5–11 y⁹⁵ 8. November 19, 2021: FDA updated EUA to allow for single booster dose for all individuals aged ≥18 y²⁵⁹ 9. December 9, 2021: FDA updated EUA to allow for single booster dose in individuals aged 16–17 y⁹⁶ 10. January 3, 2022: FDA updated EUA to expand use of booster dose in individuals aged 12–15 y; shorten time interval for booster dose to ≥5 mo and allow for third primary series dose for certain immunocompromised children aged 5–11 y⁹⁷
mRNA-1273	Moderna	mRNA (Intramuscular)	Vaccine efficacy against COVID-19 in adolescents aged 12–17 y showed 100% efficacy 14 d after second primary dose, although not statistically significant given low incidence of infection (4 cases in placebo group and none in vaccine arm)¹⁰³	1. 2-dose primary series separated by 28 d 2. 1 additional primary dose in immunocompromised persons^a (≥28 d since 2nd dose) 3. Booster dose ≥5 mo after last dose in primary series	Not approved by FDA for children	1. December 18, 2020: FDA EUA for individuals ≥18 y²⁶⁰ 2. August 12, 2021: FDA EUA for third primary dose for certain immunocompromised individuals^a ^, ²⁶⁰ 3. October 20, 2021: FDA updated EUA to allow for booster dose for high-risk populations^b aged ≥18 y administered at least 6 mo after completion of primary series, including the use of a heterologous booster dose in eligible individuals²⁶⁰ 4. November 19, 2021: FDA updated EUA to allow for single booster dose for all individuals aged ≥18 y²⁶⁰ 5. January 7, 2022: FDA updated EUA to shorten interval between completion of primary vaccine series to booster to ≥5 mo for all individuals ≥18 y²⁶¹
Ad26.COV2.S	Janssen/Johnson & Johnson	Viral vector (Intramuscular)	Data not available	1. Single primary dose 2. Booster dose ≥2 mo after primary dose	Not approved by FDA for children	1. February 27, 2021: FDA EUA for individuals ≥18 y²⁶² 2. October 20, 2021: FDA updated EUA to allow for a single booster dose at least 2 mo after completion of the single-dose primary series for all individuals aged ≥18 y and allows for the use of a heterologous booster dose in eligible individuals²⁶² 3. December 16, 2021: CDC ACIP recommendations updated, preferring approved mRNA vaccines over Janssen vaccine for primary and booster vaccinations²⁶³

Abbreviations: ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention; COVID-19, coronavirus disease 2019; EUA, emergency use authorization; FDA, Food and Drug Administration; mRNA, messenger RNA.

Moderately to severely immunocompromised persons may include (not limited to) individuals undergoing active treatment for solid tumor and hematologic malignancies, receiving a solid organ transplant and taking immunosuppressive therapy, receiving chimeric antigen receptor T-cell or hematopoietic cell transplant; individuals who have moderate or severe primary immunodeficiency, advanced or untreated human immunodeficiency virus infection, receiving active treatment with high-dose corticosteroids, alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutics agents classified as severely immunosuppressive, tumor necrosis factor blockers, and other immunosuppressive or immunomodulatory biologic agents.

High-risk populations include individuals 65 y and older; individuals 18 to 64 y with an underlying medical condition putting them at high risk for severe COVID-19, and individuals 18 to 64 y with frequent institutional or occupational exposure to SARS-CoV-2 putting them at risk for serious complications of COVID-19, including severe COVID-19. Interim updated CDC list of high-risk underlying conditions include but are not limited to asthma, cancer, cerebrovascular disease, chronic kidney disease, certain types of chronic lung diseases, certain types of chronic liver disease, cystic fibrosis, diabetes mellitus (type 1 and type 2), Down syndrome, heart conditions, human immunodeficiency virus, hypertension, immune deficiencies, certain mental health disorders (ie, mood disorders, schizophrenia spectrum disorders), obesity (body mass index [BMI] ≥30 kg/m²) and overweight (BMI ≥25 kg/m² but < 30 kg/m²), pregnancy and recent pregnancy, sickle cell disease, smoking (current and former), solid organ or blood stem cell transplantation, substance use disorders, thalassemia, tuberculosis, and use of corticosteroids or other immunosuppressive medications (an ongoing updated list of high-risk underlying conditions can be found on the CDC Web site)¹⁴¹.