• COVID-19 Vaccine Safety and Efficacy Data Overview

    Updated November 4, 2021

    Vaccines for Children: The FDA issued emergency use authorization (EAU) for the Pfizer/BioNTech COVID-19 at a lower dose. This formulation is different from the one used for adolscents and adults. This dose was recommended by the CDC’s Advisory Committee on Immunization Practices, which was reviewed and approved by the AAFP.

    Booster Doses: The CDC approved booster dose recommendations after reviewing analyses of potential benefits and harms of a booster dose given 6 months after the primary two-dose series of Moderna and a booster dose given 2 months after the initial dose of the J&J vaccine. 

    Vaccines for Adults and Adolescents: The FDA issued emergency use authorizations (EAU) for three vaccines. EUAs were given for mRNA vaccines from Pfizer/BioNTech and Moderna in December 2020. The third EUA was issued on February 27, 2021 for the Janssen (J&J) COVID-19 vaccine, which uses a non-replicating adenovirus vector. These vaccines have been recommended by the CDC’s Advisory Committee on Immunization, which was reviewed and approved by the AAFP. 

    Safety and Efficacy Data Overview

    Vaccine  BNT162b2 (Pfizer-BioNTech)1,5 mRNA-1273 (ModernaTX)2 Ad26.COV2.S (Janssen)3

    Type of Vaccine, Dosing

    • mRNAa, 2 doses (30 ug each) with 21 days between doses
    • Children age 5-11, mRNA (10 ug), 2 doses with 21 days between doses
    • Booster dose: 30 ug for specific populations; 1 injection
    • mRNAa, 2 doses with 28 days between doses
    • Booster dose: half of original dose, 1 injection
    • Non-replicating adenovirus vectorb, single dose
    • Booster dose: 1 injection of original dose for adults aged 18 and older

    Populations
    included in trial
    c

    • Non-pregnant persons 16 years and older (total enrolled = 43,488)
    • Age: 21.4% of participants were >65 years of age. The median age was 51 years.
    • Sex: 49.4% female
    • Race/ethnicity: 81.9% White, 9.8% Black or African American, 4.4% Asian participants, and <3% from other racial groups; 26.2% of groups; 26.2% of participants were Hispanic/Latino
    • Most frequently reported comorbid conditions: obesity, diabetes, pulmonary disease 

     

    An additional study was conducted in individuals aged 12-15  (n = 2,260)4: 

    • Sex: 49.9% female
    • Race/ethnicity: 85.9% White, 4.6% Black or African American, 11.7% Hispanic/Latino, 6.4% Asian, and 0.4% American Indian/Alaska Native

     

    Phase 2/3 Study in children 5-11 (n = 4,367)

    • Sex: 48% female
    • Race/ethnicity (vaccine group): 79.3% White, 5.9% Black or African-American, 21% Hispanic/Latino, 5.9% Asian, and 0.8% American Indian/Alaska Native
    • Non-pregnant persons 18 years and older (total enrolled = 30,351)
    • Age: 25.3% of participants were >65 years of age. The median age was 53 years.
    • Sex: 47.4% female
    • Race/ethnicity: 79.4% White, 9.7% Black or African American, 4.7% Asian participants, and <3% from other racial groups; 20% of participants were Hispanic/Latino
    • Most frequently reported comorbid conditions: obesity, diabetes, pulmonary disease, cardiovascular disease

     

    • Non-pregnant persons 18 years and older (total enrolled = 43,783)
    • Age: 20.4% of participants were >65 years of age. The median age was 53 years.
    • Sex: 44.5% female
    • Race/ethnicity: 62.1% White, 17.2% Black or African American, 3.5% Asian participants, and 8.3% American Indian or Alaska Native; 45.1% of participants were Hispanic/Latino
    • Most frequently reported comorbid conditions: obesity, diabetes, pulmonary disease, cardiovascular disease
    Efficacyd
    • All ages (16 and older)—95% (CI 90.3 - 97.6)
      • Vaccine group = 8 cases
      • Placebo group = 162 cases
    • Over age 55: 93.8% (80.9 - 98.8)
    • 65-74 years of age: 92.9% (CI 53.2 - 99.8)
    • Females: 4 cases
    • Males: 4 cases
    • Race/ethnicity: 7 cases in white individuals, 1 case in Asian individual

     

    No significant differences between those with or without comorbid conditions.In ages 12-15: 100% efficacy

    • Vaccine group = 0 cases
    • Placebo group = 18 cases

     

    In ages 5-11: 90.7% efficacy (CI 67.4 – 98.3%)

    • Vaccine group = 3 cases
    • Placebo group = 16 cases

     

    This data is from a descriptive data set that included 2,186 participants (1450 in vaccine group; 736 in the placebo group)

    • All ages —94.1% (CI 89.3 - 96.8)
      • Vaccine group = 11 cases
      • Placebo group = 185 cases
    • Over age 65: 86.4% (61.4-95.5)
    • Females: 4 cases
    • Males: 7 cases
    • Race/ethnicity: 10 cases in white individuals, 1 case in other race/ethnic groups

    Only four cases in the vaccine group were related to comorbid conditions

    • All ages—66.9% (CI 59.0 - 73.4)
      • Vaccine group = 116 cases
      • Placebo group = 348 cases
    • Over age 65: 76.5% (CI 59.1 -87.3)
    • Females: 88 cases
    • Males: 85 cases
    • Race/ethnicity: 94 cases in white individuals, 37 cases in Black or African American individuals, 6 cases in Asian individuals

    No significant differences between those with or without comorbid conditions

    Safety (adverse events) e

    Local injection site reaction (pain, swelling)

    • 1st dose: 78.6% vs 12.8% (vaccine vs placebo)
    •  2nd dose: 73.1% vs 10.6%

    Systemic reaction within 7 days

    •  1st dose: 59.1% vs 47%
    •  2nd dose 69.9% vs 33.8%
    • Most commonly reported adverse events after 2nd dose: injection site pain (66.1%), fatigue (59.4%), headache (51.7%), chills (35.1%), muscle pain (37.3), joint pain (21.9%), fever (15.8%)
    • Withdrawal and death due to serious adverse events were rare and no differences were observed between groups

    In ages 12 -15:

    • Local and systemic reactions in the vaccine group were similar to rates in adult population
    • Most commonly reported adverse events after 2nd dose: injection site pain(78.9%), fatigue (66.2%), headache (64.5%), chills (41.5%), muscle pain (32.4), fever (19.6%)

    In ages 5-11:

    Local and systemic reactions in the vaccine group were similar or lower to rates in adult and adolescent population

    Most commonly reported adverse events after 2nd dose: injection site pain (71%), fatigue (39.4%), headache (28%), chills (9.8%), muscle pain (11.4%), fever (6.5%)

     

    NOTE: Post EUA safety surveillance has identified an increase risk of myocarditis/pericarditis in adolescents and young adults. However, cases are rare and the majority resolved with minimal therapeutic intervention.

    There has also been a small increased risk for Guillain-Barre Syndrome in adults, but cases were rare. 

    Local injection site reaction (pain, swelling)

    • 1st dose: 84.2% vs 19.8% (vaccine vs placebo)
    • 2nd dose: 88.8% vs 18.8%

    Systemic reaction within 7 days

    • 1st dose: 59.4% vs 42.2%
    • 2nd dose 79.3% vs 36.5%
    • Most commonly reported adverse events after 2nd dose: injection site pain (88.4%), fatigue (67.6%), headache (62.8%), chills (48.3%), muscle pain (6.1), joint pain (45.2%), fever (17.4%)
    • Withdrawal and death due to serious adverse events were rare and no differences were observed between groups

    NOTE: Post EUA safety surveillance has identified an increased risk of myocarditis/pericarditis in adolescents and adults. However, cases are rare and the majority resolved with minimal therapeutic intervention.

    There has also been a small increased risk for Guillain-Barre Syndrome in adults, but cases were rare.

    Local injection site reaction (pain, swelling)

    • 50.2% vs 19.4% (vaccine vs placebo)

    Systemic reaction within 7 days

    • 55.1% vs 35.1% (vaccine vs placebo)
    • Most commonly reported adverse events: injection site pain (48.6%), headache (38.9%), fatigue (38.2%), myalgia (33.2%), nausea (14.2%), and fever (9.0%)
    • Withdrawal and death due to serious adverse events were rare and no differences were observed between groups

    NOTE: Post EUA safety surveillance has identified 15 reports of Thrombosis with Thrombocytopenia Syndrome (TTS) after Janssen COVID-19 vaccination. 

           

    Source: 1Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020 FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine, 2Vaccines and Related Biological Products Advisory Committee Meeting December 17, 2020 FDA Briefing Document ModernaTX COVID-19 Vaccine, 3Vaccines and Related Biological Products Advisory Committee Meeting February 26, 2021 FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 VID-19 Vaccine, and 4Fact Sheet for Healthcare Providers Administering Vaccine.

    a Note the mRNA vaccine platforms use a small piece of messenger RNA that serves as a blueprint for cells to make a viral protein which causes production of neutralizing antibody. This platform is not an actual virus and will not give recipient COVID-19.  

    Note the adenovirus vaccine platforms use a replication deficient adenovirus that has been modified to include a piece of double-stranded DNA that is the blueprint for the production of the SARS-CoV-2 spike protein which causes production of neutralizing antibody. These platforms do not replicate in cells and do not cause disease due to adenoviruses or COVID-19.

    c Demographic information was pulled from the source report. 

    d Vaccine efficacy was a measurement of confirmed COVID-19 cases in the vaccine group compared to the placebo group. CI = 95% confidence intervals. Therefore, the endpoint measured the prevention of disease and not the prevention of infection. 

    e Adverse events are represented by percentages of participants reporting an event in the vaccine group.