• COVID-19 Vaccine Safety and Efficacy Data Overview

    Updated: May 12, 2021

    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 mRNA-1273 (ModernaTX)2 Ad26.COV2.S (Janssen)3
    Type of Vaccine, Dosing mRNAa, 2 doses with 21 days between doses mRNAa, 2 doses with 28 days between doses Non-replicating adenovirus vectorb, single dose

    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
    • 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—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

     

    • 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%)

     

    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

    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. 

    • 13 cases occurred among women aged 18−49 years, and 2 occurred among women aged ≥50 years. This translates into 7.0 cases per million Janssen COVID-19 vaccine doses administered to women aged 18−49 years and 0.9 per million to women aged ≥50 years. Median age was 37 years (range = 18−59 years), and median interval to symptom onset was 8 days (range = 6−15 days). No consistent risk factors were found consistently in all the cases. No cases occurred in individuals who were pregnant or had recently given birth. No cases had a documented history of previous thrombotic events, a known diagnosis of an underlying clotting disorder, or a family or personal history of clotting disorders. 
           

    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. Note that both manufacturers have begun including persons aged 12-17 years old but these data were not included in the FDA briefing document. Pregnancy did occur in some participants in both trials, but data are insufficient to determine safety and efficacy in this population or in persons who are lactating or immunocompromised.   

    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.