• COVID-19 Vaccine Safety and Efficacy Data Overview

    Updated: February 27, 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. More information can be found here: https://www.fda.gov/media/146305/download

    The two mRNA vaccines have been recommended by the CDC’s Advisory Committee on Immunization, which was reviewed and approved by the AAFP. The ACIP will be discussing the Janssen COVID-19 vaccine on Feb. 28. The session is open to the public, and AAFP expert staff will provide an efficacy and safety data overview (below), plus updated resources and patient education from the FDA and the CDC’s ACIP. 

    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 
    • 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

    • 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

     

    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
           

    Areas of insufficient evidence (data)

    • Persons with prior COVID-19 infection 
    • Children and adolescents 
    • Pregnant Individuals 
    • Individuals who are immunocompromised
    • Efficacy in preventing infection 
    • Efficacy against long-term effects of COVID-19  
     

     

    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, and 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

    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.