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. 2021 Jan 30;224(5):484–495. doi: 10.1016/j.ajog.2021.01.022

Table 1.

Summary of available SAR-CoV-2 vaccines

Name Vaccine type Experimental design Primary outcome Secondary Results
Pfizer-BioNTech mRNA BNT162b2 Double-blinded RCT 1:1 ratio of vaccine to placebo Efficacy against COVID-19 >7 d after second dose defined by:
  • 1)

    Severe COVID-19d

  • 1)

    Without previous COVID-19: 95.0% efficacy (95% CI, 90.3–97.6)
2 doses, 21 d apart
  • a)

    Symptomatica

  • 2)

    Safety or side effects
  • 2)

    With or without previous COVID-19: 94.6% efficacy (95% CI, 89.9–97.3)
≥16 y old
  • b)

    NAAT
  • 3)

    Efficacy after first dose
  • 3)

    Systemic complaints: first dose, 52%–59%; second dose, 39%–51%
N=43,448

  • within 4 days of symptom onsetb

  • 4)

    In persons with or without COVID-19
Multicenter, international In persons without previous COVID-19c
Probability of vaccine efficacy >30%
95.0% credible interval for vaccine efficacy
Bayesian beta-binomial mode
Moderna mRNA-1273 Observer-blinded RCT 1:1 ratio of vaccine to placebo Efficacy against COVID-19 >14 d after second dose defined by:
  • 1)

    Severe COVID-19d

  • 1)

    Without previous COVID-19: 94.1% efficacy (95% CI, 89.3–96.8)
2 doses, 28 d apart
  • a)

    Symptomatice

  • 2)

    Safety or side effects
  • 2)

    In persons with previous COVID-19: 93.6% (95% CI, 88.6–96.5)
≥18 y old
  • b)

    NAAT
  • 3)

    Efficacy after first dose
  • 3)

    Systemic complaints: first dose, 54.9%; second dose, 79.4%
N=30,420

  • within 4 days of symptom onsetf

  • 4)

    In persons with and without previous COVID-19
Multicenter, United States In persons without previous COVID-19c
Probability of vaccine efficacy >30%
1-sided O’Brien-Fleming boundary for efficacy. Lan-DeMets alpha-spending for efficacy boundaries
Oxford-AstraZeneca Adenovirus-vectored vaccine Single-blind and double-blind (1 site) RCT 1:1 ratio of vaccine to placebo 28 d apart Efficacy against COVID-19 >14 d after second dose defined by:
  • 1)

    Efficacy after both doses, full dose
  • 1)

    Persons without previous COVID-19: vaccine efficacy: 90.0% (67.4–97.0) for 0.5 and full dose
Subset: 0.5 and full dose second dose
  • a)

    Symptomaticg

  • 2)

    Safety or side effects
  • 2)

    Vaccine efficacy: 62.1% (95% CI, 41.0–75.7) 2 full doses
≥18 y old
  • b)

    NAATh

  • 3)

    Efficacy in patients with previous COVID-19
  • 3)

    1.6% severe side effects
N=23,848 In persons without previous COVID-19c
Multicenter, international Primary: efficacy after first dose is 0.5 dose
Vaccine efficacy Poisson regression model adjusted for age Excluded if NAAT is positive within 14 d after second dose

CI, confidence interval; COVID-19, coronavirus disease 2019; FDA, Food and Drug Administration; NAAT, Nucleic acid amplification-based test; NP, nasopharyngeal; RCT, randomized controlled trial; RT-PCR, reverse transcription-polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

Stafford. The coronavirus disease 2019 vaccine in pregnancy. Am J Obstet Gynecol 2021.

a

Pfizer: fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea, or vomiting

b

Respiratory specimen obtained during the symptomatic period or within 4 days before or after it that was positive for SARS-CoV-2 by nucleic acid amplification-based testing

c

Participants were assessed for the presence of SARS-CoV-2–binding antibodies specific to the SARS-CoV-2 nucleocapsid protein and had a nasopharyngeal swab for SARS-CoV-2 RT-PCR testing using protocol-defined acceptable tests

d

Severe COVID-19 as defined by the FDA includes severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction; admission to the intensive care unit; or death

e

Moderna: 2 or more the following symptoms: fever (temperature of ≥38°C), chills, myalgia, headache, sore throat, or new olfactory or taste disorder or occurring in those who had at least 1 respiratory sign or symptom (including cough, shortness of breath, or clinical or radiographic evidence of pneumonia)

f

One NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR

g

AstraZeneca: temperature of >37.8°C, cough, shortness of breath, and anosmia or ageusia. In some sites, the list of qualifying symptoms for swabbing was broader and included myalgia, chills, sore throat, headache, nasal congestion, diarrhea, runny nose, fatigue, nausea, vomiting, and loss of appetite

h

One NP swab or nasal swab positive for SARS-CoV-2 by RT-PCR by home kits using protocol-defined acceptable tests.