Vaccine Effectiveness against Pre-Omicron variants- Adults- Monovalent BNT162b2 Vaccine Boosters
Page last reviewed 12 February 2023
Key Points
Key Points are meant to be a scientific, factual summary of the available information that relates solely to the Pfizer-BioNTech COVID-19 Vaccine, as supported by referenced publications within this section. Conclusions should not be drawn from the inclusion or absence of information.
- The emergence of SARS-CoV-2 variants, such as Delta, highlighted waning immunity, which has been observed at > 3 months following 2 BNT162b2 monovalent vaccine doses.(1-3)
- CDC has made updated recommendations for COVID-19 vaccination in individuals 6 months of age and older. Please see product labeling and CDC Interim Clinical Considerations for current vaccine dosing regimens and recommendations.(4-6)
- Vaccine Effectiveness (VE) of a 3rd and 4th (booster) doses has been studied in Real World Evidence (RWE) studies.(1, 2, 7-19)
- RWE on VE against several outcomes of interest (such as confirmed infection, symptomatic infection, Emergency Department (ED) admissions, severe disease, and hospitalization) has varied across studies, and these cannot be compared due to differences in study design and methodology. VE% (95% CI) ranges for BNT162b2, at listed times post last vaccine dose, are summarized below for periods of Delta (B.1.617.2) variant predominance (pre-Omicron period):
Table Data
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Confirmed infection
| VE % (95% CI) of 3rd (1st booster) dose (1, 7, 8, 15-17) [Reference: Unvaccinated] Age ≥ 16 years |
VE % (95% CI) of 3rd (1st booster) dose(2, 9-14, 17, 19) [Reference: 2 doses] Age ≥ 16 years |
|---|---|
| > 7 days:93 (78-98)(17) ≥ 14 days:88 (86–89)(7) 2 weeks, 16-59 years:93 (91-94)(16), ≥ 60 years: 76 (71-81)(16) 16 weeks, 16-59 years:78 (68-84)(16), ≥ 60 years: 93 (90-95)(16) |
≥ 7 days:27 (24–30) (9) to 88 (87–90)(10) |
Symptomatic infection
| VE % (95% CI) of 3rd (1st booster) dose (1, 7, 8, 15-17) [Reference: Unvaccinated] Age ≥ 16 years |
VE % (95% CI) of 3rd (1st booster) dose(2, 9-14, 17, 19) [Reference: 2 doses] Age ≥ 16 years |
|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | > 7 days: 80 (62–89)(17) to 91 (89–92)(10) ≥ 14 days: 84 (78–88)(11) |
ED admissions
| VE % (95% CI) of 3rd (1st booster) dose (1, 7, 8, 15-17) [Reference: Unvaccinated] Age ≥ 16 years |
VE % (95% CI) of 3rd (1st booster) dose(2, 9-14, 17, 19) [Reference: 2 doses] Age ≥ 16 years |
|---|---|
| ≥ 14 days:83 (79–86) (1) ≥ 3 months:72 (58–82) (1) |
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology |
Severe disease
| VE % (95% CI) of 3rd (1st booster) dose (1, 7, 8, 15-17) [Reference: Unvaccinated] Age ≥ 16 years |
VE % (95% CI) of 3rd (1st booster) dose(2, 9-14, 17, 19) [Reference: 2 doses] Age ≥ 16 years |
|---|---|
| 2 weeks, 16-59 years:92 (70-98) (16) 2 weeks, ≥ 60 years:82 (75-87) (16) 16 weeks, 16-59 years: 100 (16) 18 weeks, ≥ 60 years: 100 (16) |
≥ 7 days:92 (82–97)(10) |
Hospitalization
| VE % (95% CI) of 3rd (1st booster) dose (1, 7, 8, 15-17) [Reference: Unvaccinated] Age ≥ 16 years |
VE % (95% CI) of 3rd (1st booster) dose(2, 9-14, 17, 19) [Reference: 2 doses] Age ≥ 16 years |
|---|---|
| ≥ 14 days:87 (81–92) (1) to 88 (86–90) (8) 2 weeks:92 (78-97) (16) 16 weeks:94 (48- 99) (16) ≥ 3 months: 71 (40–86) (1) |
≥ 7 days:79 (71–85)(9) 89 (87-91)(19) 93 (88–97)(10) |
Death
| VE % (95% CI) of 3rd (1st booster) dose (1, 7, 8, 15-17) [Reference: Unvaccinated] Age ≥ 16 years |
VE % (95% CI) of 3rd (1st booster) dose(2, 9-14, 17, 19) [Reference: 2 doses] Age ≥ 16 years |
|---|---|
| 2-16 weeks:100 (16) 1 month:98 (97-99) (15) |
≥ 7 days:81 (59–97)(10) |
- The initial booster studies reported data collected during a period of Delta and Omicron variant predominance.(1, 2, 7-19)
- VE has been observed to wane over time with new SARS-CoV-2 variants. (2, 3, 7, 9, 17)
- BNT162b2 monovalent vaccine, in the studies described in this summary, was associated with reduction of risk against more severe outcomes, such as COVID-19 related hospitalization or death, particularly for individuals who received booster doses.(2, 3, 9-11, 13-16, 18, 19)
References: (1) Tartof, Lancet Respir Med, 2022; (2) Patalon; (3) Chemaitelly; (4) CDC COVID-19 Vaccination Schedule for People who are NOT Moderately or Severely Immunocompromised; (5) CDC COVID-19 Vaccination Schedule for People who ARE Moderately or Severely Immunocompromised; (6) Stay Up to Date with COVID-19 Vaccines Including Boosters | CDC.; (7) Tartof, Lancet Reg Health Am, 2022; (8) Drawz; (9) Butt, CID May 2022; (10) Barda; (11) Butt, CID March 2022; (12) Abu-Raddad; (13) Magen; (14) Gazit; (15) Lytras; (16) Glatman- Freedman EID 2022; (17) Richterman; (18) Sharma; (19) Waxman;
Publications have reported different definitions of COVID-19 outcomes. Definitions can be found under Primary Endpoints and Definitions for each study below.
