Vaccine Effectiveness against Omicron- Adults- Monovalent BNT162b2 Vaccine Boosters
Page last reviewed 24 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.
Vaccine effectiveness (VE) of 3rd and 4th (booster doses) of monovalent BNT162b2 vaccine have been evaluated against several outcomes of interest, such as confirmed and symptomatic COVID-19 infection, Emergency Department (ED) visits, hospitalization, hospitalization/ICU admission or death, during a period of Omicron (B.1.1.529, BA.1/2) predominance. (1-13)
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Omicron variant- lineage B.1.1.529
- The emergence of SARS-CoV-2 variants of concern (VOC), such as Omicron, highlighted waning immunity, which has been observed at > 3 months following 2 BNT162b2 monovalent COVID-19 vaccine doses.(1, 14, 15)
- 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. (16-18)
- Vaccine Effectiveness (VE) of a 3rd and 4th (booster) doses has been studied in Real World Evidence (RWE) studies. (1-14, 19, 20)
- RWE on VE against several outcomes of interest (such as confirmed infection, symptomatic infection, ED visits, 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 Omicron (B.1.1.529) variant predominance:
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Confirmed infection
| VE % (95% CI) of 3rd (1st booster) dose [Reference: Unvaccinated] Age ≥ 18 years |
VE % (95% CI) of 3rd (1st booster) dose [Reference: 2 doses] Age ≥ 18 years |
VE % (95% CI) of 4th (2nd booster) dose [Reference: 3 doses] Age ≥ 60 years |
|---|---|---|
| > 7 days: 54 (23-73) (10) < 8 weeks: 75 (50-87)(10) > 16 weeks: 55 (5-69)(10) |
>7 days: 11 (7–14) (3) to 50 (42-56)(10) < 8 weeks: 66 (51-76)(10) > 16 weeks: 55 (19-76) (10) |
7–30 days: 45 (44–47)(6) 14–30 days: 52 (49–54)(6) |
Symptomatic infection
| VE % (95% CI) of 3rd (1st booster) dose [Reference: Unvaccinated] Age ≥ 18 years |
VE % (95% CI) of 3rd (1st booster) dose [Reference: 2 doses] Age ≥ 18 years |
VE % (95% CI) of 4th (2nd booster) dose [Reference: 3 doses] Age ≥ 60 years |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | ≥ 7 days: 39 (23-52)(10) to 49 (47–52)(5) ≥ 15 days: 50 (48–52) (5) |
7–30 days: 55 (53–58)(6) 14–30 days: 61 (58–64)(6) |
ED visits
| VE % (95% CI) of 3rd (1st booster) dose [Reference: Unvaccinated] Age ≥ 18 years |
VE % (95% CI) of 3rd (1st booster) dose [Reference: 2 doses] Age ≥ 18 years |
VE % (95% CI) of 4th (2nd booster) dose [Reference: 3 doses] Age ≥ 60 years |
|---|---|---|
| ≥ 14 days: 75 (70–79)(1) < 3 months: 77 (72–81)(1) ≥ 3 months: 53 (36–66)(1) |
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology |
Hospitalization
| VE % (95% CI) of 3rd (1st booster) dose [Reference: Unvaccinated] Age ≥ 18 years |
VE % (95% CI) of 3rd (1st booster) dose [Reference: 2 doses] Age ≥ 18 years |
VE % (95% CI) of 4th (2nd booster) dose [Reference: 3 doses] Age ≥ 60 years |
|---|---|---|
| ≥ 14 days: 82 (77–87)(1) < 3 months: 85 (80–89) (1) ≥ 3 months: 55 (28–71)(1) |
> 7 days: 50 (41–57)(3) | 7–30 days: 68 (59–74) (6) 14–30 days: 72 (63–79) (6) |
Hospitalization or death
| VE % (95% CI) of 3rd (1st booster) dose [Reference: Unvaccinated] Age ≥ 18 years |
VE % (95% CI) of 3rd (1st booster) dose [Reference: 2 doses] Age ≥ 18 years |
VE % (95% CI) of 4th (2nd booster) dose [Reference: 3 doses] Age ≥ 60 years |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | ≥ 7 days: 77 (56–88) (5) | 7–30 days: 62 (50–74) (6) 7–27 days: 73 (66–79) (7) 14–30 days: 64 (48–77) (6) |
ICU admission or death
| VE % (95% CI) of 3rd (1st booster) dose [Reference: Unvaccinated] Age ≥ 18 years |
VE % (95% CI) of 3rd (1st booster) dose [Reference: 2 doses] Age ≥ 18 years |
VE % (95% CI) of 4th (2nd booster) dose [Reference: 3 doses] Age ≥ 60 years |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | > 7 days: 88 (68–96) (3) | Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology |
Death
| VE % (95% CI) of 3rd (1st booster) dose [Reference: Unvaccinated] Age ≥ 18 years |
VE % (95% CI) of 3rd (1st booster) dose [Reference: 2 doses] Age ≥ 18 years |
VE % (95% CI) of 4th (2nd booster) dose [Reference: 3 doses] Age ≥ 60 years |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | 7–30 days: 74 (50–90)(6) 14–30 days: 76 (48–91) (6) |
Omicron variant- sublineage BA.1/ BA.2
- The effectiveness of protection provided by previous infection with variants other than Omicron (B.1.1.529), vaccination with 2 or 3 doses of BNT162b2 and hybrid immunity (previous non-Omicron variant infection and vaccination with BNT162b2) against symptomatic BA.1/BA.2 and any Omicron infection has been analyzed in a matched, test-negative, case-control study. (12)
- The observed effectiveness of previous infection with variants other than Omicron alone against symptomatic BA.2 infection was 46.1% (95% CI, 39.5-51.9) and 50.2% (95% CI, 38.1-59.9) against symptomatic BA.1 infection.
- The highest observed effectiveness against symptomatic BA.2 infection was 77.3% (95% CI, 72.4- 81.4) and 74.4% (95% CI, 63.4- 82.2) against symptomatic BA.1 infection, observed in participants with previous infection and who had received 3 doses of vaccine.
- Previous infection alone, BNT162b2 vaccination alone and hybrid immunity all showed >70% effectiveness against severe, critical, or fatal COVID-19 infection VE% (95% CI) of 3 doses of BNT162b2 (without previous SARS-CoV-2 infection), at listed times post last vaccine dose, during a period of BA.1/BA.2 predominance, against symptomatic infection (12, 13), and hospitalization(13) or death(13) were reported:
Table Data
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Symptomatic infection
| Variant | VE% (95% CI) of 3rd (1st booster) dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|
| BA.1 | ≥ 7 days: 60 (53- 65) (12) < 1 month: 60 (51- 67) (13) ≥ 1 month: 41 (31- 49) (13) |
| BA.2 | ≥ 7 days: 52 (48- 56) (12) < 1 month: 44(37- 50) (13) ≥ 1 month: 40 (34-46) (13) |
Hospitalization or death
| Variant | VE% (95% CI) of 3rd (1st booster) dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|
| BA.1 and/or BA.2 | 1-6 weeks: 91 (79- 96) (13) ≥ 7 weeks: 90 (81- 95) (13) |
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- VE against BA.1 and BA.2 symptomatic infection was similar and waned rapidly starting at 4 months after 2nd vaccine dose; VE against hospitalization or death was durable after a 2nd dose and most robust after a 3rd (booster) dose of BNT162b2. (13)
- The initial booster studies reported data collected during a period of Delta and Omicron variant predominance.(1-14, 19, 20)
- VE has waned over time with new VOC (especially with Omicron as compared to other variants).(3, 10, 12, 14, 15, 19)
- Third and fourth (booster) doses of BNT162b2 COVID-19 monovalent vaccine, in the studies described in this summary, have been associated with reduction of risk against more severe outcomes, such as COVID-19 related hospitalization or death.(3, 4, 6-9, 11-14, 20)
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) Altarawneh; (20) Chemaitelly Nat Commun
Publications have reported different definitions of COVID-19 outcomes. Definitions can be found under Primary Endpoints and Definitions for each study below.
