Vaccine Effectiveness against Pre-Omicron variants- Adults- Primary Series of monovalent BNT162b2 Vaccine

Page last reviewed 23 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 1 and 2 doses of monovalent BNT162b2 COVID-19 vaccine against outcomes of interest, such as confirmed, symptomatic and asymptomatic COVID-19 infection, Emergency Department (ED) admissions, hospitalization, mechanical ventilation, and death have been analyzed in Real World Evidence (RWE) studies in the Pre-Omicron era^(1-14). RWE studies during periods of Alpha (B.1.1.7), Beta (B.1.351) and Delta (B.1.617.2) variant predominance, as well as unspecified pre-Omicron variants are summarized below.These studies were conducted in the US^{(3, 12-14)}, Canada⁽⁷⁾, United Kingdom^{(2, 5, 9, 11)}, Greece⁽¹⁰⁾ , Spain⁽¹⁾ and Qatar^{(4, 6, 8)}.

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Unspecified Pre- Omicron variant

Vaccine effectiveness (VE) of one and two doses of monovalent BNT162b2 vaccine was evaluated against confirmed ^(1-3) and symptomatic⁽¹⁾ COVID-19 infection, hospitalization^{(1, 3)}, and death⁽³⁾ during the pre-Omicron period with unspecified variants. VE% (95% CI) outcomes, at listed times post last vaccine dose are summarized below; the studies included cannot be compared due to differences in study design and methodology.

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Confirmed infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Dose 1]
Age ≥ 18 years	Age ≥ 18 years	Age ≥ 18 years
≥ 21 days: 66 (60-71)⁽²⁾ ≥ 14 days: 35 (25-44) ⁽¹⁾	≥ 14 days: 65 (56-73)⁽¹⁾ 2 months since dose 1: 95 (94-95)⁽³⁾ 7 months since dose 1: 67 (65-68)⁽³⁾ Time not specified: 80 (73-85)⁽²⁾	≥ 14 days: 56 (39-68)⁽¹⁾

Symptomatic infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Dose 1]
Age ≥ 18 years	Age ≥ 18 years	Age ≥ 18 years
≥ 14 days: 30 (10-45)⁽¹⁾	≥ 14 days: 82 (73-88)⁽¹⁾	≥ 14 days: 74 (59-84)⁽¹⁾

Hospitalization

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Dose 1]
Age ≥ 18 years	Age ≥ 18 years	Age ≥ 18 years
≥ 14 days: 65 (25-83)⁽¹⁾	≥ 14 days: 94 (60-99)⁽¹⁾ 2 months since dose 1: 96 (95-97)⁽³⁾ 7 months since dose 1: 89 (87-90)⁽³⁾	≥ 14 days: 84 (-29-98)⁽¹⁾

Death

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Dose 1]
Age ≥ 18 years	Age ≥ 18 years	Age ≥ 18 years
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	2 months since dose 1: 98 (96-99)⁽³⁾ 7 months since dose 1: 91 (87-93)⁽³⁾	Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology

Alpha (B.1.1.7) predominance

Vaccine effectiveness (VE) % (95% CI) of one and two doses of monovalent BNT162b2 vaccine was evaluated against confirmed ⁽⁴⁾, and symptomatic⁽⁵⁾ COVID-19 infection, and severe, critical or fatal COVID-19 disease⁽⁴⁾, during a period of Alpha (B.1.1.7) variant predominance. VE% (95% CI) outcomes, at listed times post last vaccine dose are summarized below; the studies included cannot be compared due to differences in study design and methodology.

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Confirmed infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 16 years
Time not specified: 30 (23-36)⁽⁴⁾	≥ 14 days: 90 (86-92)⁽⁴⁾

Symptomatic infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 16 years
21 days: 48 (42-53)⁽⁵⁾	14 days: 94 (92-95)⁽⁵⁾

Hospitalization or Death

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 16 years
Time not specified: 54 (26-72)⁽⁴⁾	≥ 14 days: 100 (82-100)⁽⁴⁾

Beta (B.1.351) predominance

Vaccine effectiveness (VE) % (95% CI) of one and two doses of monovalent BNT162b2 vaccine was evaluated against confirmed COVID-19 infection, and severe, critical or fatal COVID-19 disease^{(4, 6)}, during a period of Beta (B.1.351) variant predominance.⁽⁶⁾ VE% (95% CI) outcomes, at listed times post last vaccine dose are summarized below; the studies included cannot be compared due to differences in study design and methodology.

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Confirmed infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]
Age ≥ 16 years	Age ≥ 16 years
Time not specified: 17 (10-23)⁽⁴⁾	≥ 14 days: 74 (70-78)⁽⁶⁾ to 75 (71-79)⁽⁴⁾

Hospitalization or death

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]
Age ≥ 16 years	Age ≥ 16 years
Time not specified: 0 (0-19)⁽⁴⁾	≥ 14 days: 93 (82-97)⁽⁶⁾ to 100 (74-100)⁽⁴⁾

Footnotes

*Test-negative controls

Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) predominance

Vaccine effectiveness (VE) % (95% CI) of one and two doses of monovalent BNT162b2 vaccine was evaluated against symptomatic COVID-19 infection⁽⁷⁾, and hospitalization or death⁽⁷⁾, during a period of Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) variant predominance. VE% (95% CI) outcomes, at listed times post last vaccine dose are summarized below; the studies included cannot be compared due to differences in study design and methodology.

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Symptomatic infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]
Age ≥ 16 years	Age ≥ 16 years
≥ 14 days: 59 (55-62)⁽⁷⁾	≥ 7 days: 91 (88-93)⁽⁷⁾

Hospitalization or death

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: SARS-CoV-2 PCR negative*]
Age ≥ 16 years	Age ≥ 16 years
≥ 14 days: 69 (59-77)⁽⁷⁾	Any time after dose 2: 96 (82-99)⁽⁷⁾

Footnotes

*Test-negative controls

Alpha (B.1.1.7), Beta (B.1.351) and Delta (B.1.617.2) predominance

Vaccine effectiveness (VE) % (95% CI) of one and two doses of monovalent BNT162b2 vaccine was evaluated against confirmed, symptomatic and asymptomatic COVID-19 infection, and severe, critical or fatal COVID-19 disease, during a period of Alpha (B.1.1.7) , Beta (B.1.351) and Delta (B.1.617.2) variant predominance⁽⁸⁾ . VE% (95% CI) outcomes, at listed times post last vaccine dose are summarized below.

Table Data

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Confirmed infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 18 years	Age ≥ 18 years
≥ 14 days: 37 (33-40)⁽⁸⁾	1 month: 78 (76-79)⁽⁸⁾ 3 months: 70 (67-72)⁽⁸⁾ 6 months: 17 (2-30)⁽⁸⁾ ≥7 months: 22 (-2-41)⁽⁸⁾

Asymptomatic infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 18 years	Age ≥ 18 years
≥ 14 days: 22 (12-31)⁽⁸⁾	1 month: 73 (70-76)⁽⁸⁾ 3 months: 48 (37-56)⁽⁸⁾ 6 months: -2 (-52-31)⁽⁸⁾ ≥7 months: -33 (-182-37)⁽⁸⁾

Symptomatic infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 18 years	Age ≥ 18 years
≥ 14 days: 48 (44-52)⁽⁸⁾	1 month: 82 (80-83)⁽⁸⁾ 3 months: 71 (66-74)⁽⁸⁾ 6 months: 13 (-9-30)⁽⁸⁾ ≥7 months: 28 (-1-49)⁽⁸⁾

Hospitalization and death

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 18 years	Age ≥ 18 years
≥ 14 days: 66 (57-74)⁽⁸⁾	1 month: 96 (94-97)⁽⁸⁾ 3 months: 94 (89-97)⁽⁸⁾ 6 months: 89 (52-97)⁽⁸⁾ ≥7 months: 56 (-44-86)⁽⁸⁾

- In this study, the observed monovalent BNT162b2-induced protection peaked in the first month after the second dose with accelerated waning after the 4th month; protection against hospitalization and death was observed to be high with slower waning of response after the 2nd vaccine dose.⁽⁸⁾

Delta (B.1.617.2) predominance

Vaccine effectiveness (VE) % (95% CI) of one and two doses of monovalent BNT162b2 vaccine was evaluated against confirmed^{(6, 11-13)}, symptomatic^{(5, 6, 9)} and asymptomatic⁽⁶⁾ COVID-19 infection, Emergency Department (ED) admission⁽¹⁴⁾, hospitalization^{(9, 11, 13, 14)}, mechanical ventilation (intubation)⁽¹⁰⁾, hospitalization/death⁽⁶⁾, and death^{(9, 10)} during a period of Delta (B.1.617.2) variant predominance. VE% (95% CI) outcomes, at listed times post last vaccine dose are summarized below the studies included cannot be compared due to differences in study design and methodology.

Table Data

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Confirmed infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
≥ 14 days: 50 (46-52)⁽¹³⁾	≥ 7 days: 64 (59-68)⁽¹³⁾ ≥ 14 days: 52 (47-56)⁽⁶⁾ to 75 (52-87)⁽¹²⁾ 1 month: 92 (91-92)⁽¹¹⁾ 3 months: 87 (86-87)⁽¹¹⁾ 6 months: 82 (81-82)⁽¹¹⁾ 8 months: 76 (73-78)⁽¹¹⁾

Asymptomatic infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	≥ 14 days: 46 (32-57)⁽⁶⁾

Symptomatic infection

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
21 days: 36 (23-46)⁽⁵⁾	≥ 14 days: 44 (37-51)⁽⁶⁾ to 88 (85-90)⁽⁵⁾ 2-9 weeks: 90 (89-90)⁽⁹⁾ ≥ 20 weeks: 66 (66-67)⁽⁹⁾

ED admission

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	≥ 7 days: 61 (55-66) ⁽¹⁴⁾ <3 months: 78 (69-85) ⁽¹⁴⁾ 3 to <6 months: 59 (48-68) ⁽¹⁴⁾ ≥ 9 months: 57 (45-66) ⁽¹⁴⁾

Hospitalization

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
≥ 14 days: 58 (50-65)⁽¹³⁾	≥ 7 days: 76 (69-82)⁽¹⁴⁾ to 85 (76-91)⁽¹³⁾ 2-9 weeks: 99 (98-99)⁽⁹⁾ ≥ 20 weeks: 92 (91-93)⁽⁹⁾ <3 months: 78 (55-89)⁽¹⁴⁾ <6 months: 84 (74-90)⁽¹⁴⁾ ≥ 6 months: 73 (63-80)⁽¹⁴⁾ ≥ 9 months: 73 (58-83)⁽¹⁴⁾

Mechanical ventilation(intubation)

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	1 month (age 15-59): 98 (98-99)⁽¹⁰⁾ 6 months (age 15-59): 96 (94-97)⁽¹⁰⁾ 1 month (age 60-79): 97 (96-97)⁽¹⁰⁾ 6 months (age 60-79): 92 (91-93)⁽¹⁰⁾ 1 month (age ≥80): 94 (92-96)⁽¹⁰⁾ 6 months (age≥ 80): 86 (84-88)⁽¹⁰⁾

Hospitalization or death

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	≥ 14 days: 93 (85-97)⁽⁶⁾

Death

VE% (95% CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]	VE% (95% CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated]
Age ≥ 16 years	Age ≥ 15 years
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	2-9 weeks: 99 (97-99)⁽⁹⁾ ≥ 20 weeks: 92 (89-94)⁽⁹⁾ 1 month (age 15-59): 97 (95-98)⁽¹⁰⁾ 6 months (age 15-59): 94 (91-96)⁽¹⁰⁾ 1 month (age 60-79): 94 (93-95)⁽¹⁰⁾ 6 months (age 60-79): 89 (88-91)⁽¹⁰⁾ 1 month (age ≥80): 91 (88-93)⁽¹⁰⁾ 6 months (age≥ 80): 84 (82-86)⁽¹⁰⁾

Higher rates of protection against all outcomes were observed after receipt of 2 doses of monovalent BNT162b2 COVID-19 vaccine, in the studies included in this summary.^{(1, 3-9, 11-14)}
Higher rates of protection against all outcomes were observed against Alpha (B.1.1.7) variant^{(4, 5)} over Beta(B.1.351) ⁽⁴⁾ and Delta(B.1.617.2)^{(5, 6, 8-14)} variants, in the studies included in this summary.
Waning protection against COVID-19 infection^{(3, 8, 9, 11)} and ED admissions⁽¹⁴⁾ was observed at approximately >3-6 months post administration of a 2^nd dose of BNT162b2 COVID-19 vaccine, during periods of unspecified pre-Omicron⁽³⁾, combined Alpha (B.1.1.7)/ Beta(B.1.351)/ Delta(B.1.617.2)⁽⁸⁾ and Delta(B.1.617.2)^{(9, 11, 14)} variant predominance.
Protection against severe outcomes, such as hospitalization and death, were observed during the first 6 months following vaccination with a 2^nd dose of BNT162b2 vaccine in periods of mixed Alpha (B.1.1.7),Beta (B.1.351), Gamma (P.1) and Delta (B.1.617.2) predominance ^{(7, 8)} and in periods of Delta (B.1.617.2) predominance^{(8-10, 13, 14)} in the studies included in this summary.

References: (1) Martinez Baz, (2) Pritchard, (3) Lin, (4) Abu-Raddad, (5) Lopez-Bernal, (6) Tang, (7) Chung, (8) Chemaitelly, (9) Andrews, (10) Lytras, (11) Menni, (12) Richterman, (13) Tartof Lancet Reg Health Am, (14) Tartof Lancet Resp Med

Publications have reported different definitions of COVID-19 outcomes. Definitions can be found under Primary Endpoints and Definitions for each study below.