Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated — VISION Network, 10 States, December 2021–June 2022

The Omicron variant (B.1.1.529) of SARS-CoV-2, the virus that causes COVID-19, was first recognized within the United States in November 2021, with the BA.1 sublineage (together with BA.1.1) inflicting the biggest surge in COVID-19 instances up to now. Omicron sublineages BA.2 and BA.2.12.1 emerged later and by late April 2022, accounted for many instances.* Estimates of COVID-19 vaccine effectiveness (VE) might be decreased by newly rising variants or sublineages that evade vaccine-induced immunity (1), safety from earlier SARS-CoV-2 an infection in unvaccinated individuals (2), or growing time since vaccination (3). Real-world knowledge evaluating VE throughout the intervals when the BA.1 and BA.2/BA.2.12.1 predominated (BA.1 interval and BA.2/BA.2.12.1 interval, respectively) are restricted. The VISION community^† examined 214,487 emergency division/pressing care (ED/UC) visits and 58,782 hospitalizations with a COVID-19–like sickness^§ prognosis amongst 10 states throughout December 18, 2021–June 10, 2022, to judge VE of 2, 3, and 4 doses of mRNA COVID-19 vaccines (BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna]) in contrast with no vaccination amongst adults with out immunocompromising situations. VE towards COVID-19–related hospitalization 7–119 days and ≥120 days after receipt of dose 3 was 92% (95% CI = 91%–93%) and 85% (95% CI = 81%–89%), respectively, throughout the BA.1 interval, in contrast with 69% (95% CI = 58%–76%) and 52% (95% CI = 44%–59%), respectively, throughout the BA.2/BA.2.12.1 interval. Patterns had been related for ED/UC encounters. Among adults aged ≥50 years, VE towards COVID-19–related hospitalization ≥120 days after receipt of dose 3 was 55% (95% CI = 46%–62%) and ≥7 days (median = 27 days) after a fourth dose was 80% (95% CI = 71%–85%) throughout BA.2/BA.2.12.1 predominance. Immunocompetent individuals ought to obtain advisable COVID-19 booster doses to forestall average to extreme COVID-19, together with a primary booster dose for all eligible individuals and second booster dose for adults aged ≥50 years not less than 4 months after an preliminary booster dose. Booster doses must be obtained instantly when individuals develop into eligible.^¶

A 2-dose main COVID-19 mRNA vaccination sequence adopted by a 3rd (booster) dose not less than 5 months after dose 2 is advisable for adults aged ≥18 years with out immunocompromising situations. On March 29, 2022, an extra booster dose (dose 4) was approved for immunocompetent adults aged ≥50 years not less than 4 months after dose 3 (4). The VISION Network evaluated the effectiveness of 2, 3, or 4 mRNA vaccine doses throughout December 2021–June 2022, a interval throughout which totally different sublineages of Omicron circulated within the United States. VISION strategies have been described beforehand (5); briefly, eligible medical encounters embody ED/UC visits and hospitalizations amongst adults with COVID-19–like sickness and a SARS-CoV-2 molecular take a look at throughout the 14 days earlier than by 72 hours after the encounter. Variant predominance was outlined because the interval when a variant accounted for ≥75% of all sequenced specimens at a website (i.e., BA.1, December 2021–March 2022** and BA.2/BA.2.12.1, March–June 2022^††). Dates when the prevalence of BA.1 declined to <75% of sequenced specimens and the prevalence of BA.2/BA.2.12.1 had not but reached 75% had been thought of a “washout” interval; encounters by June 10, 2022, had been included until BA.2/BA.2.12.1 prevalence declined to <75% at a website earlier than that date. Patients had been excluded if 1) a medical occasion occurred throughout the washout interval; 2) a possible immunocompromising situation was current; 3) an mRNA vaccine dose was obtained earlier than it was advisable^§§; 4) any doses of a non–mRNA vaccine reminiscent of JNJ-78436735 (Janssen [Johnson & Johnson]) had been obtained; 5) <14 days had elapsed since receipt of dose 2 or <7 days since receipt of dose 3 or dose 4; or 6) a earlier SARS-CoV-2 an infection was documented within the affected person’s medical document earlier than the index encounter (to scale back the affect of safety from earlier an infection).^¶¶ VE was estimated utilizing a test-negative case-control design, evaluating the percentages of being vaccinated (receipt of 2 doses ≥14 days earlier than the encounter, 3 doses ≥7 days earlier than the encounter, or 4 doses ≥7 days earlier than the encounter) versus being unvaccinated (zero doses obtained) between individuals with optimistic and damaging SARS-CoV-2 take a look at outcomes, utilizing multivariable logistic regression, weighted for inverse propensity to be vaccinated, and adjusted for age, calendar time of index date (days since January 1, 2021),*** examine website, and native virus circulation. VE for 4 vaccine doses was assessed just for adults aged ≥50 years throughout the BA.2/BA.2.12.1 interval, aligning with the March 29, 2022, authorization for the fourth dose. Nonoverlapping 95% CIs had been thought of statistically vital. Analyses had been carried out utilizing R software program (model 4.1.2; R Foundation). The examine was reviewed and accepted by institutional evaluate boards at collaborating websites or beneath reliance settlement with the institutional evaluate board of Westat, Inc. This exercise was carried out in line with relevant federal regulation and CDC coverage.^†††

Among 214,487 ED/UC encounters with a COVID-19–like sickness prognosis that met inclusion standards, 124,033 (57.8%) occurred throughout the BA.1 interval, throughout which 40,801 (32.9%) sufferers had a optimistic SARS-CoV-2 take a look at consequence; 90,454 (42.2%) occurred throughout the BA.2/BA.2.12.1 interval, throughout which 10,177 (11.3%) had a optimistic SARS-CoV-2 take a look at consequence. During the BA.1 interval, 51,359 (41.4%) ED/UC sufferers had been unvaccinated, 40,026 (32.3%) had obtained 2 mRNA vaccine doses, and 32,648 (26.3%) had obtained 3 doses (Table 1). During the BA.2/BA.2.12.1 interval, 27,907 (30.9%) ED/UC sufferers had been unvaccinated; 22,657 (25.0%) had obtained 2 mRNA vaccine doses, 35,796 (39.6%) had obtained 3 doses; and 4,094 (4.5%) had obtained 4 doses. Receipt of 3 versus 2 doses was related to the next VE towards an ED/UC encounter throughout each intervals, and VE was greater throughout the BA.1 interval than the BA.2/BA.2.12.1 interval (Table 2). During the BA.1 interval, VE declined to 73% ≥120 days (median = 132 days) after the third vaccine dose; throughout the BA.2/BA.12.1 interval, VE declined to 26% at ≥120 days (median = 166 days) after the third dose.

Among 58,782 hospitalizations with a COVID-19–like sickness prognosis that met inclusion standards, 35,399 (60.2%) occurred throughout the BA.1 interval, throughout which 10,534 (29.8%) sufferers had a optimistic SARS-CoV-2 take a look at consequence; 23,383 (17.9%) occurred throughout the BA.2/BA.2.12.1 interval, throughout which 1,564 (6.7%) sufferers had a optimistic take a look at consequence (Table 3). During the BA.1 interval, 14,742 (41.6%) sufferers hospitalized with COVID-19–like sickness had been unvaccinated, 10,086 (28.5%) had obtained 2 mRNA vaccine doses, and 10,571 (29.9%) had obtained 3 doses. During the BA.2/BA.2.12.1 interval, 6,682 (28.6%) sufferers hospitalized with COVID-19–like sickness had been unvaccinated, and 5,461 (23.4%), 10,036 (42.9%), and 1,204 (5.1%) had obtained 2, 3, and 4 mRNA vaccine doses, respectively. VE towards COVID-19–related hospitalization was 61% ≥150 days after dose 2 throughout the BA.1 interval (median = 289 days) in contrast with 24% throughout the BA.2/BA.2.12.1 interval (median = 371 days) (Table 2). VE related to a 3rd mRNA vaccine dose was greater than that related to a second vaccine dose however declined throughout each intervals at ≥120 days to 85% throughout the BA.1 interval (median = 132 days) and 52% throughout the BA.2/BA.2.12.1 interval (median = 168 days).

Among adults aged ≥50 years eligible to obtain a fourth mRNA vaccine dose, VE for COVID-19–related ED/UC encounters throughout the BA.2/BA.2.12.1 interval was 32% at ≥120 days after the third dose (median interval = 170 days) however elevated to 66% ≥7 days after the fourth dose (median interval = 28 days). VE towards COVID-19–related hospitalization was 55% ≥120 days after the third dose however elevated to 80% ≥7 days after the fourth dose.

Acknowledgments

¹CDC COVID-19 Emergency Response Team; ²Westat, Rockville, Maryland.; ³Baylor Scott & White Health, Temple, Texas; ⁴Texas A&M University College of Medicine, Temple, Texas; ⁵Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; ⁶Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; ⁷Department of Population and Family Health, Columbia University Mailman School of Public Health, New York, New York; ⁸New York Presbyterian Hospital, New York, New York; ⁹Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah; ¹⁰HealthPartners Institute, Minneapolis, Minnesota; ¹¹School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado; ¹²Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana; ¹³School of Medicine, Indiana University, Indianapolis, Indiana; ¹⁴Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, California; ¹⁵Paso Del Norte Health Information Exchange, El Paso, Texas; ¹⁶Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, New York; ¹⁷Fairbanks School of Public Health, Indiana University, Indianapolis, Indiana; ¹⁸Children’s Minnesota, Minneapolis, Minnesota; ¹⁹Brigham Young University Department of Public Health, Provo, Utah.

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Abbreviations: ED = emergency division; ICD-9 = International Classification of illnesses, Ninth Revision; ICD-10 = International Classification of illnesses, Tenth Revision; KPNC = Kaiser Permanente Northern California; KPNW = Kaiser Permanente Northwest; N/A = not relevant; NH = non-Hispanic; PHIX = Paso del Norte Health Information Exchange; RT-PCR = reverse transcription–polymerase response; SMD = standardized imply or proportion distinction; UC = pressing care.
* Medical occasions with a discharge code in line with COVID-19–like sickness had been included; utilizing ICD-9 and ICD-10 codes, COVID-19–like sickness diagnoses included acute respiratory sickness (e.g., respiratory failure or pneumonia) or associated indicators or signs (e.g., cough, fever, dyspnea, vomiting, or diarrhea). Clinician-ordered molecular assays (e.g., real-time RT-PCR) for SARS-CoV-2 occurring ≤14 days earlier than to <72 hours after the encounter date had been included.
^† Partners contributing knowledge on medical occasions throughout dates of estimated ≥75% Omicron BA.1 predominance had been in California (Dec 21, 2021–Mar 6, 2022), Colorado (Dec 25, 2021–Mar 12, 2022), Indiana (Dec 31, 2021–Mar 4, 2022), Minnesota and Wisconsin (Jan 1–Mar 5, 2022), New York (Dec 18, 2021–Feb 26, 2022), Oregon and Washington (Jan 1–Mar 12, 2022), Texas (Baylor Scott & White Health [Dec 18, 2021–Mar 5, 2022] and PHIX [Jan 8–Mar 19, 2022]), and Utah (Dec 27, 2021–Mar 19, 2022).
^§ Partners contributing knowledge on medical occasions throughout dates of estimated ≥75% Omicron BA.2/BA.2.12.1 predominance had been in California (Mar 25–Jun 10, 2022), Colorado (Apr 9–Jun 4, 2022), Indiana (Mar 19–Jun 10, 2022), Minnesota and Wisconsin (Apr 9–Jun 4, 2022), New York (Mar 26–Jun 10, 2022), Oregon and Washington (Apr 9–Jun 10, 2022), Texas (Baylor Scott & White Health [Mar 26–Jun 4, 2022] and PHIX [Apr 23–Jun 10, 2022]), and Utah (Mar 28–Jun 10, 2022).
^¶ Vaccination was outlined as having obtained the listed quantity of doses of an mRNA-based COVID-19 vaccine throughout the specified vary of quantity of days earlier than the medical occasion index date, which was the date of respiratory specimen assortment related to the latest optimistic or damaging SARS-CoV-2 take a look at consequence earlier than the medical occasion or the admission date if testing solely occurred after the admission.
** An absolute SMD ≥0.20 signifies a nonnegligible distinction in variable distributions between medical occasions for vaccinated versus unvaccinated sufferers or for sufferers with SARS-CoV-2–optimistic take a look at consequence versus these with SARS-CoV-2–damaging outcomes. For mRNA COVID-19 vaccination standing, a single SMD was calculated by averaging absolutely the SMDs obtained from pairwise comparisons of every vaccinated class versus unvaccinated; extra particularly as the typical of absolutely the worth of the SMDs for 1) vaccinated with 2 doses 14–149 days earlier versus unvaccinated, 2) vaccinated with 2 doses ≥150 days earlier versus unvaccinated, 3) vaccinated with 3 doses 7–119 days earlier versus unvaccinated, 4) vaccinated with 3 doses ≥120 days earlier versus unvaccinated, and 5) vaccinated with 4 doses ≥7 days earlier versus unvaccinated.
^†† Other race contains Asian, Native Hawaiian or different Pacific islander, American Indian or Alaska Native, Other, and a number of races.
^§§ Chronic respiratory situation was outlined because the presence of discharge code for bronchial asthma, power obstructive pulmonary illness, or different lung illness utilizing ICD-9 or ICD-10 prognosis codes.
^¶¶ Chronic nonrespiratory situation was outlined because the presence of discharge code for coronary heart failure, ischemic coronary heart illness, hypertension, different coronary heart illness, stroke, different cerebrovascular illness, diabetes sort I or II, different diabetes, metabolic illness, scientific weight problems, clinically underweight, renal illness, liver illness, blood dysfunction, immunosuppression, organ transplant, most cancers, dementia, neurologic dysfunction, musculoskeletal dysfunction, or Down syndrome utilizing ICD-9 and ICD-10 prognosis codes.

Abbreviations: ED = emergency division; ICD-9 = International Classification of Diseases, Ninth Revision; ICD-10 = International Classification of Diseases, Tenth Revision; N/A = not relevant; PHIX = Paso Del Norte Health Information Exchange; Ref = referent group; RT-PCR = reverse transcription–polymerase chain response; UC = pressing care; VE = vaccine effectiveness.
* VE was calculated as ([1−odds ratio] x 100%), estimated utilizing a test-negative design, adjusted for age, geographic area, calendar time (days since January 1, 2021), and native virus circulation (share of SARS-CoV-2–optimistic outcomes from testing throughout the counties surrounding the ability on the date of the encounter) and weighted for inverse propensity to be vaccinated or unvaccinated (calculated individually for every set of VE estimates amongst ED or UC encounters and hospitalizations by Omicron–predominant interval and age group). Generalized boosted regression timber had been used to estimate the propensity to be vaccinated primarily based on sociodemographic traits, underlying medical situations, and facility traits.
^† Medical occasions with a discharge code in line with COVID-19–like sickness had been included. COVID-19–like sickness diagnoses included acute respiratory sickness (e.g., respiratory failure or pneumonia) or associated indicators or signs (e.g., cough, fever, dyspnea, vomiting, or diarrhea) utilizing ICD-9 and ICD-10 codes. Clinician-ordered molecular assays (e.g., real-time RT-PCR) for SARS-CoV-2 occurring ≤14 days earlier than to <72 hours after the encounter date had been included.
^§ Vaccination was outlined as having obtained the listed quantity of doses of an mRNA-based COVID-19 vaccine throughout the specified vary of quantity of days earlier than the medical occasion index date, which was the date of respiratory specimen assortment related to the latest optimistic or damaging SARS-CoV-2 take a look at consequence earlier than the medical occasion or the admission date if testing solely occurred after the admission.
^¶ Partners contributing knowledge on medical occasions throughout dates of estimated ≥75% Omicron BA.1 predominance had been in California (Dec 21, 2021–Mar 6, 2022), Colorado (Dec 25, 2021–Mar 12, 2022), Indiana (Dec 31, 2021–Mar 4, 2022), Minnesota and Wisconsin (Jan 1–Mar 5, 2022), New York (Dec 18, 2021–Feb 26, 2022), Oregon and Washington (Jan 1–Mar 12, 2022), Texas (Baylor Scott & White Health [Dec 18, 2021–Mar 5, 2022] and PHIX [Jan 8–Mar 19, 2022]), and Utah (Dec 27, 2021–Mar 19, 2022).
** Partners contributing knowledge on medical occasions throughout dates of estimated ≥75% Omicron BA.2/BA.2.12.1 predominance had been in California (Mar 25–Jun 10, 2022), Colorado (Apr 9–Jun 4, 2022), Indiana (Mar 19–Jun 10, 2022), Minnesota and Wisconsin (Apr 9–Jun 4, 2022), New York (Mar 26–Jun 10, 2022), Oregon and Washington (Apr 9–Jun 10, 2022), Texas (Baylor Scott & White Health [Mar 6–Jun 4, 2022 and PHIX [Apr 23–Jun 10, 2022]), and Utah (Mar 28–Jun 10, 2022).
^†† For estimation of 4-dose mRNA VE amongst sufferers aged ≥50 years throughout the Omicron BA.2/BA.2.12.1–predominant interval, unvaccinated sufferers whose medical occasion index date was earlier than Apr 5, 2022 had been excluded from the referent group (1,836 ED or UC encounters and 999 hospitalizations excluded amongst unvaccinated sufferers) as a result of the earliest medical occasion index date included amongst 4-dose mRNA-vaccinated sufferers was 7 days after Mar 29, 2022 when a second booster mRNA vaccine dose (fourth dose) was first included in suggestions for adults aged ≥50 years (not less than 4 months after receiving a 3rd mRNA dose).
^§§ VE estimates with 95% CIs >50 share factors aren’t proven as a result of of imprecision.

Abbreviations: ICD-9 = International Classification of Diseases, Ninth Revision; ICD-10 = International Classification of Diseases, Tenth Revision; KPNC = Kaiser Permanente of Northern California; KPNW = Kaiser Permanente Northwest; N/A = not relevant; NH = non-Hispanic; PHIX = Paso del Norte Health Information Exchange; RT-PCR = reverse transcription–polymerase chain response; SMD = standardized imply or proportion distinction.
* Hospitalizations with a discharge code in line with COVID-19–like sickness had been included. COVID-19–like sickness diagnoses included acute respiratory sickness (e.g., respiratory failure or pneumonia) or associated indicators or signs (e.g., cough, fever, dyspnea, vomiting, or diarrhea) utilizing prognosis ICD-9 and ICD-10 codes. Clinician-ordered molecular assays (e.g., real-time RT-PCR) for SARS-CoV-2 occurring ≤14 days earlier than to <72 hours after the encounter date had been included.
^† Partners contributing knowledge on hospitalizations throughout dates of estimated ≥75% Omicron BA.1 predominance had been in California (Dec 21, 2021–Mar 6, 2022), Colorado (Dec 25, 2021–Mar 12, 2022), Indiana (Dec 31, 2021–Mar 4, 2022), Minnesota and Wisconsin (Jan 1–Mar 5, 2022), New York (Dec 18, 2021–Feb 26, 2022), Oregon and Washington (Jan 1–Mar 12, 2022), Texas (Baylor Scott & White Health [Dec 18, 2021–Mar 5, 2022] and PHIX [Jan 8–Mar 19, 2022]), and Utah (Dec 27, 2021–Mar 19, 2022).
^§ Partners contributing knowledge on hospitalizations throughout dates of estimated ≥75% Omicron BA.2/BA.2.12.1 predominance had been in California (Mar 25–Jun 10, 2022), Colorado (Apr 9–Jun 4, 2022), Indiana (Mar 19–Jun 10, 2022), Minnesota and Wisconsin (Apr 9–Jun 4, 2022), New York (Mar 26–Jun 10, 2022), Oregon and Washington (Apr 9–Jun 10, 2022), Texas (Baylor Scott & White Health [Mar 26–Jun 4, 2022] and PHIX [Apr 23–Jun 10, 2022]), and Utah (Mar 28–Jun 10, 2022).
^¶ Vaccination was outlined as having obtained the listed quantity of doses of an mRNA-based COVID-19 vaccine throughout the specified vary of quantity of days earlier than the hospitalization index date, which was the date of respiratory specimen assortment related to the latest optimistic or damaging SARS-CoV-2 take a look at consequence earlier than the hospitalization or the admission date if testing solely occurred after the admission.
** An absolute SMD ≥0.20 signifies a nonnegligible distinction in variable distributions between hospitalizations for vaccinated versus unvaccinated sufferers or for sufferers with SARS-CoV-2–optimistic outcomes versus these with SARS-CoV-2–damaging outcomes. For mRNA COVID-19 vaccination standing, a single SMD was calculated by averaging absolutely the SMDs obtained from pairwise comparisons of every vaccinated class versus unvaccinated; extra particularly, as the typical of absolutely the worth of the SMDs for 1) vaccinated with 2 doses 14–149 days earlier versus unvaccinated, 2) vaccinated with 2 doses ≥150 days earlier versus unvaccinated, 3) vaccinated with 3 doses 7–119 days earlier versus unvaccinated, 4) vaccinated with 3 doses ≥120 days earlier versus unvaccinated, and 5) vaccinated with 4 doses ≥7 days earlier versus unvaccinated.
^†† Other race contains Asian, Native Hawaiian or different Pacific islander, American Indian or Alaska Native, Other, and a number of races.
^§§ Chronic respiratory situation was outlined because the presence of discharge code for bronchial asthma, power obstructive pulmonary illness, or different lung illness utilizing ICD-9 and ICD-10 prognosis codes.
^¶¶ Chronic nonrespiratory situation was outlined because the presence of discharge code for coronary heart failure, ischemic coronary heart illness, hypertension, different coronary heart illness, stroke, different cerebrovascular illness, diabetes sort I or II, different diabetes, metabolic illness, scientific weight problems, clinically underweight, renal illness, liver illness, blood dysfunction, immunosuppression, organ transplant, most cancers, dementia, neurologic dysfunction, musculoskeletal dysfunction, or Down syndrome utilizing ICD-9 and ICD-10 prognosis.