On July 15, 2022, this report was posted on-line as an MMWR Early Release.
Ruth Link-Gelles, PhD1; Matthew E. Levy, PhD2; Manjusha Gaglani, MBBS3,4; Stephanie A. Irving, MHS5; Melissa Stockwell, MD6,7,8; Kristin Dascomb, MD, PhD9; Malini B. DeSilva, MD10; Sarah E. Reese, PhD2; I-Chia Liao, MPH3; Toan C. Ong, PhD11; Shaun J. Grannis, MD12,13; Charlene McEvoy, MD10; Palak Patel, MBBS1; Nicola P. Klein, MD, PhD14; Emily Hartmann, MPP15; Edward Stenehjem, MD9; Karthik Natarajan, PhD8,16; Allison L. Naleway, PhD5; Kempapura Murthy, MBBS3; Suchitra Rao, MBBS11; Brian E. Dixon, PhD12,17; Anupam B. Kharbanda, MD18; Akintunde Akinseye, MSPH2; Monica Dickerson1; Ned Lewis, MPH14; Nancy Grisel, MPP9; Jungmi Han16; Michelle A. Barron, MD11; William F. Fadel, PhD12,17; Margaret M. Dunne, MSc2; Kristin Goddard, MPH14; Julie Arndorfer, MPH9; Deepika Konatham3; Nimish R. Valvi, DrPH, MBBS12; J. C. Currey15; Bruce Fireman, MA14; Chandni Raiyani, MPH3; Ousseny Zerbo, PhD14; Chantel Sloan-Aagard, PhD15,19; Sarah W. Ball, ScD2; Mark G. Thompson, PhD1; Mark W. Tenforde, MD, PhD1 (View author affiliations)
What is already identified about this subject?
Little is understood about COVID-19 vaccine effectiveness (VE) throughout the Omicron variant BA.2/BA.2.12.2–predominant interval or VE of a fourth COVID-19 vaccine dose in individuals aged ≥50 years.
What is added by this report?
VE throughout the BA.2/BA.2.12.2 interval was decrease than that throughout the BA.1 interval. A 3rd vaccine dose offered extra safety towards average and extreme COVID-19–related sickness in all age teams, and a fourth dose offered extra safety in eligible adults aged ≥50 years.
What are the implications for public well being follow?
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 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.
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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.
Data from the Omicron BA.1 sublineage surge within the United States throughout December 2021–February 2022 decided that VE was decreased in contrast with that throughout the earlier Delta-predominant interval (6). To date, estimates of variations in VE between the Omicron BA.1 and subsequent BA.2/BA.2.12.1 sublineage intervals have been restricted. In this estimate of VE towards ED/UC visits and hospitalizations throughout the BA.1 and BA.2/BA.2.12.1 intervals, VE declined throughout each intervals ≥150 days after the second vaccine dose, highlighting the necessity for a 3rd dose (i.e., the primary booster) for eligible adults. Recent receipt of a 3rd dose elevated VE; nevertheless, some decline was noticed ≥120 days after receipt of the dose. Among eligible adults aged ≥50 years, a fourth vaccine dose ≥120 days after receipt of the third dose improved VE throughout the BA.2/BA.2.12.1 interval, though follow-up time after dose 4 was restricted. These findings spotlight the significance of staying updated with COVID-19 vaccination, together with advisable booster doses.
Although knowledge on neutralizing antibodies have discovered BA.1 and BA.2 to be related, current knowledge point out barely extra immune escape for BA.2.12.1 (1). Data reported on Omicron sublineage VE have been restricted. A examine within the United Kingdom discovered inconsistent variations in VE for symptomatic COVID-19 and COVID-19–related hospitalization, with greater VE towards symptomatic COVID-19 however bigger declines in VE towards hospitalization noticed throughout a interval of BA.2 predominance versus a interval of BA.1 predominance beginning 10–14 weeks after a 3rd COVID-19 vaccine dose (7). A examine in Qatar discovered that after a second or third mRNA vaccine dose, declines in VE towards symptomatic COVID-19 throughout BA.1 and BA.2 intervals had been related, however the examine didn’t determine sufficient extreme instances to separate VE estimates by predominant variant (8). Differences between the present examine and earlier research, together with variations in proportions of individuals with earlier SARS-CoV-2 an infection and the absence of BA.2.12.1 infections exterior the United States would possibly account for some variability in findings. After the BA.1 surge within the United States, a bigger proportion of adults had been discovered to have skilled a current SARS-CoV-2 an infection throughout the BA.2/BA.2.12.1 interval, with antibody proof of SARS-CoV-2 an infection growing from 33.5% in December 2021 to 57.7% by February 2022 (9). Unvaccinated individuals had been used as a referent group in VE analyses. If unvaccinated individuals had been extra prone to have skilled current an infection, and infection-induced immunity gives some safety towards re-infection, this might end in decrease VE noticed throughout the BA.2/BA.2.12.1 interval. Although adults with documented previous SARS-CoV-2 an infection had been excluded, infections are prone to be considerably underascertained as a result of of lack of testing or elevated at-home testing (10). In addition, though time since receipt of the second or third vaccine dose was stratified by time intervals, on common the time since vaccination was longer throughout the BA.2/BA.2.12.1 interval. These variations had been significantly pronounced within the evaluation of ≥150 days after the second vaccine dose (median 289 days for hospitalized adults throughout the BA.1 interval in comparison with 371 days throughout the BA.2/BA.2.12.1 interval), which might account for some variations in VE estimates and highlights the significance of a 3rd dose (first booster) for many who haven’t but obtained it.
The findings on this evaluation are topic to not less than 4 limitations. First, earlier SARS-CoV-2 an infection was seemingly underascertained and would possibly differentially have an effect on noticed VE throughout the BA.1 and BA.2/BA.2.12.1 intervals. Second, residual confounding in VE estimates is feasible. Third, no genetic characterization was accessible for SARS-CoV-2–optimistic specimens; subsequently, date of testing was used to ascribe seemingly sublineage, and BA.2 and BA.2.12.1 sublineages had been mixed, given their overlap in circulation. Finally, this report didn’t assess VE towards essentially the most extreme COVID-19–related illness (e.g., respiratory failure) as a result of of smaller numbers of these instances.
VE ought to proceed to be monitored within the setting of newly rising sublineages and variants, together with Omicron sublineages BA.4 and BA.5, which grew to become predominant within the United States in late June 2022. Eligible adults ought to keep updated with advisable COVID-19 vaccinations, together with a primary booster dose for all eligible individuals and second booster dose for adults aged ≥50 years. Booster doses must be obtained instantly when individuals develop into eligible.
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.
- Hachmann NP, Miller J, Collier AY, et al. Neutralization escape by SARS-CoV-2 Omicron subvariants BA.2.12.1, BA.4, and BA.5. N Engl J Med 2022;387:86–8. (*10*) PMID:35731894
- Altarawneh HN, Chemaitelly H, Hasan MR, et al. Protection towards the Omicron variant from earlier SARS-CoV-2 an infection. N Engl J Med 2022;386:1288–90. https://doi.org/10.1056/NEJMc2200133 PMID:35139269
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- Food and Drug Administration. Coronavirus (COVID-19) replace: FDA authorizes second booster dose of two COVID-19 vaccines for older and immunocompromised people. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and
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- Thompson MG, Natarajan Okay, Irving SA, et al. Effectiveness of a 3rd dose of mRNA vaccines towards COVID-19–related emergency division and pressing care encounters and hospitalizations amongst adults during times of Delta and Omicron variant predominance—VISION Network, 10 States, August 2021–January 2022. MMWR Morb Mortal Wkly Rep 2022;71:139–45. https://doi.org/10.15585/mmwr.mm7104e3 PMID:35085224
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- Rader B, Gertz A, Iuliano AD, et al. Use of at-home COVID-19 checks—United States, August 23, 2021–March 12, 222. MMWR Morb Mortal Wkly Rep 2022;71:489–94. https://doi.org/10.15585/mmwr.mm7113e1 PMID:35358168
|Encounter sort||Omicron BA.1–predominant interval¶||Omicron BA.2/BA.2.12.1–predominant interval**|
|Total||No. (%) of optimistic take a look at outcomes†||Median interval since final dose,
%* (95% CI)
|Total||No. (%) of optimistic take a look at outcomes†||Median interval since final dose
%* (95% CI)
|ED or UC, age group (days since final dose)|
|All ages, yrs|
|Unvaccinated (Ref)||51,359||23,175 (45.1)||—||—||27,907||3,501 (12.6)||—||—|
|2 doses (14–149)||7,286||2,377 (32.6)||107 (76–129)||47 (44–50)||1,774||110 (6.2)||104 (71–128)||51 (38–60)|
|2 doses (≥150)||32,740||11,365 (34.7)||267 (232–306)||39 (37–41)||20,883||2,584 (12.4)||352 (278–398)||12 (7–17)|
|3 doses (7–119)||29,333||3,667 (12.5)||66 (41–89)||84 (83–85)||9,142||441 (4.8)||94 (72–108)||56 (51–61)|
|3 doses (≥120)||3,315||217 (6.5)||132 (125–142)||73 (68–77)||26,654||3,186 (11.9)||166 (145–190)||26 (21–30)|
|Unvaccinated (Ref)||33,003||14,236 (43.1)||—||—||18,429||2,269 (12.3)||—||—|
|2 doses (14–149)||4,909||1,621 (33.0)||106 (76–129)||40 (36–44)||1,192||75 (6.3)||105 (72–129)||47 (31–60)|
|2 doses (≥150)||16,313||5,918 (36.3)||252 (220–288)||24 (21–28)||11,203||1,427 (12.7)||332 (254–379)||7 (0–14)|
|3 doses (7–119)||8,755||1,259 (14.4)||55 (33–79)||76 (75–78)||4,132||207 (5.0)||91 (69–107)||55 (47–62)|
|3 doses (≥120)||426||39 (9.2)||130 (124–141)||29 (−1–50)||7,613||1,096 (14.4)||159 (140–182)||17 (10–25)|
|Unvaccinated (Ref)||18,356||8,939 (48.7)||—||—||9,478||1,232 (13.0)||—||—|
|2 doses (14–149)||2,377||756 (31.8)||109 (77–129)||59 (54–63)||582||35 (6.0)||102 (68–128)||59 (40–71)|
|2 doses (≥150)||16,427||5,447 (33.2)||283 (248–316)||52 (50–54)||9,680||1,157 (11.9)||376 (319–414)||18 (10–26)|
|3 doses (7–119)||20,578||2,408 (11.7)||71 (46–93)||87 (86–88)||5,010||234 (4.7)||96 (73–109)||58 (51–64)|
|3 doses (≥120)||2,889||178 (6.2)||133 (125–143)||81 (77–84)||19,041||2,090 (11.0)||170 (147–193)||32 (26–38)|
|4 doses (≥7)††||N/A||—||—||—||4,094||355 (8.7)||28 (17–42)||66 (60–71)|
|Hospitalization, age group (days since final dose)|
|All ages, yrs|
|Unvaccinated (Ref)||14,742||6,829 (46.3)||—||—||6,682||494 (7.4)||—||—|
|2 doses (14–149)||1,236||297 (24.0)||105 (73–129)||68 (63–73)||343||12 (3.5)||102 (71–128)||57 (19–77)|
|2 doses (≥150)||8,850||2,542 (28.7)||289 (252–322)||61 (58–63)||5,118||393 (7.7)||371 (308–413)||24 (12–35)|
|3 doses (7–119)||9,146||786 (8.6)||72 (47–93)||92 (91–93)||2,350||72 (3.1)||94 (74–108)||69 (58–76)|
|3 doses (≥120)||1,425||80 (5.6)||132 (125–142)||85 (81–89)||7,686||519 (6.8)||168 (146–191)||52 (44–59)|
|Unvaccinated (Ref)||4,057||1,515 (37.3)||—||—||—||—||—||—|
|2 doses (14–149)||392||83 (21.2)||101 (67–127)||64 (52–73)||—||—||—||—|
|2 doses (≥150)||1,304||329 (25.2)||258 (226–294)||52 (43–59)||—||—||—||—|
|3 doses (7–119)||812||53 (6.5)||57 (36–81)||91 (87–94)||—||—||—||—|
|3 doses (≥120)||56||1 (1.8)||133 (126–142)||94 (62–99)||—||—||—||—|
|Unvaccinated (Ref)||10,685||5,314 (49.7)||—||—||4,595||393 (8.6)||—||—|
|2 doses (14–149)||844||214 (25.4)||108 (76–129)||71 (65–75)||—||—||—||—|
|2 doses (≥150)||7,546||2,213 (29.3)||294 (259–325)||63 (60–66)||4,139||352 (8.5)||381 (325–418)||22 (8–34)|
|3 doses (7–119)||8,334||733 (8.8)||73 (49–94)||92 (91–93)||1,957||57 (2.9)||95 (74–108)||73 (63–81)|
|3 doses (≥120)||1,369||79 (5.8)||132 (125–142)||86 (82–89)||7,113||480 (6.8)||169 (147–191)||55 (46–62)|
|4 doses (≥7)††||N/A||—||—||—||1,204||74 (6.2)||27 (17–41)||80 (71–85)|
Suggested quotation for this text: Link-Gelles R, Levy ME, Gaglani M, et al. 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. MMWR Morb Mortal Wkly Rep 2022;71:931–939. DOI: http://dx.doi.org/10.15585/mmwr.mm7129e1.
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