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Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting.
Magen, Ori; Waxman, Jacob G; Makov-Assif, Maya; Vered, Roni; Dicker, Dror; Hernán, Miguel A; Lipsitch, Marc; Reis, Ben Y; Balicer, Ran D; Dagan, Noa.
  • Magen O; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Waxman JG; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Makov-Assif M; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Vered R; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Dicker D; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Hernán MA; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Lipsitch M; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Reis BY; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Balicer RD; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
  • Dagan N; From the Clalit Research Institute, Innovation Division (O.M., J.G.W., M.M.-A., R.D.B., N.D.), and the Tel-Aviv District, Community Division (R.V.), Clalit Health Services, and the Sackler Faculty of Medicine, Tel-Aviv University (D.D.), Tel Aviv, the Department of Internal Medicine D, Hasharon Hosp
N Engl J Med ; 386(17): 1603-1614, 2022 04 28.
Article in English | MEDLINE | ID: covidwho-1788353
ABSTRACT

BACKGROUND:

With large waves of infection driven by the B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), alongside evidence of waning immunity after the booster dose of coronavirus disease 2019 (Covid-19) vaccine, several countries have begun giving at-risk persons a fourth vaccine dose.

METHODS:

To evaluate the early effectiveness of a fourth dose of the BNT162b2 vaccine for the prevention of Covid-19-related outcomes, we analyzed data recorded by the largest health care organization in Israel from January 3 to February 18, 2022. We evaluated the relative effectiveness of a fourth vaccine dose as compared with that of a third dose given at least 4 months earlier among persons 60 years of age or older. We compared outcomes in persons who had received a fourth dose with those in persons who had not, individually matching persons from these two groups with respect to multiple sociodemographic and clinical variables. A sensitivity analysis was performed with the use of parametric Poisson regression.

RESULTS:

The primary analysis included 182,122 matched pairs. Relative vaccine effectiveness in days 7 to 30 after the fourth dose was estimated to be 45% (95% confidence interval [CI], 44 to 47) against polymerase-chain-reaction-confirmed SARS-CoV-2 infection, 55% (95% CI, 53 to 58) against symptomatic Covid-19, 68% (95% CI, 59 to 74) against Covid-19-related hospitalization, 62% (95% CI, 50 to 74) against severe Covid-19, and 74% (95% CI, 50 to 90) against Covid-19-related death. The corresponding estimates in days 14 to 30 after the fourth dose were 52% (95% CI, 49 to 54), 61% (95% CI, 58 to 64), 72% (95% CI, 63 to 79), 64% (95% CI, 48 to 77), and 76% (95% CI, 48 to 91). In days 7 to 30 after a fourth vaccine dose, the difference in the absolute risk (three doses vs. four doses) was 180.1 cases per 100,000 persons (95% CI, 142.8 to 211.9) for Covid-19-related hospitalization and 68.8 cases per 100,000 persons (95% CI, 48.5 to 91.9) for severe Covid-19. In sensitivity analyses, estimates of relative effectiveness against documented infection were similar to those in the primary analysis.

CONCLUSIONS:

A fourth dose of the BNT162b2 vaccine was effective in reducing the short-term risk of Covid-19-related outcomes among persons who had received a third dose at least 4 months earlier. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / BNT162 Vaccine Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Humans / Middle aged Country/Region as subject: Asia Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / BNT162 Vaccine Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Humans / Middle aged Country/Region as subject: Asia Language: English Journal: N Engl J Med Year: 2022 Document Type: Article