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Evaluating Vaccine Efficacy Against Severe Acute Respiratory Syndrome Coronavirus 2 Infection.
Lin, Dan-Yu; Gu, Yu; Zeng, Donglin; Janes, Holly E; Gilbert, Peter B.
  • Lin DY; Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Gu Y; Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Zeng D; Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina, USA.
  • Janes HE; Vaccine and Infectious Disease Division, Fred Hutch, Seattle, Washington, USA.
  • Gilbert PB; Vaccine and Infectious Disease Division, Fred Hutch, Seattle, Washington, USA.
Clin Infect Dis ; 74(3): 544-552, 2022 02 11.
Article in English | MEDLINE | ID: covidwho-1684550
ABSTRACT
Although interim results from several large, placebo-controlled, phase 3 trials demonstrated high vaccine efficacy (VE) against symptomatic coronavirus disease 2019 (COVID-19), it is unknown how effective the vaccines are in preventing people from becoming asymptomatically infected and potentially spreading the virus unwittingly. It is more difficult to evaluate VE against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection than against symptomatic COVID-19 because infection is not observed directly but rather is known to occur between 2 antibody or reverse-transcription polymerase chain reaction (RT-PCR) tests. Additional challenges arise as community transmission changes over time and as participants are vaccinated on different dates because of staggered enrollment of participants or crossover of placebo recipients to the vaccine arm before the end of the study. Here, we provide valid and efficient statistical methods for estimating potentially waning VE against SARS-CoV-2 infection with blood or nasal samples under time-varying community transmission, staggered enrollment, and blinded or unblinded crossover. We demonstrate the usefulness of the proposed methods through numerical studies that mimic the BNT162b2 phase 3 trial and the Prevent COVID U study. In addition, we assess how crossover and the frequency of diagnostic tests affect the precision of VE estimates.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / BNT162 Vaccine Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: Cid

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / BNT162 Vaccine Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: Cid