Study registration: *
Publication Kim S, J Infect Dis, 2021
Dates: 2020-12-14 to 2021-05-28
Funding: Public/non profit (US Centers for Disease Control and Prevention; National Institutes of Health )
Conflict of interest: Yes (M. P. N. reports grants from Merck, outside the submitted work. R. K. Z. reports grants from Sanofi Pasteur, outside the submitted work. G. K. B. reports grants from Merck, outside the submitted work, and consulting fees from New World Medical. E. T. M. reports grants from Merck, outside the submitted work, and consulting fees from Pfizer. A. S. M. reports consulting fees from Sanofi Pasteur and Seqirus. L. E. L. reports grants from Xcenda, eMAXHealth, AstraZeneca, Pfizer, and Evidera, outside the submitted work. M. L. J. reports grants from Sanofi Pasteur. All other authors report no potential conflicts.)

Methods

Study design:Test-negative
Description of participants: Adolescents and adults with COVID-like symptoms at 5 centers in the USA.
Inclusion criteria:
  • Age ≥16 years
  • COVID-like symptoms (acute onset of fever or feverishness, cough, or loss of taste or smell with symptom duration <10 days)
  • respiratory specimen collected for SARS-CoV-2 molecular testing within 10 days of illness onset
  • illness onset on or after 1 February 2021, for those aged ≥65 years, and on or after 22 March 2021, for those aged 16–64 years
  • be- ginning dates of inclusion in analyses varied by site according to local COVID-19 vaccination policies for all persons aged ≥65 or ≥16 years.

Exclusion criteria:
  • Received first dose <14 days be- fore illness
  • vaccinated with Johnson & Johnson’s Janssen vaccine
  • self- reported vaccine receipt without documentation.

Follow-up duration (months): 5.5
Vaccines:
  • 1 or 2 doses of BNT162b2 or mRNA-1273
Variant description :
Variant name: Alpha
Evidence: Indirect evidence (prevalence of variant in the population: 56)
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated: NR
Data accessibility: Correspondence: Sara S. Kim, Influenza Division, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop 24/7, Atlanta, GA 30329 (skim10@cdc.gov).

General comment Concerns about uncontrolled confounding; factors such as socio-economic status and comorbidities were not adjusted for.