Covid-19 Living Data

Study registration: *
Publication Patalon T, medRxiv, 2021
Dates: 2021-01-01 to 2021-08-21
Funding: Public/non profit (NIAID of the National Institutes of Health.)
Conflict of interest: Yes (DMW has received consulting fees from Pfizer, Merck, Affinivax, and Matrivax for work unrelated to this paper and is Principal Investigator on grants from Pfizer and Merck to Yale University for work unrelated to this manuscript. VEP has received reimbursement from Merck and Pfizer for travel to Scientific Input Engagements unrelated to the topic of this manuscript and is a member of the WHO Immunization and Vaccine-related Implementation Research Advisory Committee (IVIR-AC). JW discloses consulting fees from Revelar Inc.)

Methods
Methods	Study design:Test-negative Description of participants: Aged 40 and up Maccabi Healthcare Services members in multiple centres in Israel Inclusion criteria: Aged 40 and up Maccabi Healthcare Services member vaccinated with two or three doses of BNT162b2 between January 2021-August 21, 2021 tested between August 1-21, 2021. Exclusion criteria: Disengaged from Maccabi Healthcare Services for any reason prior to March 2020 tested positive for SARS-CoV-2 by PCR test before the start of the follow-up period. Follow-up duration (months): 7.73
Vaccines:	3 doses of BNT162b2, with 3rd dose at least 5 months after 2nd dose
Variant description :
Variant description :	Variant name: Delta Evidence: Indirect evidence (prevalence of variant in the population: 1 to 99%)
Documents available	Protocol NR Statistical plan NR Data-sharing stated: Yes Data accessibility: Specific requests for remote access to de-identified community-level data should be referred to KSM, Maccabi Healthcare Services Research and Innovation Center (Kahn Sagol Maccabi (KSM) Research & Innovation Center, Maccabi Healthcare Services, Tel Aviv, Israel).
General comment	The preprint was used in data extraction and risk of bias assessment. Results were extracted for the longest follow up time, which was 14-20 days after booster. Prevalence of Delta variant was not reported, but states it was the dominant strain in Israel. Concerns over uncontrolled confounding. We have concerns due to the use of a test-negative design and a lack of a statistical analysis plan.