PREPRINT: Impact of vaccination on SARS-CoV-2 cases in the community: a population-based study using the UK COVID-19 Infection Survey

Objectives: To assess the effectiveness of COVID-19 vaccination in preventing SARS-CoV-2 infection in the community. Design: Prospective cohort study. Setting: The UK population-representative longitudinal COVID-19 Infection Survey. Participants: 373,402 participants aged ≥16 years contributing 1,610,562 RT-PCR results from nose and throat swabs between 1 December 2020 and 3 April 2021. Main outcome measures: New RT-PCR-positive episodes for SARS-CoV-2 overall, by self-reported symptoms, by cycle threshold (Ct) value (<30 versus ≥30), and by gene positivity (compatible with the B.1.1.7 variant versus not). Results: Odds of new SARS-CoV-2 infection were reduced 65% (95% CI 60 to 70%; P<0.001) in those ≥21 days since first vaccination with no second dose versus unvaccinated individuals without evidence of prior infection (RT-PCR or antibody). In those vaccinated, the largest reduction in odds was seen post second dose (70%, 95% CI 62 to 77%; P<0.001).There was no evidence that these benefits varied between Oxford-AstraZeneca and Pfizer-BioNTech vaccines (P>0.9).There was no evidence of a difference in odds of new SARS-CoV-2 infection for individuals having received two vaccine doses and with evidence of prior infection but not vaccinated (P=0.89). Vaccination had a greater impact on reducing SARS-CoV-2 infections with evidence of high viral shedding Ct<30 (88% reduction after two doses; 95% CI 80 to 93%; P<0.001) and with self-reported symptoms (90% reduction after two doses; 95% CI 82 to 94%; P<0.001); effects were similar for different gene positivity patterns. Conclusion: Vaccination with a single dose of Oxford-AstraZeneca or Pfizer-BioNTech vaccines, or two doses of Pfizer-BioNTech, significantly reduced new SARS-CoV-2 infections in this large community surveillance study. Greater reductions in symptomatic infections and/or infections with a higher viral burden are reflected in reduced rates of hospitalisations/deaths, but highlight the potential for limited ongoing transmission from asymptomatic infections in vaccinated individuals. Registration: The study is registered with the ISRCTN Registry, ISRCTN21086382.

Competing Interest Statement
All authors have completed the ICMJE uniform disclosure from at www.icmje.org/coi_disclore.pdf and declare: DWE declares lecture fees from Gilead, outside the submitted work; EP, PCM, NS, DWE, JIB, DC, TEAP, ASW, and KBP are employees of the University of Oxford, but not involved in the development or production of the vaccine; JIB act as an unpaid advisor to HMG on Covid but does not sit on the vaccine task force and it not involved in procurement decisions, sits on the Board of OSI who has an investment in Vaccitech who have a royalty from the Oxford-AstraZeneca vaccine when, if ever, it makes a profit; HVS reports personal fees from BioSpyder Technologies, Inc, outside the submitted work; ASW besides funding for this specific study, also received grants from Medical Research Council UK during the conduct of the study; there are no other relationships or activities that could appear to have influenced the submitted work.

Clinical Trial
ISRCTN21086382.

Clinical Protocols
https://www.ndm.ox.ac.uk/covid-19/covid-19-infection-survey/protocol-and-information-sheets

Funding Statement
This study is funded by the Department of Health and Social Care with in-kind support from the Welsh Government, the Department of Health on behalf of the Northern Ireland Government and the Scottish Government. EP, KBP, ASW, TEAP, NS, DE are supported by the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford in partnership with Public Health England (PHE) (NIHR200915). ASW and TEAP are also supported by the NIHR Oxford Biomedical Research Centre. EP and KBP are also supported by the Huo Family Foundation. ASW is also supported by core support from the Medical Research Council UK to the MRC Clinical Trials Unit [MC_UU_12023/22] and is an NIHR Senior Investigator. PCM is funded by Wellcome (intermediate fellowship, grant ref 110110/Z/15/Z) and holds an NIHR Oxford BRC Senior Fellowship award. DWE is supported by a Robertson Fellowship and an NIHR Oxford BRC Senior Fellowship. The views expressed are those of the authors and not necessarily those of the National Health Service, NIHR, Department of Health, or PHE. The funder/sponsor did not have any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study received ethical approval from the South Central Berkshire B Research Ethics Committee (20/SC/0195).

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

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