COVID-19 is the infectious disease caused by the novel coronavirus known as SARS-CoV-2, that appeared in 2019. The World Health Organisation (WHO) declared the novel coronavirus a pandemic on 11 March 2020. The evolution of the pandemic is varying across countries, affected in part by different containment strategies ranging from extreme lockdown to relative inaction. As a result, there are regional waves of the disease and pockets of vulnerable populations. Globally, governments have acknowledged that effective vaccines against COVID-19 are the only way to guarantee a safe and sustained exit strategy from repeated lockdowns.

The objective of this study is to estimate the vaccine effectiveness against hospitalizations due to circulating COVID-19 VoC among subjects eligible for vaccination with the AstraZeneca or any other COVID-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission.

The study design is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing testing for SARS-CoV-2

LatInamerican Vaccine Effectiveness against hospitalizations due to circulating COVID-19 VoC RWE study is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing testing for SARS-CoV-2 by RT-PCR or rapid antigen test with the participation of countries from six LatAm Marketing Companies (Argentina, Brazil, Colombia, Costa Rica, Mexico and Panama).

This study will generate new information regarding vaccine effectiveness (VE) in the RW setting for populations where evidence is still unavailable

Inclusion Criteria:

• 18y and older
• Ever eligible for vaccination with the AstraZeneca or any other COVID-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission.
• Hospitalization due to COVID-19 like case
• Willing and able to provide informed consent (or by legal accepted representative if patient are not able to provide their signature by themselves)

Exclusion Criteria:

• Cannot be swabbed or other conditions that contra-indicate swabbing
• COVID-19 hospitalization within 3 months prior to the current admission. Hospital transfers are not considered as a prior hospitalization.

Subjects older than 18y that are hospitalized due COVID-19 like symptoms

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.

For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.