Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications OJ/2021/DPR/12924  Deliverable (DL)  Description  Estimated  frequency/ Volume  File / form at type  DL 3.2.1. Study  protocol  The study protocol should contain the proposed study methodology, including, if  relevant, potential alternate or complementary methodologies that achieve the  study objectives. The feasibility of recruiting enough unvaccinated residents and/or  staff to assess vaccine effectiveness should be assessed in detailed, proposing  alternative methodologies as required.  It should build on previous work performed by ECDC, including a protocol for a  feasibility study on vaccine effectiveness in long-term care facilities.  The methodology can include retrospective data collection for factors that may  affect the likelihood for symptomatic COVID-19.  The study protocol should describe the proposed study methodology(s) with (A) a  detailed assessment of its feasibility and risks; (B) a detailed description of the  countries that will be invited, the number of long-term care facilities, and the  expected number of vaccinated and unvaccinated participants; (C) relevant sample  size calculations and a statistical analysis plan; (D) a plan for periodic assessment for  the potential expansion of the study(s) to more countries and/or long-term care  facilities; (E) the planned professional interaction with other relevant activities for  COVID-19 in long-term care facilities.  In the first 12  weeks of the first  specific contract  Word  DL 3.2.2. Protocol for  COVID-19 vaccine  effectiveness in long- term care facilities  The protocol should be directly based on the Study protocol DL 3.2.1.  The contractor is expected to deliver an ECDC protocol for vaccine effectiveness  studies in long-term care facilities, for symptomatic, severe, and fatal cases of  laboratory-confirmed COVID-19. The protocol should summarise the study  methodology, contain the data collection tool (e.g. a questionnaire) and be designed  to acquire data compatible with the ECDC TESSy platform. As part of the laboratory component of the study, it is expected that contractor will  ensure that the long-term care facilities/countries implementing the protocol identify  data flows which will allow capturing information on SARS-CoV variants (such as  Every two years  Word 