Provision Language
Definitions
“Project Data” means any de-identified data provided by the MoH to PFIZER in the framework of the Project.
2. The Project
2.1 Objective of the Project. To measure and analyze epidemiological data arising from the Product rollout, to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel.
2.2 Principles of Collaboration. The Parties agree that the Project is intended to generate and analyze epidemiological and population level vaccine effectiveness data, vitally necessary for public health purposes that may inform vaccine technical recommendations globally. The data generated by the Project is aimed at helping end the global COVID–19 pandemic for the benefit of all patients inside and outline of Israel. The Project will be based on the current medical literature, and guidelines adopted by the respected medical bodies.
To conduct the Project and measure population level impact of the Project, MoH is relying on receipt of Product doses, in accordance with the terms of the Manufacturing and Supply Agreement, as may be amended from time to time, and on the project delivery rate by PFIZER to allow maintaining vaccination rate sufficient to achieving herd immunity and enough data as soon as possible, and should be agreed by the two Parties. Nothing in this agreement shall modify or amend in any way the terms of the Manufacturing and Supply Agreement. In case of a conflict between terms of the Manufacturing and Supply Agreement in regard to the manufacturing and supply of the Product, the terms of the Manufacturing and Supply Agreement will control. [redacted text]
2.3 Collaboration & Governance. During the Term, unless the Parties mutually agree to a different frequency, the Parties shall meet weekly by video conference/teleconference at a mutually convenient time to review and discuss the status of the development and implementation of the Project. Project team members shall be determined by the Parties. Each Party shall be responsible for its own costs associated with any meetings.
3. Funding/Contribution of the Parties
No funding will be provided under this Agreement. Project Data is collected on a routine basis by MoH for epidemiological, logistical and oversight purposes to monitor pandemic and vaccination status, including data detailed in Exhibit A. To maintain the viability and relevance of the Project , MoH will use its best efforts to ensure timely reporting to PFIZER in accordance with Exhibit B. Both Parties acknowledge that the viability and success of the Project is dependent on the rate and scope of vaccinations in Israel. [redacted text] MoH will assure rapid distribution, deployment, and use of the Product, maintaining all Product storage requirements and ensuring patient safety while ensuring timely and accurate collection of epidemiological data, under applicable regulation requirements.
Pfizer will collaborate with the MoH in the Project by providing, subject to PFIZER’s assessment, qualified PFIZER colleagues and consultants with technical knowledge and subject matter expertise in infectious disease, respiratory disease, vaccines, epidemiology, infectious disease modeling, data analysis and public health, and by providing MoH with the Pfizer Data, subject to applicable legal requirements and based on PFIZER’s reasonable determination.
MoH will share aggregate Project Data with Pfizer and the Parties will jointly analyze such Project Data. MoH reserves the right to continue analyzing and reporting Public Health data collected by the MoH, and information about the product safety and efficacy, publicly. MoH and Pfizer will jointly report in submission for publication, to peer–reviewed scientific or medical journals, the results of the Project. PFIZER will provide to MoH the result of the Project analyses conducted by Pfizer or its consultant.
Exhibit A
MoH and Pfizer will collaborate on analysis of the data points listen in this Exhibit A. MoH will provide Pfizer with the data specified in Exhibit B.
Endpoints (beginning and ending dates to be mutually agreed by the Parties
- Confirmed COVID–19 cases/week
- Confirmed COVID–19 hospitalizations/week
- Confirmed COVID–19 severe/ critical cases /week
- Confirmed COVID–19 ventilator use/week
- Confirmed COVID–19 deaths/weeks
- Symptomatic cases/week
- Weekly numbers of vaccines, as total by age and other demographic subgroups
- Number of cases per week by age groups, and other demographic factors
- Additional subgroup analyses and vaccine effectiveness analysis as agreed by the Parties
Additional potential analysis: Direct medical costs averted based on modeled impact of national vaccination program on outpatient visits, hospitalization, ICU admissions, etc.
Exhibit B: Data Transfer Requirements
MoH will transmit to PFIZER in electronic form aggregate pandemic data as described in this Exhibit. MoH will use a mutually agreeable electronic transmission method that protects the security and integrity of the data.
1. Status Reports
MoH will provide to PFIZER weekly data transfers that include the following information:
1.1 Epidemiological Data
Each data transfer will include, at a minimum, current counts of the following
- Confirmed COVID–19 cases/week
- Confirmed COVID–19 hospitalizations/week
- Confirmed COVID–19 severe/critical cases /week
- Confirmed COVID–19 ventilator use/week
- Confirmed COVID–19 deaths/weeks
- Symptomatic cases/week
- Weekly numbers of vaccines, as total by age and other demographic subgroups
- Number of cases per week by age groups, and other demographic factors
2. Ancillary Documents
Both Parties will provide to each other as needed the following Ancillary Documents:
2.1 If relevant an electronic “Data Dictionary” consisting of all data variable used, annotated with variable names and corresponding datasets;
2.2 documentation of statistical programming algorithms used to create the analysis datasets, methodologies used to convert source data into output (derived) data; and the relevant statistical analysis assumptions or plans; if needed to understand the datasets (e.g., Statistical Analysis Plan, List of Tables, programming plan);
2.3 any other documentation as may reasonable be requested by either Party and mutually agreed upon by both Parties.
2.4 Transfer Schedule
MoH will transfer aggregate epidemiological data to PFIZER: (i) weekly; (ii) at the end of 1 year for any residual both Parties mutually agreed upon and other frequency mutually agreed upon. MoH will work with PFIZER if changes are needed in the data formatting or transmission process to ensure data quality and usability. Analysis of the data associated with the vaccination project will be independently or jointly performed by MOH and Pfizer and shared with the other Parties. Any analysis/results Pfizer may perform will be shared with the MOH to discuss and finalize jointly.