WHO & COVAX Vaccine Safety Working Group Active Vaccine Safety Surveillance Survey

On behalf of the COVAX Vaccine Safety Working group:

After COVID-19 vaccines are introduced into countries, it will be vital to generate real-world data on vaccine safety following immunization, as many questions will remain unanswered by the clinical trials. Active Vaccine Safety Surveillance (AVSS) will likely be conducted in a variety of countries, in a variety of populations, and using a variety of study designs. We are reaching out to you as you or persons you know/work with may be conducting these studies. The WHO Pharmacovigilance team and the COVAX Vaccine safety working group (VSWG), with the support of Johns Hopkins International Vaccine Access Center (IVAC), are undertaking a mapping exercise to assess the landscape of COVID-19 AVSS activities, including where they will or are currently being conducted, and their key characteristics. This assessment will help WHO and COVAX VSWG to better understand the potential sources of evidence (e.g. pertaining to safety signal detection and evaluation) and to identify the gaps that may need to be filled. We understand that plans are still being made and are subject to change; thus, we will likely be reaching out again in the future to request an update. Basic information on the studies planned (e.g. country of study, study design, objective, vaccine, target population) may be shared on the COVID-19 vaccine studies module of VIEW-Hub, a publicly available website.

If you have information regarding an AVSS to share, there are two methods to inform us of planned or ongoing safety studies: (A) a short survey that provides a general description of the study(ies), and (B) a survey that enables the details of an RMP document to be abstracted (consisting of a short form to complete for each study listed in the RMP). If you have other documents that are not RMPs but describe planned or ongoing studies (e.g., study protocol), please fill out the general survey (i.e. option A). Only one survey needs to be completed.

Please fill out with any relevant details either:

1. the general survey, which will take less than 10 minutes of your time:

or

1. the RMP document survey, which will take approximately 5 minutes per study entry. This survey will allow up to 20 study entries. If you have more, please fill out multiple surveys:

Note: if the summary section of the RMP is public, we would be happy to complete it for you if the document could be provided.

Questions can be addressed to Marley Jurgensmeyer (mjurgen4@jhu.edu) or Parisa ShamaeiZadeh (pshamae1@jhmi.edu)

We will appreciate to receive your feedback by Friday the 4th of February 2022.