Risk Management Plans and Periodic Safety Reports for COVID-19 Vaccines: Recommendations for Their Request, Preparation, Management, and Assessment

ABSTRACT

The continuous assessment of benefits and risks, as well as effective communication among stakeholders, is key for protecting and promoting public health, and for strengthening public trust in vaccines and the authorities that oversee the vaccination process. During the current COVID-19 pandemic, the private sector has played a critical role in the rapid development of vaccines. Moreover, primary responsibility for vaccine safety and efficacy monitoring rests with use authorization holders. National regulatory authorities have to make decisions based on limited safety and efficacy data at the time of authorization. Thus, constant monitoring is necessary as soon as a vaccine is authorized in order to detect and assess possible safety issues associated with its use. This document establishes recommendations and considerations to guide the development of strategies to assess the risk management plans and periodic safety reports required for use authorization of COVID-19 vaccines and for safety monitoring once their use is authorized. It is intended mainly for national regulatory authorities in the Region of the Americas, and may be considered by COVID-19 vaccine use authorization holders when preparing risk management plans and periodic safety reports for submission to health authorities.