FDA issues guidance on emergency use authorisation for COVID-19 vaccines

The US Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorisation (EUA) for an investigational vaccine intended to prevent COVID-19.

The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.

This guidance provides further information on the EUA process for investigational vaccines and provides additional context to the information provided in the agency’s June guidance regarding the development and licensure of COVID-19 vaccines.

An EUA is a different standard than an approval, as noted in the June guidance, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine’s safety and effectiveness.

This guidance reiterates that any assessment regarding an EUA will be made on a case-by-case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.

The FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorisation.

The VRBPAC is currently scheduled to meet on October 22, 2020 to discuss the general development, authorisation and/or licenure of COVID-19 vaccines. While this meeting is not intended to discuss any particular vaccine candidate, the agency is prepared to rapidly schedule additional future meetings of this committee after submission of any BLA or request for EUA to further ensure transparency.

Peter Marks, Director, Center for Biologics Evaluation and Research- FDA, commented, “Being open and clear about the circumstances under which the issuance of an emergency use authorisation for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available. The FDA’s new guidance on emergency use authorisation of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorisation decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorised or approved.”