The release of the guidance has been a subject of political drama over recent weeks, with the timing of a vaccine authorization around the November 3 election being a hot issue. With the U.S. Food and Drug Administration (FDA) issuing its guidance on October 6, the industry welcomes greater regulatory clarity, as well as applauding the agency's efforts to earn the public's trust in COVID-19 vaccines.
From the FDA: What a COVID-19 vaccine EUA will require
While Emergency Use Authorization (EUA) is a different standard to an approval (an EUA allows the use of medical products for serious or life-threatening diseases when there are no adequate, approved and available alternatives), both pathways require data to demonstrate a vaccine’s safety and effectiveness.
The FDA notes that any assessment made on investigational vaccines for COVID-19 will be made on a case-by-case basis: considering the target population, characteristics of the product, preclinical and human clinical study data, and the overall scientific evidence.
It highlights that applicants need to show the available safety and effectivness information about their product; while from a manufacturing viewpoint, a vaccine must to be able to prove quality and consistency.
The FDA’s guidance says data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen, to help provide adequate information to assess a vaccine’s benefit-risk profile (particularly with regards to any adverse effects, and to assess a longer term protective effect).
This timeline puts the likely date of US vaccine availability past the election.
Release of guidance 'critical for building public confidence'
The FDA wants the release of the guidance to help assure the public over the safety and efficacy of any vaccine that is authorized or approved.
Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research said: "Being open and clear about the circumstances under which the issuance of an emergency use authorization 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 authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization 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 authorized or approved."
BIO: 'The release of this information is vital'
In the furore preceding the release of the FDA guidance, the Biotechnology Innovation Organization (BIO) had urged Secretary Azar to release guidance as soon as possible to give companies all the tools they need to produce a vaccine as quickly as possible.
Dr. Michelle McMurry-Heath, president & CEO, BIO, welcomed the release of the guidance this week. “The release of this information is vital for the scientists and researchers working on the frontlines combating this pandemic, as well as for building public confidence in the scientific solutions our industry is committed to delivering,” she said Tuesday.
“We applaud the FDA for following their tried and true tradition of releasing their guidance in a public and transparent way. Science should stand on its own.
"While we are still reviewing the details, this is an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people’s trust in any future vaccines. We look forward to ongoing communication with the independent experts at the FDA to further clarify the steps needed to bring a safe and effective vaccine to the American public.”
PhRMA: 'We welcome the agency’s efforts to instill confidence in potential vaccines'
The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents biopharmaceutical research companies, also welcomes the guidance. It emphasises the need for all involved in vaccines to share as much information as possible.
“PhRMA supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines. To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time. We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.
“Science is guiding every aspect of our work. We remain focused on ensuring the highest of standards of patient safety, research, clinical testing and manufacturing are upheld throughout the vaccine research and development process.”
At a glance: FDA COVID-19 vaccine guidance
The aim of the FDA guidance is to explain the scientific data and information that would support Emergency Use Authorization (EUA) for an investigational vaccine intended to prevent COVID-19.
This includes chemistry, manufacturing and controls information, nonclinical and clinical data, information on the supply chain (such as anticipated storage and distribution conditions), and regulatory and administrative information.
It builds on the FDA’s June guidance for the development and licensure of COVID-19 vaccines.
The FDA says it would expect that, following a submission of an EUA request and issuance of an EUA, an applicant would continue to collect data in ongoing trials and would work towards submission of a Biologics License Application (BLA).
The COVID-19 vaccine guidance documents are specifically related to COVID-19 vaccines: with different considerations for drugs and biological products intended for the treatment of COVID-19.
The FDA has also launched a new webpage on COVID-19 vaccine guidance to highlight new information as and when it becomes available.