On February 4, the U.S. Food and Drug Administration (FDA) announced the scheduling of a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the request for emergency use authorization for a COVID-19 vaccine from Janssen Biotech Inc. Additionally, Acting Commissioner of the FDA Janet Woodcock, MD, issued a statement on the agency’s support of medical product development aimed at addressing new variants of the virus.
Janet Woodcock, MD
FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” said Dr. Woodcock. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”
The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than 2 business days prior to the meeting. In general, advisory committees include a Chair, members with scientific and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be added for individual meetings as needed.
The members of the VRBPAC are independent scientific and public health experts from around the country who provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request. However, final decisions on whether to authorize the vaccine for emergency use are made by the FDA.
In terms of timing for convening the VRBPAC meeting following the submission of the EUA request, this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.
While the FDA cannot predict how long its ongoing evaluation of the data and manufacturing information will take following the VRBPAC meeting to make a decision on the request for an EUA, the agency will review the request as expeditiously as possible, taking into consideration the discussion by the advisory committee, while still doing so in a thorough and science-based manner.
The FDA intends to issue a Federal Register notice as soon as possible with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted. These comments will be reviewed by the FDA.
The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube, Facebook, and Twitter channels; the meeting will also be webcast from the FDA website.
FDA Continues to Support Medical Product Development to Address New Virus Variants
On February 4, Dr. Woodcock issued the following statement.
As the public health agency responsible for regulating medical products, we must ensure that health-care providers have the most up-to-date diagnostics, treatments, and vaccines in their toolbox to fight this pandemic. We understand the need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified.
Since the beginning of the pandemic, the FDA has anticipated the possible emergence of coronavirus variants. The FDA continues to monitor the identified and emerging variants circulating globally, as well as their detection in the United States.
We have been actively assessing the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the impact that each variant may have on effectiveness or utility of authorized medical products.
Our agency has had experience with evolving infectious diseases. Influenza vaccines and diagnostics are often modified each year to address the predicted predominant strains circulating globally. The agency has created and used regulatory processes that facilitate these updates. We will utilize our experience with influenza to help inform a path forward if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective. Similarly, the FDA also has vast experience with human immunodeficiency virus developing resistance to antiviral drugs, and will follow regulatory pathways to quickly enable new antiviral drug development for resistant virus.
We have already been communicating with individual medical product sponsors to provide information as they evaluate the impact of COVID-19 variants on their products. As part of our commitment to a public and transparent process, the FDA is developing guidance for diagnostic, therapeutic, and vaccine developers to help guide ongoing medical product development.
For therapeutics—particularly virus-targeting monoclonal antibodies—we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of preclinical, clinical, and chemistry, manufacturing, and controls data.
For diagnostics, we have been monitoring for new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them, and communicating with the public when helpful information becomes available. At this time, we believe the risk that the currently known mutations will impact overall testing accuracy of molecular tests is low. Moving forward, we are considering expanding the role of in silico monitoring by sponsors prior to and following authorization to assess for mutations that impact the performance of the test, test designs to minimize the impact of new mutations, and ways to label authorized products to be transparent about what we know the test can detect.
For authorized vaccines, our teams are currently deliberating and discussing the types of data needed to support changes in the composition of the vaccine, either through altering the existing vaccine or through the addition of new vaccine component(s), including how sponsors could demonstrate immune response to new variants through streamlined clinical programs that still gather the crucial data the FDA needs to demonstrate effectiveness, but can be executed quickly to gather this data. To be clear, while we continue to develop an understanding of and address any impact of variants on FDA-regulated products, at this time, available information suggests that the authorized vaccines remain effective in protecting the American public against currently circulating strains of COVID-19.
We believe these guidances will demonstrate our flexibility to work with individual sponsors to support their modification or development of products to fight COVID-19. The FDA’s response to the COVID-19 pandemic continues to be an all-hands-on-deck effort to enable the agency to simultaneously address multiple public health needs. With emergence of multiple variants and their potential impact on the performance and efficacy of vaccines, therapeutics, and diagnostics, it is critical that the FDA is transparent about its thinking in this space so that all parties know they are receiving consistent advice and other individuals have insight into the agency’s decision-making process.
In addition to these guidances, the FDA is undertaking scenario planning to prepare us to anticipate and address impacts to products and supply chains as quickly as possible, no matter what path the pandemic takes in the next months. As we continue this process, we are committed to sharing this information with the public when it is ready.
We are committed to identifying efficient processes for authorized products that may need to be modified, based on information on emerging variants. We do not believe there will be the need to start at square one with any of these products—we recognize we are in a pandemic and we need to arm health-care providers with the most appropriate tools to fight this pandemic on the front lines. We do not want to create obstacles to getting these tools to the front lines.
As with any evolving situation, we will be continuously monitoring the situation and updating our plans as more information becomes available. We are committed to communicating with you as we continue to determine the best paths forward. We urge Americans to continue to get tested, get their vaccines, and follow important health measures—wash your hands, wear a mask, and maintain social distance.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.