If you’ve been following the FDA’s COVID-19 vaccine development process, you most likely have heard of the Vaccine and Related Biological Products Advisory Committee (VRBPAC). The committee is made up of independent advisors who will help determine whether COVID-19 vaccines are safe and effective. It is is one of the FDA’s many science advisory committees which has operated since 1979, making recommendations to the agency annually on which flu strains are circulating, and therefore what the annual flu vaccine should guard against, and reviews clinical trial data to help the agency decide whether to approve new vaccines for use.
Its meetings don’t usually make headlines, but on Thursday, October 22nd, the committee will meet to discuss the development of COVID-19 vaccines and the FDA expects tens of thousands of people to attend virtually. I’ve studied and attended a good number of science advisory committee meetings, so I’ve put together some answers to questions you might have in advance of Thursday’s meeting.
What is the Vaccine and Related Biological Products Advisory Committee?
VRBPAC is one of the FDA’s 47 committees, providing independent science advice to the agency to help it make evidence-based decisions. As a federal advisory committee, its meetings are open to the public and incorporate public comments into its decisionmaking processes. The federal advisory committee system provides an important way for the nation’s experts to inform government decisions on everything from drug approvals to environmental pollution to worker safety. The process happens entirely transparently with opportunities for the public to attend and comment, to see how science advice is developed and communicated and to participate in the meetings.
According to its charter, VRBPAC “reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the (FDA) has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.”
This is not the only advisory committee that stands to make an important decision about the COVID-19 vaccines. The CDC’s Advisory Committee on Immunization Practices (ACIP) weighs the evidence and makes recommendations to health providers about which populations should receive each licensed vaccine. Together, these committees will play a vital role in ensuring that the rollout of a COVID-19 vaccine will be one that we can fully trust.
What will the committee talk about during the all-day meeting?
The committee’s agenda should be available later this week, but FDA has already acknowledged that it will be a general discussion about the development, authorization, and/or licensure of vaccines, which means they won’t do a deep dive on any one vaccine or application just yet.
At this meeting, they will likely discuss FDA’s recently released guidance document for the pharmaceutical industry (which as my colleague Anita Desikan explains was a big win for science and transparency) and there should be questions raised about the diversity of participants in the vaccine clinical trials to ensure that the drugs are safe and effective for everyone. There will also be an hour in the afternoon dedicated to presentations from members of the public, which is a requirement of the Federal Advisory Committee Act (FACA). This is an opportunity for individuals to raise concerns, highlight research, and otherwise participate in the public meeting.
Is FDA required to implement the committee’s recommendations?
Like all federal advisory committees, VRBPAC’s role is advisory in nature and FDA officials have the discretion to accept its recommendations. However, according to the Federal Advisory Committee Act (FACA) database, of the 105 recommendations made from fiscal year 2003 to FY2019, 84 percent of the committee’s recommendations have been fully implemented by the agency and 10 percent were partially implemented. It would be very unusual for FDA not to listen to VRBPAC’s advice on COVID-19 vaccines.
Who are the members of the committee and how do we know they will objectively weigh the evidence?
According to its 2020 charter, the Secretary should appoint scientists “knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.” Individuals serve overlapping terms of up to four years. According to the FY2018 membership balance plan, “During the appointment process, the committee is reviewed in totality for balance with regard to geographic location and female and minority representation. A balanced committee is characterized by necessary knowledge, insight, and scientific perspective from the community or expertise area which the members serve.”
The committee roster is made up of 17 highly qualified experts, or “nerdy virologists,” though the roster of individuals actively participating in the meeting hasn’t yet been released. The charter requires that there are fifteen voting members, including ex-officio members from HHS, CDC and NIH and a consumer advocate (Sheldon Toubman from the New Haven Legal Assistance Association). Two members represent industry (Paula Annunziato from Merck and Gregg Sylvester from Seqirus) and do not have voting power. Present and voting at the meeting will be two members with stated conflicts of interest whose waivers were made publicly available, Jeannette Lee and James Hildreth. Dr. Lee has a $25,000 to $50,000 stock holding in Philip Morris International which stands to gain from a COVID-19 vaccine candidate. She also is an expert in biostatistics, specifically as it relates to design of clinical trials, which is incredibly important for the committee deliberations. Dr. Hildreth is the president of Meharry Medical College which is participating in a COVID-19 vaccine clinical trial and while he’s not the Principal Investigator, the school is receiving $500,000 to $750,000 for it. He is a preeminent scientist (immunology, virology, internal medicine, and public health) with specific expertise in health disparities which is particularly important for discussions around COVID-19, as it is disproportionately affecting communities of color. Three other members (Paul Spearman, Hana El Sahly, and Holly Janes) will be recusing themselves from the meeting because of their close involvement with COVID-19 vaccine trials. It is possible that there will be temporary replacement members with voting powers appointed and posted on the committee’s website up to 48 hours before the meeting. UCS recommends that conflicts be avoided in science advisory committee appointments, but we recognize that certain circumstances make it nearly impossible to do so. FDA’s waivers show that there was a lot of thought that went into the vetting and appointment process of VRBPAC and with so much scrutiny on this committee, we trust that the science, not any outside agenda, will guide the decisions made by its members.
How much of the committee’s work will be open to the public?
A good portion of the committee’s work will be open to the public. In fact, FDA’s advisory committee meetings are among the most transparent across agencies. For example, for VRBPAC meetings, FDA’s website includes the full agenda, briefing documents, committee roster, meeting minutes, meeting transcripts, powerpoint slides, written public comments, and full videos of committee meetings, while most other advisory committees post only meeting summaries or meeting minutes.
Notably, the FDA is required, by statute, to disclose on its website the type, nature, and magnitude of the financial interests of each advisory committee member who has received a waiver and the reasons for granting the waiver. These waivers describe conflicts that the agency feels will not detract from the unique expertise that the committee member can bring to the group This is not something that all agencies make public, but is one of our recommendations to promote scientific integrity and transparency in our recently released fact sheet on conflicts of interest.
A vaccine must be approved only after rigorous, independent scientific review affirming its safety
In her testimony at a briefing before the House Committee on Oversight and Reform this summer, former chair of the VRBAC Dr. Ruth Karron stated that, “building confidence in COVID-19 vaccines is critical, because the best vaccine in the world won’t work if it isn’t used. There are many partners in that process, but it begins here, by soliciting public engagement and developing public trust for the ways in which these vaccines are evaluated in clinical trials, and providing open, transparent, independent expert review and analysis of clinical trial data, to be included in the decision-making process for vaccine licensure or Emergency Use Authorization.”
Science advisory committees like VRBPAC are necessary checks on the work of agencies and in this case the stakes are very high. As seven former FDA commissioners explained in a September op-ed, “If the FDA makes available a safe and effective vaccine that people trust, we could expect to meaningfully reduce covid-19 risk as soon as next spring or summer. Without that trust, our health and economy could lag for years.” We need to support and promote the work of these independent experts volunteering their time for this vital function and the career scientists at FDA who are committed to scientific integrity and doing everything they can from the inside to make sure the COVID-19 vaccine development process can be trusted.
You can find all of the meeting materials and join thousands of others tuning into the VRBPAC meeting at 10am ET on Thursday October 22nd here.