Top stories: FDA says its Advisory Committee will review COVID vaccines. What Russia’s approval of a vaccine means for the FDA. FDA Commissioner says political pressure won’t affect vaccine decision. Updated guidance calls for testing of hand sanitizers. FDA issues umbrella authorization for certain face masks.
Welcome to our COVID Weekly Recap, AgencyIQ’s weekly wrap-up of the top regulatory developments related to COVID-19. The following analysis was available to AgencyIQ subscribers earlier this week as part of our daily regulatory intelligence briefings, as well as dozens of other pieces of analysis. Contact us to find out how you can become a subscriber to AgencyIQ.
FDA says its Advisory Committee will review COVID vaccines
By Lily Rosenfield
August 10, 2020
In a viewpoint published in the Journal of the American Medical Association, leaders at the FDA, including Commissioner Stephen Hahn and CBER Director Peter Marks, note that discussion from the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) “will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy.”
- Change of tune: Previously, Peter Marks had briefly touched on the topic of advisory committees during remarks made to the Alliance for a Stronger FDA in July. At the time he said the FDA would “make use of advisory committees as appropriate.” While the FDA was still likely to utilize the expertise of VRBPAC, the statement left room for scenarios in which a vaccine could authorized without the use of an Advisory Committee. Now, leadership indicates that a meeting will be necessary in all cases.
- Public approval: The article notes the speed of vaccine development has caused anxiety among the public, specifically related to concern that the standard for approval will be lower under these circumstances. In a recent Gallup poll, 35% of participants indicated they would not receive a potential COVID-19 vaccine, even if it was free and approved by the FDA. This is a major concern for both the FDA and other public health officials who are counting on potential vaccines to quell the pandemic. An Advisory Committee review could improve public perception and increase vaccination rates.
- Populations tested:Another top concern for the FDA authors was diversity in clinical trials, given how the pandemic has disproportionately affected racial and ethnic minorities, older adults, and people with comorbidities. For the vaccine to lead to population-wide immunity – the ultimate goal—it must be able to be widely deployed and successful across all of these groups. These metrics could be a potential discussion point for VRBPAC.
- Pros and cons to using an AdComm: As AgencyIQ has previously explained, an advisory committee meeting could provide extra support for the FDA to make its decisions, since the committee is composed of external experts. It would also inoculate the FDA from some political pressure. However, the meeting could potentially slow down an approval decision, could become a spectacle, and could subject the committee’s members to enormous personal scrutiny. Consider also the potential headache if the FDA decides to go against the recommendation of its advisory committee – something which is a common occurrence.
- Date and time TBD: While it has been previously reported that the VRBPAC has a meeting scheduled for October, which was theorized to be focused on COVID, the recently-released agenda for that meeting indicates it is instead focused on influenza.
What Russia’s approval of a vaccine means for the FDA
By Alexander Gaffney, MS, RAC
August 11, 2020
Russian officials this week announced the approval of a vaccine for COVID-19—billed as the world’s first—following early-stage evidence obtained from a Phase 1 clinical trial. Safety considerations aside, the episode is indicative of some of the risks ahead for the FDA.
- Putting the approval in context: According to researchpublished in the Journal of Biostatistics in 2019, just 33.4% of vaccines that enter into Phase 1 testing go on to receive approval. While most vaccine candidates entering Phase 1 testing advance to Phase 2 (76.8%), just 58.2% of vaccine candidates entering Phase 2 advance to Phase 3.
- Approval generally requires extensive testing.Generally, vaccines are only approved in the US after products have been extensively studied since they will be used by a large population, including in those with pre-existing conditions and those who are otherwise healthy. Even for vaccines intended to treat or prevent COVID-19, the FDA says it wants to see trials with treatment arms of between 10,000 and 15,000 patients. A Phase 1 trial, in comparison, may only enroll fewer than 100 patients.
- Another issue, according to Michael Kinch, director of the Center for Research Innovation in Biotechnology at the Washington University in St. Louis, is that the experimental Russian vaccine is based on an adenovirus platform. “The problem is that between 30% and 60% of people… are resistant to this particular adenovirus. So the consequence of that is that the vaccine might not work at all,” Kinch told CNN.
- What it means for FDA:While media and public reaction to Russia’s vaccine announcement was generally skeptical, the case provides a preview of cases that are likely to occur again in the new future. Imagine a case in which a vaccine has gone through extensive testing and has obtained approval from a credible global regulator, like the European Medicines Agency, Japan’s PMDA or the UK’s MHRA. Such an event could put tremendous political pressure on the FDA to also quickly approve that same vaccine. As POLITICO’s Elizabeth Ralph put it last month: For better or worse, the race for a vaccine is now an international competition. And in any competition, there are winners and losers.
- The same goes for therapeutics. The FDA’s Coronavirus Treatment Acceleration Program (CTAP) webpageindicates that there are already 210 products in late-stage testing. If any of those products prove to be highly effective at treating COVID-19, the FDA would be under considerable pressure to match another country’s approval decision.
- However, Russia’s approval shows the limits of the vaccine race.It’s not enough to be able to claim victory by being first. Sponsors and regulators need to be able to support that determination with both initial data and long-term follow-up data. Victory can’t be declared by drawing your own finish line.
FDA Commissioner: Political pressure won’t affect vaccine decision
By Charles Friend
August 6, 2020
Commissioner Stephen Hahn wrote this week that the FDA would not compromise its safety and efficacy standards for a potential COVID-19 vaccine amidst mounting concerns that political pressure may be applied to the agency to expedite approval.
- FDA Commissioner Stephen Hahn: “I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and science. I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data.”
- These concerns have recently mountedin the public, with President Trump stating that regarding vaccine development: “I’m rushing it. I am. I’m pushing everybody.”
- Concerns about politicization:Members of Congress, academics and industry experts have expressed concern that the White House might pressure the FDA into approving or authorizing a vaccine on an expedited timeline intended to deliver a vaccine prior to the upcoming Presidential election. An open letter released Wednesday, signed by nearly 400 clinical and academic experts, urged Commissioner Hahn to ensure a transparent process for the approval or authorization of a new vaccine. Additionally, they noted that the agency should not approve any vaccine that has not provided requisite trial data.
- Development Timeline: Although some vaccine candidates have entered Phase 3 trials, which test efficacy in thousands of volunteers, FDA advisorshave indicated that it would be unlikely that a vaccine will be approved before 2021. Operation Warp Speed, the President’s initiative to accelerate the development of a potential COVID-19 vaccine, has the stated goal of providing 300 million doses of a safe, effective, vaccine by January 2021. In his op-ed, Hahn noted that he could not make any predictions about timing of an emergency use authorization or formal approval for such a vaccine.
As shortages persist, FDA issues umbrella authorization for certain face masks
By Laura DiAngelo, MPH
August 6, 2020
Following a call with the FDA earlier this week where providers and health systems called on the agency to take action to support increased supplies of personal protective equipment (PPE), the FDA on August 6 issued an Umbrella Emergency Use Authorization (EUA) for liquid-barrier face masks.
- Face masks, including both non-medical and surgical masks,are subject to different policy and regulatory enforcement procedures during the COVID-19 pandemic than in other times. The FDA has issued guidance expressing enforcement discretion (i.e., not enforcing its regular requirements) for certain masks, while it requires Emergency Use Authorization (EUAs) for others.
- In general, any face mask that intends to make a medical claim about bacterial filtration on its labeling or contains an antimicrobial must obtain an EUA from the agency before being marketed during the pandemic.
- The August 4thcall with industry highlighted ongoing challenges for providers and health systems in sourcing liquid-barrier face masks. They cited challenges with importing supplies, difficulty sourcing on the ground and confusion about the different requirements for different types of face masks.
- The new umbrella EUA will allow developers to bring certain disposable single-use surgical masks (i.e., those that provide liquid barrier protection) to market without an individual authorization. The Umbrella EUA outlinesa series of standards with which eligible masks will be required to conform, including fluid resistance requirements, flammability performance, particulate filtration efficiency requirements, airflow resistance and manufacturing standards. Evidence that the mask meets the criteria, along with a list of authorized distributors/importers, number available, labeling, and contact information, should be emailed to the FDA’s non-diagnostic EUA address to be included under the Umbrella.
- What’s next. These devices remain in severe shortage, raising new concerns for providers and health systems as the pandemic continues. How effective the Umbrella EUA will be at increasing the supply of surgical masks is yet to be seen, and its success is far from assured. For example, the Umbrella EUA for serological tests was recently revoked, as no tests were authorized under it.
Data point: 210
The number of coronavirus treatments in late-stage testing, according to the FDA’s Coronavirus Treatment Acceleration Program webpage. Once these treatments finish testing and their sponsors submit applications for approval or emergency use authorization, it could result in major bottlenecks at the FDA for certain divisions. Similar resource constraints have slowed some authorization reviews at the FDA’s diagnostic divisions, according to CDRH officials.
“The FDA is launching the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) to help apply best practices and lessons learned from the emergency response to date. Our goal is to make needed adjustments to support the ongoing COVID-19 response, while also strengthening our resilience and improving our capacity to respond to public health emergencies in the future.”
FDA Commissioner Stephen Hahn, announcing that the FDA is looking at ways that it can make sustained improvements using lessons learned during the Pandemic. Han has previously discussed this plan in the abstract, but it apparently now has a name: PREPP.