This Week at FDA: Califf confirms no VRBPAC for bivalent boosters

This Week at FDAThis Week at FDA | 26 August 2022 | By

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that both Pfizer and Moderna are seeking FDA authorization for their bivalent COVID-19 vaccines containing components of both the prototype virus and Omicron BA.4/5. FDA’s decision to authorize the updated boosters could come as early as next week, and FDA Commissioner Robert Califf has confirmed the agency will not convene an advisory committee meeting before making its decision.
 
Pfizer-BioNTech and Moderna have both completed emergency use authorization (EUA) requests for their Omicron-targeting bivalent vaccines. The requests both rely on pre-clinical data, as well as clinical data from the companies’ bivalent vaccines targeting Omicron BA.1. Pfizer expects to start a clinical study looking at the safety, tolerability and immunogenicity of its Omicron BA.4/BA.5-adapted vaccine this month.
 
“The FDA is working tirelessly to evaluate the submissions to ensure the data meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality so that these new boosters are available as soon as possible,” Califf tweeted on Thursday, noting that the agency would base its decision on “the totality of available evidence,” including clinical trial data from other bivalent mRNA vaccines, real-world evidence from current vaccines and non-clinical data on the two BA.4/5-containing vaccines.
 
Califf also said that the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) would not be convened to review the submissions. “FDA will not hold a VRBPAC meeting about these submissions, as the agency feels confident in the extensive discussion that was held in June. VRBPAC voted overwhelmingly to include an omicron component in COVID-19 boosters. FDA has no new questions that warrant committee input,” he wrote.
 
Writing in JAMA earlier in the week, Califf presented his priorities for FDA and repeated a familiar call for higher quality evidence generation. “When the FDA’s decisions generate controversy, it is often when the system fails to produce reliable evidence that clarifies an intervention’s risks and benefits during a relevant time frame. The gap between FDA clearance or approval of a medical product (particularly when the accelerated approval pathway is used) and use of the product to treat patients should be filled by an invigorated clinical research system that generates evidence that patients, clinicians, and health systems need to make well-informed decisions,” he wrote. Read more from Endpoints.
 
The Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality (OPQ) on Thursday released a report on the “state of pharmaceutical quality” in FY2021. Expect more coverage of the report in Focus next week.
 
Drugs & biologics
 
Earlier this week, FDA issued a safety alert advising health care providers and investigational new drug application (IND) sponsors of the potential risk for transmission of monkeypox virus via fecal microbiota transplantation (FMT). While the risks are still theoretical, FDA pointed to a recent study that found “monkeypox virus DNA in rectal swabs from three individuals who reported no symptoms of monkeypox disease, including two individuals who had viable monkeypox virus isolated from rectal swabs.” FDA cautioned that the risk of transmission is still unknown.
 
“Due to the potential for serious adverse events to occur, FDA has determined that additional protections are needed for any investigational use of FMT, whether used as part of a study under an Investigational New Drug Application (IND) on file with the FDA or otherwise, if it involves stool donated on or after March 15, 2022,” FDA said. Mitigation measures include donor screening questions intended to identify those who have, recently had, or who are at high risk for monkeypox. FDA also said sponsors should develop exclusion criteria based on the donor screening measures and that informed consent should reflect information about the potential risk for transmission.
 
This week, Stat reported that Morton Grove Pharmaceuticals, a subsidiary of major Indian generic drugmaker Wockhardt, has shut down its Illinois facility after entering a consent decree with the Department of Justice. The move comes after the department sued the company following years of manufacturing issues at the facility. FDA inspected the facility five times between December 2010 and May 2021, which resulted in multiple Form 483s and a 2017 warning letter.
 
FDA on Thursday approved a new single dose vial presentation of the Pfizer-BioNTech COVID-19 vaccine Comirnaty intended for use in individuals 12 and older.
 
The agency also announced a public workshop on 27-28 October focused on the use of modeling approaches to support generic drug development.
 
Medtech
 
MedtechDive reports that FDA has slapped Medtronic’s latest recall of its Heartware Ventricular Assist Device (HVAD) system with a Class I label, marking the third Class I recall of the device this year. The recall affects some 40,000 batteries for the device, which “may experience electrical faults that cause them to unexpectedly fail.”
 
FDA announced on Friday that it has removed N95 respirators from its medical device shortage list for the first time during the COVID-19 pandemic. “We have worked very closely with our partners at NIOSH, the Occupational Safety and Health Administration and with U.S. manufacturers to stabilize, rebuild and secure health care access to high-quality, single-use respirators, including those that are American-made. Today, our national capacity for production of these devices is stronger and our supply chain is more resilient because of these collective efforts on behalf of the dedicated people working to save lives,” said Suzanne Schwartz, director of the Center for Devices and Radiological Health’s Office of Strategic Partnerships and Technology Innovation.
 
The agency began testing several upcoming Electronic Medical Device Reporting (eMDR) system enhancements last Friday, with production deployments scheduled for next year. The agency also updated its coding resources for medical device reports to add or modify numerous terms, and it released a packet of files meant to aid in implementing software for generating the HL7 ICSR XML for an eMDR submission.
 
The Medical Device Innovation Consortium (MDIC) announced a new collaboration with FDA, the National Institute of Standards and Technology (NIST), National Institutes of Health (NIH) and industry stakeholders to “improve the validation and regulatory review process for cancer diagnostics based on next generation sequencing (NGS).”

 

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