In the past week, the federal government recommended a pause in the use of Johnson & Johnson’s COVID-19 vaccine due to safety concerns. In addition, the FDA issued the long-awaited guidance on remote interactive evaluations of drug manufacturing facilities. Please see details for these and other supply chain developments below:
- On April 13, the CDC and FDA recommended a pause in the use of Johnson & Johnson’s Janssen COVID-19 vaccine because of six cases of a rare and severe type of blood clot in individuals after receiving the vaccine. The pause, along with the manufacturing issues associated with J&J’s contract manufacturing site in Baltimore (see reporting in our previous issue and below), complicates J&J’s efforts to meet its vaccine supply targets.
- The CDC’s independent advisory committee, the Advisory Committee on Immunization Practices (ACIP), met on April 14 to discuss the cases and recommended a continued pause that would allow additional time to review any additional cases that might come in, conduct a complete risk assessment, and evaluate the emerging science. ACIP will reconvene to discuss the issue on April 23.
On April 16, J&J published a response in the New England Journal of Medicine arguing that “evidence is insufficient to establish a causal relationship” between its vaccine and the blood clot cases.
- On April 19, Emergent revealed that the FDA had begun an inspection of J&J’s vaccine contract manufacturing site in Baltimore on April 12 and later asked the site to suspend production until Emergent addresses the FDA’s inspection findings. Also on April 19, the House Oversight and Reform Committee and the Select Subcommittee on the Coronavirus Crisis announced that they were investigating whether Emergent had leveraged its relationship with a key Trump Administration official to receive federal contracts for manufacturing COVID-19 vaccines despite a long history of quality issues.
- On April 14, in response to continued requests from industry for remote inspections and concerns raised by members of Congress, the FDA issued Guidance for Industry: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency for the FDA’s use of remote interactive evaluations (RIEs) during the COVID-19 public health emergency. An RIE is the FDA’s use of any combination of remote interactive tools (e.g., remote livestreaming video of operations, teleconferences, and screen sharing) to support regulatory decisions and oversight of facilities.
The guidance establishes a framework for the use of RIEs, which are voluntary, for all drug inspection programs. The guidance provides details for planning, conducting, and concluding RIEs. It also provides the FDA’s current thinking on the impact of RIEs on user fee commitments and timeframes for responding to RIE observations. Please see more details and our recommendations in our advisory for this guidance.
- On April 16, the FDA revoked the emergency use authorization (EUA) for Eli Lilly’s investigational monoclonal antibody therapy bamlanivimab administrated alone to treat COVID-19. With the sustained increase of viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab alone no longer outweigh the known and potential risks.
Please do not hesitate to contact us if you have any questions about these developments.