In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in teens 16 and 17 years of age. The Administration Port Action Plan continues to improve the supply chain backlog. The FDA released an update to the Resiliency Roadmap for Inspections. Please see details for these and other supply chain developments below:
- On November 22, Pfizer and BioNTech announced that they will request full approval from the FDA for their COVID-19 vaccine in adolescents 12–15 years of age. The submission will be based in part on data from their Phase III clinical trial, which demonstrated that a two-dose regimen of its COVID-19 vaccine was 100% effective between seven days and four months after the second dose. There were no serious safety concerns observed within six months of the second dose. The company also plans to request the FDA to grant authorization of the booster dose for teens 16 and 17 years of age. The data show the booster dose restores vaccine effectiveness to 95%. It is anticipated the FDA will not delay reviewing the request because data from Israel has allayed concerns of potential myocarditis cases and infections from the new variant strain.
- On November 23, the President commented on the economy and the short-term results of innovations in supply chain processes. As a result of the implementation of the Administration’s Port Action Plan, and the continuous operation of the ports of Los Angeles and Long Beach, stalled shipping containers at the ports have decreased by 33% and shipping costs have decreased by 25%. Investments have also been made to increase port activity on the U.S. East Coast, and, in cooperation, retailers have agreed to work to bring products to market as soon as possible.
- On November 23, the United States and India released a joint statement at the conclusion of the Trade Policy Forum. The forum included the reinstitution of the working groups on agriculture, nonagriculture goods, services, investment, and intellectual property. Both countries also agreed to work to secure the supply chain for trade, technology, and pharmaceutical products. Of note, discussion covered India’s concerns regarding the FDA’s delays in regulatory inspections of health-related goods, including pharmaceuticals, due to COVID-19. The United States reported that the FDA will continue to monitor COVID-19 conditions and is conducting prioritized inspections when there is minimal risk to company and FDA officials. The agency will also continue to utilize remote evaluation techniques for regulatory decisions as appropriate.
- On November 24, the FDA announced that it is seeking comments from interested parties on the use of N-acetyl-L-cysteine (NAC) in marketed dietary supplements. The agency has previously taken the position that NAC may not be used in dietary supplements but has been petitioned to reconsider this stance. The petitions ask the FDA to determine that NAC is not excluded from the definition of a dietary supplement or to initiate rulemaking to do so. The FDA responded to the petitions that it is seeking additional information from the petitioners and interested parties. Responses are due by January 25, 2022.
- On November 29, President Biden briefed the United States on the response to the identification of the newly identified omicron COVID-19 variant. The new strain was identified in South Africa and has been classified by the World Health Organization as a “variant of concern.” As a result and to prevent transmission, the President has imposed travel restrictions for immigrants and non-immigrants from South Africa and seven neighboring countries. The President emphasized there is no need for panic, and a statement by FDA Acting Commissioner Dr. Janet Woodcock indicated the agency is working with stakeholders to address the impact of the variant on “available diagnostics, therapeutics, and vaccines.” While the variant carries mutations that may make it more transmissible and better able to evade vaccine protection, based on early reports, it does not have implications on the severity of disease. The President also revealed that his team is already working with Pfizer, Moderna, and Johnson & Johnson to develop contingency plans for vaccines or boosters if needed.
- The FDA released “An Update to the Resiliency Roadmap for FDA Inspectional Oversight” to provide stakeholders with an update on the agency’s activities since the release of the May 2021 Resiliency Roadmap. Based on the data from May through September 2021, the targets for Resiliency Roadmap inspections were exceeded in multiple categories. The roadmap reinstituted domestic surveillance activities and mission-critical foreign activities, including follow-up on prior inspections that resulted in “official action indicated” classification. The FDA has also established the Inspectional Affairs Council, charged with developing a multiyear strategic action plan for the conduct and purpose of inspections and the strategic use of remote regulatory assessments (including record requests under Section 704(a)(4) and remote interactive evaluations) for all FDA-regulated products. In addition, the FDA is planning to resume prioritized foreign inspections in February 2022.
- The FDA announced there will be a webinar to discuss the agency’s final rule on the Medical Device De Novo Classification Process on December 14, 2021 and will include a discussion on updated guidances. The process exists as a pathway outside the premarket approval process required for Class III devices for marketing authorization of novel medical devices.