Law360 | Moderna, Pfizer Playing the Long Game with Novel Vaccine IP

Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11 years of age. The FDA released draft guidance for manufacturers of medical devices marketed under EUAs or policies of enforcement discretion to assist them with transitions to traditional approvals at the end of the public health emergency. The Administration convened the Supply Chain Disruptions Task Force for an update on its progress. The FDA released guidance for laboratory staff and manufacturers on technical considerations for new strains in development of COVID-19 tests and reading results for current tests. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference for Pfizer-BioNTech and Moderna vaccine boosters. The new recommended Tris vaccine buffer leads to greater stability and requires no dilution. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

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. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

In the past week, the FDA authorized the Pfizer and Moderna booster shots for all adult age groups, while the CDC Advisory Committee on Immunization Practices also recommended the Moderna vaccine booster for all adults. Pfizer submitted an EUA request for its oral COVID-19 treatment. President Biden signed the Infrastructure Investment and Jobs Act and Executive Order for its implementation. The FDA issued updated guidance for manufacturers of SARS-CoV-2 tests. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

Health care providers and suppliers have their own new requirements for COVID-19 vaccination. Our Labor & Employment and Health Care Groups examine the Centers for Medicare & Medicaid Services’ interim final rule covering a long list of facilities and agencies.