Medical Product Supply Chain Week in Review – FDA Approves Pfizer and Moderna Booster for All Adults | Alston and bird
Over the past week, the FDA has cleared Pfizer and Moderna booster shots for all adult age groups, while the CDC’s Advisory Committee on Immunization Practices (ACIP) has also recommended a vaccine booster Moderna for all adults. Pfizer has submitted an Emergency Use Authorization (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 has released updated guidance for manufacturers of SARS-CoV-2 tests. Please see details of these and other supply chain developments below:
- On November 15, the President signed the Infrastructure Investment and Employment Act (IIJA) and an Executive Order to facilitate its implementation. IIJA Amends Homeland Security Act of 2002 to Allow Secretaries of Departments of Homeland Security, Health and Human Services (HHS), and Veterans Affairs to Transfer Personal Protective Equipment (PPE) and Equipment medically necessary to the national stock within the framework of a national procedure. production contract during a public health emergency declared by the Secretary of HHS. Generally, the Secretary of Homeland Security, at the request of the Secretary of HHS, is authorized to transfer to HHS, on a reimbursable basis, excess PPE or medically necessary equipment owned by the Department of Homeland Security (DHS). The DHS Secretary must determine whether the personal protective or medically necessary equipment requested is surplus equipment and certify that the transfer of such equipment will not adversely impact the health or safety of officers, employees, or subcontractors. DHS contractors. The IIJA also amends the Public Health Services Act to allow the Secretary of HHS, in coordination with the Secretary of DHS, to sell drugs, vaccines (and other biologicals), medical devices, or supplies. in national inventory to a federal agency, nonprofit, state, or local, tribal, or territorial entity. Products sold must have expired within one year or be determined to be no longer needed in stock due to advances in medical or technical capabilities. The IIJA also includes a subtitle “Make PPE in America Act” which requires the development of a short-term (three-year) and long-term strategy for domestic production of PPE. An Infrastructure Implementation Task Force has been established to oversee the implementation of the law. The task force will be co-chaired by Mitch Landrieu, White House infrastructure implementation coordinator, and Brian Deese, director of the National Economic Council.
- On November 15, the FDA updated its policies regarding COVID-19 test review expectations and issued several policies that provide guidance to manufacturers. The FDA’s goal is to ensure that the tests are reliable and accurate. The update included the following:
- The FDA has reissued the “Policy for Testing for Coronavirus Disease 2019 During the Public Health Emergency (Revised),” which applies to tests that use diagnostic and serological methodology. Manufacturers can submit EUA requests for home and point-of-care testing, high-volume laboratory molecular diagnostic testing, high-volume laboratory and point-of-care antibody testing, and funded testing by US government agencies. All other types must use traditional premarket channels.
- The FDA has published the “Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing”. This EUA applies to certain serial use SARS-CoV-2 nasal swab tests, which are used in testing programs by schools, workplaces, or community groups. Testing must be performed in a single CLIA-certified laboratory.
- The FDA reissued the EUA, “Laboratories that have developed a molecular test (LDT) for coronavirus disease 2019 (COVID-19)”. In its review of current policies and the changing needs of the pandemic, the agency is prioritizing mass-use testing and has updated its licensing requirements for lab-developed molecular tests. Additional testing may be permitted.
- The FDA has issued guidance on its “Policy for Applying Viral Transport Carriers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Due to the increase in serial testing, there is a need to increase the availability of transport media for clinical specimens. The FDA created this guide to support that effort and provide a standard for media manufacturers. The guidelines specifically provide criteria for commercial manufacturers on validation, agency notification and labeling expectations. Additional guidance and expectations are included for manufacturers of alternative media types and saline transport media.
- On November 16, Pfizer announced the submission of an EUA application for its oral COVID-19 antiviral drug, Paxlovid (ritonavir). The drug is intended for home use in high-risk patients to prevent hospitalization and death. According to an interim analysis of the Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, a Phase 2/3 study, Paxlovid demonstrated an 89% relative risk reduction (risk reduction 6.2% absolute) hospitalization and death among participants 18 years of age and older at high risk of disease progression. Recruitment of the trial was stopped on the recommendation of the data monitoring committee based on the interim analysis data. Trials for standard-risk patients and post-exposure prophylaxis are still ongoing. On the same day, Pfizer agreed to license Paxlovid to the Medicines Patent Pool, a United Nations-backed entity, to provide access to the drug to low- and middle-income countries. On November 18, Pfizer announced an agreement with the US government to supply 10 million courses of Paxlovid, subject to FDA regulatory clearance.
- On November 16, the Center for Devices and Radiological Health (CDRH) updated the home page for the Medical Device Development Tools program documents. The program is voluntary and supports sponsors in the development and evaluation of their medical devices to facilitate CDRH review. Program tools are evaluated and cleared by the FDA and must be able to produce scientifically plausible results.
- On November 17, the White House COVID-19 Response Team announced that the administration planned to provide funding to increase vaccine production. The Department of Health and Human Services is in contact with manufacturing companies that can increase their production of vaccines. The goal is to add at least one billion doses to the national supply through investments in infrastructure and training.
- On November 19, the FDA cleared the Pfizer and Moderna vaccine for use as a booster dose in all age groups 18 and older. The agency based its decision on data from ongoing clinical trials and real-time results from the use of the vaccine. Authorizations relate to a booster dose at least six months after the end of the initial series. The ACIP CDC then met and unanimously recommended allowing the Moderna vaccine for people 18 and older. The committee’s decision was forwarded to CDC Director Dr. Walensky and the FDA for approval.