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 (ACIP) also recommended the Moderna vaccine booster for all adults. Pfizer 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 issued updated guidance for manufacturers of SARS-CoV-2 tests. Please see details for these and other supply chain developments below:
- On November 15, the President signed the Infrastructure Investment and Jobs Act (IIJA) and an Executive Order to facilitate its implementation. The IIJA amends the Homeland Security Act of 2002 to enable the secretaries of the departments of Homeland Security, Health and Human Services (HHS), and Veterans Affairs to transfer personal protective equipment (PPE) and medically necessary equipment to the national stockpile under a domestic production contract during a public health emergency declared by the HHS secretary. In general, the secretary of Homeland Security, at the request of the HHS secretary, is enabled to transfer to HHS, on a reimbursable basis, excess PPE or medically necessary equipment possessed by the Department of Homeland Security (DHS). The DHS secretary must determine whether the requested personal protective or medically necessary equipment is excess equipment and certify that the transfer of such equipment will not adversely impact the health or safety of DHS officers, employees, or contractors. The IIJA also amends the Public Health Service Act to enable the HHS secretary, in coordination with the DHS secretary, to sell drugs, vaccines (and other biological products), medical devices, or supplies within the national stockpile to a Federal agency, nonprofit, state, or a local, tribal, or territorial entity. Products sold must be within one year of expiration or determined to no longer be needed in the stockpile due to advances in medical or technical capabilities. The IIJA also includes a “Make PPE in America Act” subtitle that requires development of a short-term (three years) and long-term strategy for domestic PPE production. An Infrastructure Implementation Task Force has been created to oversee the implementation of the Act. The task force will be co-chaired by Mitch Landrieu, coordinator of White House Infrastructure Implementation, and Brian Deese, director of the National Economic Council.
- On November 15, the FDA updated its policies regarding review expectations of COVID-19 tests and released several policies that provide guidance for manufacturers. The FDA’s goal is to ensure the tests are reliable and accurate. The update included the following:
- The FDA reissued the “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised),” which applies to tests that use diagnostic and serologic methodology. Manufacturers may submit EUA requests for at-home and point-of-care tests, high-volume lab-based molecular diagnostic tests, lab-based and point-of-care high-volume antibody tests, and U.S. government agency-funded tests. All other types are required to use the traditional premarket pathways.
- The FDA issued the “Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing.” This EUA applies to certain nasal swab serial use SARS-CoV-2 tests, which are used in testing programs by schools, workplaces, or community groups. The testing must be performed in a CLIA-certified single laboratory.
- The FDA reissued the EUA, “Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19).” In its review of current policies and the shifting needs of the pandemic, the agency is prioritizing serial use tests and updated its conditions for authorizing molecular-based laboratory developed tests. Additional tests may be authorized.
- The FDA issued guidance on its “Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Due to the increase in serial testing, it is necessary to increase the availability of transport media for clinical specimens. The FDA created this guidance to support this effort and provide a standard for manufacturers of the media. The guidance specifically provides criteria for commercial manufacturers on expectations in validation, agency notification, and labeling. Additional guidance and expectations are included for manufacturers of alternate media types and saline transport media.
- On November 16, Pfizer announced its submission of an EUA request for its oral anti-viral COVID-19 medication, Paxlovid (ritonavir). The medication is intended for at-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 a relative risk reduction of 89% (absolute risk reduction of 6.2%) of hospitalization and death in participants 18 years and older at high risk for disease progression. Trial recruitment was halted on the recommendation of the Data Monitoring Committee based on interim analysis data. The 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 , an entity backed by the United Nations, to provide access to the drug for low- and middle-income countries. On November 18, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of Paxlovid, subject to FDA regulatory authorization.
- On November 16, the Center for Devices and Radiological Health (CDRH) updated its Medical Device Development Tools program materials landing page. The program is voluntary and supports sponsors in developing and evaluating their medical devices with the goal of easing CDRH review. Tools in the program are evaluated and approved by the FDA and must be able to produce scientifically plausible output.
- On November 17, the White House COVID-19 Response Team announced that the Administration plans to provide funding to increase vaccine production. The Department of Health and Human Services is in touch with manufacturing companies that can increase their vaccine output. The goal is to add at least a billion doses to the national supply through investments in infrastructure and training.
- On November 19, the FDA authorized the use of the Pfizer and Moderna vaccine as a booster dose in all age groups 18 years and older. The agency based the decision on data from ongoing clinical trials and real-time outcomes from vaccine use. The authorizations are for a booster dose at least six-months after completion of the initial series. The CDC ACIP subsequently met and unanimously recommended authorizing the Moderna vaccine for persons 18 years of age and older. The committee decision has been forwarded for approval to CDC Director, Dr. Walensky and the FDA.