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Medical Products Supply Chain Weekly Review – FDA Approves Pfizer and Moderna Booster for All Adults | Alston & Bird

Over the past week, the FDA cleared the Pfizer and Moderna booster injections for all adult age groups, while the CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster. for all adults. Pfizer has submitted an Emergency Use Authorization (EUA) application for its oral treatment with COVID-19. President Biden signed the Infrastructure Investments and Jobs Act and the Executive Order for its implementation. The FDA has issued updated guidelines 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 Law on Investment in Infrastructure and Employment (IIJA) and a decree to facilitate its implementation. IIJA Amends Homeland Security Act 2002 to Allow Secretaries of Homeland Security, Health and Human Services (HHS) Departments, and Veterans to Transfer Personal Protective Equipment (PPE) and Equipment medically necessary for the national stock under a production contract during a public health emergency declared by the secretary of the HHS. In general, the Secretary of Homeland Security, at the request of the Secretary of HHS, is authorized to transfer to HHS, for reimbursement, excess PPE or medically necessary equipment possessed by the Department of Homeland Security (DHS). The DHS Secretary must determine whether the requested personal or medically necessary protective equipment is surplus equipment and certify that the transfer of such equipment will not have a negative impact on the health or safety of officers, employees or subordinates. treating DHS. The IIJA is also amending 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. within the national stock to a federal agency, nonprofit, state, or local, tribal, or territorial entity. Products sold must be within one year of expiration or determined to be no longer needed in inventory due to advances in medical or technical capacity. 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 the national production of PPE. An Infrastructure Implementation Working Group has been established to oversee the implementation of the law. The working group 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 released 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 re-issued the “Policy for Testing for Coronavirus-2019 Disease During 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 the US government agency. All other types must use traditional pre-market channels.
    • The FDA has published the “Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing”. This EUA applies to certain SARS-CoV-2 serial use nasal swab tests, which are used in testing programs by schools, workplaces or community groups. Testing should 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 serial use testing and has updated its conditions for authorizing molecular-based laboratory-developed tests. Additional tests may be permitted.
    • The FDA has issued guidance on its “Viral Transport Media Enforcement Policy During 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 this effort and provide a standard for media manufacturers. The guide specifically provides 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 COVID-19 oral antiviral drug, Paxlovid (ritonavir). The medicine is intended for home use in high-risk patients to prevent hospitalization and death. According to an interim review from 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% (risk reduction absolute 6.2%) of hospitalization and death in participants 18 years and older at high risk for disease progression. Recruitment for the trial was discontinued upon recommendation of the Data Oversight Committee based on 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 regulatory clearance from the FDA.
  • On November 16, the Center for Devices and Radiological Health (CDRH) updated the Medical Device Development Tools program documents landing page. The program is voluntary and supports sponsors in the development and evaluation of their medical devices with the aim of facilitating the review of CDRH. The program’s tools are evaluated and approved by the FDA and must be capable of producing scientifically plausible results.
  • On November 17, the White House COVID-19 response team announced that the administration was planning to provide funding to increase vaccine production. The Department of Health and Human Services is in contact with manufacturing companies that can increase their vaccine production. 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 vaccines for use as a booster dose in all age groups 18 years and older. The agency based its decision on data from ongoing clinical trials and real-time results from vaccine use. The authorizations relate to a booster dose at least six months after the end of the initial series. The CDC ACIP then met and unanimously recommended that the Moderna vaccine be allowed for people 18 years of age and older. The committee’s decision has been forwarded for approval to CDC director Dr. Walensky and the FDA.

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Joan J. Dean

The author Joan J. Dean