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FDA Approves Booster Dose for Teens – Medical Products Supply Chain Weekly Review | Alston & Bird

During the holidays, the CDC updated its recommendations for quarantine and post-exposure masking. The FDA has cleared the booster dose of Pfizer vaccine for adolescents 12 to 15 years old and for immunocompromised children 5 to 11 years old. The FDA has released draft guidelines for manufacturers of medical devices marketed under EUA or enforcement discretion policies to help them transition to traditional approvals at the end of the health emergency. public. The Administration has convened the Supply Chain Disruption Working Group for an update on its progress. The FDA has issued guidance for lab staff and manufacturers on technical considerations for new strains in developing COVID-19 tests and reading current test results. Please see details of these and other supply chain developments below:

  • On December 22, the President convened a meeting of the Supply Chain Disruption Task Force with stakeholders from the business sector. The implementation of the recommendations of the Working Group has led to drastic improvements in the flow of goods in the main ports. Dwell times in the ports of Long Beach and Los Angeles have been reduced from 12 to 5 days and from 9 to 4 days, respectively. The Port of Savannah with the Georgia Ports Authority has set up inland pop-up container sites that are accessible by truck and train, speeding up the movement of containers to these locations. The involvement of commercial carriers has also accelerated the movement of goods through the supply chain. The ports of Long Beach and Los Angeles are still operating towards 24/7 operation.
  • On December 22, administration officials met with EU officials on COVID-19 and global health security to assess each country’s progress towards the goal of the partnership cemented in September to defeat the global pandemic . Increasing the global production of vaccines and supplies is a major component of the initiative. The meeting also focused on developing strategies for future actions, including establishing a source of funding for such efforts.
  • On December 22, the FDA Center for Device and Radiological Health (CDRH) released a draft guidance document “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUA) During Coronavirus Disease 2019 (COVID-19) Public health emergency ”and“ Transition plan for medical devices that fall under enforcement policies during the public health emergency of coronavirus disease 2019 (COVID-19). These proposed transition plans are guided by the principles of ensuring continued access of patients, providers and consumers to quality products; adequately prepare manufacturers and other stakeholders for the transition; and avoid supply chain disruptions. The plans would provide guidance on the requirements and timelines for marketing presentations. Assessment methods would include a risk-based approach that takes into account the intended uses, regulatory history and the level of risk of the device. A notice will be published for manufacturers 180 days before the expiration date of the EUA declaration. An EUA declaration is separate from a public health emergency declaration. Once an EUA declaration is terminated, all EUAs authorized under the EUA declaration are also terminated. Manufacturers must notify the FDA if they intend to continue marketing their products. The FDA intends to apply a phased approach to products marketed under discretionary enforcement policies that allow manufacturers to prepare for new requirements to avoid disruption. Comments on these draft guidelines are expected by March 23, 2022. We recommend that stakeholders carefully review the documents, submit comments if necessary, and start preparing for transitions early.
  • On December 22, the FDA released a draft guideline, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” to provide sponsors and other stakeholders with guidance on how to assess digital health technology (DHT) used in their clinical investigations. The draft guidance includes how to assess a DHT as suitable for use. When evaluating a product, sponsors and stakeholders should consider the rationale for using the product and its descriptions. Sponsors and stakeholders should also consider whether the product can offer verification, validation and usability information. In addition, investigators should determine whether DHT would provide data permitting an appropriate assessment of clinical parameters from the data from any statistical analysis. The draft guidance also emphasizes that risk considerations regarding clinical risks, confidentiality and informed consent should be considered. Comments are due by March 22, 2022.
  • On December 23, the FDA released a revised guideline, “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests,” which contains specific information regarding the omicron variant. The agency asks labs to be aware that some molecular tests fail to detect omicron and that there are other tests that detect modified omicron. Tests that do not detect omicron should not be used. Laboratories that use tests with multiple genetic targets should be aware that omicron demonstrates genetic abandonment in the results. Although this result may indicate the presence of omicron, it is not definitive. In light of this, the FDA advises labs to consider genetic sequencing if available.
  • On December 27, the CDC announced that it was recommending a five-day window for isolation and the use of masks for asymptomatic people with positive COVID-19 results. The CDC has also changed its recommendations for people exposed to someone with COVID-19 in isolation with strict mask use for five days after exposure for those exposed who are not vaccinated or have been vaccinated more. six months previously (two months for Johnson & Johnson). For those who have received a booster, isolation is not required; however, the use of a mask for five days followed by a test on the fifth day is recommended.
  • On December 29, the Center for Devices and Radiological Health (CDRH) issued an EUA for CLINITEST, a rapid self-test of the COVID-19 antigen from Siemens. This EUA is particularly important because the validation data was collected through the FDA’s collaboration with the National Institutes of Health (ITAP) Independent Testing Assessment Program. SD Biosensor Inc. has also been granted EUA for its home COVID-19 test.
  • On January 3, the FDA announced changes to the EUA for the Pfizer vaccine. The agency decided to allow a booster dose for adolescents 12 to 15 years old and to shorten the recommended time between the primary vaccination and the booster dose to five months, instead of six months. The decision was made on the basis of actual data from Israel which showed no additional security concerns. The decision to reduce the time between the primary series and the booster is taken in response to the prevalence of the more transmissible omicron variant and the need to strengthen the immune response of the population. The FDA has also cleared a third dose of Pfizer vaccine for immunocompromised children 5 to 11 years old. The agency defines immunocompromised as those who have undergone a solid organ transplant or similar conditions that compromise their immune system. The aim is to strengthen their immune response to “enable these children to obtain the maximum potential benefit from the vaccination”.

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Joan J. Dean

The author Joan J. Dean