FDA authorizes booster dose for teens – Medical Product Supply Chain Week in Review – Food, Drugs, Healthcare, Life Sciences
United States: FDA authorizes booster dose for teens – Medical Product Supply Chain Week in Review
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Over the holidays, the CDC updated its recommendations for post-exposure quarantine and masking. The FDA has authorized the booster dose of the Pfizer vaccine for adolescents 12 to 15 years old and for immunocompromised children 5 to 11 years old. The FDA has released draft guidance for manufacturers of medical devices marketed under EUAs or discretionary enforcement policies to help them transition to traditional approvals when the public health emergency ends. The Administration convened the Supply Chain Disruption Task Force to provide an update on its progress. The FDA has issued guidance for laboratory personnel 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 task force’s recommendations has led to drastic improvements in the flow of goods at major ports. Dwell times in the ports of Long Beach and Los Angeles were reduced from 12 days to 5 days and from 9 days 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 rail, expediting 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 working toward 24/7 operation.
- On Dec. 22, administration officials met with EU officials on COVID-19 and global health security to check each nation’s progress toward the goal of the partnership cemented in September to defeat the global pandemic. . Increasing global vaccine production and supplies is an important part of the initiative. The meeting also focused on developing strategies for future actions, including establishing a source of funding for these efforts.
- On December 22, the FDA’s Center for Device and Radiological Health (CDRH) released draft guidance documents “Transition Plan for Medical Device Emergency Use Authorizations (EUAs) During the coronavirus disease 2019 (COVID-19) public health emergency” and “Transition plan for medical devices that fall under enforcement policies during the coronavirus disease 2019 (COVID-19) public health emergency . 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 requirements and deadlines for marketing submissions. Evaluation methods would include a risk-based approach that takes into account the intended uses, regulatory history and risk level of the device. A notice will be posted for manufacturers 180 days prior to the EUA declaration expiration date. 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 submit their products for continued marketing. The FDA intends to apply a phased approach to marketed products 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 review the materials carefully, submit comments as needed, and start preparing for transitions early.
- On December 22, the FDA released draft guidance, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” to provide sponsors and other stakeholders with guidance on how to evaluate digital health technology (DHT) used in their clinical investigations. The draft guidelines explain how to assess a DHT as fit 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 ask if the product can offer verification, validation and usability information. Additionally, investigators must determine whether DHT would provide data that would allow proper assessment of clinical parameters from the data in any statistical analysis. The draft guidelines also emphasize 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 guidance, “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 omicron as modified. Tests that do not detect omicron should not be used. Laboratories using tests with multiple target genes should be aware that omicron demonstrates gene loss 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 Dec. 27, the CDC announced it was recommending a five-day window for isolation and the use of masks for asymptomatic people with positive COVID-19 results. The CDC also changed its recommendations for those exposed to someone with COVID-19 to self-isolate with strict mask use for five days after exposure for exposed people who are unvaccinated or have been vaccinated. more than six months ago (two months for Johnson & Johnson). For those who have received a booster, isolation is not necessary; however, use of a mask for five days, followed by testing on day five, is recommended.
- On December 29, the Center for Devices and Radiological Health (CDRH) issued an EUA for the CLINITEST, a rapid COVID-19 antigen self-test by Siemens. This EUA is of particular significance because the validation data was collected through the FDA’s collaboration with the National Institutes of Health Independent Test Assessment Program (ITAP). An EUA was also granted to SD Biosensor Inc. for its at-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 series and the booster dose to five months, instead of six months. The decision was made based on actual data from Israel that demonstrated no additional security concerns. The decision to reduce the time between the primary series and the booster is made in response to the prevalence of the more transmissible omicron variant and the need to stimulate the immune response of the population. The FDA has also authorized a third dose of the Pfizer vaccine for immunocompromised children ages 5 to 11. The agency defines the immunocompromised as those who have had 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 derive the maximum potential benefits from vaccination”.
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