Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11 years of age. The FDA released draft guidance for manufacturers of medical devices marketed under EUAs or policies of enforcement discretion to assist them with transitions to traditional approvals at the end of the public health emergency. The Administration convened the Supply Chain Disruptions Task Force for an update on its progress. The FDA released guidance for laboratory staff and manufacturers on technical considerations for new strains in development of COVID-19 tests and reading results for current tests. Please see details for these and other supply chain developments below:
- On December 22, the President convened a meeting of the Supply Chain Disruptions Task Force along with stakeholders from the business industry. Implementation of Task Force recommendations has led to drastic improvements in the flow of goods through the major ports. Dwell times at the ports of Long Beach and Los Angeles have dropped from 12 to 5 days and from 9 to 4 days, respectively. The port of Savannah with the Georgia Ports Authority has implemented pop-up container sites inland that are accessible by truck and rail, expediting the movement of containers at these locations. Participation by commercial carriers has also expedited the movement of goods in the supply chain. The ports of Long Beach and Los Angeles are still working toward 24 hours / 7 days a week operation.
- On December 22, Administration officials met with EU officials on COVID-19 and global health security to ascertain the progress each nation has made toward the goal of the partnership cemented in September to beat the global pandemic. Boosting global production of vaccines and supplies is a major part of the initiative. The meeting also focused on strategizing for future action, including establishing a funding source for such efforts.
- On December 22, the FDA Center for Device and Radiological Health (CDRH) released draft guidance documents “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” and “Transition Plan for Medical Devices That Fall Within Enforcement Policies During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” These proposed transition plans are guided by the principles of ensuring continued patient, provider, and consumer access to quality products; adequately preparing manufacturers and other stakeholders for the transition; and avoiding supply chain disruptions. The plans would provide guidance on requirements and timelines for marketing submissions. Evaluation methods would include a risk-based approach that considers intended uses, regulatory history, and level of device risk. Notice will be posted for manufacturers 180 days before 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 should notify the FDA if they intend to submit for continued marketing of their products. The FDA intends to apply a phased approach to products marketed under policies of enforcement discretion that allows manufacturers to prepare for the new requirements to avoid disruption. Comments on these draft guidances are due by March 23, 2022. We recommend that stakeholders study the documents closely, submit comments if needed, and start early to prepare for the transitions.
- 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 guidance includes how to evaluate a DHT as suitable for use. In evaluating a product, sponsors and stakeholders should review the product’s rationale for use and its descriptions. Sponsors and stakeholders should also inquire whether the product can offer information on verification, validation, and usability. Additionally, investigators should consider whether the DHT would provide data that allows for appropriate evaluation of clinical endpoints from the data in any statistical analysis. The draft guidance also emphasizes that risk considerations around clinical risks, privacy, and informed consent should be reviewed. 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,” that has specific information regarding the omicron variant. The agency is asking laboratories to be aware that certain molecular tests fail at detecting omicron and there are other tests that detect omicron as modified. Tests that do not detect omicron should not be used. Labs that use tests with multiple gene targets should be aware that omicron demonstrates gene dropout in the results. While this result may indicate the presence of omicron, it is not definitive. In light of this, the FDA is advising labs that genetic sequencing should be considered if available.
- On December 27, the CDC announced it is recommending a five-day window for isolation and mask usage for those asymptomatic individuals with positive COVID-19 results. The CDC also changed its recommendations for individuals exposed to someone with COVID-19 to isolation with strict mask usage for five days post exposure for exposed individuals who are unvaccinated or were vaccinated greater than six months prior (two months for Johnson & Johnson). For those who have received a booster, isolation is not required; however, mask usage for five days followed by a test at 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 validation data were gathered 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 COVID-19 at-home test.
- On January 3, the FDA announced changes in the EUA for the Pfizer vaccine. The agency has decided to authorize a booster dose for adolescents 12 to 15 years of age and shorten the recommended time between the primary series and booster dose to five months, instead of six months. The decision was made based on real-world data from Israel that demonstrated no additional safety concerns. The move to decrease the time between the primary series and booster is being made in response to the prevalence of the more-transmissible omicron variant and the need to boost the population’s immune response. The FDA also authorized a third dose of the Pfizer vaccine for immunocompromised children 5–11 years of age. The agency defines immunocompromised as those who have undergone a solid organ transplantation or similar conditions that compromise their immune system. The goal is to boost their immune response to “allow these children to receive the maximum potential benefit from vaccination.”
Please do not hesitate to contact us if you have any questions about these developments.