Policy Updates

12/21/21 — Federal courts have issued contradictory rulings on implementation of employee COVID-19 vaccination mandates issued by OSHA and CMS. While a stay on implementation of the OSHA vaccination mandate has been reversed, injunctions against implementation of the CMS healthcare personnal COVID-19 vaccination mandate are still in effect in 24 states. The OSHA vaccination mandate … Continued

12/16/21 — The FDA approved a manufacturing change for Comirnaty (COVID-19 Vaccine, mRNA) to include a formulation that uses a different buffer, which helps maintain a vaccine’s pH and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers. Read the FDA approval letter.

12/15/21 — FDA issued an EUA for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the prevention of COVID-19 in certain adults and children. Although vaccines have proven to be the best defense against COVID-19, some people may not have an adequate immune response or have a history of severe adverse reactions to the vaccine. … Continued

12/14/21 — Gilead Sciences Inc. announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level due to the presence of glass particulates. Veklury is used for the treatment of COVID-19 requiring hospitalization. Read the FDA notice. 

12/13/21 — Efficient Laboratories is voluntarily recalling Rompe Pecho products due to microbial contamination concerns. These products are used to treat symptoms of the flu and the common cold, and each are packaged in a box containing a bottle of the liquid product.  Read the FDA recall announcement, which includes a list of recalled products.

12/9/21 — The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. The CDC followed up on FDA’s action by likewise … Continued

Edge Pharma, LLC is voluntarily recalling all lots of all drugs due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products. Read the FDA recall notice.

12/7/21 — As the SARS-CoV-2 virus continues to mutate over time, genetic variations could impact the performance of some COVID-19 molecular, antigen, and serology tests. The FDA website “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests” provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and healthcare providers, and information … Continued

12/6/21 — Federal Courts have suspended implementation of the OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard and the CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule until the courts can review and rule on challenges to the mandates. Both agencies remain confident of their authority to implement necessary measures to protect the health … Continued