Coronavirus (COVID-19) Update: December 17, 2021

FDA News Release

• For Immediate Release: December 17, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• On December 15, 2021, the FDA approved an abbreviated new drug application (ANDA 211538) for Vasopressin Injection, 20 Units/mL Multiple Dose Vials, indicated to increase blood pressure in adults with vasodilatory shock (sudden relaxation of blood vessels) who remain hypotensive (low blood pressure) despite fluids and catecholamines (a class of neurotransmitters). The most common adverse reactions include decreased cardiac output, bradycardia (slow heart rate), tachyarrhythmias (rapid heart rate), hyponatremia (low sodium levels), and ischemia (inadequate blood supply to a part of the body). This action is the first approval of an ANDA for this product. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
• On December 16, 2021, the FDA approved a manufacturing change for Comirnaty (COVID-19 Vaccine, mRNA) to include a formulation that uses a different buffer. Buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers. This formulation of Comirnaty does not need to be diluted before use, thus, vaccination providers can more readily prepare and deliver appropriate doses. The new formulation contains Tris buffer, a commonly used buffer in other FDA-approved vaccines and biologics. The FDA previously authorized this vaccine formulation for the Pfizer-BioNTech COVID-19 Vaccine in October. The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.
• Testing updates:
  • As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests and 41 antigen tests. There are 67 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
  • The FDA has authorized 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 720 revisions to EUA authorizations.