- For immediate release:
The US Food and Drug Administration today announced the following measures taken in their ongoing efforts to respond 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 multidose vials, indicated to increase blood pressure in adults with vasodilatory shock (sudden relaxation of blood vessels), which remain hypotensive (low blood pressure) despite fluids and catecholamines (a class of neurotransmitters). The most common side effects include decreased heart rate, bradycardia (slow heart rate), tachyarrhythmias (fast heart rate), hyponatremia (low sodium) and ischemia (insufficient blood supply to any 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 meet critical needs of the U.S. public.
- On December 16, 2021, the FDA approved a production change for Comirnaty (COVID-19 vaccine, mRNA) to include a wording 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, allowing greater flexibility for vaccination providers. This formulation of Comirnaty does not need to be diluted before use and therefore vaccination providers can more easily 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 approved 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 Approved for Emergency Use Authorization (EUA) for persons 12 years of age and older when prepared according to their respective instructions for use may be used interchangeably .
- Test updates:
- Today, 422 tests and sampling equipment are approved by the FDA under Emergency Use Authorizations (EUAs). These include 292 molecular tests and sampling equipment, 89 antibody and other immune response tests, and 41 antigen tests. There are 67 molecular approvals and one antibody approval that can be used with home-collected samples. There is one EUA for a Molecular Prescription Home Test, three EUAs for Antigen Prescription Home Test, 11 EUAs for Antigen Over-the-Counter Home Test (OTC) and three EUAs for Molecular OTC Home Test.
- The FDA has approved 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also approved 720 revisions of EUA approvals.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.