The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA posted online background material for this week’s upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) public meeting. The VRBPAC will meet in open session on Thursday, Dec. 10, to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
- On Dec. 7, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth. This drug is listed in the FDA Drug Shortage Database. 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.
- The FDA has issued a safety communication, Wear Face Masks with No Metal During MRI Exams to inform patients and health care providers that patients may be injured if they wear face masks (such as surgical or non-surgical masks and respirators) with metal parts and coatings during a Magnetic Resonance Imaging (MRI) exam. Metal parts, like nose pieces (sometimes called nose clips or wires), nanoparticles (ultrafine particles), or antimicrobial coating that may contain metal (such as silver or copper), may become hot and burn the patient during an MRI. The FDA recommends patients wear face masks with no metal during MRIs. The FDA recently received a report that a patient’s face was burned from the metal in a face mask worn during an MRI.
- On Dec. 4, the FDA authorized the first diagnostic test for use with home-collected patient samples to detect both COVID-19 and influenza A and B (flu).The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can self-collect a nasal sample at home and then ship it to Quest Diagnostics for analysis, using the instructions in the collection kit.
- Testing updates:
- As of Dec. 8, 297 tests and sample collection devices are authorized by FDA under EUAs; these include 228 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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