- 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 September 17, the FDA issued one Letter to healthcare providers to alert clinical laboratory staff and healthcare providers about the potential for false positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP kits. The letter to healthcare providers provides important information about Abbott Alinity w SARS-CoV-2 AMP and Alinity w Resp-4-Plex AMP kits, including details of potential false positive results, recommendations for clinical laboratory staff and healthcare providers, actions taken by the FDA and reporting instructions of problems with Alinity m SARS-CoV-2 AMP or Alinity m Resp-4-Plex AMP kits.
- On September 16, the FDA revised Emergency use authorization (EUA) for bamlanivimab and etesevimab, co-administered, to include an emergency use as post-exposure prophylaxis (prevention) of COVID-19 in adult and pediatric patients (12 years and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. Bamlanivimab and etesevimab, co-administered, are not approved for pre-exposure prophylaxis to prevent COVID-19 before exposure to the SARS-CoV-2 virus – only after exposure to the virus. Bamlanivimab and etesevimab, co-administered, should only be used as post-exposure prophylaxis for specific patient populations. Prophylaxis with bamlanivimab and etesevimab, co-administered, is not a substitute for COVID-19 vaccination. The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. The FDA encourages you to get vaccinated if you are eligible. Learn more about FDA approved or authorized Vaccines against covid-19.
- On September 15, the FDA issued a revised guide, Enforcement policy for face masks, barrier face dressings, face shields, surgical masks and respirators during Coronavirus disease (COVID-19) public health emergency (revised)to help extend the availability of face masks, barrier face masks and face shields to the general public, including healthcare professionals, as well as surgical masks and particle filtering face masks (MFFs) (including N95 respirators) to healthcare professionals for the duration of COVID -19 public health emergency.
- September 14, FDA authorized the use, under the Emergency Use Permit (EUA) for the Janssen COVID-19 vaccine, of two additional batches of vaccine drug manufactured at the Emergent facility. To date, a total of eight batches of Janssen drug fabric manufactured at the Emergent facility have been approved. The FDA conducted a thorough review of the plant records and the results of quality tests performed by the manufacturer. Based on this review and given the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions facility in Janssen EUA as an authorized manufacturing facility, the agency continues to address issues with Janssen and Emergent BioSolutions management.
- Test updates:
- Today, 410 tests and sampling equipment are approved by the FDA under emergency use permits (EUAs). These include 288 molecular tests and sampling equipment, 88 antibody and other immune response tests, and 34 antigen tests. There are 62 molecular approvals that can be used with home-collected samples. There is one molecular prescription home test, three antigen prescription home tests, seven over-the-counter antigen tests (OTC) in the home, and two OTC molecular tests.
- The FDA has approved 15 antigen tests and eight molecular tests for serial screening programs. The FDA has also approved 636 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.