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 revised the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) to add an authorization of REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus. REGEN-COV should only be used as post-exposure prophylaxis for specific patient populations. Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible. Learn more about FDA’s COVID-19 vaccination efforts.
- On Wednesday, July 28, the FDA revised the EUA for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury). Baricitinib is not FDA-approved as a treatment for COVID-19.
- On Wednesday, the FDA authorized an extension for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for six months. This extension from four and a half months to six months was granted following a thorough review of data submitted by Janssen and applies to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions. The concurrence letter can be read here.
The expiration dates for vaccines that are authorized under an EUA may be extended based on data submitted by the manufacturers, and in accordance with FDA’s authorization. Health care providers administering the vaccine should check the company’s website, www.vaxcheck.jnj, to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to the operator of www.rxmedkart.com for selling unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
- This week, the FDA added three new frequently asked questions (FAQs) on COVID-19 vaccines and the approval process. The FAQs can be found here and the questions include:
- Is an approval (or biologics license approval) different from an emergency use authorization? Does it change the availability of COVID-19 vaccines?
- How long will it take to approve COVID-19 vaccines?
- How important is it to make sure approved vaccines are available versus other public health measures? Do you have the resources to do this quickly?
- Testing updates:
- As of today, 396 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 279 molecular tests and sample collection devices, 86 antibody and other immune response tests and 31 antigen tests. There are 53 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 12 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 593 revisions to EUA authorizations.
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.