Each week the FDA updates their Frequently Asked Questions to answer some pressing questions about COVID-19. While there's still no answer to the all-important question, "When will this be over?" FAQ updates are still worth checking out for the latest information from the Food and Drug Administration.
Previous highlights included information about pets and COVID-19 after confirmed cases in New York house cats. This week, the FDA focuses on the drug remdesivir, smoking, and vaping.
Q: Is remdesivir approved by the FDA to treat COVID-19?
A: No. Remdesivir is an investigational antiviral drug. It is not currently FDA-approved to treat or prevent any diseases, including COVID-19.
Q: Are there data showing remdesivir might benefit patients with COVID-19?
A: In vitro (laboratory) testing of remdesivir demonstrated it is active against SARS-CoV-2 (the virus causing COVID-19). Preliminary results from a placebo-controlled clinical trial of remdesivir by the National Institute for Allergy and Infectious Diseases suggested that patients taking remdesivir experienced faster time to recovery as compared to patients taking a placebo. Preliminary results from a Phase 3 trial evaluating 5-day and 10-day dosing durations of remdesivir in hospitalized patients with severe COVID-19 disease, but most of whom were not receiving mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at baseline, reported that patients receiving a 10-day treatment course achieved similar improvement as those taking a 5-day treatment course. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing clinical trials.
Because remdesivir may possibly help very sick patients, FDA is allowing this drug to be provided to hospitalized patients with severe COVID-19 under an Emergency Use Authorization (EUA) issued May 1, 2020. Under the EUA, health care providers and patients are provided with information about the risks of remdesivir. However, final data from clinical trials included in an FDA application are necessary for us to determine whether the drug is safe and effective in treating or preventing COVID-19.
Q: How can remdesivir be obtained for use under the EUA?
A: HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) recently announced the allocation plan for remdesivir. Gilead Sciences, Inc. donated vials of the investigational antiviral drug remdesivir to treat hospitalized COVID-19 patients with severe disease in areas of the country hardest hit by the pandemic. State health departments will distribute the doses to appropriate hospitals in their states because state and local health departments have the greatest insight into community-level needs in the COVID-19 response. Healthcare providers interested in administering the donated experimental drug should contact their state health department.
Outside of the EUA, remdesivir remains available through the following mechanisms:
Expanded Access Protocol (NCT04323761)
Emergency investigational new drug applications (EINDs) for pregnant women and children
Q: Am I at risk for serious complications from COVID-19 if I smoke cigarettes?
A: Smoking cigarettes can leave you more vulnerable to respiratory illnesses, such as COVID-19. For example, smoking is known to cause lung disease, and people with underlying lung problems may have increased risk for serious complications from COVID-19, a disease that primarily attacks the lungs. Smoking cigarettes can also cause inflammation and cell damage throughout the body and can weaken your immune system, making it less able to fight off disease.
There’s never been a better time to quit smoking. If you need resources to help you quit smoking, the FDA’s Every Try Counts campaign has supportive tips and tools to help you get closer to quitting for good.
Q: If I vape tobacco or nicotine am I at risk for complications from COVID-19?
A: E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of COVID-19 or the severity of COVID-19 outcomes is not known. However, many e-cigarette users are current or former smokers, and cigarette smoking increases the risk of respiratory infections, including pneumonia.
Q: What is FDA doing to respond to foodborne illnesses during the COVID-19 pandemic?
A: The virus that causes COVID-19 is a virus that causes respiratory illness. Viruses like norovirus and hepatitis A that can make people sick through contaminated food usually cause gastrointestinal or stomach illness. Currently there is no evidence of food, food containers, or food packaging being associated with transmission of COVID-19.
The CDC, FDA, and USDA continue to work with state and local partners to investigate foodborne illness and outbreaks during the COVID-19 pandemic. The FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network manages outbreak response, as well as surveillance and post-response activities related to incidents involving multiple illnesses linked to FDA-regulated human food products. During this coronavirus outbreak, CORE’s full-time staff will continue to operate to prepare for, coordinate and carry out response activities to incidents of foodborne illnesses.
The FDA’s Center for Veterinary Medicine manages outbreak responses for animal food and is similarly staffed and prepared to respond to incidents of foodborne illness in animals.
To see the FDA's answers to more common questions, please click here.