Results of AstraZeneca Plc’s U.S. COVID-19 vaccine trial are being reviewed by independent monitors, and emergency authorization could come in about a month, a top U.S. official said on Monday. The independent monitors are analyzing data from the 32,000-person U.S. study to determine whether the vaccine is safe and effective. If the results are positive and all goes well, the U.S. Food and Drug Administration would review the data and issue the authorization, Dr. Francis Collins, director of the National Institutes of Health (NIH), said in an interview.
Collins estimates that the FDA would need about three weeks to analyze the trial data, after which an expert advisory panel will meet and vote on whether to recommend authorization. “We expect data from our US Phase III trial to be available soon, and we plan to file for emergency use authorization shortly thereafter,” AstraZeneca spokeswoman Michele Meixell said in a statement.
Low-Cost Leprosy Drug Clofazimine is Under Review to be Repurposed for COVID-19
New COVID-19 drugs such as Gilead Sciences’ remdesivir have their limitations, stressing the need for additional therapeutic options. To accelerate the drug development process, scientists have been looking to repurpose existing medicines. Now, an international team has locked onto an old leprosy drug, clofazimine, as a promising candidate. Treatment with clofazimine significantly reduced viral load and shedding in hamsters infected with SARS-CoV-2, the novel coronavirus behind COVID-19, researchers from Sanford Burnham Prebys Medical Discovery Institute and the University of Hong Kong reported in a new Nature study. It also showed a synergistic effect with remdesivir, which is approved by the FDA under the brand name Veklury for hospitalized patients.
The University of Hong Kong has launched a phase 2 study testing the combination of clofazimine and interferon beta for hospitalized COVID-19 patients. As an old oral drug that’s included in the World Health Organization’s List of Essential Medicines, clofazimine holds potential as an affordable COVID-19 treatment, the researchers suggested.