Covid Vaccines Stole the Limelight from Therapies, it Seems.
(Thursday, October 28, 2021)
Vaccines have overwhelmingly dominated the public and regulatory attention since the beginning of the pandemic. Most of the public funding and resources seems to have been devoted to developing effective vaccines rather than therapies. And it has worked, for the vaccines. While we have several vaccines for Covid and billions of people worldwide have been vaccinated, there is still only one drug approved by either the FDA or EMA, Gilead’s remdesivir (Veklury). Both the FDA and EMA have given emergency authorizations to about 10 treatments for Covid, and almost all of them are intended for patients with advanced disease. From the pool of more than 100 therapies in development since last year, a few have been identified as most promising both by the FDA and EMA. EMA this week published a list of 10 most promising Covid therapies that are divided in three categories: monoclonal antibodies to the virus, anti-viral drugs, and immunomodulators that may help the patient indirectly. The list is mostly similar to that compiled by the FDA, with a few minor differences. And these therapies are projected to be the closest to being formally approved, i.e., upgraded from the current status of emergency authorization. The emergency authorizations have been a great vehicle to make new drugs available to patients faster but lacks the full public trust in the therapy afforded by the full approvals. The list of Covid therapies has stayed almost unchanged for the last year indicating that either the research in these treatments has hit major issues such as lack of patient pools to conduct clinical trials in or that the industry and government interest in developing these have waned due to the availability of highly effective and widely available vaccines. While vaccines have been universally accepted as the most potent way to avoid Covid infections, therapeutics are still needed for patients who are hospitalized with Covid either because they were not vaccinated or have breakthrough infections with the virus. Then there is a need for developing treatments for long Covid, patients who have Covid related issues long after they healed from the initial infection. With the soon to be authorized vaccination for children 5-11 years of age, the infection rates will drop even further making it even harder to test new therapies for Covid. We are likely reaching a cliff for Covid therapies where treatments that have still not reached a reasonable regulatory milestone will need to drop off completely. If you have a therapy in development for Covid, you need to rush or plan to close.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC