Covid EUA Holders: Are You Ready For Life After the Pandemic?
(Thursday, May 20, 2021)
Almost all the products used to diagnose, prevent, and treat Covid infection, in the US, were authorized under the Emergency Use Authorizations (EUA), and now that the pandemic seems to be getting under control, at least in the US, it is critical that manufacturers of these products start thinking of life after the emergency both from the regulatory and business perspectives. It could be as soon as July that the US government may declare that the pandemic emergency is over, probably during the July 4th festivities. It is widely believed that SARS-CoV-2 virus will be around for some time, and the products needed to manage Covid will be needed for many years, but the business and financial aspects of these products will be quite different in future. So, the first thing to consider is if there is sufficient demand to justify staying in the market. The market for masks and diagnostics is shrinking rapidly, so small manufacturers who came up solely to service the pandemic demand may find it less attractive to file the expensive regulatory applications. For the vaccine products, with most of the individuals in the US, on track to get vaccinated by this fall, the decisions to pursue market approvals will rely heavily on the need for repeat vaccinations going forward. Both Pfizer and Moderna have announced that they plan to file BLAs shortly, but for all the other manufacturers whose vaccines are in development or close to clinical use, it is going to be a hard decision. Many vaccine manufacturers are now looking towards marketing their products in non-US locations. The US approval would help with marketing the same products in other countries as well. So, they may seek US approval solely to make it easier to sell elsewhere. In the last 18 months of the pandemic, there is still no good therapeutic product for the infection. Remdesivir remains the only FDA-approved drug. Hence, therapeutic products are still needed. Even with reduced infection rates, there is a significant demand for therapeutic products for seriously ill patients. Therapeutics manufactures hence should continue their regulatory programs. No matter what product you have, it is time now to plan for the post-pandemic world.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC