The race to the first Food and Drug Administration (FDA) approved COVID19 vaccine is on, but is the answer that easy? Probably not, but we all have high hopes for returning to the “normal” world we once knew. Although we are all hoping for a one hundred percent effective vaccine with life-long immunity, reality may be completely different.
The current COVID19 pandemic has left us all longing for the good ole days when we could visit the supermarket without standing in line or wearing a mask. How about performing routine surgeries without the additional concern of an infectious disease that could completely shut down your operation with little warning? Have you tried visiting a family member in a nursing facility? The list goes on…
With all the uncertainty and additional work that has taken over our day to day, many of us have turned our attention to potential game changing solutions. One of those would be an effective vaccine, but how close are we and what do we know about the process thus far? Although the situation is fluid and new information comes out daily, the FDA recently provided guidance to manufacturers clarifying their expectations when FDA Commissioner Stephen Hahn testified before the Senate’s Health, Education, Labor and Pensions Committee. Here are some of the points he made:
- To receive approval, any COVID-19 vaccine will have to prevent disease, or decrease its severity, in at least 50 percent of the people who receive it.
- Manufacturers would be required to monitor the vaccine’s performance after approval for any emerging safety problems. (This is fairly standard and happens with all new drug approvals.)
- Vaccine trials must use a diverse patient population including the elderly and minorities.
- The FDA is committed to expediting the availability of the vaccine but assured the Committee that decisions would be made based on sound science and data.
Despite this guidance, the FDA can still use temporary approvals, also known as emergency use authorizations, which typically are based on less stringent requirements. Additionally, the debate will go on as to whether fifty percent is a high enough bar, but ultimately, the first vaccine is not likely to be the best COVID-19 vaccine we ultimately have.
Our team will continue to monitor the situation and provide updates to our clients as needed. We are keenly aware of the impact an effective vaccine would have in general, but specifically to those we serve. We continue to be here for you and are always available to provide updates or guide you in making decisions that increase patient safety, enhance regulatory compliance and help you run a more efficient organization.
The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.