Expert Alert

Developing vaccines and drugs 101 during a pandemic

Jason Varin
Jason Varin

With Operation Warp Speed and the Food and Drug Administration (FDA) working to expedite COVID-19 vaccines, treatments and diagnostics, there has become an increased interest in the development process.

University of Minnesota Assistant Professor Jason Varin with the College of Pharmacy addresses how vaccines and drugs are commonly developed and how the FDA can adapt this process to address public health emergencies, such as the current pandemic. 

Jason Varin, PharmD
“A standard drug or medical device approval can consume many years from product conception to patient use. While the FDA approval process typically takes up to 10 months, the necessary steps that need to be taken before applying for FDA approval can take up to 10 or more years. These steps include three clinical phases which initially test safety and dosage of the product on dozens of healthy individuals and the later phases focus on efficacy, side effects and adverse reactions in hundreds/thousands of individuals with the targeted condition(s). After completion of Phase 3 trials, the FDA approval process reviews the data and decides if the drug should be approved for the indicated use(s). 

“During the pandemic, there has been an uptick of applications for drugs, vaccines and therapies used to diagnose and treat COVID-19, seeking Emergency Use Authorization (EUA) from the FDA. The EUA process provides a path to reduce potential public health harm with a product that has not completed the standard approval process — but, the early data indicates its benefit will likely outweigh the risks. Based on the preliminary data of a vaccine study, experts may determine there is limited risk compared to the benefit of saving lives, reducing illness and shortening the duration of the crisis, thus reducing the harm to our economy and businesses that have been impacted. 

“Once a vaccine is authorized or approved, it is imperative that our pharmacies and clinics, including rural and underserved areas, are able to provide immunization services to their communities. To ensure swift and widespread immunization our federal, state, and local governments must collaborate and provide support for these vital providers including access to vaccine and supplies, PPE, and financial support for front line immunizers and equipment such as special vaccine freezers which may cost $10 thousand or more.”


Contact
Jason Varin
Assistant Professor at the College of Pharmacy
varin@umn.edu

Jason Varin is an assistant professor at the College of Pharmacy on the University of Minnesota Twin Cities campus. He also practiced as a community pharmacist for 22 years and has served as President of the Minnesota Pharmacists Association. 

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Tue, 12/08/2020 - 21:03
Developing vaccines and drugs 101 during a pandemic
https://twin-cities.umn.edu/news-events/developing-vaccines-and-drugs-101-during-pandemic
University of Minnesota, Twin Cities