NOV 17, 2021 11:00 AM PST

FDA greenlights clinical trials for novel COVID-19 vaccine and delivery system

WRITTEN BY: J. Bryce Ortiz

Last week the United States Food and Drug Administration (FDA) authorized the biotechnology company Inovio to move forward with clinical trials in the United States to test their DNA-based plasmid COVID vaccine and new delivery system. This authorization is good news for the biotechnology company who is aiming to test its vaccine, called INO-4800, in conjunction with its delivery system called CELLECTRA 2000 in patients in the United States. The company is already performing clinical trials in several other countries. 

The FDA authorized the company to push forward with clinical trials after receiving new data on the delivery system. CELLECTRA 2000 is unique delivery system for vaccines. According to the company, the CELLECTRA device uses a series of brief electrical pulses to reversibly open small pores in cell membranes that allow for better penetrance of the company’s DNA-based vaccines. This activity of the device helps to overcome limitations of other DNA- or RNA-based vaccines. In clinical studies, researchers found that in healthy adults this method of vaccine delivery had minimal side effects and minimal pain with some mild side effects that resolved within one day. The data from this studies and others helped the FDA make its decision to approve the device for future clinical trials.

Inovio was also approved to move forward with clinical trials on its novel DNA-based Covid-19 vaccine, INO-4800. The vaccine is made up of a SARS-CoV-2 Spike DNA-based plasmid. This unique design allows the vaccine to provide immunity against variants of the SARS-CoV-2 virus including strains such as the delta variant. In a recent clinical trial, published in the journal npj Vaccines, researchers found that the INO-4800 vaccine induced neutralizing antibodies against all SARS-CoV-2 variants tested. Additionally, the vaccine had a similar safety and tolerability profile compared to other available COVID-19 vaccines. The clinical trial approval is another promising step in the progress of drug delivery and design researchers to help rid the world of COVID-19. 

 

Sources: Inovio NewsInovioHuman Vaccine ImmunotherapyeClinicalMedicine

About the Author
PhD in Neuroscience
Science and medical writer | Researcher | Interested in the intersection between translational science, drug development, and policy
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