FDA pauses the planning stages of Inovio’s late-stage COVID-19 vaccine trials

pharmafile | September 29, 2020 | News story | Manufacturing and Production COVID-19 vaccine, FDA, coronavirus vaccines 

The FDA has put Inovio’s planning stages for the final trials of its coronavirus vaccine on hold as the regulator seeks more information about how they will be carried out.

The company’s mid-to-late trials had been waiting for a final regulatory approval before launching the trials this month. This is the second time Inovio has faced delays from the FDA on the project. The company has said none of the delays are due to over-reported side-effects from the early trials they conducted with their vaccine.

The FDA has questions around the vaccine candidate itself but also the delivery device known as Cellectra 2000. Innovio has said that it is working to address the questions raised and will respond to the agency next month. The FDA then has 30 days to respond and notify Inovio whether or not it can proceed with late-stage trials.

Inovio’s INO-48000 vaccine is being partly funded by the US’ Operation Warp Speed and has the goal of being released by January 2021. The company has said it is the only vaccine on the scheme that is stable at room temperature for more than a year and does not need to be frozen in storage like mRNA vaccines, such as the one Pfizer and BioNTech are developing.

Conor Kavanagh

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