Since the current pandemic caused by the SARS-CoV-2 coronavirus broke out, laboratories around the world have been working around the clock to develop the long-awaited vaccine. Obtaining a safe and effective vaccine takes time, and although given the emergency of the situation many of the usual protocols have been accelerated, it should be noted that the vaccine against the new coronavirus is not likely to be available, at least, until within a year and a half.
Currently there are already some vaccines that, once the pre-clinical trials in animals have passed, are in phase 1 of clinical trials in humans. One of them is the vaccine developed by the American company Moderna, which was the first to initiate these tests. For its part, in China, tests were also started a few days ago to test its prototype with healthy volunteers from the city of Wuhan, the epicenter of the pandemic.
The Bill and Melinda Gates Foundation did not want to be left behind either, and has financed the development of a new vaccine in collaboration with Inovio, a small pharmaceutical and biotechnology company based in Pennsylvania (USA). Now, a statement from said company has just announced that its DNA vaccine has just passed pre-clinical trials and that the US Food and Drug Administration (FDA) has just approved the start of human trials, which will begin immediately.
This will be phase 1 of clinical trials
“This is a significant step in the global fight against COVID-19. Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods,” said J. Joseph Kim, President of Inovio. Phase 1 of the trial will include forty healthy volunteers from Philadelphia and Kansas City, where the evaluation of candidates has already begun to speed up the process. “We published the study registration in advance,” explains Pablo Tebas, disease specialist infectious diseases and Professor of Medicine at the Hospital of the University of Pennsylvania. “There has been a lot of interest in this vaccine among people who want to do what they can to help protect the general public from this pandemic as soon as possible,” he says.
Each participant will receive two doses of the vaccine four weeks apart , and the company expects data regarding the initial immune response and safety to be ready by the end of the summer. The company already has experience working with coronavirus, having also completed a phase I study to test a vaccine against Middle East Respiratory Syndrome (MERS). In this case, the product was well tolerated and induced high levels of antibodies in 95% of the subjects, in addition to inducing T cell responses in 90% of the participants. Immune responses were maintained for 60 weeks after dosing.
In view of these results, the company representatives are optimistic regarding the vaccine against SARS-CoV-2, although they are prudent given the magnitude of the challenge: “Produce a COVID-19 vaccine in the next 12 years 18 months is not only a scientific challenge, but it will also require new levels of collaboration and investment in industry and government, ”says Richard Hatchett, director of the Coalition for Epidemic Preparedness and Innovation. ” There is still a long way to go before we have a vaccine that is safe, effective and accessible globally and ready for its wider use .”
