Since the outbreak of the current SARS-CoV-2 pandemic, laboratories around the world have been working around the clock to develop the vaccine that can finally combat this virus. Achieving a safe and effective vaccine takes time, and while many of the standard protocols have been accelerated in the wake of the emergency, it should be noted that a vaccine against the new coronavirus is not likely to be available for at least a year and a half.
There are already some vaccines available, which after pre-clinical testing in animals, are in Phase 1 of clinical trials on humans. One of these is the vaccine developed by the US company Moderna, which was the first to start these trials. China also began testing its prototype a few days ago with healthy volunteers from the city of Wuhan, the epicentre of the pandemic.
The Bill and Melinda Gates Foundation has also been active in funding the development of a new vaccine in collaboration with Inovio, a small pharmaceutical and biotechnology company based in Pennsylvania, USA. Now, a statement from that company has just announced that their 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 the Phase 1 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 expedite the process. "We published the registration for the study in advance," explained Pablo Tebas, an infectious disease specialist and professor of Medicine at the University of Pennsylvania Hospital. "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 initial immune response and safety data to be ready by the end of the summer. The company already has experience working with coronaviruses, having also completed the Phase I study to test a vaccine against Middle East Respiratory Syndrome (MERS). In this case, the product was well tolerated and induced high antibody levels in 95 per cent of the subjects, as well as inducing T-cell responses in 90 per cent of the participants. The immune responses were maintained for 60 weeks after the application of the dose.
In light of these results, company representatives are optimistic about the SARS-CoV-2 vaccine, but cautious about the magnitude of the challenge: "Producing a COVID-19 vaccine in the next 12-18 months is not only a scientific challenge but will also require new levels of collaboration and investment from industry and government," said Richard Hatchett, director of the Coalition for Preparedness and Innovation in Emergencies. "There is still a long way to go before we have a safe, effective and globally accessible vaccine ready for broader use.