In a race against time, teams of scientists across the world are working towards developing an effective and safe vaccine to prevent infection from the SARS-CoV-2 virus that causes COVID-19 disease.
What is happening with this vaccine?
Inovio Pharmaceuticals has developed a new COVID-19 vaccine that has shown promise in preclinical studies and is thus entering into Phase 1 human clinical trials this week. The United States regulatory body Food and Drug Administration (FDA) has approved the trial design by Inovio, which allows them to try their vaccine candidate INO-4800 by administering it as an injection into volunteers.
INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine. Image Credit: Anyaivanova / Shutterstock
How will this vaccine work?
The vaccine has been tried on lab animals and has shown a robust immunological response. An immune response can predict if the body can prevent the virus from infecting the host cells.
The team of researchers developing the vaccine explains that it is a specially engineered and designed plasmid. A plasmid is a small independent part of the cell that has a genetic structure independent of the cell body. This engineered plasmid is created in a manner that can produce an antibody that can fight off the invading virus. DNA vaccines have been in use for several animal infections in veterinary medicine. As of now, none of these DNA vaccines are approved for use in humans.
History of this vaccine
Inovio has been working on this DNA vaccine for a few years now. They have used it against the Middle East Respiratory Syndrome (MERS). The vaccine was found to produce adequate antibodies in those whom it was injected. In these candidates, it helped produced antibodies to fight off the virus, and the antibodies persisted for a long time.
What is being done now?
Since Inovio already had their vaccines developed to an extent, they could accelerate the production of the INO-4800 over a few weeks to produce an adequate number of doses to start their clinical trials. They have on the cards Phase 1 and Phase 2 trials, which would prove the vaccine safe and effective for human use and see if it can prevent the COVID-19 infection.
What will be done in the trials?
Inovio would recruit 40 healthy adult volunteers for their phase 1 trial. These volunteers will be screened at Philadelphia's Perelman School of Medicine at the University of Pennsylvania or the Center for Pharmaceutical Research in Kansas City. The participants would receive two doses of the vaccine each, and these would be four weeks apart. Over the coming weeks, the trial would generate immunological as well as safety data after the drug is injected into the volunteers. By the end of summer or early fall, results regarding the safety of the vaccine are expected. If this phase 1 trial is successful, the next phase will recruit around 1,000 participants.
Bill and Melinda Gates Foundation
The mass production of the vaccine doses for use in the clinical trials is funded by the Bill and Melinda Gates Foundation and other organizations. Inovio has said in its statement that if the trials prove to be successful, they would have a short time to develop one million doses of the vaccine by the end of this year. These would be used in more extensive efficacy trials as well as in regions that are worst affected by the disease, after authorization, they said.
While the Bill and Melinda Gates Foundation has provided $5 million to Inovio, Coalition for Epidemic Preparedness and Innovation has provided $9 million. The latter is a public-private foundation based in Norway.
Gates said that his foundation is supporting seven "most promising" vaccine candidates in their development, INO-4800 being one of them. He said, "Our early money can accelerate things." He added, "To get to the best case, we need to do safety and efficacy and build manufacturing." He acknowledged that they might lose "a few billion dollars" trying to find the right vaccine. But he called the whole effort "worth it" given the situation of the pandemic. The Bill & Melinda Gates Foundation in February committed a total of $100 million for the worldwide fight against COVID-19.
Other vaccines in the pipeline
INO-4800 is the second vaccine that has been administered to volunteers as part of phase 1 safety trials Moderna has already begun its phase 1 trial in the middle of March by injecting its candidate mRNA vaccine on volunteers.
So when can we have the vaccine ready?
Finally, the Inovio officials hope that the vaccine, if proven successful in phases 1 and 2 clinical trials, could receive approval for broad population use only around a year or 18 months from now at the most. They assure that the trials and the research on the vaccines