A new vaccine candidate for coronavirus pneumonia-19 entered the 1 clinical human trial on Monday, local time, after the US Food and Drug Administration accepted the application of Inovio Pharmaceutical Company according to the regulatory agency's new drug research plan. Inovio plans to inject the candidate INO-4800 DNA vaccine it developed into the first volunteer subject. Previous preclinical studies on animals showed that the immune response was enhanced and the results were promising.
Inovio's candidate DNA vaccine can make patients produce the required targeted antibodies by injecting specific engineering plasmids to fight specific infections. Although DNA vaccine can be used for veterinary drugs infected by many animals, it has not been approved for human use.
In other words, Inovio's work didn't start from scratch. The company has previously completed the 1 phase study of the candidate DNA vaccine for Middle East respiratory syndrome, and the results show that the effect is good. The antibody level produced by the subjects is high and lasts for a long time.
Inovio quickly expanded its scale in a short time, and developed and produced thousands of doses of INO-4800 in just a few weeks to support its 1 phase and phase 2 trials. The company was able to do this partly because of the support of the Bill and Melinda Gates Foundation and other non-profit organizations. Inovio said that if the clinical trial is successful, by the end of this year, the company will be able to prepare as many as 6.5438+0 million doses of vaccine for more trials and potential emergencies.
This is the second vaccine in the United States to conduct 1 clinical trials in human subjects. Moderna company started the experiment in mid-March. Inovio's trial will consist of 40 volunteers, all of whom are healthy adults selected by the University of Pennsylvania's perelman School of Medicine or the Kansas City Drug Research Center. The company is expected to conduct this research in the next few weeks, and it is expected to provide data about the immune response of the subjects and information about the safety of this therapy to human beings before the end of this summer.
Any extensive approval or use may still take at least one year to 18 months, but human trials are still very fast, so I hope we don't have to wait too long.
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