Sinovac, Inc., has released an update on the new crown vaccine, announcing that more than 90% of I/II volunteers have produced neutralized antibodies that are expected to prevent COVID-19 infection. CoronaVac will enter Phase III clinical trials, and Coshing is working with Brazil’s Instituto Butantan on a new project.
According to new research, the global blockade has prevented hundreds of millions of infections and countless deaths. They have also given the world valuable time to advance the trial of COVID-19 therapy. We have seen an increase in research on existing drugs that may be useful for COVID-19 therapies. In addition, researchers have developed drugs that treat the disease and provide temporary immunity, and more than 130 teams have developed candidate vaccines. Of these, about 10 have reached the human trial stage, and some have shown promising results. The latest data come from China, where a candidate vaccine has yielded results in monkeys, but can produce the same response in human volunteers. This is CoronaVac of Kexing Holdings Biotech Co., Ltd., which is ready to enter Phase III clinical trials.
The company announced the preliminary results in a press release, rather than sharing the full study, but the results will soon be published in academic journals. This is similar to Moderna’s publication of the COVID-19 vaccine findings, but Coshing has released more data. The I/II trial was a standard randomized double-blind experiment, consisting of 743 volunteers. Of these, 143 were in Phase I and 600 in Phase II.
No serious adverse reactions were observed in the Phase I/II trial, The Koxing reported. Phase II trials showed that 14 days after vaccination, the immune system induces neutralizing antibodies. “The neutralizing antibody impotence rate after 14 days of full immunity is over 90%, indicating that the vaccine has good immunogenicity,” the company said.
The volunteers were given two doses of the vaccine 14 days apart. Another team in the study received the drug within a 28-day interval, but the results of the group have not been released, Bloomberg reported.
Koxing is using the killed version of the virus to produce the same immune response as a real infection. Neutralizing antibodies are special proteins that the immune system can produce against each new pathogen that prevents the entity from entering cells. In this case, the antibody blocks the coronavirus from infecting lung cells, where the virus begins to multiply. This is how vaccines can provide immunity to COVID-19, assuming that drugs like CoronaVac pass all regulatory hurdles.
Coshing also said it plans to submit a Phase III clinical study program to China’s State Drug Administration to test the vaccine in other markets. Specifically, Cochen will conduct a three-phase study in cooperation with Instituto Butantan in Brazil. Currently, Brazil is the center of the new GLOBAL COVID-19 outbreak. Brazil has nearly 890,000 cases and more than 43,000 deaths, with the number of newly confirmed cases and deaths second only to the United States and the second largest in the world.
With the domestic COVID-19 outbreak under control, vaccine manufacturers have been looking for other markets to test their candidate vaccines. Similarly, researchers working on vaccines at Oxford University have been looking for other markets for Phase III studies because they fear there may not be enough patients in the UK to complete the study before September.
It is unclear when The Results of Kexing’s Phase III study will be available, and in addition to the company’s vaccine, four other candidate stakes in China have been phase III clinical trials.