- Another potential coronavirus treatment is moving to the final stage of clinical trials, another vaccine candidate from China that can elicit the immune response desired to prevent an infection.
- With Phase 2 of a China National Biotec Group drug trial completed, the company is moving to the last stage ahead of potential regulatory approval.
- Phase 3 will be conducted in international markets because China’s COVID-19 caseload is too low for studying the effects of a potential vaccine.
Five vaccine candidates are now in the advanced phases of clinical trials in China, with a second one having just cleared Phase 2 trials. Sinovac announced a few days ago that 90% of volunteers who received the test drug developed the kind of antibodies that can neutralize the novel coronavirus. The company said the CoronaVac treatment has reached Phase 3, and that it’s heading to Brazil to move forward to the final phase of testing.
China National Biotec Group (CNBG) also announced that one of its candidates has cleared Phase 2 with promising results, and it’s now looking at securing Phase 3 volunteers overseas for the final stage of the study. China may be experiencing a serious COVID-19 outbreak in Beijing right now, but the country doesn’t have enough sick people overall for Phase 3 trials to go forward locally. This phase can include anywhere from thousands to tens of thousands of people who receive the vaccine candidate. But if the volunteers can’t be reliably exposed to the virus, researchers won’t be able to measure the efficacy of the vaccine candidate. Oxford researchers faced the same problem for their candidate.
The CNBG vaccine was developed by the Wuhan Institute of Biological Products, with Phase 1 trials having kicked off in April. Volunteers aged 18 to 59 years old received different versions of the drug a few weeks apart. The researchers looked at low, medium, and high doses of the compound that were administered two weeks, three weeks, and four weeks apart. The study was randomized, double-blind, and placebo-controlled, which is the medical standard for any new therapy study.
The vaccine candidate actually involves the full inactivated SARS-CoV-2 virus, which is the pathogen that causes COVID-19. That’s just one of the vaccine technologies used to develop drugs that can prevent the infection. The vaccine candidate is safe, and no accidents or severe adverse effects were observed.
“High levels of antibodies” were induced in different inoculation programs and in different dose groups, CNBG told The South China Morning Post. All the test subjects who received high doses four weeks apart developed neutralizing antibodies.
“This study is the world’s first clinical trial to obtain safety and effectiveness data of a two-dose inactivated COVID-19 vaccine… The research also involves the longest period, the most comprehensive data and the most satisfying clinical research results of COVID-19 vaccine clinical trial,” the company said.
CNBG is moving to Phase 3 trials with the drug, and it plans to test it in other markets where there are enough COVID-19 cases going around. The group said that it had reached “intention of cooperation” with other companies and institutions in numerous countries. The lab also has a second vaccine candidate in development with a different subsidiary, the Beijing Institute of Biological Products.
The company has built facilities for the drug that will be able to produce between 200 million and 220 million doses per year. That’s not enough to meet global demand, of course. No single vaccine candidate will be able to satisfy demand. That’s why the world needs different effective vaccines to prevent the transmission of the disease. Aside from China’s five vaccines that are in clinical trials right now, at least three others are in testing in the US and Europe. In total, over 130 vaccine experiments for the novel coronavirus are underway.
Like Sinovac’s study, this one wasn’t printed in a medical journal for the time being, but the research will be released in the future. Moderna announced partial results of its own trial in a similar fashion, producing fewer details about the volunteers who were inoculated.
It’s unclear when the CNBG will complete Phase 3 trials, but Chinese officials said a few weeks ago they’re studying the possibility of using the vaccine candidates this year before the final results come in.