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The development of the Chinese state-backed vaccine in accordance with the National Biotech Group of China (CNBG) in Beijing published an interim investigation into the randomized Phase I/II trials of its SARS-CoV-2 inactivated vaccine candidate SARS-CoV-2 in the Journal of the American Medical Association. (JAMA) last week. In more detail, knowledge encouraged the company in its plans to produce 220 million doses consistent with the year.
Developed through CNBG’s subsidiary, the Wuhan Institute of Biological Products, the vaccine demonstrated immunogenicity and had a low rate of adverse occasions in the subject Phase I trial and in the Phase II trial of 224 subjects, according to the interim report.
“This is the first Phase I and II clinical trial report of a COVID-19 vaccine of inactivated total virus in healthy adults. The inactivated vaccine was well tolerated in all dose equipment under other injection procedures, with no serious adverse events related to the vaccine,” the researchers said at JAMA on August 13.
In the Phase I trial, low, medium and high dose teams gained 3 injections at 2, 5 mg/dose, 5 mg/dose and 10 g/dose, respectively, on days 0, 28 and five6. the average neutralizing antibody titers in these equipment on the 14th day after the 3rd injection were 316, 206 and 297, respectively, with a seroconversion rate of one hundred percent in low- and high-dose equipment.
In the Phase II trial, the subjects won two injections of five mg/dose, and the moment dose was administered 14 or 21 days later. The geometric average titers of neutralizing antibodies were 121 in a 14-day organization and 247 in the 21-day organization. The seroconversion rate on both teams is 97.6%. The full effects of the mid-middle examination are here.
“Most participants began generating antibody responses after the time of injection and remained at peaks 14 days after the third injection,” the researchers noted.
They stated that the effects of Phase I and II trials showed that a longer period (21 days and 28 days) between the first and the time of injection produced higher antibody responses compared to a shorter period program (14-day group). Antibody titers began to accumulate after the moment dose and accumulated more after the third dose, suggesting that a booster injection is needed.
They noted that the antibody titrates produced through the CNBG vaccine were comparable to the grades observed in Moderna Inc. mNT-1273 vaccine, Biontech SE’s BNT-162b1 RNA vaccine and the Astrazeneca plc and ChAdOx1 nCoV-19 vaccine from Oxford University, and more. that The Ad5 Vector Vaccine from Cansino Biologics Inc., Ad5-nCoV.
In terms of safety, no issues reported adverse occasions other than mild side effects compared to seven days after the end of treatment. In the Phase I trial, 20.8%, 16.7% and 25% of low-, medium- and high-dose equipment reported adverse occasions, respectively. In the Phase II trial, seven-day adverse occasions occurred in 6% and 19% of subjects that won the average dose on days 0 and 14 or on days 0 and 21.
The maximum effect of non-unusual appearance pain at the injection site, followed by fever. All side effects were mild and resolved spontaneously and did not require treatment. There were also no primary differences between 3 injections in the Phase I trial or two injections in the Phase II trial.
“The interim report showed that the candidate vaccine had positive results. The framework would possibly have induced the production of antibodies opposed to coronavirus and there were no serious adverse reactions,” said Kwan-long Mung, a cancer researcher at the University of Turku. Bioworld.
“But it remains to be noted how long the antibodies will last. This is just an interim report in which the number of B cells and reminiscence plasma cells has not been discussed. We’ll want to see an official report on whether this vaccine candidate paints paints or not,” he added.
CNBG researchers also noted that it is unclear whether the degrees of antibodies induced by the vaccine will persist and whether long-term reminiscent T cells will be the susceptibility and pathogenesis of SARS-CoV-2 infection. Subjects from Phase I/II studies will be monitored for up to one year.
The mid-term investigation was conducted on 16 June and updated on 27 July. In June, the company issued a brief stating that the seroconversion rate was 97.6% for the mid-dose group, which was receiving injections on the 14th and 21st. schedule. and one hundred percent for those who won doses 28 days apart.
The candidate vaccine is lately in Phase III trials recruiting 15,000 subjects in Abu Dhabi, United Arab Emirates. This is a randomized, double-blind, placebo-controlled parallel to evaluate the protective effect of the vaccine in the prevention of severe cases of SARS-CoV-2 pneumonia and COVID-19 deaths within 14 days of two injections. It is expected to be completed until July 15, 2021.
However, the state-supported vaccine manufacturer wants the vaccine to be obtained as soon as possible. CNBG President Liu Jingzhen told Chinese state media last month that his vaccine could be announced this year. The company is preparing to deliver an annual production capacity of 220 million doses of its production facilities in Beijing and Wuhan.
The CNBG also has a currently inactive COVID-19 vaccine candidate, known as BBIBP-CorV, developed through its subsidiary, the Beijing Institute of Biological Products. It is reported that the knowledge of Phase I/II will soon be released for this vaccine.
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