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In late 2019 a novel viral disease emerged in Wuhan, China. By early 2020 it was spread around the globe causing a pandemic situation. The pandemic continues to spread unabated affecting the health and changing the lifestyles of people globally. To reduce the disease burden and stop the community-wide transmission of that disease, COVID-19 across the globe, specific therapeutic agents or vaccines are urgently needed. Several groups of Chinese scientists are developing potential vaccine candidates to counter attack the pandemic. This is a short description of one of the Chinese potential approaches.
Sinovac Biotech Ltd is a biopharmaceutical company based in Beijing, China that focuses on the research, development, manufacture and commercialisation of vaccines that protect against human infectious diseases. Sinovac has already presented the world successful vaccines to prevent Hepatitis, H1N1, Japanese encephalitis etc… and now they are developing a vaccine candidate for COVID-19 which they have branded CoronaVac.
China has been vaccinating high-risk groups with investigational Covid-19 vaccines since July. The government may expand the emergency use programme to potentially prevent possible outbreaks in the coming months. Sinovac Biotech has also received emergency use approval for its potential Covid-19 vaccine CoronaVac under the above-mentioned programme in China to vaccinate high-risk groups.
The vaccine candidate was an inactivated SARS-CoV-2 whole virus vaccine with aluminium hydroxide as adjuvant. An inactivated whole virus vaccine is a vaccine which contains live viral bodies. Viruses for inactivated vaccines are grown under controlled conditions and are killed as a means to reduce infectivity and thus prevent infection from the vaccine. An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. In other words, adjuvants help vaccines work better. Though the viral bodies in the vaccine is inactivated they still bear characteristic features, so the immune system will identify the virus and make antibodies to counterattack the virus.
Neither the subject nor the doctor administrating the vaccine knew whether the vaccine candidate or a placebo was administrated to each subject. Only those directing the study knew the treatment that each participant receives. (double-blind, randomized and placebo-controlled clinical trial). These double-blind studies prevent bias when doctors evaluate patients’ outcomes. This improves reliability of clinical trial results. Subjects with high-risk epidemiological history, positive antibody results, high temperature, allergy to a vaccine component, and other unsuitable conditions were excluded from the study.
A total of 600 healthy adults aged 18–59 years were randomly assigned into 3 groups in a ratio of 2:2:1 to receive 2 injections of the trial vaccine at a dose of 3 μg/0.5 mL or 6 μg /0.5mL, or placebo on a Day 0,14 schedule or a Day 0,28 schedule, according to a random list generated by an independent statistician. To assess immune response, blood samples were collected from each participant at different time points (0/28/42th day for Day 0,14 schedule, and 0/56th day for Day 0,28 schedule). The concentration of antibodies synthesized in the body was measured using standard techniques.
The antibody concentration of subjects on Day 0, 28 schedule increased significantly 28 days after the second injection, when compared to those of subjects on Day 0,14 schedule within each dosage group. In addition, the antibody concentration significantly decreased with increasing age; younger subjects tended to have a higher level of antibody concentration. This result suggests that CoronaVac may be a more suitable vaccine for the younger patients.
For safety evaluation of CoronaVac, the participants who received at least one dose of vaccination was included. All vaccinated subjects were observed for immediate adverse events (AEs) (negative events) on-site for at least 30 minutes after each administration.
This trial demonstrated that the 2 doses of different dosage of CoronaVac were well in healthy adults aged 18–59 years. The incidence rates of unpleasant reactions in the 6 μg and 3 μg group were comparable, indicating that there was no dose-related aggravating concern on safety. Most reactions reported were generally assessed to be mild. After each injection, pain at the injection site was the most frequently reported local symptoms, which reported in 61 subjects (20.3%) on Day 0,14 schedule and 31 subjects (10.3%) on Day 0, 28 schedule. Mild fatigue and fever was also recorded in some subjects.
Sinovac has conducted two more trials one on the elderly population and the on children. The Reuters reported that Sinovac’s coronavirus vaccine candidate appeared to be safe for older people, according to preliminary results from an early to mid-stage trial, while the immune responses triggered by the vaccine were slightly weaker than younger adults. The complete results of the mentioned trials involving 421 participants have not been published and were not made available to Reuters
According to “The Hindu”, the Chinese authorities have approved a trial which includes a total of 552 healthy participants aged between three and 17 who will take two doses of CoronaVac or a placebo in a combined Phase 1 and Phase 2 trial which was estimated to begin on September in the northern Chinese province of Hebei.
The Company has partnered with several companies outside of China for phase III trials, which has already begun. The Company has so far started two phase III clinical trials, one in Brazil which started on July, and one in Indonesia which started on August. Sinovac also announced it is constructing a commercial vaccine production plant in China that is expected to manufacture up to 100 million doses of CoronaVac annually.
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