CoronaVac COVID-19 Vaccine Description
According to Sinovac Biotech Ltd., the CoronaVac COVID-19 Vaccine candidate is based on an inactivated pathogen made by growing the whole virus in a lab and then killing it.
Sinovac's strategy contrasts with many other COVID-19 vaccine development efforts involving their vaccine candidates' DNA or RNA.
Sinovac has received approval from China’s National Medical Products Administration (NMPA) to conduct Phase I/II human clinical trials in China on April 13, 2020, to determine the vaccine candidate’s safety, tolerance, dosage, and immunization schedule.
On June 13, 2020, Sinovac announced positive preliminary results of the phase I/II clinical trial for the Company’s CoronaVac vaccine, which showed favorable immunogenicity and safety profiles. The phase II clinical trial results show that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0 and 14-day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce a positive immune response.
The Company said it 'expects to submit a phase II clinical study report and a phase III clinical study protocol to China’s National Medical Products Administration (NMPA) shortly and commence application of phase III clinical trials outside of China.'
On May 22, 2020, Sinovac announced a transaction in which Advantech Capital and Vivo Capital have invested $15 million in Sinovac Research and Development Co., Ltd. (“Sinovac R&D”), a wholly-owned subsidiary of Sinovac, to further the development of an inactivated vaccine against COVID-19 named CoronaVac.
The Company has partnered with several companies outside of China for phase III efficacy studies, which are expected to start in the second half of 2020. The Company has started two phase III clinical trials so far, one in Brazil, which started on July 21, 2020, and one in Indonesia, which started on August 11, 2020.
Brazilian officials announced Sinovac and Instituto Butantan, a leading Brazilian producer of immunobiological products, signed a clinical development collaboration agreement to advance the clinical trials of CoronaVac, Sinovac’s inactivated vaccine candidate against COVID-19 to Phase III.
On September 22, 2020, a Sinovac press statement said: 'In recent months, the Company’s Phase I/II clinical trials of CoronaVac in adults (18 to 59 years old) and elderly volunteers (60 years old and above) were conducted in China’s Jiangsu and Hebei Provinces on April 16th and May 22nd, respectively. The vaccine candidate appeared to be well tolerated for different dosages, and no serious vaccine-related adverse events were reported, demonstrating a good safety profile for the vaccine candidate. Both seroconversion rates in adults and elderly volunteers were above 90%, indicating favorable immunogenicity of CoronaVac.'
The Lancet published a study on November 17, 2020, that concluded, 'Taking safety, immunogenicity, and production capacity into account, the 3 μg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials.'
Sinovac also announced it is constructing a commercial vaccine production plant in China, expected to manufacture up to 100 million doses of CoronaVac annually.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
CoronaVac COVID-19 Vaccine Indication
CoronaVac is an experimental vaccine against SARS-CoV-2, which causes COVID-19 disease.
No pediatric or pregnancy vaccine efficacy has been disclosed.
Asrorun Niam Sholeh of Indonesia council’s fatwa commission told a news conference on January 8, 2021, that Sinovac’s CoronaVac was 'holy and halal.'
CoronaVac COVID-19 Vaccine Dosage
The CoronaVac vaccine is currently packaged as a half-milliliter injection.
A group of healthy adults aged 18-59 was vaccinated with a 0, 14 schedule. Preliminary phase I/II results were recently reported. There was no serious adverse event after vaccinating a total of 743 volunteers in the trials, demonstrating a good safety profile for the vaccine candidate.
Over 90% seroconversion was observed in phase II clinical trial, after a 2-dose vaccination, 14 days apart.
CoronaVac COVID-19 Vaccine Distribution Agreements
On October 20, 2020, Brazil’s health minister Eduardo Pazuello was reported by SCMP to have said 'the federal government had reached a deal with Sao Paulo state to buy 46 million CoronaVac vaccine doses to be administered starting in January 2020.'
And Turkey's Health Minister Fahrettin Koca told parliament on November 19, 2020, and it will sign a contract within days to buy about 20 million doses of COVID-19 vaccine from China's Sinovac Biotech.
CoronaVac COVID-19 Vaccine News
January 13, 2021 - AP reported Turkish health authorities announced the Chinese Sinovac vaccine's emergency use. Turkey has agreed to purchase 50 million doses of Sinovac's CoronaVac vaccine and has taken delivery of an initial 3 million doses, Reuters reported.
January 13, 2021 - The SCMP reported São Paulo-based Butantan Institute submitted data to Brazil’s health regulator, listing an efficacy rate of 50.4% for the CoronaVac vaccine. The information was confirmed by officials from the research institute funded by the São Paulo state government.
January 10, 2021 - The Indonesian FDA issued emergency authorization for Sinovac Biotech's CoronaVac vaccine after it was found to be 65.3% effective in a local clinical trial.
January 8, 2021 - Reuters reported Asrorun Niam Sholeh of the Indonesia council’s fatwa commission told a news conference that Sinovac’s CoronaVac was 'holy and halal.'
January 3, 2021 - Indonesia announced it would start distributing the CoronaVac vaccine, developed by China’s Sinovac Biotech Ltd, to all its 34 provinces, Kompas reported.
December 25, 2020 - Reuters reported the CoronaVac COVID-19 vaccine developed by Sinovac Biotech Ltd showed efficacy between 50% and 90% in Brazilian trials, Sao Paulo’s state health secretary said. Results of clinical trials in Brazil are known exclusively by Sao Paulo state’s Butantan Institute biomedical research center.
December 25, 2020 - The AP reported the experimental COVID-19 vaccine developed by Sinovac was found to be 91.25% effective. Dr. Serhat Unal said the finding is based on early results of late-stage trials in the country and added that the CoronavVac vaccine was safe.
December 21, 2020 - Anvisa's technical team inspect the CoronaVac vaccine factory and concluded the technical evaluation of the complementary information sent by the company Sinovac and by the Butantan Institute after the inspection. Thus, the evaluation's conclusion made it possible to publish on (12/21) the certification of Good Practice of Manufacturing Company. Brazil’s Sao Paulo state has said it will announce on Wednesday if CoronaVac is effective against the coronavirus.
December 15, 2020 - Brazil Governor Doria said that the Butantan Institute had changed its plans and would present the health regulator with a request for a definitive authorization of CoronaVac in Brazil, rather than one that would only allow for emergency use. The application will be submitted on December 23, 2020.
December 8, 2020 - Sinovac Biotech Ltd.’s coronavirus shot created antibodies among 97% of those administered with it in a final stage trial in Indonesia, but its efficacy has yet to be determined.
December 7, 2020 - Sinovac Biotech Ltd. announced that Sinovac had secured approximately US$500 million in funding for further development, capacity expansion, and manufacturing of the CoronaVac, its COVID-19 vaccine candidate, as well as to conduct other development and operational activities.
December 6, 2020 - Indonesia announced it received its first shipment of 1.2 million CoronaVac coronavirus vaccine from China’s Sinovac Biotech Ltd. Jokowi added that the government plans to receive another 1.8 million doses in early January 2021.
December 1, 2020 - Turkey's Health Minister Fahrettin Koca confirmed the first coronavirus vaccination date, saying health care workers will be the first to be inoculated after Dec. 11, 2020. “We will be delivered at least 10 million doses of the vaccine in December, and this could go up to 20 million." Turkey has agreed with China to purchase 50 million vaccine doses. The Chinese vaccine will be free for everyone in Turkey.
November 18, 2020 - 120,000 doses of CoronaVac arrived at São Paulo, Brazil, international airport, the state government said. The vaccines, which arrived in seven refrigerated containers, are part of an order announced in October of 6 million doses imported from China, ready for use in January 2021.
November 17, 2020 - The Lancet Infectious Diseases published results in Phase I and Phase II clinical trials in China involving more than 700 participants. “Our findings show that CoronaVac is capable of inducing a quick antibody response within 4-weeks of immunization by giving 2-doses of the vaccine at a 14-day interval,” Zhu Fengcai, one of the authors of the paper, said.
November 11, 2020 - Brazil's National Health Surveillance Agency authorized the resumption of phase III clinical trial of CoronaVac, the inactivated COVID-19 vaccine sponsored by Butantan Institute.
November 11, 2020 - In a new statement, the company said 'After communicating with the Brazilian partner Butantan Institute, we learned the head of Butantan Institute believed that this serious adverse event is not related to the vaccine. Sinovac will continue to communicate with Brazil on this matter. The clinical study in Brazil is strictly carried out following GCP requirements, and we are confident in the safety of the vaccine.'
November 10, 2020 - BloombergQuint reported that the Chinese vaccine candidate's final-stage trial had been halted in Brazil due to a serious adverse event.
October 23, 2020 - Brazilan regulator Anvisa is reported to have said that 'Sao Paulo state’s Butantan Institute can proceed to import 6 million doses of the CoronaVac vaccine.'
October 21, 2020 - Brazilian President Jair Bolsonaro announced he rejected the planned purchase of 46 million doses of the CoronaVac vaccine candidate, produced by a Chinese firm.
October 19, 2020 - Brazil's São Paulo’s Butantan Institute announced the 2-dose vaccine CoronaVac, proved safe in a trial so far involving 9,000 volunteers.
October 16, 2020 - The eastern city of Jiaxing's center for disease control and prevention said in a statement on WeChat that 2-doses of the vaccine candidate, called CoronaVac, will cost 200 yuan ($29.75) per dose and that vaccinations for key groups, including medical professionals have begun, reported Reuters.
September 30, 2020 - The government of Brazil’s Sao Paulo state signed a contract to receive 46 million doses of a potential vaccine from China’s vaccine producer frontrunner Sinovac Biotech. But a company source told the Global Times the price of each dose would not be as low as $1.96, as what the Sao Paulo governor implied.
September 23, 2020 - Sinovac Biotech Ltd. announced that the inactivated COVID-19 vaccine candidate "CoronaVac" was approved by the National Medical Products Administration for a clinical trial in adolescents and children on August 10, 2020.
September 22, 2020 - Sinovac Biotech announced that it has recently commenced phase III clinical trials for its inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences, or “CoronaVac,” in Turkey.
September 9, 2020 - Sinovac Biotech Ltd. announced that the inactivated COVID-19 vaccine candidate developed “CoronaVac,” shows good safety and immunogenicity on healthy adults aged 60 and above from its phase I/II clinical studies conducted in China, which is comparable to the result in healthy adults aged from 18 to 59 in the earlier studies.
September 6, 2020 - Reuters reported about 90% of Sinovac Biotech Ltd 2,00 to 3,000 employees and their families had taken the experimental coronavirus vaccine, CoronaVac, which is in Phase 3 vaccine candidate.
September 5, 2020 - Sinovac Biotech Ltd announced (2) additional countries agreeing to run late-stage clinical tests of their coronavirus vaccine candidate, CoronaVac, currently being tested in Brazil, Indonesia.
August 28, 2020 - Reuters reported Sinovac Biotech vaccine candidate CoronaVac was approved for emergency use as part of a China program to vaccinate high-risk groups such as medical staff.
August 28, 2020 - The Company has started two phase III clinical trials, one in Brazil, which started on July 21, 2020, and one in Indonesia, which started on August 11, 2020.
August 25, 2020 - Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced it had signed agreements with PT Bio Farma, a leading biopharmaceutical company in Indonesia, for the supply, local production, and technology licensing in respect of the CoronaVac, Sinovac’s inactivated vaccine candidate against COVID-19.
July 21, 2020 - "Trials of CoronaVac, one of the vaccines that have advanced furthest in testing in the world, will begin at the Clinical Hospital of Sao Paulo," the state's governor, Joao Doria, told a news conference. Sinovac is partnering with a Brazilian public health research center, the Butantan Institute, on the trials.
July 16, 2020 - China-owned Sinovac announced that its employees, including top executives, received experimental vaccine shots even before the government approved testing in people, reported the AP.
July 6, 2020 - Sinovac Biotech Ltd. announced an update to its previously announced partnership with Butantan, a leading Brazilian producer of immunobiological products and vaccines.
July 3, 2020 - Reuters reported Brazilian health regulator Anvisa approved clinical trials of a potential coronavirus vaccine developed by China’s Sinovac. Sao Paulo state Governor Joao Doria said 9,000 volunteers have already been registered to test the vaccine against COVID-19.
On June 30, 2020, over 90% seroconversion was observed in phase II clinical trials after a two-dose vaccination 14 days apart. A Phase II study on elderly adults is being conducted, followed by children and adolescent groups. The Company expects to complete the phase II trial at the end of 2020. The Company has partnered with several companies outside of China for phase III efficacy studies, which are expected to start in the second half of 2020.
June 13, 2020 - Sinovac announced positive preliminary results of phase I/II clinical trial for the Company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles. There are 143 volunteers in phase I, and 600 volunteers are in phase II. There have been no severe adverse events reported in either phase I or phase II trials. The phase II clinical trial results show that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0 and 14-day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce a positive immune response.
June 11, 2020 - Brazilian officials announced an agreement with China’s Sinovac Biotech to produce its coronavirus vaccine in the state of Sao Paulo, where tests involving 9,000 volunteers are to begin in June 2020.
May 22, 2020 - Sinovac Biotech received approval from governmental authorities to conduct both phase 1 and phase 2 human clinical trials for CoronaVac in China
May 6, 2020 - Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today the publication of the preclinical study on animals for its vaccine candidate against COVID-19. This is the first challenge study of its SARS-CoV-2 vaccine candidate on animals to prove that the vaccine candidate is safe and protects rhesus macaques.
April 17, 2020 - Sinovac Biotech Ltd. announced that the Company had commenced Phase I clinical trial, a randomized, double-blinded, placebo-controlled study, for its vaccine candidate against COVID-19. Enrollment of the first group of volunteers and the first dose of vaccination for these volunteers have been completed.
April 16, 2020 - Dynavax Technologies Corporation and Sinovac Biotech Ltd. announced a collaboration that will combine Dynavax’s CpG 1018, the adjuvant contained in the U.S. FDA-approved HEPLISAV-B vaccine, with Sinovac’s chemically inactivated coronavirus vaccine candidate.
CoronaVac COVID-19 Vaccine Clinical Trials
Clinical Trial NCT04456595: Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals (PROFISCOV) - Last Update Posted: December 11, 2020.
This is a phase III clinical trial to assess the efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in healthcare professionals.
Clinical Trial NCT04383574: Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection (COVID-19) - Last Update Posted: September 10, 2020.
The phase I/II clinical trials on elderly volunteers were randomized, double-blinded, and placebo-controlled trials with two-dose immunization scheduled at 28-day intervals. CoronaVac was tested on 421 healthy adults aged 60 to 89 years old in phase I/II clinical trial. The vaccine candidate appeared to be well tolerated for low dose, medium dose, and high dose groups. No vaccine-related serious adverse event was reported. The seroconversion rate and GMT level for elderly volunteers were comparable to the adult group aged 18 to 59. According to the results, the medium dose was selected to enter the phase III trial. The seroconversion rate and GMT for the medium-dose group were 98.0% and 42.2 in elderly volunteers, respectively, and 97.4% and 44.1 in healthy adults. The detailed data will be published in a peer-reviewed journal.
Clinical Trial NCT04352608: Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19) - Last Update Posted: August 4, 2020.
This study is a randomized, double-blinded, and placebo-controlled phase 1/2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
- The Phase I clinical trial, which evaluates the safety, tolerance, and preliminary immunogenicity of CoronaVac, commenced in April 2020.
- The Phase II clinical trial evaluates the immunogenicity and safety of CoronaVac in a larger population to define dosage, regimen, and immunization schedule. China's first recombinant vaccine candidate for novel coronavirus is entering Phase II of a human clinical trial, with 500 volunteer participants.
- The trial is led by the Jiangsu Provincial Center for Disease Control and Prevention and jointly conducted with the Hubei Provincial Center for Disease Control and Prevention and Zhongnan Hospital of Wuhan University.