CoronaVac SARS-CoV-2 Vaccine Description
According to Sinovac Biotech Ltd., the CoronaVac SARS-CoV-2 Vaccine candidate is based on an inactivated pathogen made by growing the whole virus in a lab and then killing it, which is how polio shots are made.
Sinovac's strategy contrasts with many other COVID-19 vaccine development efforts that involve using the DNA or RNA of their vaccine candidates. These newer technologies take longer to manufacture because the live virus must be grown in cultures and then inactivated.
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 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) in the near future 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 is expected to start in the second half of 2020. The Company has so far 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.
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 dosage 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.'
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.
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 SARS-CoV-2 Vaccine Indication
CoronaVac is an experimental vaccine against SARS-CoV-2 which causes the COVID-19 disease.
CoronaVac SARS-CoV-2 Vaccine Dosage
The CoronaVac vaccine is currently packaged as a half-milliliter injection.
A group of healthy adults aged 18-59 years old were 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 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.'
CoronaVac SARS-CoV-2 Vaccine News
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, which is produced by a Chinese firm.
October 19, 2020 - Brazil's São Paulo’s Butantan Institute announced the 2-dose vaccine CoronaVac, proved to be 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 have taken the experimental coronavirus vaccine, CoronaVac, which is in Phase 3 vaccine candidate.
September 5, 2020 - Sinovac Biotech Ltd announced there are (2) additional countries agreeing to run late-stage clinical tests of their coronavirus vaccine candidate, CoronaVac, which is currently being tested in Brazil and Indonesia.
August 28, 2020 - Reuters reported Sinovac Biotech vaccine candidate CoronaVac was approved for emergency use as part of a program in China to vaccinate high-risk groups such as medical staff.
August 28, 2020 - The Company has so far 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 has 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.
June 30, 2020 - Over 90% seroconversion was observed in phase II clinical trial after a two-dose vaccination 14 days apart. A Phase II study on elderly adults is being conducted which will be 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 is 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 are 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 a 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 provides protection to rhesus macaques.
April 17, 2020 - Sinovac Biotech Ltd. announced that the Company has 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 SARS-CoV-2 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: July 2, 2020. This is a phase III clinical trial to assess 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 9, 2020.
The phase I/II clinical trial on elderly volunteers were randomized, double-blinded, and placebo-controlled trials with two-dose immunization scheduled at 28-day intervals. CoronaVac was tested on a total of 421 healthy adults aged between 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. Both the seroconversion rate and GMT level for elderly volunteers were comparable to the adult group aged 18 to 59 years old. According to the results, the medium dose was selected to enter into 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: April 28, 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 in order to define dosage, regimen, and immunization schedule. It is China's first recombinant vaccine candidate for novel coronavirus 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.