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' RNA.
Sinovac’s mission is to Supply Vaccines to Eliminate Human Diseases. Provide Chinese Children with Top Quality Vaccine; Provide Children around the World with Vaccines Made in China. To achieve these objectives, Sinovac focuses on research, development, manufacturing, and marketing of human-use and animal-use vaccines. The Company also provides services for disease control and prevention, collaborating with the Chinese governments at the national, state, and local levels.
CoronaVac's Drugbank Accession Number: DB15806
CoronaVac COVID-19 Vaccine History
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.
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.'
On February 3, 2021, The Lancet published a study that concluded 'CoronaVac was well tolerated and induced humoral responses in adults aged 60 years and older, which supports this vaccine's use in an older population.'
On February 5, 2021, the company announced the phase III trials conducted in Brazil and Turkey evaluated the vaccine candidate's efficacy in healthcare workers who provide treatment to COVID-19 patients. After 14 days following vaccination with 2 doses of vaccine following a 0, 14-day schedule, the efficacy rate against diseases caused by COVID-19 was 50.65% for all cases, 83.70% for cases requiring medical treatment 100.00% for hospitalized, severe, and fatal cases.
There are two stages of phase III clinical trial in Turkey. Participants comprised health care workers in the first stage (K-1) and the general population in the second stage (K-2), with all participants ranging from 18 to 59. As of December 23, 2020, 918 participants enrolled in K-1 and 6,453 participants in K-2 for 7,371 participants. Among them, 1,322 participants completed the two-dose vaccination and entered the 14-day observation period after receiving the second dose of the vaccination. Based on an analysis of 29 cases, the efficacy rate for COVID-19 prevention was 91.25% after 14 days following the two-dose vaccination, in adherence with the 0, 14-day schedule.
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. Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program.
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 schedules reported Preliminary phase I/II results. 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
As of February 8, 2021, CoronaVac is being used under emergency use approval in Indonesia, Brazil, Turkey, and Chile. Sinovac is also actively seeking regulatory approval of CoronaVac in other countries and regions worldwide to maximize global accessibility and affordability of the COVID-19 vaccine and ensure global prevention, and mitigate spread.
On March 4, 2021, Yu Qingming, chairman of Sinopharm Group, indicated to local media the annual output of the vaccines is expected to reach 3 billion doses in the future.
CoronaVac COVID-19 Vaccine News
April 7, 2021 - A non-peer-reviewed study: Effectiveness of CoronaVac in the setting of high SARS-CoV-2 P.1 variant transmission in Brazil: A test-negative case-control study. Interpretation - Administration of at least one dose of CoronaVac showed effectiveness against symptomatic SARS-CoV-2 coronavirus infection in the setting of epidemic P.1 transmission.
April 6, 2021 - Researchers from Turkey-based Manisa Celal Bayar University and Hospital reported CoronaVac's immunity rate was 25.3% after 28 days of the first dose and 97.92% after 28 days after the second vaccine. The effective antibody response was found to be 29.5% in women after the first vaccine; 18.6% of males; 99.2% of women after the second vaccination; It was recorded as 95.7% in males.
April 1, 2021 - Sinovac Biotech Ltd. announced that the third production line of CoronaVac® was completed and put into commercial production. Including this new production line, Sinovac’s annual capacity of CoronaVac has reached 2 billion doses. At this time, over 200 million doses of CoronaVac have been delivered to over 20 countries, including China.
March 31, 2021 - The Cambodian government will start vaccinating Cambodians with the recently-purchased CoronaVac COVID-19 vaccine from Chinese firm Sinovac Biotech while also expanding priority groups to legislature staffers, garment workers, and public utility workers. Cambodia recently received 1.5 million doses of the CoronaVac vaccine purchased for $15 million.
March 25, 2021 - A plane with the first batch of CoronaVac vaccine produced by Sinovac Biotech arrived in Ukraine. At the Kiev Boryspil airport, the cargo was met by Chinese Ambassador to Ukraine Fan Xianrong, Deputy Foreign Minister of Ukraine Yevhen Yenin, and Deputy Health Minister Viktor Lyashko.
March 21, 2021 - The AP reported Sinovac said its COVID-19 vaccine is safe in children ages 3-17, based on preliminary data, and it has submitted the data to Chinese drug regulators. Early and mid-stage clinical trials with over 550 subjects showed the vaccine would induce an immune response, Gang Zeng, the medical director at Sinovac, said at a news conference.
March 5, 2021 - Local media reported the Tunisian Ministry of Health announced that the Sinovac COVID-19 vaccine had been officially approved for marketing in Tunisia. “The promotion license was granted after evaluating the file submitted by the Chinese laboratory by the National Laboratory for the Control of Medicines and National Center for Pharmacovigilance with the contribution of other experts in the fields of virology, toxicology, immunology and infectious diseases in Tunisia,” according to a ministry statement.
March 4, 2021 - State media reported, 'Yin Weidong, Sinovac Biotech CEO, he is confident in vaccine safety after large-scale vaccine monitoring.'
March 1, 2021 - The arrival of 600,000 doses of Sinovac Biotech’s CoronaVac in the Phillippines was greeted with sincere gratitude. President Duterte said the Chinese donation underscored the friendly relations between Manila and Beijing. These doses will begin the COVID-19 vaccine drive in the Philippines.
February 11, 2021 - Mexico approves Chinese COVID vaccines CanSino and CoronaVac. Deputy health minister Hugo Lopez-Gatell announced the approval as Mexico struggles to manage the pandemic. "I have given the authorization for emergency use of both vaccines," Lopez-Gatell, who serves as the spokesman for the government's pandemic coordination, said during a press conference.
February 8, 2021 - Sinovac Biotech Ltd. announced that the China National Medical Products Administration had granted conditional marketing authorization to Sinovac for CoronaVac, Sinovac’s COVID-19 vaccine, in individuals aged 18 and above.
February 6, 2021 - Reuters reported Indonesia's Food and Drug Agency said in a letter seen by Reuters that it had authorized the use of Sinovac’s CoronaVac vaccine for the elderly. It was sent to Sinovac’s Indonesian partner, state-owned Bio Farma.
February 5, 2021 - Sinovac officially filed conditional market authorization for CoronaVac with China’s National Medical Products Administration. Sinovac continues to seek regulatory approval for CoronaVac in other countries while contributing to making the COVID-19 vaccine accessible and affordable globally to ensure the prevention and control of the COVID-19 pandemic.
February 5, 2021 - Sinovac Biotech Ltd. announced phase III results. Sinovac had started its phase III trials on CoronaVac, conducted in Brazil, Turkey, Indonesia, and Chile. Late-stage trial data of its COVID-19 vaccine from Brazil and Turkey showed it prevented hospitalization and death in COVID-19 patients but had a much lower efficacy rate in blocking infections.
February 3, 2021 - The Lancet published: Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. CoronaVac is safe and well-tolerated in older adults. Neutralizing antibody titers induced by the 3 μg dose were similar to those of the 6 μg dose and higher than those of the 1·5 μg dose, supporting the use of the 3 μg dose CoronaVac in phase 3 trials to assess protection against COVID-19.
January 26, 2021 - Chile's Undersecretary Paula Daza met with experts from the scientific society to learn about the preliminary results of the Phase 3 clinical study of the Sinovac vaccine carried out by scientists from the Catholic University led by Dr. Alexis Kalergis, director of the Millennium Institute in Immunology and Immunotherapy. Concerning the meeting between the health authority and scientific staff, the director delivered preliminary results on the behavior of the vaccine and pointed out that "in about 650 people enrolled, both the safety and capacity of the vaccine are very encouraging in our population." Also, he added that "the antecedents to date show that in terms of safety and immunogenicity, both in the adult population and in the elderly, they go the same way."
January 26, 2021 - Local media reported Pharmaniaga Berhad announced it would supply the Malaysian government with 12 million doses of the Covid-19 vaccine developed by China’s Sinovac Lifesciences Co Ltd. “We will manufacture, fill and finish CoronaVac as well as handle the logistics and distribution of the vaccine to the government designated hospitals, clinics, and other facilities,” Pharmaniaga’s group managing director Zulkarnain Md Europe said.
January 20, 2021 - Agence France Presse reported the South American country of Chile's director Heriberto Garcia told reporters the vaccine approval was given after trials showed CoronaVac was safe and 78 percent effective in preventing infection given in two doses to people aged between 18 and 60.
January 20, 2021 - Local media reported Health Minister Fahrettin Koca called Turkey's progress "one of the fastest in the world.” Turkey turned to CoronaVac as its first option in mass inoculation. The vaccine had received emergency approval after the initial shipment of 3 million doses last month.
January 13, 2021 - The 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 2,000 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 NCT04617483: A Randomized, Double-Blinded Phase 3 Clinical Trial, to Evaluate the Non-inferiority of the Commercial-Scale Inactivated SARS-CoV-2 Vaccine Against That of the Pilot Scale Among Adults Aged 26-45 Years, and the Open-labelled, Bridging Non-inferiority of the Vaccine Induced Immunogenicity in Elderly Against That in Adults. Estimated Completion Date: May 31, 2021
Clinical Trial NCT04582344: Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine (Vero Cell), Inactivated in Turkey. This study is a randomized, double-blinded, multi-center, placebo-controlled phase III clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the efficacy, safety, and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were manufactured by Sinovac Research & Development Co., Ltd. A total of 13.000 subjects will be enrolled. Estimated Completion Date: April 15, 2021
Clinical Trial NCT04508075: A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia. Approximately 1620 subjects were 18-59 enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms: the vaccinated and placebo groups, with a ratio of 1:1. The vaccinated arms will be grouped into three different lot numbers (lot 1/lot 2/ lot 3) of the SARS-CoV-2 vaccine. Estimated Completion Date: September 2021
Clinical Trial NCT04651790: Multi-center, Phase 3, Double-blind, Randomized, Placebo-controlled, Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Inactivated Vaccine Against the SARS-CoV-2 Infection in High Risk of Infection 2300 Adults in Chili. Estimated Completion Date: March 2022
Clinical Trial NCT04456595: Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals (PROFISCOV). This is a phase III clinical trial to assess the efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in 13,060 Brazilian healthcare professionals. Estimated Completion Date: October 2021
Clinical Trial NCT04383574: Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection (COVID-19). 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).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.