CoronaVac (Sinovac) COVID-19 Vaccine Description
Sinovac Biotech Ltd. CoronaVac COVID-19 Vaccine 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.
The Sinovac CoronaVac vaccine (PiCoVacc) does not need to be frozen, and both the vaccine and raw material for formulating vaccine doses could be transported and refrigerated at 2–8 °C (36–46 °F).
CoronaVac is a 2-dose β-propiolactone-inactivated, aluminum hydroxide-adjuvanted vaccine administered on a 0/14-28-day schedule to prevent COVID-19. A real-world study of millions of people who received CoronaVac found published by the WHO found the vaccine 67% effective against symptoms, reduced hospitalizations by 85%, intensive care visits by 89%, and deaths by 80%.
The European Medicines Agency launched a rolling review for CoronaVac on May 4, 2021.
The WHO published an assessment of the CoronaVac vaccine and validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use on June 1, 2021. This WHO Emergency Use Listing is a prerequisite for COVAX Facility vaccine supply and international procurement. It also enables countries to expedite their own regulatory approval. In addition, an article published by the journal Nature on June 4, 2021, stated: “CoronaVac will significantly contribute to the global fight against COVID-19 as a safe and moderately effective SARS-CoV-2 vaccine,” says Murat Akova, a clinical researcher in infectious diseases at Hacettepe University in Ankara.
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.'
On July 7, 2021, the NEJM published an ORIGINAL ARTICLE: Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile. This study was conducted from February 2 through May 1, 2021, and the cohort included approximately 10 million persons. Among persons who were fully immunized, the adjusted vaccine effectiveness was 65.9% for the prevention of Covid-19 and 87.5% for the prevention of hospitalization, 90.3% for the prevention of ICU admission, and 86.3% for the prevention of Covid-19–related death.
On July 8, 2021, The Lancet published 'Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomized, placebo-controlled, phase 3 trial in Turkey.' This study's conclusion found 'CoronaVac has high efficacy against PCR-confirmed symptomatic COVID-19 with a good safety and tolerability profile.'
The NEJM published a new study on September 2, 2021 - Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile. Among persons (10m) who were fully immunized, the adjusted vaccine effectiveness was 65.9% for the prevention of Covid-19 and 87.5% for the prevention of hospitalization, 90.3% for the prevention of ICU admission, and 86.3% for the prevention of Covid-19–related death.
CoronaVac's (PiCoVacc) Drugbank Accession Number: DB15806
CoronaVac (Sinovac) COVID-19 Vaccine History
Sinovac has received approval from China’s National Medical Products Administration 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.
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. In addition, 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, Sinovac 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 two doses 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.
The WHO listed the Sinopharm COVID-19 vaccine for emergency use on May 7, 2021. The WHO’s Emergency Use Listing is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
On May 16, 2021, a study run by the Center of Excellence in Clinical Virology of the Faculty of Medicine at Chulalongkorn University located in Thailand found 99.49% of the recipients had developed antibody responses four weeks after their second injection, even though only 65.9% had developed immune responses three weeks after the first vaccination, reported local media. The media reported China authorized the emergency use of the CoronaVac vaccine for children aged between 3 and 17 on June 5, 2021.
On June 28, 2021, The Lancet published a locally-funded study that concluded by stating: CoronaVac was well tolerated and safe and induced humoral responses in children and adolescents aged 3–17 years. The study results support using a 3 μg dose with a two-immunization schedule for further studies in children and adolescents.
The journal Nature published a new study on July 30, 2021: Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. These data support the use of CoronaVac in patients with ARD, suggesting reduced but acceptable short-term immunogenicity. The trial is still ongoing to evaluate the long-term effectiveness/immunogenicity.
Sinovac Biotech Life Sciences Ltd. is a Beijing, China-based biopharmaceutical company that focuses on researching, developing, manufacturing, and commercializing 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. Sinovac’s mission is to Supply Vaccines to Eliminate Human Diseases.
CoronaVac (Sinovac) COVID-19 Vaccine Indication and Variants
Sinovac's CoronaVac is a vaccine targeted against the SARS-CoV-2 beta coronavirus, which causes COVID-19 disease. Brazil's Instituto Butantan announced on On March 10, 2021, CoronaVac was found efficient against three variants: B.1.1.7, 501.V2, and Brazil's B.1.1.28, from which variants P.1 from Manaus and P.2 from Rio de Janeiro are derived.
On August 15, 2021, media reported that Gao Qiang, general manager with Sinovac Life Sciences Corp, revealed that Sinovac had completed preclinical research on the Delta and Gama variant. As a result, it will submit application materials for clinical research in the near future.
The BMJ published original research on August 20, 2021, that concluded 'Vaccination with CoronaVac was associated with a reduction in symptomatic covid-19, hospital admissions, and deaths in adults aged ≥70 years in a setting with the extensive transmission of the SARS-CoV-2 coronavirus gamma variant. However, vaccine protection was low until the completion of the two-dose regimen, and CoronaVac's effectiveness was observed to decline with increasing age among this elderly population.
A study conducted in Thailand and published by The Lancet on August 26, 2021, stated: the delta variant, which is the most transmissible, possibly among the most virulent of all VOCs identified to date, and a dominant variant in many countries, appears to be most refractory to neutralization.
CoronaVac (Sinovac) COVID-19 Vaccine for Children
In June 2021, China authorized the CoronaVac vaccine for children aged between 3 and 17 years.
The Lancet published the results from a double-blind, randomized, phase 1/2 clinical trial of CoronaVac in healthy children and adolescents aged 3–17 years old at Hebei Provincial Center for Disease Control and Prevention Zanhuang (Hebei, China) on June 28, 2021. CoronaVac was well tolerated and safe and induced humoral responses in children and adolescents aged 3–17. Neutralizing antibody titers induced by the 3·0 μg dose were higher than those of the 1·5 μg dose. The results support using a 3·0 μg dose with a two-immunization schedule for further studies in children and adolescents.
"Children and adolescents with COVID-19 usually have mild or asymptomatic infections compared to adults. However, despite this, a small number may still be at risk of severe illness, and this population can still transmit the virus to others. Thus, it is vital to test the safety and effectiveness of COVID-19 vaccine candidates in younger age groups," stated Gao Qiang, general manager of Sinovac Life Sciences Co., Ltd., in an article published by China.org on July 2, 2021.
CoronaVac (Sinovac) COVID-19 Vaccine Dosage
The Sinovac CoronaVac vaccine is currently packaged as a half-milliliter injection. A group of healthy adults aged 18-59 was vaccinated with 0, 14 schedules reported Preliminary phase I/II results. Over 90% seroconversion was observed in phase II clinical trial, after a 2-dose vaccination, 14 days apart.
On June 1, 2021, the WHO’s Strategic Advisory Group of Experts on Immunization also completed its vaccine review. As a result, based on the available evidence, the WHO recommends the vaccine for use in adults 18 years and older in a two-dose schedule with a spacing of two to four weeks.
A non-peer-reviewed study published on July 25, 2021, Immunogenicity and safety of a third dose, and immune persistence of CoronaVac vaccine in healthy adults aged 18-59 years: interim results from a double-blind, randomized, placebo-controlled phase 2 clinical trial. Conclusions: The third dose of CoronaVac administered six or more months after a second dose effectively recalled a specific immune response to the SARS-CoV-2 virus, resulting in a remarkable increase in antibody levels and indicating that a two-dose schedule generates good immune memory.
On August 8, 2021, a new non-peer-reviewed study was published: A booster dose is immunogenic and will be needed for older adults who have completed two doses of vaccination with CoronaVac: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. Conclusion and relevance: Neutralizing antibody titers declined substantially six months after two doses of CoronaVac among older adults. A booster dose rapidly induces robust immune responses.
CoronaVac (Sinovac) COVID-19 Vaccine Side Effects
In this case series and nested case-control study done in Hong Kong published in The Lancet on August 16, 2021, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun–BioNTech [equivalent to Pfizer–BioNTech]) or CoronaVac. The age-standardized incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event.
In November 2020, The Lancet published a side-effect study 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 August 16, 2021, The Lancet published a study that 'suggests an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event.'
CoronaVac (Sinovac) COVID-19 Vaccine News
September 22, 2021 - The United Nations Children's Fund delivered 159,600 doses of the CoronaVac COVID-19 vaccine to Ukraine.
September 17, 2021 - Brazil media reported Germany will recognize the CoronaVac vaccine for visitor requirements.
September 16, 2021 - The Daily Sabah reported the Turkish Thoracic Society announced the results of two studies on CoronaVac, a coronavirus vaccine developed by China’s Sinovac and in use in Turkey. One study shows the vaccine's safety and reports only minor side effects, while the second study proved it helped reduce COVID-19 hospitalizations.
September 15, 2021 - The Global Times learned from Sinovac Biotech an additional 101,000 doses of their inactivated COVID-19 vaccine CoronaVac will arrive in Singapore on Sept 20th.
September 4, 2021 - Brazil's Anvisa determined the precautionary interdiction of totaling 12,113,934 CoronaVac vaccine doses, prohibiting the distribution and use of batches in the plant not approved in the Authorization for Emergency Use. In these terms, the vaccine packaged in a place not approved by the AUE is configured as a product not regulated by Anvisa.
August 25, 2021 - The Republic of the Philippines government announced it purchased 10 million additional CoronaVac vaccine doses.
August 24, 2021 - The Journal of Medical Virology published a new study: The effectiveness of inactivated SARS-CoV-2 vaccine (CoronaVac) on antibody response in participants aged 65 years and older. Lower rates of antibody response were detected in participants aged 65 years and older and those with comorbidities both in our study and similar studies in the current literature.
August 20, 2021 - The British Medical Journal published original research - Research: Effectiveness of the CoronaVac vaccine in older adults during a gamma variant associated epidemic of covid-19 in Brazil: a test-negative case-control study. However, vaccine protection was low until the completion of the two-dose regimen, and vaccine effectiveness was observed to decline with increasing age among this elderly population. And, the BMJ published related Editorials: Real-world effectiveness of covid-19 vaccines.
August 10, 2021 - SINOVAC Biotech Ltd. announced the publication of two non-peer-reviewed papers. The publications detail findings from clinical studies on the immunogenicity, safety, and immune response of CoronaVac® in two- and three-dose schedules. The results indicate that a third booster dose of CoronaVac® induces a strong immune response in healthy adults with no serious adverse reactions related to the vaccine.
August 9, 2021 - Pennsylvania-based INOVIO announced that it had received a regulatory allowance for two clinical trials investigating heterologous boosting with INO-4800, its DNA vaccine candidate for COVID-19, through partner and trial-sponsor Advaccine Biopharmaceuticals Suzhou Co., Ltd., together with Sinovac Biotechnology. The studies will evaluate the safety, tolerability, and immunogenicity of heterologous prime-boost sequential immunizations using INO-4800 and CoronaVac.
August 7, 2021 - The Indonesian health ministry was reported by The Strait Times to confirm the CoronaVac vaccine's high-efficiency rate.
August 4, 2021 - Sinovac Biotech announced it would build a fill-and-finish vaccine production plant in Chile with an investment of US$60 million, reported the SCMP.
July 29, 2021 - The Philippines received another 1.5 million doses of the CoronaVac vaccine. Then, on August 5, 2021, 1 million vaccine doses arrived.
July 27, 2021 - SINOVAC Biotech Ltd. announced the pre-print of a paper titled Immunogenicity and safety of a third dose, and immune persistence of CoronaVac vaccine in healthy adults aged 18-59 years: interim results from a double-blind, randomized, placebo-controlled phase 2 clinical trial. The non-peer-reviewed paper includes published data on July 25, 2021, on immunogenicity and safety profiles of homologous two-dose schedules and interim results on immune persistence and the immunogenicity and safety of the third dose of CoronaVac. The results indicate that a two-dose schedule generates good immune memory. A strong immune response was induced quickly after a third dose was given 6-8 months after the second dose. The neutralizing antibody titers at day 28 after the third dose increased by three to five times higher than the level recorded on day one, 28 after the second shot. In addition, the findings brought on evidence showing that longer intervals between the third dose and the second dose result in higher antibody levels. Seropositive rates in all dose groups were above 90.0% on day 28 after the second and third doses. The severity of solicited local and systemic adverse reactions reported within 28 days after the third dose were grade 1 to grade 2 in all vaccination cohorts. No serious adverse reactions were considered related to the vaccination. A lower adverse reaction rate was observed after the third dose compared to the previous two-dose schedule.
July 25, 2021 - A non-peer-reviewed study found a third dose of CoronaVac administered 6+ months after a second dose effectively recalled specific immune response to SARS-CoV-2, resulting in a remarkable increase in antibody levels.
July 21, 2021 - The Public Health Institute of the Republic of Chile approved the emergency use of CoronaVac via Twitter.
July 15, 2021 - A non-peer-reviewed study indicates that NAb titers elicited by CoronaVac are much lower when compared to natural infection.
July 15, 2021 - Reuters reported Chile's late-stage study recommended a third vaccine dose was needed to protect against the more contagious SARS-CoV-2 coronavirus Delta variant.
July 12, 2021 - SINOVAC Biotech Ltd. announced today that it had signed an advance purchase agreement with Gavi, the Vaccine Alliance, on behalf of COVAX Facility, to provide up to 380 million doses of inactivated COVID-19 vaccine, CoronaVac®for distribution through the COVAX Facility.
July 8, 2021 - The Lancet published the results from a new study: Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomized, placebo-controlled, phase 3 trial in Turkey. This interim analysis indicated that, in a population aged 18–59 years, CoronaVac had high efficacy for preventing symptomatic COVID-19 (83·5% relative to placebo) and COVID-19-related hospitalization (100%) at least 14 days after the second dose.
July 8, 2021 - The Lancet published a commentary: CoronaVac: more data for regulators and policymakers. In Summary, 'Tanriover and colleagues' study suggests that CoronaVac is another useful tool in the global fight against COVID-19, although more data are needed on its efficacy against emerging SARS-CoV-2 coronavirus variants and its duration of protection across different age groups and geographical settings and in the presence of comorbidities.
July 7, 2021 - The NEJM published an Original Article: Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile. The study's conclusion - Our results suggest that the inactivated SARS-CoV-2 vaccine effectively prevented Covid-19, including severe disease and death, a finding that is consistent with the results of phase 2 trials of the vaccine.'
July 3, 2021 - The South African Health Products Regulatory Authority authorized the CoronaVac COVID-19 vaccine, manufactured by Sinovac Life Sciences Co and imported by Curanto Pharma (Pty) Ltd.
July 1, 2021 - Local media reported the South Africa Health Products Regulatory Authority revealed that the process of reviewing the CoronaVac vaccine is at an advanced stage and will be approved for use in the coming days.
June 30, 2021 - Sinovac Biotech Ltd. announced The Lancet Infectious Diseases published results from the Phase I/II clinical trials of an inactivated COVID-19 vaccine known as CoronaVac® in over 500 healthy children and adolescents aged 3-17 in China. The results of the immunogenic evaluation showed that more than 96% of children and adolescents who received two vaccine doses developed antibodies against SARS-CoV-2; the study reported
June 22, 2021 - Reuters reported Chile is studying the possibility of issuing a third booster dose of COVID-19 vaccines.
June 15, 2021 - China media reported a small Brazilian city is emerging from the pandemic after 96% of adults in the city of Serrana in Sao Paulo state were given two CoronaVac vaccine doses, coronavirus infections were drastically reduced, as were COVID-19 deaths. The vaccine experiment was conducted by the Butantan Institute, a Brazilian state-owned research center, and the Sao Paulo University of Medicine.
June 14, 2021 - Local media reported that the Lekhim group of companies has delivered to Ukraine the last CoronaVac vaccine purchased at public expense.
June 9, 2021 - The BRACE COVID-19-Specific vaccine sub-study investigates biomarkers of protection against SARS-CoV-2 infection and reinfection induced by natural infection and COVID-specific vaccination. BCOS will also look at whether the BCG vaccine improves the immune response to CoronaVac vaccination.
June 6, 2021 - Sinovac Chairman Yin Weidong stated, 'China has authorized the emergency use of the CoronaVac vaccine for children between 3 and 17 years. And China's National Health Commission reported that over 763 million doses of Covid-19 vaccines had been administered across China.
June 4, 2021 - The Singapore Ministry of Health confirmed it would invite private healthcare institutions licensed under the Private Hospitals and Medical Clinics Act to apply to be licensed providers for the Sinovac-CoronaVac vaccine and draw on the existing stock of 200,000 doses at no cost.
June 4, 2021 - The journal Nature reported that CoronaVac was 51% effective at preventing COVID-19 in late-stage trials. Importantly, clinical trials suggest that CoronaVac, an inactivated-virus vaccine, is 100% effective at preventing severe disease and death. CoronaVac is one of two Chinese vaccines already sustaining vaccination campaigns in more than 70 nations.
June 2, 2021 - The WHO published: The Sinovac COVID-19 vaccine: What you need to know.
June 1, 2021 - The WHO’s Strategic Advisory Group of Experts on Immunization completed its vaccine review. Based on the available evidence, WHO recommends the vaccine for use in adults 18 years and older in a two-dose schedule with a spacing of two to four weeks. Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population. However, few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group.
May 30, 2021 - The southeastern Brazilian state of Sao Paulo has seen a 95% drop in COVID-19 deaths in the city of Serrana after it concluded vaccination of almost all adults, TV Globo reported.
May 29, 2021 - CNA reported Uraguray Health Administration reported the CoronaVac vaccines we very effective. It reduced infection with the SARS-CoV-2 coronavirus by 57% and intensive care admissions by 95% in people who had received two vaccine doses.
May 27, 2021 - The Lancet published: Serum neutralizing activity against SARS-CoV-2 variants elicited by CoronaVac. 'Our findings underscore the need for enhanced viral surveillance and assessment of currently authorized vaccine effectiveness against emerging variants, especially in the presence of E484K.'
May 26, 2021 - The JAMA published 'A Randomized Clinical Trial: Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults.' Conclusions and Relevance In this prespecified interim analysis of a randomized clinical trial, treating adults with either 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19 and serious adverse events rare.
May 25, 2021 - The Rio Times reported Sinovac shipped 3,000 liters of the active pharmaceutical ingredient needed for CoronaVac vaccine production to São Paulo on May 25th. The Butantan Institute will produce 5 million vaccine doses with the raw material. Deliveries of finished doses are scheduled for June 2021.
May 24, 2021 - The WHO published 'interim guidance for the CoronaVac vaccine.
May 24, 2021 - China media reported a survey conducted by Social Weather Station from April 28 to May 2, 2021, found that 39% of the 1,200 Filipinos said they prefer the COVID-19 vaccine made by Sinovac Biotech.
May 21, 2021 - A non-peer-reviewed study: Effectiveness of the CoronaVac vaccine in the elderly population during a P.1 variant-associated epidemic of COVID-19 in Brazil: A test-negative case-control study. Interpretation - CoronaVac was 42% effective in the real-world setting of extensive P.1 transmission, but significant protection was not observed until completing the two-dose regimen.
May 18, 2021 - Local media reported Dr. Rafael Araos, an adviser to the Chile Undersecretariat of Public Health, commented that despite the COVID-19 variants in circulation, "the vaccine is performing adequately," he told reporters at a press conference. The vaccine's efficacy in preventing hospitalization rose to 87 percent, in preventing admission to an intensive care unit, to 90.3 percent, and in preventing deaths caused by COVID-19, to 86 percent, according to Araos.
May 11, 2021 - Bloomberg reported that the Sinovac Biotech Covid-19 vaccine showed 98% effectiveness in preventing death in Indonesian healthcare workers and 96% in preventing their hospitalization.
May 7, 2021 - The WHO listed the Sinopharm COVID-19 vaccine for emergency use. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a China National Biotec Group subsidiary.
May 4, 2021 - The European Medicines Agency's human medicines committee confirmed it had started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. Studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.
April 22, 2021 - Sinovac Biotech Ltd. has filed its 2020 annual report on Form 20-F with the U.S. Securities and Exchange Commission for the year ended December 31, 2020. Mr. Weidong Yin, Chairman, President, and CEO of Sinovac, commented, “Sinovac experienced an exceptionally strong year in 2020. Despite the unprecedented COVID-19 pandemic, we are pleased with our record financial performance for the fourth and full fiscal years. In addition, we moved quickly to develop an inactivated COVID-19 vaccine, also known as CoronaVac, within a year and without having to sacrifice product quality.”
April 17, 2021 - According to the Chilean health ministry report, which the Global Times obtained from Sinovac Biotech, CoronaVac was found 85% effective in preventing hospitalization related to COVID-10 and 89% effective in preventing ICU admission. This COVID-19 vaccine becomes effective 14 days after injection of two shots, and the shots are administered at a 28-day interval.
April 7, 2021 - A non-peer-reviewed study: Effectiveness of CoronaVac setting 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 - A study led by academics from the University of Chile presented to the Ministry of Health shows the effectiveness of 56.5 percent in preventing infections in those who have received the second dose of any of the vaccines at least two weeks ago.
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 29.5% in women after the first vaccine; 18.6% in males; 99.2% of women after the second vaccination; 95.7% in males.
April 3, 2021 - The safety of CoronaVac® was evaluated in 4 clinical trials conducted domestic and overseas, including randomized, double-blind, placebo-controlled phase I/II clinical trials in people aged 18-59 years and in elderly aged 60 years and above, a phase III clinical efficacy trial in Brazilian health professionals aged 18 years and above, and a phase IIIb bridging trial in different production scales and different populations. Systematic safety observation was carried out within 7 days after each vaccination. Adverse events were collected by a voluntary report of subjects and regular follow-up of investigators on 8-14/28 days—long-term serious adverse events within 12 months after the full vaccination is still ongoing.
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. In addition, 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 expanding priority groups to legislature staffers garment 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 CoronaVac vaccine produced by Sinovac Biotech arrived in Ukraine. At the Kiev Boryspil airport, the Chinese ambassador met the cargo 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 1, 2021 - The arrival of 600,000 doses of Sinovac Biotech’s CoronaVac in the Phillippines was greeted warmly. 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 individuals 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. In addition, 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 13, 2021 - The AP reported Turkish health authorities announced the Chinese Sinovac vaccine's emergency use.
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 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 that the experimental COVID-19 vaccine developed by Sinovac was 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 inspected the CoronaVac vaccine factory and concluded the technical evaluation of the complementary information sent by Sinovac and the Butantan Institute after the inspection. Thus, the evaluation's conclusion made it possible to publish on (12/21) the Good Practice of Manufacturing Company certification. In addition, Brazil’s Sao Paulo state has said it will announce on Wednesday if CoronaVac is effective against the coronavirus.
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 vaccines 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 the 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 vaccine's safety.'
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 - Brazil’s Sao Paulo state government 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's 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 the 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 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 - The AP reported that China-owned Sinovac announced that its employees, including top executives, received experimental vaccine shots even before the government approved testing in people.
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 phase I/II clinical trial results for the Company’s COVID-19 vaccine candidate, CoronaVac, which showed favorable immunogenicity and safety profiles.
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 it 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 vaccination dose for these volunteers has been completed.
April 16, 2020 - Dynavax Technologies Corporation and Sinovac Biotech Ltd. announced a collaboration to 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
The CoronaVac vaccine continues to be studied for efficacy, safety, and immunogenicity.