CoronaVac® COVID-19 Vaccine (Sinovac) Description For 2022
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 other COVID-19 vaccine development efforts involving their vaccine candidates' RNA. 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 theoretical advantage of inactivated vaccines is that they contain additional viral proteins, including nucleoprotein, which could broaden protection beyond anti-spike protein responses and reduce the escape of variants from vaccine immunity. For example, a peer-reviewed study published on Nov. 24, 2021, concluded that 'CoronaVac induces higher CD4+ and CD8+ T-cell responses to the structural protein than (Pfizer-BioNTech) BNT162b2 vaccine.
The WHO published an assessment of the CoronaVac vaccine and validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use on Jun. 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 regulatory approval. In addition, an article published by the journal Nature on Jun. 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 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%.
Asrorun Niam Sholeh of Indonesia council's fatwa commission told a news conference on Jan. 8, 2021, that Sinovac's CoronaVac was 'holy and halal.'
The NEJM published a new study on Sept. 2, 2021 - Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile. Among 10 million 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. The WHO published 'Interim recommendations for CoronaVac, developed by Sinovac' on Oct. 21, 2021.
The Lancet published on Jan. 21, 2022, results from a peer-reviewed, phase 4 study conducted in Brazil that reported a comprehensive analysis of the immunogenicity and safety of homologous and heterologous boosting of the inactivated vaccine CoronaVac. It showed low concentrations of antibodies present six months after two doses of CoronaVac and largely undetectable neutralizing antibodies. However, the third dose of CoronaVac boosts these responses, which are stronger with two different viral vector vaccines tested; the highest antibody concentrations are observed after an mRNA boost. It also showed that heterologous boosting increases live virus neutralization titers against delta and omicron variants. The study preprint was published on Dec. 30, 2021.
The peer-reviewed journal Vaccines published results from a study on Mar. 18, 2022: HCWs who had two doses of CoronaVac before or after the natural SARS-CoV-2 infection elicited significantly higher antibody responses compared to uninfected vaccinated HCWs. The lower percentages of plasmablasts in the VAI group may indicate their migration to lymph nodes and initiation of the germinal center reaction phase, and the IFN-γ response did not differ among the groups.
The Lancet published a study on Apr. 23, 2022, suggesting a homologous or heterologous booster dose for individuals with a complete primary vaccination schedule with CoronaVac provides a high level of protection against COVID-19, including severe disease and death. Heterologous boosters showed higher vaccine effectiveness than homologous boosters for all outcomes, providing additional support for a mix-and-match approach.
And on Jul. 15, 2022, The Lancet published: Vaccine effectiveness of one, two, and three doses of BNT162b2 and CoronaVac against COVID-19 in Hong Kong: a population-based observational study - Interpretation: Third doses of CoronaVac provide substantial additional protection against severe COVID-19 and should be prioritized, particularly in older adults and other high-risk populations who received CoronaVac primary schedules.
As of Jul. 2022, CoronaVac is available in about sixty countries, including Argentina, Australia, Brazil, and Malaysia. SINOVAC has provided over 2.8 billion doses of CoronaVac globally, among which about 300 million doses were donated in China. CoronaVac clinical studies are listed here. CoronaVac's (PiCoVacc) Drugbank Accession Number: DB15806
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 Omicron BA.x Variant
The U.S. NIH's OpenData Portal SARS-CoV-2 Variants & Therapeutics reported CoronaVac's status. On Apr. 14, 2022, SINOVAC announced that its COVID-19 vaccine (Omicron strain) had been approved for human clinical trials in Hong Kong, the first for the Omicron strain inactivated vaccine. A previous assessment from World Health Organization incident manager Abdi Mahamud announced on Jan. 5, 2022, found the CoronaVax (Sinovac) vaccine offers protection against severe illness, hospitalization, and death from the Omicron variant despite declines in protective antibodies.
The Lancet HIV published a study on Mar. 23, 2022 - Safety and immunogenicity of CoronaVac in people living with HIV: a prospective cohort study. Results Interpretation: Immunogenicity following CoronaVac in people with HIV seems strong but reduced compared with people with no known immunosuppression. Our findings highlight the need for strategies to improve vaccine immunogenicity in people with HIV.
Sinovac has received approval from China's National Medical Products Administration to conduct Phase I/II human clinical trials in China on Apr. 13, 2020. 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 Jun. 13, 2020, Sinovac announced positive preliminary results of a phase I/II clinical trial, 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. In addition, the neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce a positive immune response.
On Sept. 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 Nov. 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 Feb. 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 Feb. 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 patients requiring medical treatment 100% for hospitalized, severe, and fatal cases. There are two stages of phase III clinical trial in Turkey.
The European Medicines Agency launched a rolling review for CoronaVac on May 4, 2021. The WHO published on Jun. 1, 2021: Background document on the inactivated vaccine Sinovac-CoronaVac against COVID-19. The WHO listed the Sinopharm COVID-19 vaccine for emergency use on May 7, 2021.
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 that 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. As a result, the media reported China authorized the emergency use of the CoronaVac vaccine for children aged between 3 and 17 on Jun. 5, 2021.
On Jun. 28, 2021, The Lancet published a locally-funded study that concluded by stating: that 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 Jul. 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.
The Health Bureau of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China approved the CoronaVac vaccine for children aged 6 months to 3 years on August 1, 2022. As of August 2022, CoronaVac has been approved for use in minors in 14 countries in Latin America, including Chile, Colombia, Ecuador, and Brazil, as well as in other countries in the Asia and Africa regions.
A non-peer-reviewed study published by The Lancet on Feb. 15, 2022, suggests that a complete primary immunization schedule with the inactivated SARS-CoV-2 vaccine effectively protects against severe Covid-19 disease for children 6-16 years. Brazil's Anvisa approved the emergency use of the Coronavac vaccine on Jan. 20, 2022, for those without underlying health risks aged 6 to 17. In June 2021, China authorized the CoronaVac vaccine for children 3 and 17 years. On Oct. 25, 2021, local city and provincial level governments in China issued notices announcing that children ages 3-11 will be required to get their vaccinations, reported VOA. Hong Kong launched similar policies in November 2021. And the CoronaVac can be used for pediatric vaccination in the Philippines.
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 Jun. 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 children and adolescents.
China's Department of Health announced on Feb. 27, 2022, that the CoronaVac vaccination service would be provided to pregnant women receiving antenatal services. And the WHO recommends the use of the Sinovac-CoronaVac vaccine in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks.
On April 5, 2022, the journal BMC published a study that concluded 'A complete regimen of CoronaVac in pregnant women was effective in preventing symptomatic COVID-19 and highly effective against severe illness in a setting that combined high disease burden and marked COVID-19-related maternal deaths.'
A University of Hong Kong study revealed that three vaccine doses of CoronaVac offered significant protection against death or severe illness in those over 60 years old. On June 1, 2021, the WHO's Strategic Advisory Group of Experts on Immunization 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. The WHO's SAGE said on October 11, 2021, moderately and severely immunocompromised persons should be offered an additional dose of all WHO-approved vaccines "since these individuals are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of severe COVID-19 disease." The experts added that people aged 60 and older who received the Sinovac vaccine should get a third vaccine dose.
The Lancet published a study on December 7, 2021, that found a third dose of CoronaVac in adults administered eight months after a second dose effectively recalled specific immune responses to SARS-CoV-2, which had declined substantially six months after two doses of CoronaVac, resulting in a remarkable increase in the concentration of antibodies and indicating that a two-dose schedule generates good immune memory, and a primary third dose is given two months after the second dose induced slightly higher antibody titers than the primary two doses.
On February 9, 2022, the peer-reviewed journal Nature published a study's findings supporting a BNT162b2 booster vaccine dose after two doses of CoronaVac, particularly for the elderly. On April 19, 2022, another study found that researchers suggested a booster dose with BNT for countries with two doses of primary CV regimens when considering waning immunity.
CoronaVac Side Effects
This vaccine is an inactivated vaccine with an adjuvant commonly used in many other vaccines with a well-documented safety profile, such as Hepatitis B and Tetanus vaccines, says the WHO. A study published on October 7, 2021, concluded anaphylaxis related to CoronaVac was extremely rare.
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.'
The 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).
Sinovac - CoronaVac Vaccine Financial News
May 6, 2022 - Sinovac Biotech Ltd. is aware that the Company has been identified by the U.S. Securities and Exchange Commission under the Holding Foreign Companies Accountable Act of the United States on May 4, 2022.
April 29, 2022 - Sinovac reported sales in 2021 were $19.4 billion, compared to $510.6 million in 2020, and close to half of CoronaVac's revenues in 2021 were generated from international markets.
December 11, 2021 - Seeking Alpha published: Greatly Transformed Sinovac Set To Reawaken On Wall Street?
December 9, 2021 - The Eastern Caribbean Supreme Court's Court of Appeal upheld the 2018 Judgment, further confirming SINOVAC's position that the board was properly elected, and the Rights Agreement was triggered by a group led by 1Globe Capital, LLC, Chiangjia Li, and OrbiMed Advisors LLC.
CoronaVac News For 2020 - 2022
June 30, 2022 - The peer-review journal The Lancet published - Effectiveness of CoronaVac and BNT162b2 COVID-19 mass vaccination in Colombia: A population-based cohort study. Interpretation: Two doses of either CoronaVac in a population between 40 and 79 years of age, or BNT162b2 among vaccinated above 40 years old significantly reduced deaths of confirmed COVID-19 in a cohort of individuals from Colombia. Vaccine effectiveness for CoronaVac and BNT162b2 declined with increasing age.
June 28, 2022 - The peer-review journal Nature published - Immunogenicity and reactogenicity of SARS-CoV-2 vaccines BNT162b2 and CoronaVac in healthy adolescents. 'We find higher S, neutralizing, avidity, and Fc receptor-binding antibody responses in adolescents receiving BB than CC, and a similar induction of strong S-specific T cells by the two vaccines, in addition to N- and M-specific T cells induced by CoronaVac but not BNT162b2, possibly implying differential durability and cross-variant protection by BNT162b2 and CoronaVac. Our results support the use of both vaccines in adolescents.'
June 11, 2022 - A new study being presented at the Endocrine Society's meeting in Atlanta, Ga., found two vaccines do not cause significant fluctuations in thyroid function and are not associated with increased risks of emergency department visits or unscheduled hospitalizations.
May 19, 2022 - The WHO's SAGE issued updated interim policy recommendations for the use of the Ad5-nCoV-S recombinant (Ad5-nCoV) vaccine against COVID-19.
May 6, 2022 - The journal Nature published an article that concluded: Overall, the results show that the vaccines can't suppress viral circulation, but they are effective against severe disease. But Madhi points out that a large number of unrecorded infections in children means the effectiveness estimates are probably not comparing vaccine-induced immunity with no immunity, but a 'hybrid' immunity — conferred by both vaccination and infection — with immunity from infection alone.
May 5, 2022 - Research being presented at this year's European Congress on Obesity suggests that adults with severe obesity generate a significantly weaker immune response to COVID-19 vaccination compared to those with normal weight. In those with previous SARS-CoV-2 infection, antibody levels in patients with severe obesity and vaccinated with Pfizer/BioNTech or CoronaVac were not significantly different from normal-weight controls (average 39,043 vs 14,115 AU/ml and 3,221 vs 7,060 AU/ml, respectively).
April 29, 2022 - Mr. Weidong Yin, Chairman, President, and CEO of SINOVAC, commented, "As a major COVID-19 vaccine provider, Sinovac has been committed to using its resources to help the global population prevail against the virus since the onset of this unfortunate pandemic."
April 14, 2022 - Sinovac Biotech Ltd. announced that its inactivated COVID-19 vaccine (Omicron strain) had been approved for clinical trial in Hong Kong, China.
March 31, 2022 - Local media reported China had supplied 3,443,360 doses of the CoronaVac vaccine to Nepal, which will be used as first, second, and booster shots.
March 22, 2022 - The WSJ reported a study by scientists at the University of Hong Kong showed three doses of CoronaVac were 98% effective in preventing the worst outcomes, while two shots were about 72% effective against severe illness and death.
March 15, 2022 - A non-peer-reviewed study: Effectiveness of CoronaVac in children 3 to 5 years during the omicron SARS-CoV-2 outbreak - found the effectiveness of CoronaVac in children was modest; however, protection against severe disease remained high during the Omicron B.1.1.529 lineage outbreak in Chile.
March 13, 2022 - Philippine authorities authorized pediatric vaccinations with the CoronaVax vaccine. "We thank the FDA and our vaccine experts for approving Sinovac's CoronaVac for ages six and above," IP Biotech Group chairman Enrique Gonzales said in a media statement.
February 21, 2022 - Chinese regulatory authorities have approved mix and match boosting with domestic vaccines.
February 18, 2022 - The Journal of Medical Virology published results of a study evaluating the antibody responses of cancer patients who received 2 doses of the inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences (Beijing, China). Antibody positivity rate was 46.8% in patients who received chemotherapy at any time between the first dose of the vaccine and the date of blood collection, and it was 73.8% in the group that did not receive chemotherapy (p<0.001). As a result, the expected antibody response was not obtained with two doses of the Sinovac vaccine. Therefore, if the Sinovac vaccine is to be preferred for these patients, the appropriate booster time for the 3rd dose should be determined or other vaccines, such as mRNA vaccines, with reported higher antibody responses should be considered.
January 21, 2022 - A peer-reviewed study published by The Lancet found 'Antibody concentrations were low at 6 months after previous immunization with two doses of CoronaVac. However, all vaccines administered as a third dose induced a significant increase in binding and neutralizing antibodies, which could improve protection against infection. In The Lancet, Sue Costa Clemens and colleagues provide timely results of a randomized trial on the reactogenicity and immunogenicity of a homologous and three different heterologous booster vaccines among individuals who had received two doses of the CoronaVac vaccine.'
January 21, 2022 - Those aged between 12 and 17 in Singapore who are medically ineligible for the PfizerBioNTech/ Comirnaty vaccine will be offered a Sinovac-CoronaVac booster dose under a dedicated public health program, said the MOH.
January 13, 2022 - The journal Nature published an article: Omicron thwarts some of the world's most-used COVID vaccines.
December 16, 2021 - Sinovac Biotech says that a third shot of its COVID-19 vaccine is 94% effective against the omicron variant.
December 7, 2021 - The Lancet Infectious Disease reported a third CoronaVac dose administered eight months after a second dose effectively recalled specific immune responses to the SARS-CoV-2 coronavirus resulting in a remarkable increase in the concentration of antibodies and indicating that a two-dose schedule generates good immune memory, and a primary third dose is given 2 months after the second dose induced slightly higher antibody titers than the primary two doses.
December 3, 2021 - The Lancet Rheumatology reported a study provides evidence that, in patients with autoimmune rheumatic diseases who have been exposed to natural SARS-CoV-2 infection, a single dose of CoronaVac might be sufficient to produce robust antibody responses, by contrast with unexposed individuals who need at least two doses.
December 1, 2021 - A non-peer-reviewed study - The immunogenicity and safety of different COVID-19 booster vaccination - Heterologous COVID-19 boosting vaccination with BNT162b2 is the most immunogenic following CoronaVac or ChAdOx1 primary series.
November 21, 2021 - A non-peer-reviewed study conducted in Thailand: Immunogenicity of heterologous prime/boost inactivated and mRNA COVID-19 vaccine - found the heterologous CoronaVac / BNT162b2 could be used as an alternative regimen in countries experiencing vaccine shortages and in individuals experiencing the adverse events following CoronaVac.
November 19, 2021 - The Government of Hong Kong - China confirmed it has lowered the CoronaVac vaccination age from 18 to 3 years.
November 17, 2021 - Malaysia Drug Control Authority agreed to give conditional approval for the use of CoronaVac vaccines as booster doses that will be given after 3 to 6 months from the second dose received. The administration of booster doses to specific target groups will be detailed by the COVID-19 Booster Immunization Task Force and will be notified from time to time.
November 15, 2021 - Malaysian pharmaceutical company Pharmaniaga announced the delivery of localized Chinese COVID-19 vaccines to Myanmar. The initial order was some 200,000 doses of locally filled-and-finished CoronaVac vaccine.
November 9, 2021 - SINOVAC Biotech Ltd. announced results from statistics analysis under blind status in a phase 3 study indicating that CoronaVac is safe for healthy people of different races in the pediatric and adolescent population ranging from 3 to 17 years of age.
November 5, 2021 - Pharmaniaga Berhad has offered the COVID-19 vaccine to the Ministry of Health to cater to the preference of the public for the vaccine as their booster shot.
November 5, 2021 - Media reported the Butantan Institute must file a new request with the National Health Surveillance Agency in Brazil for the approval of the use of the CoronaVac vaccine in children and adolescents between 3 and 17 years old. In Brazil, the immunizing agent against covid-19 is authorized only for those over 18 years of age.
November 5, 2021 - Local news reported Italy's Ministry of Health is going to apply a booster dose to people vaccinated with the CoronaVac vaccine.
November 1, 2021 - Yale Medicine published: Comparing the COVID-19 Vaccines: How Are They Different?
October 30, 2021 - A non-peer-reviewed study: Comparison of the immunogenicity of BNT162b2 and CoronaVac COVID-19 Vaccines in Hong Kong. Through the head-to-head comparison, vaccination with BNT162b2 induces significantly higher levels of SARS-CoV-2 specific binding and neutralizing antibody responses when compared to CoronaVac. CoronaVac induces higher CD4+ and CD8+ T cell responses to the structural protein than BNT162b2.
October 23, 2021 - Singapore media reported the Ministry of Health confirmed the CoronaVac vaccine will be included in the national vaccination program to allow the "small minority" of unvaccinated individuals who cannot take an mRNA vaccine due to medical conditions.
October 21, 2021 - These WHO interim recommendations for use of the Sinovac-CoronaVac were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization and the evidence summary included in the background document and annexes.
October 19, 2021 - The Global Times reported data from Chile has shown that the third shot of the CoronaVac vaccine increased effectiveness against COVID-19 at 14 days after the booster shot can reach 80.2% while increasing the effectiveness against hospitalization to 88%.
October 14, 2021 - The journal Nature published an article: China's COVID vaccines have been crucial — now immunity is waning.
October 12, 2021 - The NST (AFP) reported CoronaVac vaccinated individuals are allowed to perform the Umrah in Saudi Arabia on the condition that they get a third dose of the COVID-19 vaccine.
October 11, 2021 - The WHO announced CoronaVac COVID-19 vaccinated people should receive a 3rd 'booster' dose due to their higher risk of breakthrough infections.
October 7, 2021 - The WHO announced its Strategic Advisory Group of Experts on Immunization issued advice that people over 60 should receive a third dose of the same or another vaccine to ensure sufficient protection.
October 5, 2021 - The Norwegian Ministry of Health and Care Services announced international travelers who have been vaccinated with the Sinovac vaccine will no longer be subject to the COVID-19 entry rules, SchengenVisaInfo.com reported. "There is no longer a need for global travel advice. We will now go back to assessing countries on an individual basis to determine the need for travel advice.'
October 4, 2021 - Chinese ambassador to Cairo Liao Liqiang announced that procedures to send two million doses of the Sinovac vaccine from China to Egypt, reported local media.
October 4, 2021 - The journal Transplant Infectious Disease published a study: Antibody response to two doses of inactivated SARS-CoV-2 vaccine (CoronaVac) in Kidney Transplant Recipients. Conclusion: 'We found the antibody response to the inactivated vaccine to be considerably low (18.8%) in KTR. Increased age and impaired renal function were associated with worse antibody response. Based on the knowledge that mRNA vaccines yield better humoral responses, this special population might be considered for additional doses of mRNA vaccination.'
October 1, 2021 - Australia's Therapeutic Goods Administration confirmed following an assessment to determine the protection offered by certain of these vaccines against infection and serious illness, the Coronavac vaccine is considered a 'recognized vaccine' for incoming international travelers to be regarded as appropriately vaccinated.
October 1, 2021 - Milina media reported 2.5 million doses of government-procured Sinovac vaccine landed on NAIA Terminal 2 via Philippine Air Lines flight PR 359.
September 30, 2021 - Malaysia Drug Control Authority has given its conditional approval for the use of the CoronaVac vaccine for those aged 12 and above. The CoronaVac vaccine is manufactured by Sinovac Life Sciences Co. Ltd. of China and Malaysia's Pharmaniaga Lifesciences Sdn Bhd.
September 29, 2021 - Local media reported according to the written statement from the university, Manisa Celal Bayar University's Scientific Research Projects Unit investigated the 6th-month follow-up results of the two-dose Sinovac SARS-CoV-2 inactivated vaccine. "In those with only two doses of CoronaVac, the levels of antibody protection decreased to 56% after the third month following the second vaccine. This data has proven that applying a 3rd dose of the vaccine is a sound decision," the statement read.
September 27, 2021 - Algeria confirmed plans to export to Africa the CoronaVac vaccine produced by the pharmaceutical group Saidal, said the Minister of Pharmaceutical Industry Abderrahmane Lotfi Djamel Benbahmed. "The actual production of the Covid-19 vaccine will start on 29 September 2021," affirmed Benbahmed, underlining that the group intends to produce 1 million doses in October, 2 million in November, 3 million in December, and over 5.3 million doses as of January 2022.
September 23, 2021 - The US Centers for Disease Control and Prevention announced that the Sinovac Coronavac vaccine would be allowed to enter the USA. In effect, all WHO and U.S. FDA-approved or authorized COVID-19 vaccines will be admitted for use.
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.
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 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 - 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 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.
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.
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.
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.
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 (Sinovac) Clinical Trials
The CoronaVac vaccine continues to be studied for efficacy, safety, and immunogenicity.
On November 24, 2021, a peer-reviewed study was published: The 'Comparison of the immunogenicity of BNT162b2 and CoronaVac COVID-19 vaccines in Hong Kong, was published. Both vaccines induced SARS-CoV-2-specific CD4+ and CD8+ T-cell responses at one-month post-vaccination but CoronaVac elicited significantly higher structural protein-specific CD4+ and CD8+ T-cell responses.