CoronaVac® COVID-19 Vaccine
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. An 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.
On Dec. 1, 2023, the U.S. CDC Emerging Infectious Disease - Volume 30, Number 1—January 2024 - reported that CoronaVac is a popular vaccine choice in the pan-Pacific region and many developing countries. A double-blind, randomized, controlled, phase 3 trial conducted in Turkey showed CoronaVac has a good safety profile and can effectively reduce the risk for PCR-confirmed, symptomatic SARS-CoV-2 infection and severe COVID-19. Results from a large-scale, prospective cohort study in Chile suggested that CoronaVac can effectively prevent SARS-CoV-2 infection and reduce the risks of COVID–19–induced hospitalization, severe disease, and death. 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 World Health Organization (WHO) published an assessment of the CoronaVac vaccine. It validated the vaccine for emergency use on Jun. 1, 2021, and remains one of the 12 COVID-19 vaccines granted an EUL by the WHO. The WHO Emergency Use Listing (EUL) is a prerequisite for COVAX Facility supply and international procurement and expedites their regulatory approval. CoronaVac was the first COVID-19 vaccine used in children as young as three years old under the WHO's EUL. In addition, a real-world study of millions of people who received CoronaVac 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 Lancet published a study on Apr. 23, 2022, suggesting homologous or heterologous booster doses for individuals with a complete primary vaccination schedule with CoronaVac, which provide a high level of protection against COVID-19, including severe disease and death. In addition, heterologous boosters showed higher vaccine effectiveness than homologous boosters for all outcomes, providing additional support for a mix-and-match approach.
The peer-reviewed journal Nature Communications published results from a study on August 13, 2022, which concluded that post-second dose, hospital admission vaccine effectiveness was 59.2% (95% CI 11.3–84.5) at ≥14 days. The Lancet published a study's findings on Dec. 12, 2022, stating receipt of a CoronaVac booster was associated with a significantly lower risk of omicron BA.2 infection and symptomatic infection.
As of March 2023, the cumulative global supply exceeds 2.9 billion doses. CoronaVac clinical studies are listed here. CoronaVac's (PiCoVacc) Drugbank Accession Number: DB15806.
SINOVAC's broad-spectrum neutralizing antibody products, SA55 Injection and Nasal Spray, intended for preventing and treating COVID-19 infections, were approved for a clinical trial in China. SINOVAC can large-scale manufacture of broad-spectrum neutralizing antibody products in compliance with good manufacturing practices.
Sinovac Biotech Life Sciences Ltd. is a Beijing, China-based biopharmaceutical company that researches, develops, manufactures, and commercializes 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 Availability 2023
CoronaVac® has been approved for use in more than 60 countries and regions worldwide. CoronaVac received the definitive registration of use granted by the Hong Kong Department of Health on December 22, 2022, under the Pharmacy and Poisons Ordinance Cap 138 in December 2022, as one of the first COVID-19 vaccines approved for such official registration in Hong Kong. In addition, on May 10, 2023, Sinovac announced it would provide CoronaVac (original strains) to self-paying groups in Hong Kong.
CoronaVac HIV
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 without immunosuppression. Our findings highlight the need for strategies to improve vaccine immunogenicity in people with HIV.
CoronaVac History
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. In addition, 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, a wholly-owned subsidiary of Sinovac, to further the development of an inactivated vaccine against COVID-19 named CoronaVac.
CoronaVac Children
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 six months to 3 years on August 1, 2022. As of Sept. 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 between 3 and 17 years. On Oct. 25, 2021, local city and provincial 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. AoronaVac 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 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.
CoronaVac Women
China's Department of Health announced on Feb. 27, 2022, that the CoronaVac vaccination service would be provided to pregnant women receiving antenatal services. The WHO recommends using 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.'
CoronaVac Dosage
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. 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. In addition, the WHO's SAGE said on October 11, 2021, that 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 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 third primary dose is given two months after the second dose induced slightly higher antibody titers than the prior 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 inactivated 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. In addition, a study published on October 7, 2021, concluded anaphylaxis related to CoronaVac was extremely rare.
In this case series and nested case-control study 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.' Then, on August 16, 2021, The Lancet published a study suggesting 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 Production
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 Financial News
August 15, 2023 - Sales for the first half of 2023 were $140.4 million, compared to $1.2 billion in the prior year. The decrease was mainly due to decreased sales of CoronaVac®. The negative gross margin of 34.2% was caused by the sharply reduced sales of CoronaVac combined with the COVID-19 employee incentive plan established in 2022.
December 29, 2022 - Company sales for the first half of 2022 were $1.2 billion, compared to $11.0 billion in the prior year. The decrease was due to the lower sales of CoronaVac® as the initial two-dosage vaccination schedules were completed around the globe in 2021, and third booster shots were only administered in certain countries, including China, in 2022.
CoronaVac News
August 15, 2023 - Mr. Weidong Yin, Chairman, President, and CEO of SINOVAC, commented, "After experiencing three years of the COVID-19 pandemic, the world is still facing the threat of various infectious diseases in 2023.
May 1, 2023 - Sinovac Biotech Ltd. confirmed over 2.9 billion doses of CoronaVac® have been delivered globally, making SINOVAC the largest China-based COVID-19 vaccine provider to the international market.
December 22, 2022 - The registration of the Comirnaty and CoronaVac vaccines in Hong Kong.
October 6, 2022 - The journal Nature Communications published: Effectiveness of an inactivated COVID-19 vaccine with homologous and heterologous boosters against Omicron in Brazil. Waning against severe COVID-19 after 120 days was only observed after a homologous booster.
October 3, 2022 - Nature Communications published a study that concluded - Altogether, we show a reduction in immunity 6-months of Sinovac-CoronaVac 2nd dose, particularly in males and those under immunosuppressives therapies.
September 6, 2022 - Mr. Weidong Yin, the Chairman, President, and CEO of SINOVAC, said, "SINOVAC has made great progress collaborating with global partners in developing and manufacturing the COVID-19 vaccine. We are proud that CoronaVac® can protect individuals as young as six months of age, and this clinical approval will allow even better vaccine protection."
August 26, 2022 - The JAMA Network published Original Research: Analysis of COVID-19 Incidence and Severity Among Adults Vaccinated With 2-Dose mRNA COVID-19 or Inactivated SARS-CoV-2 Vaccines With and Without Boosters. The estimated 3-dose inactivated SARS-CoV-2 booster effectiveness against severe COVID-19 was 69.6%.
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-19 vaccines.
December 16, 2021 - Sinovac Biotech says that a third shot of its COVID-19 vaccine is 94% effective against the omicron variant.
November 19, 2021 - The Government of Hong Kong - China, confirmed it had lowered the CoronaVac vaccination age from 18 to 3 years.
September 23, 2021 - The US Centers for Disease Control and Prevention announced that the Sinovac Coronavac vaccine would be allowed to enter the USA.
July 21, 2021 - The Public Health Institute of the Republic of Chile approved the emergency use of CoronaVac.
June 2, 2021 - The WHO published the Sinovac COVID-19 vaccine: What you need to know.
May 24, 2021 - The WHO published 'interim guidance for the CoronaVac vaccine.
February 8, 2021 - Sinovac Biotech Ltd. announced that the China National Medical Products Administration had granted conditional marketing authorization to Sinovac for CoronaVac.
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.'
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, and to conduct other development and operational activities.
December 6, 2020 - Indonesia announced it received its first shipment of 1.2 million CoronaVac.
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.
