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CoronaVac, also known as the Sinovac COVID-19 vaccine, is a
whole inactivated virus An inactivated vaccine (or killed vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then killed to destroy disease-producing capacity. In contrast, live vaccines use pathogens ...
COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...
developed by the Chinese company
Sinovac Biotech Sinovac Biotech Ltd. () is a Chinese biopharmaceutical company based in Haidian District, Beijing that focuses on the research, development, manufacture, and commercialization of vaccines that protect against human infectious diseases. The comp ...
. It was Phase III clinical trialled in Brazil, Chile, Indonesia, the Philippines, and Turkey and relies on traditional technology similar to other inactivated-virus COVID-19 vaccines, such as the Sinopharm BIBP vaccine, another Chinese vaccine, and
Covaxin Covaxin (codenamed as BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. As of October 2021, 110.6 million ...
, an Indian vaccine. CoronaVac does not need to be frozen, and both the final product and the raw material for formulating CoronaVac can be transported refrigerated at 2–8 °C (36–46 °F), temperatures at which flu vaccines are kept. A real-world study of tens of millions of Chileans who received CoronaVac found it 66% effective against symptomatic COVID-19, 88% effective against hospitalization, 90% effective against ICU admissions, and 86% effective against deaths. In Brazil, after 75% of the population in
Serrana, São Paulo Serrana is a municipality in the state of São Paulo in Brazil. The population is 45,644 (2020 est.) in an area of 126 km2. The elevation is 427 m. COVID-19 vaccine study While other communities were struggling to deal with the COVID-19 p ...
, received CoronaVac, preliminary results show deaths fell by 95%, hospitalizations by 86%, and symptomatic cases by 80%. In Indonesia, real world data from 128,290 healthcare workers showed 94% protection against symptomatic infection by the vaccine, beating results in clinical trials. Phase III results from Turkey, published in ''
The Lancet ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles, ...
'', showed an efficacy of 84% based on 10,218 participants in the trials. Phase III results from Brazil previously showed 50.7% efficacy at preventing symptomatic infections and 83.7% effectiveness in preventing mild cases needing treatment. Efficacy against symptomatic infections increased to 62.3% with an interval of at least 21 days between the doses. CoronaVac is being used in vaccination campaigns in various countries in Asia, South America, Central America, and Eastern Europe. By April 2021, Sinovac had a production capacity of 2 billion doses per year. It is currently being manufactured at several facilities in China, with overseas manufacture planned for Brazil in September 2021 and eventually Egypt and Hungary. On June 1, 2021, the
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(WHO) validated the vaccine for emergency use. Sinovac has signed purchase agreements for 380 million doses from
COVAX COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Hea ...
. As of July 2021, CoronaVac was the most widely used COVID-19 vaccine in the world, with 943 million doses delivered. As of October 14, 2021, CoronaVac is the COVID-19 vaccine with the most doses administered worldwide. A recent study jointly conducted by the LKS Faculty of Medicine, The University of Hong Kong (HKUMed), and the Faculty of Medicine, The Chinese University of Hong Kong (CU Medicine), showed that a third dose of the Comirnaty vaccine given to those who received two doses of either Comirnaty or CoronaVac provides protective levels of measured antibodies against the
Omicron variant Omicron (B.1.1.529) is a variant of SARS-CoV-2 first reported to the World Health Organization (WHO) by the Network for Genomics Surveillance in South Africa on 24 November 2021. It was first detected in Botswana and has spread to become the ...
of SARS-CoV-2. Three doses of CoronaVac, however, did not provide adequate levels of protective antibodies by the same measure, in direct contradiction to claims made by the vaccine manufacturer.


Medical uses

The vaccine is given by
intramuscular injection Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have ...
into the
deltoid muscle The deltoid muscle is the muscle forming the rounded contour of the human shoulder. It is also known as the 'common shoulder muscle', particularly in other animals such as the domestic cat. Anatomically, the deltoid muscle appears to be made up o ...
. The initial course consists of two doses. The
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(WHO) recommends an interval of 4 weeks between doses, with data from Chile suggesting that a longer interval provides more robust immunity. Early evidence suggests that immunity wanes rapidly, so a
booster dose A booster dose is an extra administration of a vaccine after an earlier (primer) dose. After initial immunization, a booster provides a re-exposure to the immunizing antigen. It is intended to increase immunity against that antigen back to protec ...
after the initial course might be needed.


Effectiveness

In Brazil, a study was conducted in Serrana, population 45,000, where authorities attempted to vaccinate the entire adult population with CoronaVac. After 75% of the adult population received the vaccine, preliminary results show deaths fell by 95%, hospitalizations by 86% and symptomatic cases by 80%. According to Ricardo Palacios, a director at São Paulo's
Instituto Butantan Instituto Butantan (in modern Portuguese, Instituto Butantã, ) is a Brazilian biologic research center located in Butantã, in the western part of the city of São Paulo, Brazil. Instituto Butantan is a public institution affiliated with the S ...
, “The most important result was understanding that we can control the pandemic even without vaccinating the entire population.” In July 2021, researchers from the
Chilean Ministry of Health Chilean may refer to: * Something of, from, or related to Chile, a country in South America * Chilean people * Chilean Spanish * Chilean culture * Chilean cuisine * Chilean Americans See also *List of Chileans This is a list of Chileans who ar ...
published a paper containing real-world data for their vaccination campaign. The study was conducted between 2 February and 1 May 2021, consisting of 10.2 million people. The effectiveness of CoronaVac vaccine after the second dose was in preventing symptomatic disease, for hospitalization, for ICU admission, and in preventing COVID-19 related deaths. The effectiveness after the first dose was against symptomatic disease, against hospitalization, against ICU admission, and against deaths. The study concluded that the vaccine was effective in preventing COVID-19. In May 2021, real-world data from Indonesia showed the vaccine was highly effective, with 94% of inoculated health care workers protected against symptomatic infection by the vaccine, besting results of clinical trials. In this study of 128,290 health workers in Jakarta, less than 1% of the vaccinated healthcare workers contracted symptomatic COVID-19, compared to more than 8% among the unvaccinated healthcare workers. The vaccine reduced the risk of hospitalization and death of the inoculated medical workers by 96% and 98% respectively. Uruguay released real-world data based on 795,684 people who have received both doses of CoronaVac for more than 14 days as of 1 June 2021. In this group, 8,298 tested positive, 45 were admitted to the ICU, and 35 died of COVID-19. This indicated 64.52% and 61.47% effectiveness in reducing COVID-19 cases for people aged 18–49 and 50 and older respectively. The vaccine was 94.95% and 92.18% effective in reducing ICU admissions, and 95.35% and 95.2% effective to prevent deaths. Among fully-vaccinated healthcare professionals, the vaccine was 66% effective in preventing cases, and 100% effective in preventing ICU admissions and deaths. Preliminary results from a test-negative case-control study from 19 January to 13 April 2021 in
Manaus Manaus () is the capital and largest city of the Brazilian state of Amazonas. It is the seventh-largest city in Brazil, with an estimated 2020 population of 2,219,580 distributed over a land area of about . Located at the east center of the s ...
suggest that, after just one dose, the vaccine is effective against asymptomatic infections and against symptomatic disease. The one-dose group consisted of 53,176 healthcare professionals. During the study, 66% of the samples were of the Gamma variant. The same study found paradoxically reduced effectiveness against symptomatic disease in another group that received two doses, an effect attributed by the authors to unmeasured
confounding In statistics, a confounder (also confounding variable, confounding factor, extraneous determinant or lurking variable) is a variable that influences both the dependent variable and independent variable, causing a spurious association. Con ...
leading to downward bias in the efficacy estimate. In Chile, the effectiveness against symptomatic disease dropped from 67% between February–April 2021 to 58.5% in early July. Because of this, on 11 August, Chile began giving an additional dose of the Oxford–AstraZeneca vaccine to people over 55 who were fully vaccinated with CoronaVac before 31 March. In October 2021, a large scale study in Chile with 2,017,878 participants reported that, with a CoronaVac booster, effectiveness against hospitalization increased from 84% to 88% and effectiveness against symptomatic disease increased from 56% to 80%. The greatest increases were seen with a heterologous Oxford–AstraZeneca vaccine booster, resulting in 96% effectiveness against hospitalization and 93% against symptomatic disease. A study by the University of Hong Kong in December 2021 found that a third dose of CoronaVac does not provide sufficient protection against the Omicron variant, directly contradicting the vaccine manufacturer's claim and a study by the
Pontifical Catholic University of Chile The Pontifical Catholic University of Chile (''PUC or UC Chile'') ( es, Pontificia Universidad Católica de Chile) is one of the six Catholic Universities existing in the Chilean university system and one of the two pontifical universities i ...
that it does. In April 2022, a Singapore study by infectious diseases experts from the
National Centre for Infectious Diseases The National Centre for Infectious Diseases (Abbreviation: NCID; ms, Pusat Nasional bagi Penyakit Berjangkit; ta, தேசிய தொற்றுநோய் மையம்; Chinese: ), previously known as the Communicable Disease Centre ...
and the Ministry of Health found that CoronaVac recipients were 4.59 times more likely to have severe COVID-19 as well as 2.37 times more likely to be infected, compared to those who took the Pfizer-BioNTech vaccine.


Variants

In the following tables, a vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95%
confidence interval In frequentist statistics, a confidence interval (CI) is a range of estimates for an unknown parameter. A confidence interval is computed at a designated ''confidence level''; the 95% confidence level is most common, but other levels, such as 9 ...
. Effectiveness is generally expected to slowly decrease over time.


In the elderly

A test-negative case-control study from 17 January to 29 April 2021 in the
state of São Paulo State may refer to: Arts, entertainment, and media Literature * ''State Magazine'', a monthly magazine published by the U.S. Department of State * ''The State'' (newspaper), a daily newspaper in Columbia, South Carolina, United States * ''Our S ...
, during which 86% of the collected genotype isolates were of the Gamma variant, with 43,774 participants aged 70 years or older, found an effectiveness after two doses of against symptomatic disease, against hospitalization and against death. After a single dose, the effectiveness was only against symptomatic disease, against hospitalization and against death, highlighting the importance of receiving the second dose. The study also found that effectiveness against symptomatic disease decreased with increasing age: Preliminary data from a large effectiveness study in Brazil with 61 million individuals from 18 January to 30 June 2021, when the Gamma variant was dominant in the country, indicate that effectiveness is markedly reduced in those aged 90 or older, attributable to
immunosenescence Immunosenescence is the gradual deterioration of the immune system, brought on by natural age advancement. A 2020 review concluded that the adaptive immune system is affected more than the innate immune system. Immunosenescence involves both the ...
:


Specific populations

On 21 October 2021, the WHO recommended a third dose as part of the initial course for older adults 3–6 months after the second dose and for immunocompromised individuals 1–3 months after the second dose because these groups mount a weaker immune response compared to healthy adults. Where supplies are limited, the third dose for seniors should be given after achieving high coverage with two doses.


Manufacturing

As an
inactivated vaccine An inactivated vaccine (or killed vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then killed to destroy disease-producing capacity. In contrast, live vaccines use pathogens ...
like the Sinopharm BIBP vaccine and
Covaxin Covaxin (codenamed as BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. As of October 2021, 110.6 million ...
, CoronaVac uses a more traditional technology that is similar to the inactivated
polio vaccine Polio vaccines are vaccines used to prevent poliomyelitis (polio). Two types are used: an inactivated poliovirus given by injection (IPV) and a weakened poliovirus given by mouth (OPV). The World Health Organization (WHO) recommends all chil ...
. Initially, a sample of
SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a ...
from China was used to grow large quantities of the virus using
vero cell Vero cells are a lineage of cells used in cell cultures. The 'Vero' lineage was isolated from kidney epithelial cells extracted from an African green monkey (''Chlorocebus'' sp.; formerly called ''Cercopithecus aethiops'', this group of monkeys ha ...
s. From then on, the viruses are soaked in
beta-propiolactone β-Propiolactone is an organic compound of the lactone family, with a four-membered ring. It is a colorless liquid with a slightly sweet odor, highly soluble in water and miscible with ethanol, acetone, diethyl ether and chloroform.''Merck Index ...
, which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with the
adjuvant In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analgesic ...
aluminium hydroxide Aluminium hydroxide, Al(OH)3, is found in nature as the mineral gibbsite (also known as hydrargillite) and its three much rarer polymorphs: bayerite, doyleite, and nordstrandite. Aluminium hydroxide is amphoteric, i.e., it has both basic and ...
. CoronaVac does not need to be frozen, and both the vaccine and raw material for formulating the new doses could be transported and refrigerated at , temperatures at which flu vaccines are kept. CoronaVac could remain stable for up to three years in storage, which might offer some advantage in vaccine distribution to regions where cold chains are not developed. In November 2020, Brazil's
Instituto Butantan Instituto Butantan (in modern Portuguese, Instituto Butantã, ) is a Brazilian biologic research center located in Butantã, in the western part of the city of São Paulo, Brazil. Instituto Butantan is a public institution affiliated with the S ...
began building a facility to manufacture 100 million doses of CoronaVac a year, with a target completion date in September 2021. On 10 December, São Paulo Governor João Doria said that in the interim, prior to the local manufacture of CoronaVac, Instituto Butantan aimed to
fill and finish In the pharmaceutical industry, fill and finish (also referred to as fill finish, fill-finish or fill/finish) is the process of filling vials with vaccine , biological and pharmaceutical Drug Substances (DS) and finishing the process of packaging t ...
1 million doses of the vaccine per day. In April 2021, Sinovac said its third manufacturing plant for Coronavac was ready and had started manufacturing bulk vaccine ingredients, doubling its annual capacity to 2 billion doses. In April 2021,
Bio Farma PT Bio Farma (Persero) is an Indonesian state-owned enterprise based in Bandung, West Java and the only local vaccine manufacturer in Indonesia, which produces vaccines and sera to support immunization in Indonesia and other countries. Bio Fa ...
of Indonesia had filled and finished 35 million doses of CoronaVac, but was facing some production delays because of diminished supply of bulk delivered CoronaVac from China. In May 2021, Malaysian company Pharmaniaga obtained local approval for its fill and finish CoronaVac. In May 2021, Turkey was provided a license to produce CoronaVac. In May 2021, Hungary announced an agreement to fill and finish CoronaVac, with the goal to eventually manufacture it locally in a new plant in
Debrecen Debrecen ( , is Hungary's second-largest city, after Budapest, the regional centre of the Northern Great Plain region and the seat of Hajdú-Bihar County. A city with county rights, it was the largest Hungarian city in the 18th century and i ...
. In June 2021, Egypt announced that it will produce about 40 million doses by the end of the year. Distribution of the locally produced vaccine will begin by August and it will be used locally and sent to other African nations.


History


Clinical trials


Phase I–II

In April 2020, CoronaVac began Phase I–II trials in China with 744 participants on adults over the age 18-59, and In May, CoronaVac began Phase I–II trials in China with 422 participants on elderly adults over the age 60 and above. Preliminary results indicate that neutralizing antibodies fell below the seropositive threshold 6 to 8 months after the first two doses, and that a third dose given 6 or more months after the second dose raised neutralizing antibody levels beyond that of an initial course consisting of 3 doses. In the
Phase II trial The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...
completed in July 2020 published in ''
The Lancet ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles, ...
'', CoronaVac showed
seroconversion In immunology, seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization, including vaccination. During infection or immunization, antigens enter the blood, and the adaptive immune system ...
of neutralising antibodies for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group. Phase II results for older adults published in ''
The Lancet ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles, ...
'' showed CoronaVac was safe and well tolerated in older adults, with neutralising antibody induced by a 3 μg dose similar to those of a 6 μg dose.


Phase III

In July 2020, Sinovac began Phase III trials to evaluate efficacy and safety on 9,000 volunteer healthcare professionals in Brazil, collaborating with Butantan Institute. On 19 October,
São Paulo São Paulo (, ; Portuguese for 'Saint Paul') is the most populous city in Brazil, and is the capital of the state of São Paulo, the most populous and wealthiest Brazilian state, located in the country's Southeast Region. Listed by the GaWC a ...
Governor
João Doria João Agripino da Costa Doria Júnior (; born 16 December 1957) is a Brazilian politician, businessman and journalist who served as Governor of São Paulo, from January 2019 to March 2022. He previously served as the 52nd Mayor of São Paulo fr ...
said the first results of the clinical study conducted in Brazil proved that among the vaccines being tested in the country, CoronaVac is the safest, the one with the best and most promising immunization rates. On 23 October, São Paulo increased the number of volunteers in the trial to 13,000. Brazil briefly paused the trials on 10 November after the suicide of a volunteer before resuming them the next day. The suicide was unrelated to the vaccine trial. In August, a trial was started in Chile run by
Pontifical Catholic University of Chile The Pontifical Catholic University of Chile (''PUC or UC Chile'') ( es, Pontificia Universidad Católica de Chile) is one of the six Catholic Universities existing in the Chilean university system and one of the two pontifical universities i ...
which was expected to include 3,000 volunteers between the ages of 18 and 65. In August, Sinovac began trials in Indonesia with
Bio Farma PT Bio Farma (Persero) is an Indonesian state-owned enterprise based in Bandung, West Java and the only local vaccine manufacturer in Indonesia, which produces vaccines and sera to support immunization in Indonesia and other countries. Bio Fa ...
in
Bandung Bandung ( su, ᮘᮔ᮪ᮓᮥᮀ, Bandung, ; ) is the capital city of the Indonesian province of West Java. It has a population of 2,452,943 within its city limits according to the official estimates as at mid 2021, making it the fourth most ...
involving 1,620 volunteers. In September, Turkey began trials with 13,000 volunteers on a two-dose 14-day interval. The monitoring process took place at 25 centers in 12 cities across the country. In October, Sinovac began trials in China involving 1,040 volunteers. In April 2021, Sinovac began Phase II/III trials for the elderly aged 60–80 in the Philippines involving 352 volunteers.


Children and adolescents trials

In September 2020, Sinovac began Phase I–II trials in China on children and adolescents ages 3–17. In May 2021, Sinovac began Phase IIb trials in China with 500 participants for children and adolescents 3–17 years old. In June 2021, it was announced that the vaccine was safe and immunogenic in this age group. In July, Sinovac began Phase III trials in Chile with 14,000 participants for children and adolescents and expand from 6 months to 17 years old.


Results of Phase III trials

Peer-reviewed Phase III results from Turkey showed an efficacy of . The final efficacy rate was based on 41 infections, 32 of which had received a placebo. The vaccine prevented hospitalization and severe illness in 100% of cases, with all six people who were hospitalized in the placebo group. The final results were based on 10,218 participants in the trials. Phase III results from Brazil submitted to Lancet showed 50.7% efficacy at preventing symptomatic infections, 83.7% effective in preventing mild cases needing treatment. Efficacy against symptomatic infections increased to 62.3% with an interval of 21 days or more between the doses. A total of 12,396 volunteers participated in the study between 21 July and 16 December 2020. All participants received at least one dose of the vaccine or placebo. Of this total, 9,823 participants received both doses. Further detail published by Sinovac showed an efficacy against all symptomatic cases, against cases that require medical treatment, and against severe, hospitalized and fatal cases. In the placebo group (N=4870), there were 168 COVID cases, 30 cases requiring medical attention, and 10 severe cases including one death. In the vaccine group (N=4953), there were 85 COVID cases, 5 cases requiring medical attention, and no severe cases or deaths. On 1 April 2021, a preliminary report from a
phase III clinical trial The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...
in Chile revealed that CoronaVac is safe and induces
humoral Humoral immunity is the aspect of immunity that is mediated by macromolecules - including secreted antibodies, complement proteins, and certain antimicrobial peptides - located in extracellular fluids. Humoral immunity is named so because it invo ...
and
cell-mediated immunity Cell-mediated immunity or cellular immunity is an immune response that does not involve antibodies. Rather, cell-mediated immunity is the activation of phagocytes, antigen-specific cytotoxic T-lymphocytes, and the release of various cytokines in ...
in adults (18–59 years old) and the elderly (60 years or older) similar to previous phase II trials conducted in China with the same age groups and immunization schedule consisting of two doses with a 14-day interval. The side effects were mild and local, mainly limited to pain at the injection site, which was more common in adults.
Seroconversion In immunology, seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization, including vaccination. During infection or immunization, antigens enter the blood, and the adaptive immune system ...
rates for adults 14–28 days after the second dose were 95.6% for the
IgG Immunoglobulin G (Ig G) is a type of antibody. Representing approximately 75% of serum antibodies in humans, IgG is the most common type of antibody found in blood circulation. IgG molecules are created and released by plasma B cells. Each IgG ...
specific against the S1-RBD (
receptor Receptor may refer to: * Sensory receptor, in physiology, any structure which, on receiving environmental stimuli, produces an informative nerve impulse *Receptor (biochemistry), in biochemistry, a protein molecule that receives and responds to a ...
binding domain In molecular biology, binding domain is a protein domain which binds to a specific atom or molecule, such as calcium or DNA. A protein domain is a part of a protein sequence and a tertiary structure that can change or evolve, function, and live ...
of the S1 subunit of the
spike protein In virology, a spike protein or peplomer protein is a protein that forms a large structure known as a spike or peplomer projecting from the surface of an enveloped virus. as cited in The proteins are usually glycoproteins that form dimers or ...
) and 96% for
neutralizing A neutralizing antibody (NAb) is an antibody that defends a cell from a pathogen or infectious particle by neutralizing any effect it has biologically. Neutralization renders the particle no longer infectious or pathogenic. Neutralizing antibod ...
anti-S1-RBD IgG. For the elderly, seroconversion rates were 100% 14 days and 87.5% 28 days after the second dose for the S1-RBD specific IgG, 90% 14 days, and 100% 28 days after the second dose for neutralizing anti-S1-RBD IgG. As found in studies in animals, seroconversion rates for IgG specific against the N (
nucleocapsid A capsid is the protein shell of a virus, enclosing its genetic material. It consists of several oligomeric (repeating) structural subunits made of protein called protomers. The observable 3-dimensional morphological subunits, which may or may ...
)
protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, respo ...
were weak for both groups, although CoronaVac contains significant amounts of the N protein. A robust increase of
T helper cells The T helper cells (Th cells), also known as CD4+ cells or CD4-positive cells, are a type of T cell that play an important role in the adaptive immune system. They aid the activity of other immune cells by releasing cytokines. They are considere ...
(CD4+) secreting
interferon gamma Interferon gamma (IFN-γ) is a dimerized soluble cytokine that is the only member of the type II class of interferons. The existence of this interferon, which early in its history was known as immune interferon, was described by E. F. Wheelock ...
was detected 14 days after both doses in response to stimulation with peptides of the S protein and of other viral particles, but the response to S protein peptides was reduced in the elderly due to a natural reduction of activated CD4+ T cells in this age group, as found in studies of other vaccines. The immune response of
cytotoxic T cell A cytotoxic T cell (also known as TC, cytotoxic T lymphocyte, CTL, T-killer cell, cytolytic T cell, CD8+ T-cell or killer T cell) is a T lymphocyte (a type of white blood cell) that kills cancer cells, cells that are infected by intracellular pa ...
(CD8+) was not as robust. The observed CD4+ T cell response is considered a balanced immune response capable of viral clearance and is similar to that observed in other COVID-19 vaccines, such as BNT162b1 and
Convidecia AD5-nCOV, trade-named Convidecia, is a single-dose viral vector vaccine for COVID-19 developed by CanSino Biologics. It conducted its Phase III trials in Argentina, Chile, Mexico, Pakistan, Russia, and Saudi Arabia with 40,000 participants. I ...
.


Variability in results

In early January 2021, Brazilian health officials announced that the vaccine had an efficacy of 78%. One week later, they revised this figure to 50.4%, stating that the revised figure now included "very mild" cases of COVID-19 among trial participants which were omitted in the earlier analysis. Ricardo Palácios, Medical Director of Brazil's
Instituto Butantan Instituto Butantan (in modern Portuguese, Instituto Butantã, ) is a Brazilian biologic research center located in Butantã, in the western part of the city of São Paulo, Brazil. Instituto Butantan is a public institution affiliated with the S ...
, said Sinovac's relatively low efficacy rate of 50% was due to more rigorous standards for what counted as an infection among trial participants. The Institute split cases in six categories: asymptomatic, very mild, mild, two levels of moderate, and severe; the first two didn't require medical assistance. Possible explanations for lower efficacy rate included: trial was largely made up of frontline health care workers who were more exposed to the virus; two vaccine doses were given at shorter intervals (2 weeks); counting very mild cases; and the Gamma variant (lineage P.1), more transmissible and perhaps evaded immunity better, was circulating. According to Instituto Butantan director Dimas Covas, the Brazilian group was considered more vulnerable to infection and exposure to higher viral loads. In Turkish and Indonesian Phase III trials, the composition of volunteers was similar to that of the general population.


Variants

On 10 March,
Instituto Butantan Instituto Butantan (in modern Portuguese, Instituto Butantã, ) is a Brazilian biologic research center located in Butantã, in the western part of the city of São Paulo, Brazil. Instituto Butantan is a public institution affiliated with the S ...
Director Dimas Covas said CoronaVac was efficacious against three variants of COVID-19 in the country;
Alpha Alpha (uppercase , lowercase ; grc, ἄλφα, ''álpha'', or ell, άλφα, álfa) is the first letter of the Greek alphabet. In the system of Greek numerals, it has a value of one. Alpha is derived from the Phoenician letter aleph , whic ...
(lineage B.1.1.7),
Beta Beta (, ; uppercase , lowercase , or cursive ; grc, βῆτα, bē̂ta or ell, βήτα, víta) is the second letter of the Greek alphabet. In the system of Greek numerals, it has a value of 2. In Modern Greek, it represents the voiced labiod ...
(lineage B.1.351), and lineage B.1.1.28 (identified in Brazil), from which
Gamma Gamma (uppercase , lowercase ; ''gámma'') is the third letter of the Greek alphabet. In the system of Greek numerals it has a value of 3. In Ancient Greek, the letter gamma represented a voiced velar stop . In Modern Greek, this letter re ...
and Zeta (lineages P.1 and P.2) descend. Preliminary results from a large study of health care workers suggest one dose of CoronaVac is still about 50% effective against symptomatic COVID-19 in Manaus. In April 2021, it was reported that over 75% of new cases were being caused by the highly transmissible Gamma variant. In June, Thailand's Public Health Ministry stated the vaccine had 71%-91% efficacy against infection by the
Alpha Alpha (uppercase , lowercase ; grc, ἄλφα, ''álpha'', or ell, άλφα, álfa) is the first letter of the Greek alphabet. In the system of Greek numerals, it has a value of one. Alpha is derived from the Phoenician letter aleph , whic ...
strain. In June 2021,
Reuters Reuters ( ) is a news agency owned by Thomson Reuters Corporation. It employs around 2,500 journalists and 600 photojournalists in about 200 locations worldwide. Reuters is one of the largest news agencies in the world. The agency was estab ...
reported that more than 350 Indonesian doctors and medical workers out of 5,000 in Kudus contracted the
Delta Delta commonly refers to: * Delta (letter) (Δ or δ), a letter of the Greek alphabet * River delta, at a river mouth * D ( NATO phonetic alphabet: "Delta") * Delta Air Lines, US * Delta variant of SARS-CoV-2 that causes COVID-19 Delta may also ...
strain despite being vaccinated with the CoronaVac, an infection rate of 7%. In response,
Griffith University Griffith University is a public research university in South East Queensland on the east coast of Australia. Formally founded in 1971, Griffith opened its doors in 1975, introducing Australia's first degrees in environmental science and Asian s ...
epidemiologist Dicky Budiman questioned the efficacy of CoronaVac against the variant but overall still recommended that people take the vaccine, expressing "confidence that to a certain degree Sinovac has effectiveness against the new variant". He stated that the situation was due to various factors, including a "lack of proper protective gear and the overall situation in Indonesia". The vast majority of those infected were protected from severe symptoms and recovered without hospitalization.


Authorizations

The
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(WHO) validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use on 1 June 2021. The recommendation was given with limited evidence at the time of approval for groups other than healthy adults. The WHO
Strategic Advisory Group of Experts The Strategic Advisory Group of Experts (SAGE) is the principal advisory group to World Health Organization (WHO) for vaccines and immunization. Established in 1999 through the merging of two previous committees, notably the Scientific Advisory Grou ...
expressed high level of confidence in the efficacy of the vaccine for adults, moderate confidence in the efficacy for older adults and individuals with comorbidities, moderate confidence in its safety for adults and low confidence in its safety for the elderly and individuals with comorbidities. In late August 2020, China approved CoronaVac for emergency use to vaccinate high-risk groups such as medical staff. In early February, China approved CoronaVac for general use. On 5 June 2021, China approved CoronaVac for emergency use with children and adolescents for 3–17 years old. In January 2021, Bolivia authorized use of CoronaVac. In April, Panama approved emergency use of Coronavac. On 4 May, the EMA's human medicines committee (CHMP) started a rolling review of CoronaVac. In June, Bangladesh approved Coronavac for emergency use.


Society and culture


Economics

As of 7 July 2021, CoronaVac is the most widely used COVID-19 vaccine in the world, with 943 million doses delivered globally. In July, Sinovac signed advanced purchase agreements with
GAVI GAVI, officially Gavi, the Vaccine Alliance (previously the GAVI Alliance, and before that the Global Alliance for Vaccines and Immunization) is a public–private global health partnership with the goal of increasing access to immunization ...
to supply
COVAX COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Hea ...
with 50 million doses in the third quarter of 2021 and up to a total of 380 million doses by the first half of 2022.


Asia

In January, Azerbaijan launched its vaccination campaign with CoronaVac. It purchased 4 million doses from Turkey and 5 million doses from China. In May, Armenia received 100,000 doses from China. In February, Cambodia approved Coronavac for emergency use and started vaccinations in March. By July, the country had received 10.5 million doses. In October, Saudi Arabia signed an agreement to distribute CoronaVac to 7,000 healthcare workers, after conducting Phase III trials with the
Saudi Arabian National Guard The Saudi Arabian National Guard or SANG ( ar, الحَرَس الوَطنيّ, al-Ḥaras al-Waṭanī), also known as the "White Army", is one of the three major branches of the military forces of the Kingdom of Saudi Arabia. The national gua ...
. In November, Turkey signed a contract to buy 50 million doses of CoronaVac. Turkey approved emergency use on 13 January and President
Recep Tayyip Erdoğan Recep Tayyip Erdoğan (born 26 February 1954) is a Turkish politician serving as the List of presidents of Turkey, 12th and current president of Turkey since 2014. He previously served as prime minister of Turkey from 2003 to 2014 and as Lis ...
received his first dose at Ankara City Hospital. In February, Turkey signed a deal for another 50 million doses for a total of 100 million doses. By March 10.7 million doses had been administered, and 852 of the 1.3 million people who had received both doses were later diagnosed with the disease. 53 were hospitalized, but none of those hospitalized were intubated or died. In December, Hong Kong ordered 7.5 million doses of CoronaVac. The vaccination campaign with CoronaVac began on 26 February. By December 2020, Indonesia had signed agreements for 140 million doses of CoronaVac. Indonesia approved emergency use authorization on 11 January and President
Joko Widodo Joko Widodo (; born 21 June 1961), popularly known as Jokowi, is an Indonesian politician and businessman who is the 7th and current president of Indonesia. Elected in July 2014, he was the first Indonesian president not to come from an elite ...
received the first shot of the vaccine. By June, Indonesia had received 118.7 million bulk doses. In January, Malaysia ordered 12 million doses which was approved for emergency use in March. Science, Technology and Innovation Minister
Khairy Jamaluddin Khairy Jamaluddin Abu Bakar ( Jawi: ; born 10 January 1976) is a Malaysian politician. He most recently served as Minister of Health in the Barisan Nasional (BN) administration under former Prime Minister Ismail Sabri Yaakob from August 2021 t ...
received the first dose as part of the vaccination campaign. In March, Kazakhstan ordered 3 million doses, of which 500,000 doses arrived in June and has been approved for use by the Ministry of Health. In May, Oman received its first batch of the vaccine. In April, Pakistan granted emergency use authorization for CoronaVac and received 14.5 million doses by July. In January, the Philippines announced the country had secured 25 million doses. The vaccine was approved on 22 February but not for all health workers as it had lower efficacy when used with health workers compared to healthy individuals aged 18–59. The first 600,000 doses of CoronaVac arrived on 28 February, and the country had received 7.5 million doses by June. Singapore signed advance purchase agreements for CoronaVac. In February, the first doses arrived and in June it was approved for use under the Special Access Route. In May, Tajikistan's Ministry of Health announced it would receive 150,000 doses. In February, Thailand approved emergency use and started its vaccination program on 27 February. As of June, Thailand had received 10.5 million doses. In May 2021, Georgia began vaccinations with CoronaVac, for which it received 1 million doses by July. In May 2021, Turkmenistan received a delivery of CoronaVac. In May 2021, AKIPress reported Uzbekistan plans to use CoronaVac. In October 2021, Singapore included CoronaVac in its National Vaccination Programme for people aged 18 and over who are ineligible for
mRNA vaccine An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into immune cells, which use the designed mRNA as a blueprin ...
s due to allergies or serious adverse reactions after the first dose.


Africa

In March, Benin received 203,000 doses of CoronaVac and started vaccinations on 29 March prioritizing healthcare workers, people over 60, and those with co-morbidities. In April, Botswana received 200,000 doses of CoronaVac as a donation and purchased an additional 200,000 doses to be used in the vaccination program. In March, Djibouti received 300,000 doses of CoronaVac. In April, Egypt approved emergency use of CoronaVac. In April, Guinea received 300,000 doses of CoronaVac which it had purchased. In April, Libya received 150,000 doses of CoronaVac from Turkey. In April, Somalia received 200,000 doses of CoronaVac. In July, South Africa approved CoronaVac for emergency use, and was expected to receive 2.5 million doses shortly. In April, Togo received 200,000 doses of CoronaVac. In March, Tunisia's Ministry of Health approved marketing authorization for CoronaVac and the first 200,000 doses arrived on 25 March. In March, Zimbabwe approved emergency use and the first 1 million doses arrived on 30 March.


Europe

In March, Albania launched its vaccination campaign using mainly CoronaVac, a week after securing 1 million doses from Turkey. By June, Northern Cyprus received 190,000 doses donated by Turkey. In March, Bosnia received 30,000 doses donated by Turkey. In June, North Macedonia received 30,000 doses donated by Turkey and another 500,000 doses it purchased. In March, Ukraine granted approval for use of CoronaVac. Ukrainian Pharmaceutical Company Lekhim has an agreement to deliver 5 million doses. 1.7 million doses had been delivered by June. In April, Moldova purchased 400,000 doses of CoronaVac.


South America

In Brazil, São Paulo governor
João Doria João Agripino da Costa Doria Júnior (; born 16 December 1957) is a Brazilian politician, businessman and journalist who served as Governor of São Paulo, from January 2019 to March 2022. He previously served as the 52nd Mayor of São Paulo fr ...
signed a $90 million contract with Sinovac in September to receive the initial 46 million doses of CoronaVac. The price for CoronaVac was announced to be US$10.3 (about R$59). In January, Brazil announced it would obtain 100 million total doses. On 17 January, Brazil's health regulatory agency
Anvisa Brazilian Health Regulatory Agency ( pt, Agência Nacional de Vigilância Sanitária, links=no, italics=yes, ''Anvisa'', literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during Presi ...
approved emergency use of CoronaVac. In early February, Brazil said it intends to buy an additional 30 million doses on top of existing 100 million doses. A total of 39.7 million doses had been delivered by early April. In October, Chile signed an agreement to purchase 20 million doses of CoronaVac which was approved for emergency use on 20 January. By early March, the country had received 10 million doses of CoronaVac and had vaccinated 4.1 million people. In February, Colombia had purchased 5 million doses and was in talks for an additional 5 million doses, which had been approved for emergency use on 5 February. In February, Ecuador signed a deal for 2 million doses which was approved for emergency use, with the first 1 million doses arrived in early April. In March, Paraguay received a donation of 20,000 doses from Chile. Paraguay began vaccinations with CoronaVac on 10 March. In January, Uruguay purchased 1.75 million doses, of which the first 192,000 doses arrived on 25 February and vaccinations started on 1 March.


North America

By June 2021, Dominican Republic had received 7.8 million doses of an order for 10 million doses. In March 2021, El Salvador received 1 million doses of a total 2 million dose order for CoronaVac. The immunization campaign was initially focused on teachers, health professionals, firefighters, police, and military personnel. The first doses were provided to public school teachers beginning on March 30, with rollout expanding to private school teachers shortly after. Vaccination of the general public was planned for April 15, after the vaccination of the priority groups. In February 2021, Mexico approved emergency use of CoronaVac. The country had ordered 20 million doses by March 2021, of which 7 million had been received by May.


Oceania

In March, Fiji said it would be receiving a donation of CoronaVac.


Controversies


China state media propaganda

In January 2021, as part of a misinformation campaign, multiple Chinese state and CCP-affiliated media outlets, including CGTN and the ''
Global Times The ''Global Times'' () is a daily tabloid newspaper under the auspices of the Chinese Communist Party's flagship newspaper, the ''People's Daily'', commenting on international issues from a Chinese ultra-nationalistic perspective. The publi ...
,'' have touted CoronaVac and Chinese vaccines as "relatively safer due to their mature technology". Pushing back against concerns of CoronaVac efficacy over the lack of transparency over releasing test results, China state media have raised doubts about the efficacy of the Pfizer–BioNTech vaccine, calling for an investigation into the deaths of elderly people in Norway and Germany after receiving the vaccine. According to Reuters, the reports made allegations of "deliberately downplaying the deaths” and “using propaganda power to promote the Pfizer vaccine and smearing Chinese vaccines". According to a ''Ming Pao'' report published on 21 March 2022, of the 1,486 who died of COVID-19 after receiving at least one dose, 1,292 of them or 87%—had gotten the Sinovac vaccine. The Centre for Health Protection’s Chuang Shuk-kwan said that the ''Ming Pao'' report was inaccurate and has defended CorovaVac, saying “The issue is not about which jab offers more protection. The most important thing is whether you get vaccinated.” Earlier in February 2022, health authorities refused to disclose data on which Covid-19 vaccine had been taken by Omicron patients, claiming the information “was not readily available.” Hong Kong government data showed CoronaVac to be the preferred vaccine among those aged 70 and over, in part because some elderly care homes only offer this vaccine. However, CoronaVac's limited effectiveness compared to the BioNTech vaccine, along with the zero-COVID strategy, have been regarded as factors behind Hong Kong's spiking cases as of March 2022.


Politicization

CoronaVac has been championed by the governor of
São Paulo São Paulo (, ; Portuguese for 'Saint Paul') is the most populous city in Brazil, and is the capital of the state of São Paulo, the most populous and wealthiest Brazilian state, located in the country's Southeast Region. Listed by the GaWC a ...
,
João Doria João Agripino da Costa Doria Júnior (; born 16 December 1957) is a Brazilian politician, businessman and journalist who served as Governor of São Paulo, from January 2019 to March 2022. He previously served as the 52nd Mayor of São Paulo fr ...
. A political showdown began in October 2020, when Bolsonaro vetoed a deal between the Brazilian health ministry and the São Paulo government for the purchase of 46 million doses of the vaccine. After Instituto Butantan announced CoronaVac's efficacy rate, Bolsonaro mocked the vaccine's effectiveness against COVID-19. In March 2021, the Paraná Pesquisas opinion polling institute found that the vaccines preferred by Brazilians are CoronaVac and the Oxford–AstraZeneca vaccine, chosen by 23.6% and 21.2% of Brazilians interviewed, respectively, against 11.3% of those who would prefer the Pfizer–BioNTech vaccine. During the pandemic parliamentary inquiry in Brazil, senators have expressed that anti-China rhetoric has contributed to delaying access to vaccines in Brazil.


Delays in releasing results

On 23 December 2020, researchers in Brazil said the vaccine was more than 50% effective, but withheld full results at Sinovac's request, raising questions about transparency as it was the third delay in releasing results from the trials. Scientists said the lack of transparency risked damaging CoronaVac's credibility.


References


Further reading

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External links


Clinical Research Protocol for CoronaVac Phase III Trials in Brazil
* * * * {{DEFAULTSORT:Coronavac Clinical trials Chinese COVID-19 vaccines Inactivated vaccines Products introduced in 2020