CoronaVac

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CoronaVac
SINOVAC COVID-19 vaccine.jpg
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Trade namesCoronaVac
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank

CoronaVac, also known as the Sinovac COVID-19 vaccine,[1] is an inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.[2] It was in Phase III clinical trials in Brazil,[3] Chile,[4] Indonesia,[5] the Philippines,[6] and Turkey.[7] It relies on traditional technology similar to BBIBP-CorV and BBV152, other inactivated-virus COVID-19 vaccines in Phase III trials.[8] 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 2–8 °C (36–46 °F), temperatures at which flu vaccines are kept.[9]

A real-world study of millions of Chileans who received CoronaVac found it 67% effective against symptoms, reduced hospitalizations by 85%, intensive care visits by 89%, and deaths by 80%.[10] In Indonesia, real world data showed 94% of inoculated health care workers protected against symptomatic infection by the vaccine, beating results in clinical trials.[11] Phase III results from Brazil had previously showed 50.7% efficacy at preventing symptomatic infections and 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.[12] Final Phase III results from Turkey announced on 3 March 2021 showed an efficacy of 84%.[10]

Politicization, transparency issues and some incomplete trial data in Brazil contributed to a lack of trust in CoronaVac there.[13][14][15]

CoronaVac is being used in vaccination campaigns by certain countries in Asia,[16][17][18] South America,[19][20][21] North America,[22][23][24] and Europe.[25][26][27] In April, Sinovac had a production capacity of 2 billion doses a year[28] and had delivered 300 million total doses.[29] It is currently being manufactured at several facilities in China,[28] with planned overseas manufacture in Brazil in September 2021[30] and eventually in Egypt.[31]

Technology[edit]

As an inactivated vaccine like BBIBP-CorV and BBV152, CoronaVac uses a more traditional technology[32][8] that is similar to the inactivated polio vaccine. Initially, a sample of SARS-CoV-2 from China was used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone, which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with an aluminium-based adjuvant.[33]

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 2–8 °C (36–46 °F), temperatures at which flu vaccines are kept.[9] 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.[34]

Efficacy[edit]

Empty bottle of CoronaVac

A real-world study of millions of Chileans who had received CoronaVac found it 67% effective against symptoms, reduced hospitalizations by 85%, intensive care visits by 89%, and deaths by 80%. The study covered 10.5 million people. It counted cases starting 14 days after application of the second dose of the vaccine, which in Chile was given 28 days after the first. It is one of the broadest studies so far published of any of the vaccines used against the new coronavirus.[10]

May 2021 reports from real-world data in Indonesia provided more encouraging results. According to Pandji Dhewantara, the health ministry official who oversaw the study, 94% of inoculated health care workers had been protected against symptomatic infection by the vaccine, besting results in clinical trials.[11] In this study, 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.[35][36]

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 July 21 and December 16, 2020. All participants received at least one dose of the vaccine or placebo. Of this total, 9,823 participants received both doses.[12] Further detail published by Sinovac showed an efficacy 50.65% (95% CI, 35.6662.15%) against all symptomatic cases, 83.70% (57.9993.67%) against cases that require medical treatment, and 100.00% (56.37100.00%) 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.[37]

Phase III results from Turkey showed an efficacy of 84%. 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 13,000 participants in the trials.[10]

On 1 April 2021, a preliminary report[38] from a phase III clinical trial in Chile[39] revealed that CoronaVac is safe and induces humoral and cell-mediated immunity 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 adverse effects were mild and local, mainly limited to pain at the injection site, which was more common in adults. Seroconversion rates for adults 14–28 days after the second dose were 95.6% for the IgG specific against the S1-RBD (receptor binding domain of the S1 subunit of the spike protein) and 96% for neutralizing 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) protein were weak for both groups, although CoronaVac contains significant amounts of the N protein. A robust increase of T helper cells (CD4+) secreting interferon gamma 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 (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.

Variability in results[edit]

Officials in Brazil said the lowered figure of 50.4% included "very light" cases of COVID-19 among participants omitted in the earlier analysis. Ricardo Palácios, Medical Director of Brazil's Instituto Butantan, said Sinovac's relatively low efficacy rate of 50% was due to more rigorous standards for what counts as an infection among trial participants. The Institute included six types of cases in its results: asymptomatic, very mild, mild, two levels of moderate, and severe, while western vaccine makers generally included only mild, moderate, and severe categories. Brazil's trial was also largely made up of frontline health care workers. "They are more exposed to the virus and may explain the relatively low efficacy rate," said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations.[40]

The release of more definitive data on CoronaVac's efficacy was delayed because Sinovac needed to reconcile results from different trials using varying protocols.[14] 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.[41]

COVID-19 variants[edit]

On March 10, Instituto Butantan Director Dimas Covas said CoronaVac was efficient against three variants of COVID-19 in the country; British B.1.1.7, South African 501.V2, and Brazil's B.1.1.28, from which variants P.1 from Manaus, and P.2 from Rio de Janeiro are derived.[42]

CoronaVac and other inactivated virus vaccines have all parts of the virus. Butantan said this may generate a more comprehensive immune response compared to other vaccines using only a part of the spike protein used by COVID-19 to infect cells.[42] 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 where over 75% of new cases are caused by the highly transmissible P.1 variant.[43]

Clinical trials[edit]

Phase I–II[edit]

In the Phase II trial completed in July 2020 published in The Lancet, CoronaVac showed seroconversion 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.[44]

In May, CoronaVac began Phase I–II trials in China on adults over the age 60, and in September CoronaVac began Phase I–II trials in China on children ages 3–17.[45] Phase II results for older adults published in The Lancet 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.[46]

Phase III[edit]

Latin America[edit]

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.[47][48] On 19 October, São Paulo Governor João Doria 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.[49] On 23 October, São Paulo increased the number of volunteers in the trial to 13,000.[50]

Brazil briefly paused the trials on 10 November after the suicide of a volunteer before resuming them on 11 November. Instituto Butantan said the suicide had no relation to the vaccine trial.[51][52]

In August, a trial was started in Chile run by Pontifical Catholic University of Chile which was expected to include 3,000 volunteers between the ages of 18 and 65.[4]

Europe[edit]

In September, Turkey began trials with 13,000 volunteers on a two-dose 14-day interval.[53] The monitoring process took place at 25 centers in 12 cities across the country.[54]

The Governor of West Java Ridwan Kamil participating in phase 3 trial of the Sinovac COVID-19 vaccine in Indonesia.

Asia[edit]

In August, Sinovac began trials in Indonesia with Bio Farma in Bandung involving 1,620 volunteers.[5]

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.[55]

Manufacturing[edit]

Brazilian version of CoronaVac, filled and finished by Instituto Butantan

In April, 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.[28]

In November, Brazil's Instituto Butantan began building a facility to manufacture 100 million doses of CoronaVac a year, with a target completion date in September 2021.[56] 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 1 million doses of the vaccine per day.[30]

In Egypt, the government approved a manufacturing agreement to make 80 million doses a year for domestic use and export to African countries.[31]

In Indonesia, Bio Farma had by April 2021 filled and finished 35 million doses of CoronaVac, but was facing some production delays because of diminished supply of bulk delivered CoronaVac from China.[57]

Meanwhile in Malaysia, Pharmaniaga has obtained local approval for its fill and finish CoronaVac.[58]

In May 2021, Turkey was provided a license to produce CoronaVac.[59]

Market and deployment[edit]

  Full authorization
  Emergency authorization
  Eligible COVAX recipient (ongoing assessment)[60]

By May, 300 million doses of CoronaVac had been delivered to all countries.[29]

Asia[edit]

On 19 January, Azerbaijan launched its vaccination campaign with CoronaVac. Azerbaijan plans to receive 4 million doses and aims to vaccinate 40% of the population.[61]

In May, Armenia received 100,000 doses from China.[62]

In February, Cambodia approved Coronavac for emergency use[63] and started vaccinations in March.[64] The country had received 2 million doses by May[65] and ordered another 5 million doses.[66]

In late August, China approved CoronaVac for emergency use to vaccinate high-risk groups such as medical staff.[67] In early February, China approved CoronaVac for general use.[18]

In December, Hong Kong ordered 7.5 million doses of CoronaVac.[68] The vaccination campaign with CoronaVac began on 26 February.[69]

In August, Indonesia signed an agreement for 50 million doses[70] which later increased to 140 million doses.[71] Indonesia approved emergency use authorization on 11 January and[72] President Joko Widodo received the first shot of the vaccine, which would be free for all Indonesian citizens. Clinical trials in Indonesia showed that Coronvac was 65% effective against all symptomatic cases, which exceeds the requirement of 50% effectiveness established by the WHO.[16] By April, Indonesia had received 59.5 million bulk doses of CoronaVac.[73]

In January, Malaysia ordered 12 million doses[74] which was approved for emergency use in March.[75] Science, Technology and Innovation Minister Khairy Jamaluddin received the first dose as part of the vaccination campaign.[76]

In April, Pakistan granted emergency use authorization for CoronaVac[77] and purchased 5 million doses.[78]

In January, the Philippines announced the country had secured 25 million doses.[79] 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,[80] and the country had received 5 million doses by early May.[81]

Singapore has signed advance purchase agreements for CoronaVac.[82] In February, the first doses arrived in the country.[83]

In February, Thailand approved emergency use[84] and started its vaccination program on 27 February.[17] As of May, Thailand had received 3.5 million doses with another 2 million to arrive later that month.[85]

In May 2021, Turkmenistan received a delivery of CoronaVac.[86]

In May 2021, AKIPress reported Uzbekistan plans to use CoronaVac.[87]

Africa[edit]

In March, Benin received 203,000 doses of CoronaVac[88] and started vaccinations on March 29 prioritizing healthcare workers, people over 60, and those with co-morbidities.[89]

In April, Botswana received 200,000 doses of CoronaVac as a donation and purchased an additional 200,000 doses.[90]

In March, Djibouti received 300,000 doses of CoronaVac.[91]

In April, Egypt approved emergency use of CoronaVac.[92]

In April, Guinea received 300,000 doses of CoronaVac which it had purchased.[93]

In April, Libya received 150,000 doses of CoronaVac from Turkey.[94]

In April, Somalia received 200,000 doses of CoronaVac.[95]

In March, South Africa's drug regulator began assessing CoronaVac for use in the country.[96] South African firm Numolux said it could supply 5 million doses once it secured regulatory clearances.[97]

In April, Togo received 200,000 doses of CoronaVac.[98]

In March, Tunisia's Ministry of Health approved marketing authorization for CoronaVac[99] and the first 200,000 doses arrived on March 25.[100]

In March, Zimbabwe approved emergency use[101] and the first 1 million doses arrived on March 30.[102]

Europe[edit]

In November, Turkey signed a contract to buy 50 million doses of CoronaVac.[103] Turkey approved emergency use on 13 January[104] and President Recep Tayyip Erdoğan received his first dose at Ankara City Hospital.[105] In February, Turkey signed a deal for another 50 million doses for a total of 100 million doses.[25] 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.[106]

In March, Albania launched its vaccination campaign using mainly CoronaVac,[27] a week after securing 1 million doses from Turkey.[107]

By March, Northern Cyprus received 80,000 doses donated by Turkey.[108]

In March, Bosnia received a donation of 30,000 doses from Turkey.[109]

In April, Georgia received 100,000 doses from China.[110]

In March, Ukraine granted approval for use of CoronaVac. Ukrainian Pharmaceutical Company Lekhim has an agreement to deliver 5 million doses.[111] Vaccinations began on April 13[26] and 1.2 million doses were delivered by May.[112]

In April, Moldova purchased 400,000 doses of CoronaVac.[113]

On the 4th of May, the EMA's human medicines committee (CHMP) started a rolling review of CoronaVac.[114]

South America[edit]

São Paulo State Secretary of Health Jean Gorinchteyn (left) and Instituto Butantan chairman Dimas Covas (right) holding single-dose prefilled syringes of CoronaVac, part of the fourth shipment of Sinovac-manufactured vaccine to arrive in Brazil

In Brazil, São Paulo governor João Doria signed a $90 million contract with Sinovac in September to receive the initial 46 million doses of CoronaVac.[115] The price for CoronaVac was announced to be US$10.3 (about R$59).[116] In January, Brazil announced it would obtain 100 million total doses.[117] On 17 January, Brazil's health regulatory agency Anvisa approved emergency use of CoronaVac.[118] In early February, Brazil said it intends to buy an additional 30 million doses on top of existing 100 million doses.[19] A total of 39.7 million doses had been delivered by early April.[119]

In January, Bolivia authorized use of CoronaVac.[120]

In October, Chile signed an agreement to purchase 20 million doses of CoronaVac[121] which was approved for emergency use on 20 January.[122] By early March, the country had received 10 million doses of CoronaVac and had vaccinated 4.1 million people.[123]

In February, Colombia had purchased 5 million doses and was in talks for an additional 5 million doses,[124] which had been approved for emergency use on February 5.[125]

In February, Ecuador signed a deal for 2 million doses which was approved for emergency use,[126] with the first 1 million doses arrived in early April.[127][128]

In March, Paraguay received a donation of 20,000 doses from Chile.[129] Paraguay began vaccinations with CoronaVac on March 10.[130]

In January, Uruguay purchased 1.75 million doses,[131] of which the first 192,000 doses arrived on 25 February and vaccinations started on 1 March.[21]

North America[edit]

By March 8, Dominican Republic had vaccinated 400,000 people and had reserved delivery for 10 million additional doses of CoronaVac.[23]

In March, El Salvador received 1 million doses of a total 2 million dose order for CoronaVac. Public sector teachers would receive the first dose between March 30 and April 5.[24]

In February, Mexico approved emergency use of CoronaVac.[132] The country has ordered 20 million doses,[133] of which the first 200,000 doses arrived in February[134] and are being used in the vaccination campaign.[22]

In April, Panama approved emergency use of Coronavac.[135]

Oceania[edit]

In March, Fiji said it would be receiving a donation of CoronaVac.[136]

Controversies[edit]

Politicization and public opinion[edit]

CoronaVac has been championed by the governor of São Paulo, João Doria.[137] 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.[138] After Instituto Butantan announced CoronaVac's efficacy rate, Bolsonaro mocked the vaccine's effectiveness against COVID-19.[139] Critics warned that politicization of vaccines can increase people's hesitancy to inoculation.[137]

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.[140] In April 2021, Fernando Reinach, a biochemist at the University of São Paulo, said that with an efficacy rate of 50% for CoronaVac, "you can't expect, even if the entire population is vaccinated, that cases will disappear." Microbiologist Natália Pasternak said, "People already look at this vaccine like 'second best'."[141]

Delays in releasing results[edit]

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.[15] When São Paulo state officials announced the protection rate, they declined to provide a more detailed breakdown of the trial, such as information about age groups and side effects of the vaccine.[14] Scientists said the lack of transparency about the data ran the risk of damaging CoronaVac's credibility, with Brazilians and others world-wide already reluctant to take it.[13]

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