CoronaVac

CoronaVac is a COVID-19 vaccine developed by the Chinese biopharmaceutical company Sinovac.[1] Phase III clinical trials[2][3] began in mid-2020 in Brazil, Chile, Indonesia and Turkey. CoronaVac is an inactivated virus vaccine, a more traditional technology shared by BBIBP-CorV and BBV152, other inactivated-virus vaccines for COVID-19 in Phase III trials.[4][5]

CoronaVac
Vaccine description
Target diseaseCOVID-19
TypeInactivated SARS-CoV-2
Clinical data
Routes of
administration		Intramuscular injection
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank
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Brazil announced, on 12 January 2021, an efficacy rate of 50.38% based on full data of a trial with 12,508 participants, almost 30% lower than previously announced, barely enough to get WHO and Brazilian approval.[6][7][8] The local trial partner, Instituto Butantan, said the lower figure was due to more rigorous standards of infection counting compared to other vaccine makers.[9] On 7 January 2021, Instituto Butantan announced the vaccine was 78% effective in mild cases and 100% effective against severe and moderate infections based on 220 COVID-19 cases from 13,000 volunteers.[10][11] Politicization, transparency issues, and missing details in trial data have contributed to a lack of trust in CoronaVac among Brazilian scholars.[11]

Turkey had previously announced an efficacy rate of 91.25% from interim analysis of 29 cases based only on the data of 1,322 participants in a trial with 7,371 volunteers.[12][13][14][15] Indonesia announced an efficacy rate of 65.3% based on data from just 1,600 participants in the city of Bandung.[8][16]

Technology

CoronaVac is an inactivated vaccine. It uses a similar, more traditional technology as in BBIBP-CorV and BBV152, other inactivated-virus vaccines for COVID-19 in Phase III trials.[5][4] 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.[17] 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.[18]

Efficacy
Empty bottle of CoronaVac

On 7 January 2021, results from Phase III trials in Brazil among 13,000 volunteers revealed the vaccine was 78% effective in preventing symptomatic cases of COVID-19 requiring medical assistance (grade 3 on the WHO Clinical Progression Scale[19]) and 100% effective against moderate and severe infections,[20] although the difference between the placebo and vaccine groups was not significant in this respect due to the very small number of events. After mounting pressure from scientists, with some accusing the trial organizers of misleading the public, Butantan said on 12 January that these rates only included volunteers who had mild to severe cases of COVID-19.[8] The overall efficacy, including asymptomatic cases and symptomatic cases not requiring medical assistance (WHO grade 2), was 50.38%.[21] Of the 220 participants infected, 160 cases were in the placebo group and 60 cases in the group that received CoronaVac.[10]

On 24 December 2020, Turkey released Phase III results from an interim analysis of 29 cases which showed an efficacy rate of 91.25% based only on the data of 1,322 participants in a trial involving 7,371 volunteers.[14][15][12][13]

On 11 January, Indonesia released Phase III results from an interim analysis of 25 cases which showed an efficacy rate of 65.3% based on data of 1,600 participants in the trial.[16] The trial was conducted in the city of Bandung, and it was not clear how Indonesian scientists made their calculations.[8]

Variability in efficacy across different trials

Officials said the lowered figure of 50.4% included "very light" cases of COVID-19 among participants omitted in the earlier analysis. At a press conference on 12 January, Ricardo Palácios, Medical Director of 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.[9]

Brazilian health regulator Anvisa, which stipulated an efficacy rate of at least 50% for COVID-19 vaccines, had been pressuring Instituto Butantan to release more details since the request for emergency use was filed on 8 January.[22] However, as of 13 January, neither Sinovac nor Butantan had released all the details of the trial data to the public.[9]

The release of more definitive data on CoronaVac's efficacy was delayed because Sinovac needed to reconcile results from different trials using varying protocols.[10] 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.[23]

Clinical trials
For broader coverage of this topic, see COVID-19 vaccine.

Phase I–II

In a Phase II clinical trial completed in July 2020 and 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.[24]

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.[25]

Latin America

In late July 2020, Sinovac began conducting a Phase III vaccine trial to evaluate efficacy and safety on 9,000 volunteer healthcare professionals in Brazil, collaborating with Butantan Institute.[26][27] 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.[28] On 23 October, São Paulo announced the creation of six new centers for trials of CoronaVac, increasing the number of volunteers in the trials to 13,000.[29]

Brazil briefly paused Phase III trials on 10 November after the suicide of a volunteer before resuming on 11 November. Instituto Butantan said the suicide had no relation to the vaccine trial.[30][31]

In August, a Phase III trial was started in Chile, headed by Pontifical Catholic University of Chile, which was expected to include 3,000 volunteers between the ages of 18 and 65.[32]

Europe

In September, Turkey began Phase III trials with 13,000 volunteers on a two-dose 14-day interval.[33] The monitoring process for CoronaVac is underway at 25 centers in 12 cities across the country.[34]

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

Asia

In August, Sinovac announced trials in Bangladesh with 4,200 volunteers[35] stalled after Sinovac requested the government to co-finance it.[36] The Health Minister said Bangladesh would get access to CoronaVac even if the trial did not go ahead.

In August, Sinovac began Phase III trials in Indonesia with Bio Farma in Bandung involving 1,620 volunteers.[37] In November, Padjadjaran University Medical School provided an update that the trials were running smoothly and that "at most, they found a slight body fever which disappeared within two days".[38]

In October, Saudi Arabia signed an agreement with Sinovac to distribute CoronaVac to 7,000 healthcare workers, after conducting Phase III trials with the Saudi Arabian National Guard.[39]

Manufacturing
Brazilian version of CoronaVac, manufactured by Butantan

In January 2021, Sinovac said it aimed to double annual production capacity of CoronaVac to 1 billion doses by February once it completed its second production line.[40]

After Indonesia's Phase III trials, Bio Farma plans to ramp up production to 250 million doses a year.[41]

On 9 November, São Paulo began building a facility to produce 100 million doses a year.[42] On 10 December, João Doria said Butantan aimed to fill and finish 1 million doses per day on its production line for a vaccination campaign starting 25 January. Doria said 11 Brazilian states have contacted Butantan seeking doses of CoronaVac.[43]

In Malaysia, Pharmaniaga will manufacture, fill, and finish CoronaVac. Pharmaniaga signed a deal to obtain bulk supply of the vaccine as well as technology transfer from Sinovac.[44]

Market and deployment

Latin America
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 a potential vaccine.[45] The price for CoronaVac was announced to be US$10.3 (about R$59).[46] In January, Pazuello said Brazil would obtain 100 million total doses of CoronaVac.[47] On 17 January, Anvisa unanimously approved emergency use of CoronaVac and AZD1222, with a 54-year-old nurse in São Paulo being the first to receive a COVID-19 vaccine in the country.[48]

In January, Bolivia authorized use of CoronaVac and Sputnik V. Butantan Institute, which helped develop CoronaVac, had opened negotiations with South American countries to sell the vaccine, which would be produced in São Paulo. Approval by the government was required before it could be purchased.[49]

In October, Chile Health Minister Enrique Paris signed an agreement with Sinovac to provide 20 million doses of CoronaVac.[50] Chile approved emergency use of CoronaVac on 20 January[51] and the first two million doses arrived on January 28.[52]

In January, Colombia reached a deal for 2.5 million doses of CoronaVac.[53] Colombia's National Food and Drug Surveillance Institute approved emergency use of CoronaVac on February 3.[54]

In January, Uruguay President Luis Lacalle Pou announced the government had purchased 1.75 million doses of CoronaVac with the first batch of 200,000 to arrive in March.[55]

Europe

In November, Turkey's Minister of Health Fahrettin Koca announced the country had signed a contract to buy 50 million doses of CoronaVac for delivery in December, January, and February.[56] The Turkish Medicines and Medical Devices Agency approved Sinovac for emergency use on 13 January 2021 with vaccinations starting the next day with health workers and high risk personnel.[57][58] President Recep Tayyip Erdoğan received his first dose of CoronaVac at Ankara City Hospital.[59] As of 22 January, Turkey has vaccinated more than 1,175,000 people.[60]

In December, Ukraine signed contract to purchase 1.8 million doses of CoronaVac, which Prime Minister Denys Shmyhal said could arrive in February. One dose of CoronaVac would cost 504 hryvnias (around $18).[61]

Asia

On January 19, Azerbaijan launched its vaccination campaign with CoronaVac. Health Minister Oktay Shiraliyev received the first dose of the CoronaVac. Azerbaijan plans to receive 4 million doses of the vaccine and aims to vaccinate 40% of the population. Healthcare workers, people over 65, and security forces will be vaccinated first.[62]

In late August, China approved CoronaVac for emergency use as part of a program to vaccinate high-risk groups such as medical staff.[63] In October, Jiaxing, Zhejiang began offering CoronaVac to essential workers and other high-risk groups for 200 yuan ($29.75) per dose, as part of a two-dose regimen.[64]

In December, Hong Kong ordered 7.5 million doses of CoronaVac COVID-19 vaccine.[65] The first batch of 1 million doses of CoronaVac will arrive in January.[66]

In August, Indonesia's Foreign Minister Retno Marsudi said an agreement was signed with Sinovac for 50 million doses of the vaccine,[67] which was later updated to 140 million doses.[68] CoronaVac would cost around Rp 200,000 (US$13.57) per dose once available.[69] Indonesian Food and Drug monitoring Agency (BPOM) approved emergency use authorization of CoronaVac on 11 January.[16] Indonesian President Joko Widodo received the first shot of the vaccine, and officials said it would be free for all Indonesian citizens.[70]

In January, Malaysia's pharmaceutical company Pharmaniaga signed an agreement with the Health Ministry to supply 12 million doses of CoronaVac with the first delivery expected by February.[44]

In January, Philippines's Health Secretary Francisco Duque III announced the country had secured 25 million doses of CoronaVac. 50,000 doses of CoronaVac would arrive in February, 950,000 by March and 2-3 million per month until December with 25 million doses.[71]

Singapore has signed advance purchase agreements for CoronaVac along with mRNA vaccines tozinameran and mRNA-1273.[72][73]

In January, Thailand's Ministry of Public Health announced that, had the vaccine pass all required trials, the country would receive 2 million doses of CoronaVac to arrive in three batches of 200,000 doses in February, 800,000 in March, and another 1 million in April.[74]

Controversies

Politicization

CoronaVac has been championed by João Doria, a rival governor of São Paulo, who many believe will challenge Jair Bolsonaro for the presidency in 2022.[75] 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.[76] After Instituto Butantan announced CoronaVac's efficacy rate, Bolsonaro mocked the vaccine's effectiveness against COVID-19.[77]

Critics against the politicization of vaccines have warned that failure to follow international testing and safety protocols risks undermining public trust and can increase people's hesitancy to inoculation.[75] Doctors in São Paulo said they were struggling to convince patients that CoronaVac would be safe.[78]

Transparency

In December, Anvisa, the Brazilian Health Regulatory Agency, said emergency use authorization is not yet public in China. Anvisa said there was no information available on the criteria used by Chinese authorities when CoronaVac was granted permission for emergency use in China in June 2020.[79]

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 again about transparency as it was the third delay in releasing results from the trials.[80] São Paulo Health Secretary Jean Gorinchteyn later said the vaccine didn't reach 90% efficacy. Adding to the confusion, Turkey said its trial showed an estimated efficacy rate of 91.25%, though that was based on only 29 cases.[10] 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.[10] While the company's later disclosure provided a clearer indication of CoronaVac's efficacy, it was not a complete picture, and the lack of timely and clear disclosures contributed to a lack of trust.[10] 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.[8]

A researcher who ran one of Brazil's 16 sites conducting the CoronaVac trial said even study investigators did not know all the data.[11] Nikolai Petrovsky, a professor at the College of Medicine and Public Health at Flinders University said, "There is enormous financial and prestige pressure for these trials to massively overstate their results."[7]

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