CoronaVac

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CoronaVac
Vaccine description
TargetCOVID-19
Vaccine typeInactivated SARS-CoV-2
Clinical data
Routes of
administration		Intramuscular injection
ATC code
  • None
Legal status
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DrugBank
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CoronaVac is a COVID-19 vaccine candidate developed by the Chinese biopharmaceutical company Sinovac.[1] Beginning in mid-2020, the vaccine candidate was undergoing Phase III clinical research;[2][3] it is in Phase III trials in Brazil, Chile, Indonesia and Turkey. CoronaVac uses a similar, more traditional technology as in BBIBP-CorV and BBV152, other inactivated-virus vaccines for COVID-19 in Phase III trials.[4][5]

Brazil announced, on January 12, 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] Instituto Butantan, the organizers of the trial, said the lower figure was due to more rigorous standards of infection counting compared to other vaccine makers.[9] On January 7, 2021, without elaborating how the efficacy rate was calculated, 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]

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]

Transparency issues and missing details in trial data contributed to a lack of trust in CoronaVac, with Brazilians and others world-wide already reluctant to take it.[17][18][10][11][8]

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.[19] 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.[20]

Efficacy

Empty bottle of CoronaVac

On January 7, 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[21]) and 100% effective against moderate and severe infections,[22] 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%.[23] Of the 220 participants infected, 160 cases were in the placebo group and 60 cases in the group that received CoronaVac.[10]

On December 24, 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 January 11, 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.[24] 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.[25]

Repeated delays in releasing results from Brazil

Conflicting and incomplete information from Brazil trials in December had created confusion over the efficacy of CoronaVac. Brazil delayed releasing complete data on CoronaVac in late December, saying only that it was more than 50% effective. 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]

Clinical trials

Main article: 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.[26]

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.[27]

Phase III

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.[28][29] On October 19, 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.[30] On October 23, the government of São Paulo announced the creation of six new centers for trials of CoronaVac, increasing the number of volunteers in the trials to 13,000.[31]

Brazil briefly paused Phase III trials on November 10 after the suicide of a volunteer before resuming on November 11. Instituto Butantan said the suicide had no relation to the vaccine trial.[32][33]

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.[34]

Europe

In September, Turkey began Phase III trials with 13,000 volunteers on a two-dose 14-day interval.[35] The monitoring process for CoronaVac is underway at 25 centers in 12 cities across the country.[36]

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[37] stalled after Sinovac requested the government to co-finance it.[38] The Health Minister said Bangladesh would get access to CoronaVac even if the trial did not go ahead.[39]

In August, Sinovac began Phase III trials in Indonesia with Bio Farma in Bandung involving 1,620 volunteers.[40] 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".[41] On November 21, Bio Farma announced plans to submit interim results for the Phase III trials of CoronaVac to the Indonesian Food and Drug Monitoring Agency in January 2021.[42]

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.[43]

Manufacturing

Brazilian version of CoronaVac, manufactured by Butantan

A 20,000 square meter production plant in Beijing has been built for manufacturing the CoronaVac vaccine, with the facility planned to eventually produce 300 million doses a year.[44] In December, Sinovac said it aimed to complete construction of a second production facility by the end of 2020 to increase the production capacity of CoronaVac to 600 million doses.[45]

If Indonesia's Phase III trials succeed, Bio Farma plans to ramp up production to 250 million doses a year.[46]

On November 9, São Paulo began building a facility to produce 100 million doses a year.[47] On December 10, João Doria said Butantan aimed to fill and finish 1 million doses per day on its production line for a vaccination campaign starting January 25. Doria said 11 Brazilian states have contacted Butantan seeking doses of CoronaVac. Several countries including Honduras, Paraguay, Peru, and Uruguay had also expressed interest in purchasing CoronaVac from Brazil, while Butantan was in advanced discussions with Argentina to the supply vaccine.[48]

Market and deployment

Latin America

Brazil

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 September, São Paulo governor João Doria signed a $90 million contract with Sinovac to receive the initial 46 million doses of a potential vaccine.[49] The price for CoronaVac was announced to be US$10.3 (about R$59).[50] By December, Brazil had received 10 million doses of CoronaVac, although there was uncertainty regarding the regulatory status of the vaccine.[51] In January, Pazuello said Brazil would obtain 100 million total doses of CoronaVac.[52] On January 17, Anvisa unanimously approved emergency use of CoronaVac and AZD1222, with a 54 year-old nurse in Sao Paulo being the first to receive a COVID-19 vaccine in the country.[53]

Bolivia

In January, Bolivia authorized use of CoronaVac and Sputnik V. The country had already purchased 5.2 million doses of Sputnik V and about 2 million doses of AZD1222. 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.[54]

Chile

In October, Chile Health Minister Enrique Paris signed an agreement with Sinovac to provide 20 million doses of CoronaVac. The use of the vaccine required approval from a qualified agency, such as the Public Health Institute of Chile or ANVISA in Brazil. The Chilean government hoped ANVISA would approve CoronaVac soon so it could be used in Chile.[55]

Europe

Turkey

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 the start of inoculation on the next day with health workers and high risk personnel.[57][58] As of January 15, Turkey has vaccinated more than 600,000 people.[59]

Ukraine

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).[60]

Asia

Azerbaijan

In January, Azerbaijan's Health Ministry said it will begin vaccinating citizens with CoronaVac starting January 18, using a batch of 4 million doses from Sinovac. “Medical workers will be vaccinated first, and then over-65s from February 1,” presidential aide Shahmar Movsumov said. The doses will be first transported to Turkey to be checked and packaged, before arriving in Azerbaijan.[61]

China

In late August, China approved CoronaVac for emergency use as part of a program to vaccinate high-risk groups such as medical staff.[62] 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.[63]

Hong Kong SAR

In December, Hong Kong ordered 7.5 million doses of CoronaVac COVID-19 vaccine.[64] The first batch of 1 million doses of CoronaVac will arrive in January.[65]

Indonesia

In August, Indonesia's Foreign Minister Retno Marsudi said an agreement was signed with Sinovac for 50 million doses of the vaccine,[66] which was later updated to 140 million doses.[67] The COVID-19 vaccine will be priced around Rp 200,000 (US$13.57) per dose once available.[68] Indonesian Food and Drug monitoring Agency (BPOM) approved emergency use authorization of CoronaVac on January 11.[16] Indonesian President Joko Widodo received the first shot of the vaccine, and officials said it would be free for all Indonesian citizens.[69]

Malaysia

In January, Malaysia's pharmaceutical company Pharmaniaga signed an agreement with to purchase CoronaVac and later to produce the vaccine domestically.[70]

Philippines

In January, Philippines 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

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

Thailand

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

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.[17]

On December 23, 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.[18] 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]

Missing details

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. They did not specify when the full documentation would be published. The trial saw 160 and almost 60 participants infected in the placebo group and among those who received the vaccine, respectively. Butantan Institute declined to elaborate how the efficacy rate was calculated.[10]

The lack of data led to immediate skepticism. 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]

See also

References

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External links

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