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CoronaVac

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CoronaVac
SINOVAC COVID-19 vaccine.jpg
Vaccine description
TargetSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
TypeKilled/Inactivated
Clinical data
Routes of
administration
Intramuscular injection
ATC code
  • None
Legal status
Legal status
  • Emergency authorization for use in China, Indonesia, Brazil and Turkey
Identifiers
DrugBank

CoronaVac, also known as the Sinovac COVID-19 vaccine,[1] is an inactivated virus COVID-19 vaccine developed by Sinovac Biotech.[2] It has been 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]

Brazil announced results on 13 January 2021 showing 50.4% effective at preventing symptomatic infections, 78% effective in preventing mild cases needing treatment, and 100% effective in preventing severe cases.[10] Phase III results from an interim analysis of a small sample were announced by Turkey on 24 December 2020 with an efficacy of 91.3%.[11] Additional results were announced by Indonesia on 11 January 2021 with an efficacy of 65.3%.[12]

CoronaVac is being used in vaccination campaigns by certain countries in Asia,[13][14][15] South America,[16][17] and Europe.[18] In March, a Sinovac spokesman told Reuters production capacity for CoronaVac could reach 2 billion doses a year by June 2021.[19] As of 27 February 36 million doses had been administered in total.[20]

Politicization, transparency issues, and missing details in trial data have contributed to a lack of trust in CoronaVac in Brazil.

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.[21][22] 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.[23] 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.[24]

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[25]) and 100% effective against moderate and severe infections.[26] 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.[27] The overall efficacy, including asymptomatic cases and symptomatic cases not requiring medical assistance (WHO grade 2), was 50.38%.[28] Of the 220 participants infected, 160 cases were in the placebo group and 60 cases in the group that received CoronaVac.[29]

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 on data of 1,322 participants in a trial involving 7,371 volunteers.[30][31][32]

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.[33] The trial was conducted in the city of Bandung, and it was not clear how Indonesian scientists made their calculations.[27]

Variability in efficacy

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.[34]

The release of more definitive data on CoronaVac's efficacy was delayed because Sinovac needed to reconcile results from different trials using varying protocols.[29] 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.[35]

Clinical trials

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.[36]

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.[37] 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 were similar to those of a 6 μg dose.[38]

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.[39][40] 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.[41] 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.[42]

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.[43][44]

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.[45]

Europe

In September, Turkey began Phase III trials with 13,000 volunteers on a two-dose 14-day interval.[46] The monitoring process for CoronaVac is underway at 25 centers in 12 cities across the country.[47]

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[48] stalled after Sinovac requested the government to co-finance it.[49] 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.[50] 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".[51]

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.[52]

Manufacturing

Brazilian version of CoronaVac, manufactured by Butantan

In March, a Sinovac spokesman told Reuters production capacity for CoronaVac could reach 2 billion doses a year by June. The figure is double the capacity of 1 billion doses in bulk ingredients the firm said it could reach by February.[19]

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.[53]

After Indonesia's Phase III trials, Bio Farma plans to ramp up production to 250 million doses a year.[54]

On 9 November, São Paulo began building a facility to produce 100 million doses a year.[55] 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.[56]

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.[57]

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.[58] The price for CoronaVac was announced to be US$10.3 (about R$59).[59] In January, Brazil announced it would obtain 100 million total doses of CoronaVac.[60] On 17 January, ANVISA approved emergency use of CoronaVac, with a 54-year-old nurse in São Paulo being the first to receive a COVID-19 vaccine outside of clinical trials in the country.[16] In early February, Brazil's Ministry of Health said it intends to buy an additional 30 million doses of CoronaVac to be produced locally on top of existing 100 million doses.[61]

In January, Bolivia authorized use of CoronaVac. 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.[62]

In October, Chile Health Minister Enrique Paris signed an agreement with Sinovac to purchase 20 million doses of CoronaVac[63] which was approved for emergency use on 20 January[64] and which the first two million doses arrived on 28 January.[17]

In February, Colombia had purchased 5 million doses of CoronaVac and was in talks for an additional 5 million doses,[65] which had been approved for emergency use on 3 February.[66]

In February, Equador signed a deal for 2 million doses of CoronaVac which had been approved for emergency use.[67]

In February, Mexico approved emergency use of CoronaVac[68] and the first 200,000 doses arrived on 20 February.[69]

In January, Uruguay announced the purchased of 1.75 million doses of CoronaVac.[70] The first 192,000 doses arrived on 25 February and vaccinations started on 1 March.[71]

Europe

In November, Turkey signed a contract to buy 50 million doses of CoronaVac.[72] Turkey approved emergency use on 13 January[73] and President Recep Tayyip Erdoğan received his first dose of CoronaVac at Ankara City Hospital.[74] By February, Turkey had vaccinated 2.8 million people with CoronaVac and signed a deal for another 50 million doses for a combined 100 million doses.[18]

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).[75]

Asia

In late August, China approved CoronaVac for emergency use to vaccinate high-risk groups such as medical staff.[76] In early February, China approved CoronaVac for general use.[15]

In August, Indonesia's Foreign Minister Retno Marsudi said an agreement was signed with Sinovac for 50 million doses of the vaccine,[77] which was later updated to 140 million doses.[78] CoronaVac would cost around Rp 200,000 (US$13.57) per dose once available.[79] Indonesia approved emergency use authorization on 11 January and[33] President Joko Widodo received the first shot of the vaccine, which would be free for all Indonesian citizens.[13]

In December, Hong Kong ordered 7.5 million doses of CoronaVac COVID-19 vaccine.[80] The first batch of 1 million doses of CoronaVac will arrive in January.[81]

In early January, Thailand's Ministry of Public Health announced an order for 2 million doses of CoronaVac,[82] which was approved for emergency use on 22 February[83] and which the first 200,000 doses arrived on 24 February.[84] Thailand started its vaccination program on 27 February.[85]

In January, the Philippine's announced the country had secured 25 million doses of CoronaVac. The Philippines approved Coronavac 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.[86] The first 600,000 doses of CoronaVac arrived on 28 February.[87]

On 19 January, Azerbaijan launched its vaccination campaign with CoronaVac. Azerbaijan plans to receive 4 million doses of the vaccine and aims to vaccinate 40% of the population.[14]

On 26 January, Malaysia ordered a total of 12 million doses,[57] the first batch of which arrived 27 February.[20] CoronaVac was approved for emergency use on 2 March.[88]

Singapore has signed advance purchase agreements for CoronaVac along with mRNA vaccines tozinameran and mRNA-1273.[89] In February, the first doses arrived in the country.[90]

Africa

In February, Zimbabwe announced it would register CoronaVac for approval as it seeks to boost supplies for its vaccination program.[91]

Controversies

Politicization

CoronaVac has been championed by the governor of São Paulo, João Doria, who many believe will challenge Jair Bolsonaro for the presidency in 2022.[92] 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.[93] After Instituto Butantan announced CoronaVac's efficacy rate, Bolsonaro mocked the vaccine's effectiveness against COVID-19.[94]

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.[92] Doctors in São Paulo said they were struggling to convince patients that CoronaVac would be safe.[95]

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.[96]

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.[97] São Paulo Health Secretary Jean Gorinchteyn later said the vaccine didn't reach 90% efficacy. Turkey said its trial showed an estimated efficacy rate of 91.25%, though that was based on only 29 infected cases.[29] 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.[29] 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.[27]

A researcher who ran one of Brazil's 16 sites conducting the CoronaVac trial said even study investigators did not know all the data.[98] 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."[99]

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