CoronaVac

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CoronaVac
SINOVAC COVID-19 vaccine.jpg
Vaccine description
Target diseaseCOVID-19
Clinical data
Routes of
administration		Intramuscular injection
Legal status
Legal status
  • Emergency authorization for use in China
Identifiers
DrugBank
Part of a series on the
COVID-19 pandemic
SARS-CoV-2 without background.png
SARS-CoV-2 (Wikimedia colors).svg COVID-19 Portal

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 currently undergoing 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 being developed in Phase III trials.[4]

On December 13, Butantan Institute conducting the trials in Brazil announced that the number of confirmed cases in the Phase III trials had reached 170, which was above the 151 cases required for primary analysis, and that by December 23 the results would be announced.[5] Butantan has said the vaccine is between 50% and 90% effective in Brazil, but withheld full results at Sinovac's request, raising questions about transparency as it was the third delay in releasing results.[6][7] Separately on December 24, Turkey released Phase III results from an interim analysis of 29 cases which showed an efficacy rate of 91.25% based on the data of 1,322 participants in a trial involving 7,371 volunteers, a confusing readout compared to Brazil.[8][9][7]

Clinical research[edit]

Main article: COVID-19 vaccine

Phase I–II[edit]

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.[10]

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.[11]

CoronaVac does not need to be frozen, according to Dimas Covas, director of the Butantan Institute running the Phase III trials in Brazil. CoronaVac and the 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.[12] 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.[13]

Phase III[edit]

Latin America[edit]

In late July 2020, Sinovac began conducting a Phase III vaccine trial to evaluate efficacy and safety on 9,000 volunteer health professionals in six states of Brazil, collaborating with Butantan Institute.[14][15] 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.[16] On October 23, the government of São Paulo announced the creation of six new centers for the testing of CoronaVac in volunteers. As a result, the total of places where research is carried out in the country increased to 22.[17]

Brazil briefly paused Phase III trials on November 10 after the suicide of a volunteer before resuming on November 11.[18][19] On December 13, Covas announced the number of confirmed COVID cases in the Phase III trials had increased to 170, which was above the 151 cases required for the primary analysis, and that by December 23.[5] Butantan has said the vaccine is between 50% and 90% effective in Brazil, but withheld full results at Sinovac's request, raising questions about transparency as it was the third delay in releasing results.[7]

Butantan Director Dimas Covas said no volunteers vaccinated in the active group developed a severe case of COVID-19, contributing to optimism about its effectiveness in combatting the pandemic. Cristina Bonorino, an immunologist who sits on the scientific committee of the Brazilian Immunology Society, said that having no severe cases is good and useful for combating the pandemic, but "it hurts the image of their vaccine to have this hesitation". She said the bigger problem is "They shouldn't have made a show of something that in the end they didn't report."[6]

Also in early 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.[20]

Europe[edit]

On September 14, Turkey began Phase III trials with 13,000 volunteers on a two-dose 14-day interval.[21] The monitoring process for CoronaVac is underway at 25 centers in 12 cities across the country.[22] On December 24, CoronaVac was shown to be 91.25% effective so far based on data from 7,371 volunteers.[8][9] This was an interim analysis of 26 of 29 people who were infected with COVID-19 during the trials given placebos, with the trials continuing until 40 people became infected.[9] Health Minister Fahrettin Koca said the results were the first to be announced for CoronaVac.[9]

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 announced trials in Bangladesh with 4,200 volunteers[23] stalled after Sinovac requested the government to co-finance it.[24] The Health Minister said Bangladesh would get access to CoronaVac even if the trial did not go ahead.[25]

In August, Sinovac began Phase III trials in Indonesia with Bio Farma in Bandung involving 1,620 volunteers.[26] 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".[27] 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.[28]

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.[29]

Manufacturing[edit]

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.[30] 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.[31]

If Indonesia's Phase III trials succeed, Bio Farma plans to ramp up production to 250 million doses a year.[32]

On November 9, São Paulo began building a facility to produce 100 million doses a year.[33] 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.[34]

Market and deployment[edit]

Brazil[edit]

On September 23, governor João Doria said São Paulo had a deal with Sinovac for 60 million doses to be delivered by the end of February, which Doria said is enough to vaccinate the state's entire population.[35] Doria signed a $90 million contract with Sinovac to receive the initial 46 million doses of a potential vaccine, and said the state had a verbal agreement regarding the delivery of the remaining 14 million doses.[36] On October 21, Brazilian President Jair Bolsonaro stated his government will not buy CoronaVac because of its Chinese origin, contradicting Health Minister Eduardo Pazuello who said it the previous day that it would be added to the immunisation program.[37] On October 23, Anvisa authorised Butantan to import 6 million doses of CoronaVac. João Doria said Anvisa told him it will not bow to political pressure over the approval of potential COVID-19 vaccines.[38] On December 16, Wellington Dias, governor of Piauí, said Health Minister Eduardo Pazuello told him the federal government would purchase 46 million doses of CoronaVac.[39]

The price for CoronaVac was announced to be US$10.3 (about R$59).[40] A delegation of politicians and researchers received the first 120,000 doses of CoronaVac on November 19 at São Paulo International Airport with another 46 million doses expected to arrive by January.[41] By late December, Brazil had received 10 million doses of CoronaVac, although there was uncertainty regarding the regulatory status of the vaccine.[42]

Chile[edit]

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.[43]

China[edit]

In late August, CoronaVac was approved for emergency use as part of a program in China to vaccinate high-risk groups such as medical staff.[44] 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.[45]

Hong Kong[edit]

In December, Hong Kong ordered 7.5 million doses of CoronaVac COVID-19 vaccine.[46] The first batch of 1 million doses of CoronaVac will arrive in January.[47]

Indonesia[edit]

Indonesian Foreign Minister Retno Marsudi said an agreement was signed with Sinovac for 50 million doses of the vaccine from November 2020 to March 2021,[48] which was later updated to 140 million doses.[49] The COVID-19 vaccine will be priced around Rp 200,000 (US$13.57) per dose once available.[50] Indonesia received 1.2 million doses of CoronaVac on December 6 and expected to receive materials to produce another 15 million doses in December and 30 million doses in January.[51] By December 31, Indonesia had received 3 millions doses and planned to start vaccinating 1.3 million health workers in the second and third week of January.[52]

Philippines[edit]

In November, vaccine czar Carlito Galvez announced the Philippines planned to buy up to 50 million doses of CoronaVac.[53]

Singapore[edit]

Singapore has signed advance purchase agreements for CoronaVac along with mRNA vaccines Tozinameran and MRNA-1273.[54][55]

Turkey[edit]

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 first 3 million doses of CoronaVac arrived in Ankara's Esenboğa Airport in 17 containers on December 30.[57]

Ukraine[edit]

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).[58]

Controversies[edit]

Transparency and repeated delays in releasing results in Brazil[edit]

On December 14, 2020, Anvisa, the Brazilian Health Regulatory Agency, said emergency use authorization is not yet public in China. Anvisa said there is no information available on the criteria used by Chinese authorities when CoronaVac was granted permission for emergency use in China in June 2020.[59] 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.[6]

See also[edit]

References[edit]

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External links[edit]

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