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Vorlage:Short description CoronaVac ist ein Impfstoffkandidat gegen COVID-19 der von der chinesischen pharmazeutischen Unternehmen Sinovac entwickelt wird. Seit Mitte 2020 wird der Impfstoff in einer Phase-3-Studie untersuch. Am 19. October 2020 wurden basierend auf Untersuchungen in Brasilien erste Ergebnisse der Phase II Studie vorgestellt, die zeigen, dass der Impfstoff sicher und wirksam ist. Daraufhin wurde im Oktober von Brasiliens nationalen Zulassungsstelle Anvisa der Import von 6 Millionen Impfdosen und den Rohstoffen zur Produktion von weiteren 40 Millionen Dosen zugelassen

CoronaVac ist ein chemisch deaktivierter Totimpfstoff gegen COVID-19.

Tests

Die Ergebnisse des Phase II Studie wurden im July 2020 in The Lancet veröffentlicht. CoronaVac zeigte Serokonversion, d.h. das Bilden von Antikörpern für 109 (92%) von 118 Teilnehmern in der 3 μg Gruppe, 117 (98%) von 119 in der 6 μg Gruppe, 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.

In May, CoronaVac began Phase I & II trials in China on adults over the age 60, and in September Corondebug aVac began Phase I & II trials in China on children between age 3-17.

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 Vorlage:Convert, temperatures at which flu vaccines are kept. 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.

Latin America Phase III trials

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. On October 19, São Paulo Governor João Doria said the first results of the clinical study conducted in Brazil prove that among the vaccines being tested in the country, CoronaVac is the safest, the one with the best and most promising rates. No volunteers experienced severe adverse reactions to the vaccine; 20% reported mild pain at the injection site; and less than 15% said they had headaches, nausea, or tiredness after receiving the shot. A final determination of CoronaVac's effectiveness will come once the 13,000-volunteer trial is complete, which could occur as early as mid-November. 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 increases to 22.

Brazil briefly paused Phase III trials on November 10 after the suicide of a volunteer before resuming on November 11.

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.

Asia Phase III trials

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

In August, Sinovac announced Phase III trials in Bangladesh with the International Centre for Diarrhoeal Disease Research involving 4,200 volunteers. In October, it was reported the trials were stalled after Sinovac requested the government to co-finance it. Bangladesh's National Research Ethics Committee said the request was unusual, and the government "may not be in a position to invest money for this purpose". The Health Minister has emphasized Bangladesh will get access to CoronaVac, even if the trial did not go ahead.

In August, Sinovac began a Phase III trials in Indonesia with Bio Farma in Bandung involving 1,620 volunteers. 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." 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. The interim report would include results from Phase III trials in China and Brazil, which started before Indonesia, and was intended to provide a basis to approve an emergency use authorization for CoronaVac.

In September, the Philippines Department of Health announced five hospitals as possible sites for Phase III trials in the Philippines. In October, the Philippines Food and Drug Administration said Phase III trials could begin in November.

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.

On 14 September, Turkey began Phase III trials with 13,000 volunteers on a two-dose 14-day interval.

Regulation and commercialization

Brazil

On 23 September, governor João Doria said São Paulo was to start to immunize its population with Coronavac in mid-December. The state has 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. 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. On 2 October, São Paulo state filed documents to health regulator Anvisa to register for use of CoronaVac.

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 would be added to the immunisation programme the previous day. However, on October 23, Anvisa authorised Institute 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. Asked if São Paulo would guarantee the acquisition of additional doses, to total 100 million, Doria said “The answer is yes, and we will also make it available to all governors who wish." On October 28, Anvisa authorised Butantan to import raw materials to manufacture 40 million doses of CoronaVac.

On October 30, the price for CoronaVac was in a letter sent by Minister of Health General Eduardo Pazuello to Butantan Institute officializing the government's plan to acquire 46 million doses of the vaccine. CoronaVac dose would cost the Ministry of Health US$10.3 (about R$59), by comparison, the flu dose is supplied for R$15.14.

On November 9, Doria said São Paulo had begun building a facility to produce 100 million doses of CoronaVac a year. 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.

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 that it could be used in Chile.

China

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, if the vaccine is successful and approved. 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. 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.

Indonesia

Indonesian Foreign Minister Retno Marsudi said a purchased agreement was signed with Sinovac for 50 million doses of the vaccine from November to March 2021. If the Phase III trials were successful, Bio Farma plans to ramp up production to 250 million doses a year. Bio Farma is to receive 15 million bulk doses of CoronaVac from Sinovac in November 2020, which would be processed in Indonesia to a ready-to-use vaccine for distribution, and confirmed the COVID-19 vaccine will be priced around Rp 200,000 (US$13.57) per dose once available. In early November, Indonesia's government announced it planned to vaccinate 9 million people with CoronaVac in December.

Turkey

On November 19, Turkey's Minister of Health said the country will sign a contract to buy at least 20 million doses of CoronaVac, adding the country was also in talks to buy doses of BNT162b2. 10 million does would arrive by December with at least as much in January, according to Health Minister Fahrettin Koca. Health care workers, members of law enforcement and people working in crowded places will be prioritized for the first mass vaccination, which is scheduled for early 2021.

See also

• CanSino Biologics
• Sinopharm

External links

• Clinical Research Protocol for CoronaVac Phase III Trials in Brazil