Additional antibody increase such as Sinovac corona vaccine and mRNA = research
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"CoronaVac" has been approved in more than 50 countries, including Brazil and China.
[Reuters] – China's Sinovac Biotech's new coronavirus vaccine ... → Continue reading
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This vaccine is another inactivated virus COVID-19 vaccine in Phase III clinical trials.BBIBP-CorV,BBV152Relies on conventional technology as well.. CoronaVac does not require cryopreservation, and both the vaccine and the ingredients for formulating the new dose are transported at the temperature at which the influenza vaccine is stored at 2-8 ° C (36-46 ° F) and refrigerated. can do.
CoronaVacInactivated vaccineIs.This is another inactivated viral vaccine for COVID-19 in Phase III trialsBBIBP-CorVandBBV152Using the same conventional technology as.. CoronaVac does not require freezing, can transport both vaccines and raw materials for preparing new doses and can be refrigerated at 2-8 ° C (35.6-46.4 ° F)... CoronaVac has the potential to remain stable after storage for up to 3 years,Cold chainMay also benefit vaccine distribution to underdeveloped areas.
A Phase III clinical trial of 2021 volunteers conducted in Brazil on January 1, 7 revealed symptomatic cases requiring medical assistance for COVID-13,000 (WHO clinical progression scale grade 19).) Was found to be 78% effective and 100% effective for moderate and severe infections...After increasing pressure from scientists, some scientists accused the trial organizers of misleading the publicSaid on January 1 that these rates were only for volunteers with mild to severe cases of COVID-12...The overall efficacy rate, including asymptomatic cases and symptomatic cases that do not require medical treatment (WHO grade 2), was 50.38%...Of 220 infected subjectsplaceboThere were 160 patients in the group and 60 patients in the CoronaVac group..
On January 2021, 1, Brazil announced that it was 13% effective in preventing symptomatic infections, 50.4% in the prevention of mild symptoms requiring treatment, and 78% in the prevention of severe cases... On December 2020, 12, Turkey announced the results of a phase III trial with an interim analysis of small samples, with an efficacy rate of 24%... On January 2021, 1, Indonesia announced an additional result with an effective rate of 11%..
On December 2020, 12, Turkey released Phase III results from an interim analysis of 24 cases, showing an efficacy rate of 29% based on data from 7,371 subjects in a study involving 1,322 volunteers..
On January 2021, 1, Indonesia announced the results of a phase III study from the results of an interim analysis of 11 patients, showing an efficacy rate of 25% based on data from 1,600 subjects.. This testBandungIt was carried out in the city, and it is not clear how Indonesian scientists calculated it..
On April 2021, 4, the Chilean Ministry of Health announced that Sinovac was effective for "16% for avoiding onset," "67% for avoiding hospitalization," "85% for avoiding entering the intensive care unit," and "85% for deterring death." Announced that sex was confirmed.
On May 2021, 5, Indonesia's Health Minister Budi pointed out that Sinovac was 11% effective in preventing infections in health care workers..
Variability in effectiveness
Authorities said the low 50.4% figure included "very mild" cases of COVID-19 among the subjects that were omitted in previous analyzes.At a press conference on January 1, Ricardo Palacios, director of the Butantan Institute, said that Sinovac's effectiveness rate was relatively low at 12% because of the stricter criteria for what is considered an infection in clinical trial participants. Said.Whereas Western vaccine makers generally only include mild, moderate, and severe categories, the Institute has six types of cases: asymptomatic, very mild, mild, two levels of moderate, and severe. Included in the results.The Brazilian clinical trial consisted primarily of on-site healthcare professionals.Foreign Affairs Council"They are exposed to more viruses, which could explain the relatively low efficacy rate," said Yanzhong Huang, Senior Fellow of Global Health..
Sinovac had to adjust the results of different trials using different protocols, delaying the release of clearer data on the effectiveness of CoronaVac...According to Dimas Cobas, director of the Butantan Institute, the Brazilian group was considered vulnerable to infection and exposure to higher viral loads.In Phase III trials in Turkey and Indonesia, the composition of volunteers was similar to that of the general population..
Ended in July 2020,LancetPublished in the magazinePhase II clinical trialにおいて、CoronaVacは、0日目と14日目の2回ワクチン接種後の28日目に、3 μg群118人中109人（92％）、6 μg群119人中117人（98％）で中和抗体のが認められた。これに対し、0日目と28日目の2回ワクチン接種後の28日目に、3 μg群117人中114人（97％）、6 μg群118人中118人（100％）で血清転換が認められた.
CoronaVac launched a phase I-II study in China in May for adults aged 5 years and older, and a phase I-II study in China for children aged 60-9 years in September. Started..In addition, the results of a phase II study in the elderly were published in The Lancet, and CoronaVac is safe and well tolerated in the elderly as well, and is a neutralizing antibody induced by administration of 3 μg. Was confirmed to be comparable to the neutralizing antibody induced by administration of 6 μg..
In late July 2020, Sinovac launched a phase III vaccine trial in collaboration with the Bhutan Institute to evaluate efficacy and safety in 7 volunteer healthcare workers in Brazil... Aug. 10,Sao PauloStateThe governor said the initial results of clinical trials conducted in Brazil proved that CoronaVac is the safest, highest rate and most promising vaccine tested in the country. Stated.. On October 10, the state of São Paulo announced that it had set up six new centers for CoronaVac clinical trials and increased the number of volunteers participating in the trials to 23..
In Brazil, Phase III trials were suspended on November 11 following a volunteer suicide on November 10, but resumed on November 11.Suicide has nothing to do with vaccine testing, according to the Butantan Institute.
In May,A phase III trial led by H. was launched in Chile and was expected to involve 18 volunteers between the ages of 65 and 3,000..
In Turkey, a phase III study was started in September with 9 dose intervals of 13,000 volunteers over a 14-day period... CoronaVac monitoring process is underway at 12 centers in 25 cities nationwide.
In August, Sinovac announced a test with 8 volunteers in Bangladesh., Sinovac requested the government to jointly invest, the test was suspended..Bangladesh's health minister said CoronaVac will be available even if the trials are not progressing.
In August, Sinovak launched a phase III trial of 8 volunteers at Bio Farma, based in Bandung, Indonesia... In August,The medical school reported the latest information that "the examination is proceeding smoothly and a slight fever that disappears within at most 2 days was found.".
In January 2021, Sinovac stated that it aims to double CoronaVac's annual production capacity to 1 billion doses by February once the second CoronaVac production line is completed..
After completing Phase III trials in Indonesia, Biopharma plans to increase production to 2 million doses annually.
On November 2020, 11, the state of São Paulo began construction of a facility that produces 9 million doses annually... Butantan is aiming to complete the production line with one million doses per day for the vaccination campaign starting January 12, according to João Doria on December 10.According to Doria, 1 Brazilian states have contacted butantã for CoronaVac..
In MalaysiaManufactures, fills and finishes CoronaVac. Phmaniaraga has signed a contract to receive a large supply of vaccines and technology transfer from Sinovac.
Market and development
In Brazil, Governor João Doria of the State of São Paulo signed a $ 9 million contract with Sinovac in September to receive the first 9,000 million doses of future vaccines... The price of CoronaVac was announced to be $ 10.3 (about 59 reals).. In January 2021, Brazil announced that it would obtain a total dose of 1 million CoronaVac... On January 1, the Brazilian Health Regulatory Agency (ANVISA) approved the emergency use of CoronaVac, and a 17-year-old nurse in São Paulo received the COVID-54 vaccine for the first time outside of a domestic clinical trial... Brazil in early FebruaryAnnounced that it intends to purchase an additional 1 million doses of CoronaVac in addition to the existing 3,000 million doses of CoronaVac for local production..
In January, Bolivia approved the use of CoronaVac. The Butantan Institute, which helped develop CoronaVac, has begun sales negotiations with South American countries to sell vaccines produced in São Paulo.This vaccine required government approval before it could be purchased.
October, ChileHealth Minister approved CoronaVac for emergency use on 1 January and the first 20 million doses arrived on 1 JanuarySigned a contract with Sinovac to purchase 2,000 million doses.. Chile in FebruarySebastian PinellaPresident inoculates CoronaVac.
In February, Ecuador signed a contract for 2 million doses of CoronaVac approved for emergency use.
Faffrettin Koja, Turkey, November 2020Announced that the country has signed a contract to purchase 5,000 million doses of CoronaVac..Turkey approved emergency use on January 2021, 1,Recep Tayyip ErdoganPresident received first dose of CoronaVac at Ankara City Hospital.. By February, Turkey had 2 million people vaccinated with CoronaVac and another 280 million doses of vaccine, signing contracts for a total of 5,000 million doses..
In December 2020, Ukraine signed a purchase agreement for 12 million doses of CoronaVac,Denys ShmyhalThe prime minister said it could arrive in February. The price of one dose of CoronaVac is 2 hryvnia (about $ 1).
On January 2021, 1, Azerbaijan launched a vaccination campaign with CoronaVac. Health Minister Oktay Shiraliyev received the first dose of CoronaVac.Azerbaijan plans to vaccinate 19 million doses, aiming to vaccinate 1% of the population.
In late August 2020, China approved CoronaVac for emergency use to vaccinate high-risk groups such as healthcare professionals... In early February 2021, China approved CoronaVac for general use.
August 2020, IndonesiaThe Foreign Minister said he had signed a 5,000 million dose vaccine contract with Sinovac.Was later updated to 1 million doses.. CoronaVac will cost approximately IDR 1 (US $ 200,000) per dose when it becomes available... Indonesia approves emergency use authorization on January 1,Joko WidodoThe president received the first vaccination of a free vaccine for all Indonesian people.
January 2021 Malaysian pharmaceutical companySigned a contract to supply 2 million doses of CoronaVac, which is scheduled for initial delivery by February.
January, PhilippinesAnnounced that the country has secured a 2,500 million dose of CoronaVac.The Philippines approved CoronaVac on 2 February, but all health care workers were less effective when used on health care workers exposed to COVID-22 compared to healthy people aged 18-59 years. Decided not to use.
In February, Zimbabwe announced that it would register CoronaVac for approval to increase its supply to vaccination programs...Next MarchEmmerson MnangagwaPresident inoculated CoronaVac himself.
CoronaVac, many in the 2022 presidential electionJair BolsonaroHas been defended by São Paulo Governor João Doria, who believes he will challenge the president..The political confrontation began in October 2020 when Mr. Bolsonaro vetoed a deal between the Brazilian Ministry of Health and the Government of São Paulo to purchase a 10 million dose of vaccine...Bolsonaro mocked the effectiveness of the vaccine against COVID-19 after the Butantan Institute announced the efficacy rate of CoronaVac.
Critics who oppose the politicization of vaccines say that non-compliance with international testing and safety protocols risks damaging public confidence and may increase people's hesitation in vaccination. Warning..Doctors in São Paulo say they are having a hard time convincing patients that CoronaVac is safe.
January,(Anvisa) said an emergency use authorization in China has not yet been announced. Anvisa said it was unable to obtain information on the standards used by Chinese authorities when CoronaVac obtained an emergency use authorization in China in June 2020..
Delayed announcement of results
On December 2020, 12, Brazilian researchers said the vaccine was more than 23% effective, but withholding full results at Sinovac's request, three delays in publishing test results. This raises questions about transparency again...Jean Golinktain, director of health at the State of São Paulo, later revealed that the vaccine was less effective than 90%.Turkey said the study showed an estimated efficacy rate of 91.25%, which was based on only 29 infected cases...São Paulo state officials refused to provide information on the detailed breakdown of the study, including age group and vaccine side effects, when announcing the protection rate...Scientists say the lack of transparency in the data risks compromising the credibility of CoronaVac, even though Brazilians and others around the world are already hesitant to vaccinate..
Researchers operating one of Brazil's 16 facilities conducting CoronaVac trials said that even researchers do not have all the data..Flinders University"There is enormous financial and prestigious pressure in these trials to exaggerate the results," said Professor Nikolai Petrovsky of the Faculty of Medicine and Public Health..
In February-April 2021, a social experiment in which CoronaVac was inoculated in a mass in Serrana, Sao Paulo, Brazil, resulted in a significant decrease of 2% in the number of newly infected persons..
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- Clinical trial protocol for CoronaVac Phase III trials in Brazil(English)
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