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Clinical human trials begin for COVID-19 vaccine in China

09:35, 25-Oct-2020
Brazil institute to import 6 million does of Chinese COVID-19 vaccine
CGTN

Brazilian health regulator Anvisa on Friday authorized a biomedical center to import six million doses of the Sinovac coronavirus vaccine, one day after President Jair Bolsonaro said Brazil would not buy the Chinese vaccine.

Sao Paulo's Butantan Institute plans to initially import Sinovac's vaccine, which is in the third phase of trials conducted with the help of a local university and not yet approved for wider use in Brazil. Butantan would ultimately manufacture the vaccine if proven effective.

Brazil's Sao Paulo Governor Joao Doria said earlier on Friday that Anvisa told him it will not bow to political pressure over the approval of potential coronavirus vaccines.

According to the Brazilian state governors, the country will include China's Sinovac vaccine against COVID-19 in its national immunization program.
Joao said after the health ministry meeting that the federal government has agreed to buy 46 million doses of the Sinovac vaccine.

The program could begin in January 2021, he said, which could make it one of the first immunization efforts against the novel coronavirus in the world.

Sao Paulo State Health Secretary Jean Gorinchteyn said the vaccine appeared to produce protective antibodies. The state hopes to obtain regulatory approval for CoronaVac by the end of the year to start inoculating its population early in 2021, in what could be the first vaccination programs in the Americas.

In addition, another Brazilian pharmaceutical company was reported on Friday to have already signed an agreement with the Russian Direct Investment Fund (RDIF) to produce Russia's Sputnik V vaccine against COVID-19 starting in the second half of November.

The company said it was bound by a confidentiality agreement not to give any technical or scientific details. It still must obtain approval from Anvisa.

With more than 5.3 million cases of coronavirus reported in Brazil, the third worst outbreak after the United States and India, the South American country has become a testing ground in the race to find a vaccine.

Late stage trials are underway for vaccines under development by Oxford University/AstraZeneca, China's Sinovac Biotech, Pfizer Inc, in partnership with BioNTech and Johnson & Johnson's pharmaceutical subsidiary Janssen.

Brazil registered 432 additional coronavirus deaths over the last 24 hours and 26,979 new cases, the health ministry said on Saturday.

(With input from Reuters)
The brazil president is a joke.

 
Trials for 2 Sinopharm COVID-19 vaccines progress
By LIU ZHIHUA | China Daily Global | Updated: 2020-10-30 00:00


China National Pharmaceutical Group Co, or Sinopharm, is stepping up efforts to develop COVID-19 vaccine candidates to contribute to global public health and safeguard the well-being of people around the world.

The third-stage clinical trials of its two inactivated vaccine candidates, developed by the company's vaccine and bioscience subsidiary China National Biotech Group, are being conducted in 10 countries, including the United Arab Emirates, Jordan, Argentina, Egypt and Peru, said Liu Jinzhen, the company's chairman.

Currently, there are around 60,000 volunteers, as people from more than 125 nations join the vaccine trials, he said.

Liu spoke at a news briefing held by the Joint Prevention and Control Mechanism of the State Council on Oct 20.

According to an Oct 19 document from the World Health Organization, there are 44 COVID-19 candidate vaccines in clinical evaluation, among which 10 have reached the final stage of testing.

China currently has 13 vaccine candidates in clinical trials, and among them three inactivated vaccines and one adenovirus vector vaccine are in phase three trials overseas, according to the Ministry of Science and Technology.

Zhang Yuntao, vice-president of CNBG and a primary researcher of the COVID-19 vaccines, said the company's phase three clinical trials of the two vaccine candidates are the largest in terms of recipient population among all the vaccine candidates under the same stage of trials.

The wide coverage of recipients from different countries will also prepare a good foundation for the vaccines to be used globally once they receive regulatory approval after successful trials, he said.

Once safety and efficiency data are obtained during the third-stage clinical trial, the vaccine candidates can apply for the review and approval of the authorities concerned for market launch. Dozens of countries have already contacted the Chinese company to express interest in buying approved vaccines, according to Liu.

In fact, both vaccine candidates have been approved for emergency use in China for incubation in high-risk groups, such as frontline medical personnel, border staff, and people traveling overseas on work.

The UAE also authorized emergency use of a Sinopharm vaccine for frontline workers last month.

Those who received two doses of the vaccines at an interval of 28 days saw their neutralizing antibody positive conversion rate reach 100 percent, Liu said.

Shi Lichen, founder of Beijing Dingchen Consultancy, spoke highly of the efforts that CNBG has made toward the research and development of the vaccines.

"The company has demonstrated high-level R&D capabilities as well as a strong sense of corporate social responsibility," he said.

CNBG launched inactivated vaccine R&D program on Feb 1, and as of April 12, one of its inactivated vaccine candidates was authorized to start phase one and two clinical trials in China.

On April 27, another inactivated vaccine candidate was also approved for clinical trials.

Since then, more than 4,000 volunteers of various ages have participated in the first-and second-stage clinical trials.

Zhang said vaccine is a "strong weapon" to protect people from infectious disease, and the company is well-poised to provide any approved COVID-19 vaccines to the world.

Sinopharm, a State-owned enterprise and China's largest pharmaceutical and healthcare company, also ramped up efforts to increase vaccine capacity, as China has stated on many occasions that it will make COVID-19 vaccines a global public good when available, to increase vaccine accessibility and affordability in developing countries, including African countries.

CNBG has completed building high biosafety production bases with capacity that will exceed 1 billion vials next year to meet widespread demand for vaccination.

The company offered a tour of its facilities to a team of African ambassadors and senior diplomats recently. Liu said the company is willing to join hands with African people to deepen cooperation in the fight against COVID-19.

This should hopefully strengthen friendship between the Chinese and African peoples, besides contributing to the shared goals of the China-Africa health community.

In June, in a keynote speech to the Extraordinary China-Africa Summit on Solidarity against COVID-19 held via video link, President Xi Jinping remarked that once the development and deployment of COVID-19 vaccine are completed in China, African countries will be among the first to benefit.

Sinopharm will endeavor to honor's China's commitment to Africa, Liu said.

Through medical gear production and distribution, the group already has built a strong presence in the global fight against the pandemic.

With the world's largest medical distribution network at its disposal, the company has provided 3 billion items of medical protection gear to more than 130 countries and regions.

Shanghai Geneodx Biotech Co Ltd, an affiliate of CNBG, is one of the first three companies in China to develop novel coronavirus test kits.

CNBG is also the first in China to develop convalescent plasma treatment for COVID-19 patients. For this purpose, it used blood plasma taken from convalescents, as recommended in the official guidelines for the treatment of the disease in China.

Sinopharm ranked 169th on the Fortune Global 500 last year, and fourth among the pharmaceutical companies on the same list.

liuzhihua@chinadaily.com.cn
 
One more Chinese COVID-19 vaccine ready for phase-3 clinical trials
Source: Xinhua| 2020-11-01 20:48:07|Editor: huaxia

BEIJING, Nov. 1 (Xinhua) -- A COVID-19 vaccine candidate developed by the Institute of Microbiology under the Chinese Academy of Sciences has shown to be safe in early-stage trials, suggesting potential for further clinical tests.

The results of phase-1 and phase-2 trials support the safety and immunogenicity of this recombinant subunit vaccine in healthy participants, and no serious adverse events have been found so far, the institute said in a statement on Friday.

Jointly developed by the institute and Chongqing Zhifei Biological Products Co., Ltd., the vaccine was issued with a clinical research permit from the National Medical Products Administration on June 19.

Researchers started phase-1 clinical trials on June 23, to determine whether the vaccine is safe for use on humans. Volunteers, aged between 18 and 59 from Beijing, Chongqing and Hunan, received the vaccine in hospitals in Chongqing and Beijing. The phase-2 trials were launched on July 10, to further evaluate the immunogenicity and safety of the vaccine.

According to the institute, the trials were randomized, double-blind and placebo-controlled.

The vaccine has been patented. Its developers are preparing for large-scale phase-3 trials to judge the vaccine's efficacy.

Four Chinese vaccine candidates have entered phase-3 clinical trials so far, said an official with the Ministry of Science and Technology at a press conference in October.
 
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Phoenix Net Finance
Today at 09:30 from Weibo


[Sinopharm Liu Jingzhen: 56,000 people left the country after being vaccinated with the COVID-19 vaccine, none of them were infected]

On November 6, the 3rd Hongqiao International Health Technology Innovation Forum was held in the 3rd CIIE Pavilion. At the forum, Liu Jingzhen, Chairman of Sinopharm Group, revealed the following when talking about topics related to the COVID-19 vaccine, at present, hundreds of thousands of people have been vaccinated urgently with two inactivated vaccines under the Sinopharm Group, and there has been no serious cases of adverse reaction. The number of people who left the country after vaccination reached 56,000, and none of them have been infected so far.


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Details about China's phase 3 coronavirus vaccine trials revealed, participants say it gives them hope
By Bang Xiao
Posted 10h hours ago

Key points:
  • Chinese international students say they were "emotional" when they were selected for the trial
  • Official figures show over 60,000 Chinese citizens have received trial COVID-19 vaccines
  • An expert warns people still need to follow precautionary measures when a vaccine is available
Yilu Wu screamed with delight after waking up to a text message revealing she had been chosen as one of the first participants in China's coronavirus vaccine trials.

The 20-year-old, who studies finance in the UK, was suddenly one step closer to getting her life back on track so she didn't hesitate to join the recent phase 3 tests.

....

 
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No infections among 56,000 people who traveled abroad after receiving Sinopharm-developed COVID-19 vaccine: developer
Source: Global Times Published: 2020/11/7 13:32:29

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vaccine Photo:VCG

None of the 56,000 people who were inoculated with a COVID-19 vaccine and travelled abroad have contracted the coronavirus, Sinopharm's chairman said on Friday.

Sinopharm Chairman Liu Jingzhen, said at a conference on Friday that some 100,000 people have been vaccinated with the company's vaccine and have shown none adverse reactions so far. Among those who were inoculated and travelled aboard, none have been infected with the virus, said Liu.

Some of those other received the emergency-use vaccine are employees of China National Petroleum Corporation, China Petrochemical Corporation and Technology giant Huawei.

Liu said that there are 99 people in Huawei's Mexico office, and 81 were vaccinated. Ten unvaccinated employees contracted with the virus in an outbreak in this office.

The fact that no one who received the vaccine has been infected, serves as more anecdotal evidence that the vaccine is working, Tao Lina, a Shanghai-based vaccine expert told the Global Times.

The data signals Sinopharm vaccine maybe close to being released on the market, Tao predicted.

Liu said that since June, Sinopharm's phase three clinic trial in dozens of countries and regions, including the UAE, Egypt, Bahrain, Peru and Morocco have more than 50,000 participants.

The results have moved the UAE ,Bahrain and other countries to approve urgent use of the Sinopharm vaccine, according to Liu, who told the conferred that he is "still alive and kicking, with no adverse reaction," after he was vaccinated in March.

Liu said the examples and scientific data prove the effectiveness of the company's COVID-19 vaccine.

Liu said Sinopharm is to produce about 100 million doses of vaccine by the end of the year, and estimates it will make 1 billion doses next year, to guarantee supplies especially for use by Chinese people, said Liu.

China has approved three vaccines for urgent use. Their vaccines have been given to high-risk groups, such as medical staff, diplomats sent to most-affected countries, and employees sent overseas under the Belt and Road Initiative.

These people have stayed abroad several months after being vaccinated, Zhou Song, general counsel CNBG, a Sinopharm subsidy said in September, according to the WeChat account of the State-owned Assets Supervision and Administration Commission of the State Council.
 
China’s CanSino launches Phase III clinical trial of COVID-19 vaccine in Mexico, 1st group gets vaccinated
Source: Global Times Published: 2020/11/7 22:26:34

53875a9c-4a64-457b-a3c2-2c9aa3a94f81.jpeg
The first group of subjects in Mexico got vaccinated on Friday.

One of China’s vaccine developers announced on Saturday that it has launched the Phase III clinical trial for its COVID-19 vaccine in Mexico and has successfully vaccinated the first group of subjects.

CanSinoBIO, the Chinese pharmaceutical company, told the Global Times on Saturday that it has initiated the Phase III clinical trial for a recombinant COVID-19 vaccine (Ad5-nCoV) it developed in Mexico.

The study was approved by the Mexican authority in October. The trial aims to recruit a total number of 15,000 subjects to further demonstrate the efficacy of the candidate.

In October, CanSinoBIO also signed an advance purchase agreement with Mexico’s government to supply 35 million doses of COVID-19 vaccine to the Mexicans in need.

Xuefeng Yu, chairman and CEO of CanSinoBIO, said, “Launching the clinical study of Ad5-nCoV in Mexico represents another milestone of CanSinoBIO,” and that the company is delighted to collaborate with Mexican local company EPIC to make this initial clinical study in Mexico possible.

Ad5-nCoV is currently undergoing phase III clinical development in both Russia and Pakistan.

Petrovax, CanSinoBIO’s partner in Russia, told the Global Times on Saturday that they have completed the vaccination of all volunteers within the local phase III clinical trial of the Ad5-nCov vaccine candidate, developed by CanSinoBIO.

Following vaccination and examination of volunteers during the first 28 days, the analytical part of the study will be launched with the primary processing of the results. The preliminary results of the study will be received by the end of 2020, according to Petrovax.

Brazilian health regulator Anvisa announced authorization for Sao Paulo's Butantan Institute biomedical center to import 6 million doses of a COVID-19 vaccine developed by Chinese company Sinovac Biotech, which is undergoing final clinical trials in Sao Paulo state, Reuters reported in October.

Vaccine experts told the Global Times previously that China is taking the lead in COVID-19 vaccine research, with China-developed candidates proving their safety and efficacy during clinical trials and emergency use on tens of thousands of Chinese people.

Liu Jingzhen, chairman of Sinopharm, another Chinese vaccine developer, said at a conference on Friday that some 100,000 people have been vaccinated with the company's vaccine and have shown no adverse reactions so far. Among those, 56,000 people were inoculated and travelled aboard, and none have been infected with the virus, said Liu.
 
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The state government of Sao Paulo, where the trial is being run, said the death of a trial volunteer had been registered as a suicide and was being investigated. A police report of the incident was seen by Reuters.

 
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Brazilian medical institute Butantan said in a statement it would restart trials later on Wednesday.
 
One more Chinese COVID-19 vaccine ready for phase-3 clinical trials
Source: Xinhua| 2020-11-01 20:48:07|Editor: huaxia

BEIJING, Nov. 1 (Xinhua) -- A COVID-19 vaccine candidate developed by the Institute of Microbiology under the Chinese Academy of Sciences has shown to be safe in early-stage trials, suggesting potential for further clinical tests.

The results of phase-1 and phase-2 trials support the safety and immunogenicity of this recombinant subunit vaccine in healthy participants, and no serious adverse events have been found so far, the institute said in a statement on Friday.

Jointly developed by the institute and Chongqing Zhifei Biological Products Co., Ltd., the vaccine was issued with a clinical research permit from the National Medical Products Administration on June 19.

Researchers started phase-1 clinical trials on June 23, to determine whether the vaccine is safe for use on humans. Volunteers, aged between 18 and 59 from Beijing, Chongqing and Hunan, received the vaccine in hospitals in Chongqing and Beijing. The phase-2 trials were launched on July 10, to further evaluate the immunogenicity and safety of the vaccine.

According to the institute, the trials were randomized, double-blind and placebo-controlled.

The vaccine has been patented. Its developers are preparing for large-scale phase-3 trials to judge the vaccine's efficacy.

Four Chinese vaccine candidates have entered phase-3 clinical trials so far, said an official with the Ministry of Science and Technology at a press conference in October.
China-developed COVID-19 vaccine to enter late-stage trial in Uzbekistan
Source: Xinhua| 2020-11-14 17:37:12|Editor: huaxia

TASHKENT, Nov. 14 (Xinhua) -- The Uzbek government has recently told media that the country will carry out a phase-3 trial of a China-developed vaccine for COVID-19, which makes the vaccine China's fifth candidate to enter late-stage human tests overseas.

The ministry has announced that 5,000 Uzbek volunteers aged between 18 and 59 will attend the third phase of the pilot process, which will continue for a year.

Developed by China's Anhui Zhifei Longcom Biopharmaceutical, the trial vaccine has been transported to Uzbekistan along with several Chinese specialists who will work on the monitoring of participants and training of Uzbek doctors.

Uzbekistan has so far confirmed 69,830 COVID-19 cases and 594 deaths, with 67,092 patients recovered.
 
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