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Clinical human trials begin for COVID-19 vaccine in China

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China’s 2nd protein subunit COVID-19 vaccine to enter clinical trials, easy to mass produce
By Hu Yuwei
Published: Feb 23, 2021 08:43 PM


Sinopharm's COVID-19 vaccine. Photo: VCG​

China's COVID-19 protein subunit vaccines have reported encouraging progress as a leading Chinese vaccine producer, Sinopharm, plans to bring its newly developed recombinant subunit vaccine candidate into clinical trials.

Sinopharm's vaccine is the second protein subunit vaccine in the country after one developed by China's Anhui Zhifei Longcom Biopharmaceutical Co, which started late-stage trials in Pakistan upon approval on Sunday.

The protein subunit vaccine is expected to perform better than the inactivated vaccines, and would be easier to mass produce, Sinopharm Chairman Liu Jingzhen suggested in a recent interview with China Central Television (CCTV).

Liu said its second COVID-19 inactivated vaccine - developed by subsidiary Wuhan Institute of Biological Products - is now applying for conditional approval for mass use.

China's first recombinant subunit COVID-19 vaccine, co-developed by Zhifei and the Institute of Microbiology of the Chinese Academy of Sciences (IMCAS), has been approved to enter phase III clinical trials in Pakistan.

The double-blinded, placebo-controlled trials will involve around 10,000 participants in Pakistan, of whom 30 percent will be seniors, according to news released by IMCAS on Sunday.

Experts said the recombinant subunit vaccine can be an important addition to the two Chinese inactivated vaccines already in mass production, considering its shorter production process.

"Traditional inactivated vaccines normally take several months to develop, and require biosafety level 3 labs for production. Meanwhile, access to the recombinant protein vaccine is easier, and the biotechnology is more mature than the mRNA and adenovirus-vector techniques used in some available vaccines," Zhuang Shilihe, a Guangzhou-based doctor closely studying the COVID-19 vaccines, told the Global Times on Tuesday.

Novavax, a US-based pharmaceutical company that developed a similar protein-based COVID-19 vaccine, reported an efficacy rate of 89.3 percent in its phase III clinical trials conducted in the UK in early February, boosting global confidence in this type of technical innovation.

Zhuang believes that protein subunit COVID-19 vaccines can perform better against new COVID-19 variants, as lab research found these new vaccines remain effective in triggering an immune response.

In a pre-print published on biology server BioRXIV on February 2, Gao Fu, director of the Chinese Center for Disease Control and Prevention, revealed that Zhifei's recombinant protein vaccine was still effective against the South African variant, although its efficacy was reduced by 1.6 times, which is within acceptable parameters. In particular, it was advantageous in comparison to the mRNA vaccine, leading with a reduction of three to eight times more.

Giving these promising signs, Uzbekistan's government has decided to purchase 1 million doses of Zhifei's vaccine and start voluntary mass vaccination, media reported.

Uzbekistan will almost double the number of volunteers from 5,000 to 9,000 involved in a phase III trial, the Uzbek Ministry of Innovative Development said in early February.
 

JSCh

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People's Daily, China @PDChina
China state-affiliated media

China has donated 50,000 doses of #COVID19 vaccine to #Iraq, the Chinese embassy in Baghdad said on Thursday. Iraqi Ministry of Health announced that Iraq approved the emergency use of China's Sinopharm vaccine in January.
CGTN @CGTNOfficial
China state-affiliated media

#Iraq will purchase #COVID19 vaccines from China’s Sinopharm, the first vaccines allowed to enter the country, according to the prime minister's office on Tuesday. The first batch of vaccines will arrive in Iraq on March 1.

7:16 AM · Feb 24, 2021
 

JSCh

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18:49, 23-Dec-2020
Phase 3 trials of Chinese COVID-19 vaccine start in Uzbekistan
CGTN

People wearing face masks wait in line to enter the grocery store amid the COVID-19 outbreak in Tashkent, Uzbekistan April 9, 2020. /Reuters

Late-stage clinical trials of a Chinese candidate coronavirus vaccine has been carried out in Uzbekistan on Tuesday after early and mid-stage results suggest it is safe and efficient, researchers said.

The ZF2001 vaccine, which uses a harmless piece of the virus to induce the human body's immune response, is one of China's five candidate vaccines that have entered human trials overseas.

"We are planning to recruit 29,000 people globally," the Chinese Academy of Sciences (CAS) wrote in a statement, adding the late-stage trials started in China's Hunan Province in November and will soon be rolled out in Indonesia, Pakistan, and Ecuador.

The vaccine did not cause serious adverse effects, other than mild side-effects including injection pain, redness and swelling, according to a paper published on Tuesday before it was peer reviewed.

The combined data from Phase 1 and 2 trials involved 950 healthy Chinese participants aged 18-59. Low dose and high dose versions were tested. The Phase 2 study also tested two doses versus three doses for both the low dose and high dose versions.

The higher dose given via three injections spaced 30 days apart did not induce an improved immune response compared to the lower dose, the paper said. The Phase 3 trial will look at the lower dose version given over three injections, it said.

Neutralizing antibodies against the virus were detected among at least 93 percent of participants who received three shots in different groups. The levels of vaccine-triggered antibodies were higher than those seen in samples of patients recovered from the disease, researchers said.

However, these antibody-based readings are on their own not sufficient to predict how effective ZF2001 will be in protecting people from the virus, researchers said, warning they could not yet determine the duration of immune responses.

The vaccine also triggered moderate cell-based immune responses, a crucial part of the human immune system that works differently from antibodies.

Production for CAS' COVID-19 vaccine has been put into operation in September, according to vaccine manufacturer Anhui Zhifei Longcom Biopharmaceutical Co. The annual output is expected to reach more than 300 million doses, the company said.

Latest data shows over 76,315 people have been infected with the coronavirus in Uzbekistan. Cases peaked between July and September and so far have not spiked again.

(With input from Reuters)
CGTN @CGTNOfficial
China state-affiliated media

#Uzbekistan officially approved the registration of the #Chinese COVID-19 vaccine, developed by Anhui Zhifei Longcom Biopharmaceutical, on Monday, according to the country’s authorities. The shot was undergoing phase 3 trials in the Central Asian nation.

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7:36 AM · Mar 2, 2021
 

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The COVID-19 vaccine developed by China's Sinovac Biotech has an efficacy of 83.5% based on final results of Phase III trials, Turkish researchers said on Wednesday, a downward revision from a preliminary finding of 91.25%.


The COVID-19 vaccine developed by China's Sinovac Biotech has an efficacy of 83.5% based on final results of Phase III trials, Turkish researchers said on Wednesday, a downward revision from a...​
7:15 PM · Mar 3, 2021
 

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