Saturday, December 28, 2024
What's new

Clinical human trials begin for COVID-19 vaccine in China

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

462cb6ab-f203-4a08-99d4-953616955d15.jpeg

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.
 
Last edited:
.
↑↑↑
UAE grants emergency approval to next-gen Sinopharm jab
By Wang Xiaoyu | chinadaily.com.cn | Updated: 2021-12-28 20:02
more_art.gif


61cafd60a310cdd3d823c134.jpeg
Photo taken on June 1, 2021 shows vials of the Sinopharm vaccine in Beijing, capital of China. [Photo/Xinhua]

Health authorities of the United Arab Emirates have recently approved a second-generation COVID-19 vaccine made by Chinese company Sinopharm for emergency use, the company said on Tuesday.

The company said in a notice the vaccine can provide wide-spectrum protection against multiple variants of the novel coronavirus.

It added the vaccine is the world's first second-generation COVID-19 vaccine that has received emergency authorization.

The product is of the recombinant protein subunit type that typically requires three doses for full immunization.

In the UAE, the vaccine will be used as a booster shot to spike immunity for people fully vaccinated with Sinopharm's two-dose inactivated vaccine, according to the notice.

Preliminary research involving about 2,000 participants in the country shows the vaccine is safe and capable of inducing high levels of neutralizing antibodies against the original strain of the novel coronavirus and major variants.

The emergency use approval has been announced as global scientists are studying whether mixing and matching different types of vaccines can further boost immunity.
 
. .
↑↑↑
UAE grants emergency approval to next-gen Sinopharm jab
By Wang Xiaoyu | chinadaily.com.cn | Updated: 2021-12-28 20:02
more_art.gif


61cafd60a310cdd3d823c134.jpeg
Photo taken on June 1, 2021 shows vials of the Sinopharm vaccine in Beijing, capital of China. [Photo/Xinhua]

Health authorities of the United Arab Emirates have recently approved a second-generation COVID-19 vaccine made by Chinese company Sinopharm for emergency use, the company said on Tuesday.

The company said in a notice the vaccine can provide wide-spectrum protection against multiple variants of the novel coronavirus.

It added the vaccine is the world's first second-generation COVID-19 vaccine that has received emergency authorization.

The product is of the recombinant protein subunit type that typically requires three doses for full immunization.

In the UAE, the vaccine will be used as a booster shot to spike immunity for people fully vaccinated with Sinopharm's two-dose inactivated vaccine, according to the notice.

Preliminary research involving about 2,000 participants in the country shows the vaccine is safe and capable of inducing high levels of neutralizing antibodies against the original strain of the novel coronavirus and major variants.

The emergency use approval has been announced as global scientists are studying whether mixing and matching different types of vaccines can further boost immunity.
Rather take a booster of mRNA vaccine that will protect against severe disease from all variants. BTW, variant specific boosters for mRNA vaccines already exist.
 
. . .
 
. . . .

Trials show China's mRNA COVID-19 vaccine safe, effective

Source: Xinhua Editor: huaxia
2022-01-26 08:26:16

1643180496855.png
A medical worker injects a dose of COVID-19 vaccine at a vaccination site of Jingcheng Hospital in Ruili City, southwest China's Yunnan Province, April 1, 2021. (Xinhua/Chen Xinbo)

BEIJING, Jan. 26 (Xinhua) -- A China-developed mRNA COVID-19 vaccine has been shown to be safe, well-tolerated and effective in early-stage human trials, according to a study published Tuesday in the Lancet Microbe journal.

The vaccine ARCoV, which encodes the SARS-CoV-2 spike protein receptor-binding domain, was jointly developed by the Academy of Military Medical Sciences, Suzhou Abogen Biosciences and Yunnan-based Walvax Biotechnology Co., Ltd.

Researchers conducted phase one trials at a hospital in Hangzhou, Zhejiang Province, from Oct. 30 to Dec. 2, 2020. A total of 120 healthy adults aged between 18 and 59 who tested negative for SARS-CoV-2 participated in the trials, which were randomized, double-blind and placebo-controlled.

The vaccination procedure included two jabs, and five quantities of the vaccine were evaluated in the tests: 5 micrograms, 10 micrograms, 15 micrograms, 20 micrograms and 25 micrograms.

The study highlighted that 15 microgram doses induced the highest titers of neutralising antibodies, roughly double the antibody titers of convalescent patients with COVID-19, indicating stronger immune responses induced by the vaccine.

The vaccine candidate in these phase one trials exhibited an acceptable safety profile and induced a strong immune response in participants. No serious adverse events were reported within 56 days after vaccination, according to the study.

A multi-regional phase three human trial with more participants is currently underway to test the efficacy of the Chinese vaccine.

Two mRNA vaccines, developed by Moderna and Pfizer-BioNTech, have been approved for emergency use.

China started building a plant to manufacture the mRNA vaccine in December 2020 in the city of Yuxi, Yunnan Province. It is expected to produce 120 million doses per year in its first phase.

According to its developers, ARCoV was manufactured as a liquid formulation and can be stored in standard refrigerated conditions (2-8 degrees Celsius), which is convenient for transportation and application.

 
. . . . .


DONOT POST GRAPHIC/BLOODY/DEAD pictures or videos. Will result in an immediate ban.

Write your reply...

Latest posts

Country Latest Posts

Back
Top Bottom