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Phase 3 trials usually involve thousands of volunteers to test the efficacy and broader safety of the vaccine candidate. Photo: Reuters

Coronavirus: Peru and Morocco to start phase 3 trials of two Chinese vaccine hopefuls

  • Candidates developed by state-owned China National Biotec Group are already being tested in Abu Dhabi, and will also be trialled in Bahrain
  • Expert says conducting the trials across multiple locations will speed up the process
Two Covid-19 vaccine candidates developed by state-owned China National Biotec Group have been approved for phase 3 trials in Peru and Morocco.

Agreements with the two governments were signed in Beijing on Thursday, according to a CNBG statement.

The potential inactivated vaccines were developed by CNBG subsidiaries in Wuhan and Beijing and finished phase 2 trials in June.

Phase 3 tests the efficacy and broader safety of the candidate and the trials usually involve thousands of volunteers.

The experimental vaccines are going through a phase 3 trial in Abu Dhabi at present, with 15,000 volunteers recruited. They will also be tested in Bahrain in a phase 3 trial involving 6,000 people.

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In Peru, the trial will start on Monday with 6,000 volunteers, according to Peruvian state news agency Andina.

It said Peru was also in talks with other Chinese vaccine makers to trial an inactivated candidate developed by Sinovac Biotech and a potential adenovirus-vectored vaccine developed by CanSino Biologics.

No details of the trials to be conducted in Morocco were given in statements from CNBG or the Moroccan government.

Liu Jingzhen, chairman of CNBG’s parent company China National Pharmaceutical Group, or Sinopharm, told Chinese state broadcaster CCTV on Thursday that “we have satisfied the requirements for phase 3 trials”.

He said two doses given 28 days apart would achieve “optimal effect”.

Liu has previously said that the two vaccine candidates could be ready by the end of this year, with a retail price for the two-dose regimen of around 1,000 yuan (US$145). The group has built two facilities to make Covid-19 vaccines, and Liu expected they would be able to produce at least 200 million doses a year.

Shanghai-based vaccine expert Tao Lina said conducting phase 3 trials across multiple locations would speed up the process.

“The point is to have a large number of participants in the phase 3 trials, so having trials at several sites simultaneously means it will save time,” Tao said. “In my mind, with such a large-scale [trial], one month [after vaccination] will be enough [to get a result].”

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Worldwide, Covid-19 vaccine candidates from six developers are going through phase 3 clinical trials, and human trials are being carried out on some 30 experimental vaccines, according to the World Health Organisation.

Several candidates, such as a vaccine developed by AstraZeneca and the University of Oxford, are going through trials in multiple countries.

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German company BioNtech, working with Fosun Pharma in China and Pfizer elsewhere, on Thursday said its second vaccine candidate had shown fewer side effects than the first one during trials.

Both candidates were given to 332 people. Of those aged between 18 and 55 who were given the first candidate, 50 per cent had adverse events thought to be related to the vaccine. For those aged between 65 and 85, it was 16.7 per cent.

But for the second vaccine hopeful, only 16.7 per cent of the younger age group had adverse events, while there were none thought to be related to the vaccine in the older age group.

The company said last month that the second candidate was moving to a phase 2/3 study involving up to 30,000 people aged from 18 to 85, starting in the United States and expected to include about 120 locations worldwide.

This article appeared in the South China Morning Post print edition as: Simultaneous trials of Chinese vaccines in multiple countries to ‘speed up process’
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