A staff member displays samples of the COVID-19 inactivated vaccine at Sinovac Biotech Ltd., in Beijing, capital of China, March 16, 2020. (Xinhua/Zhang Yuwei)
Brazil and other countries including Malaysia, Canada and the UK will join China's efforts to strengthen global cooperation in COVID-19 vaccine trials, as the Institute Butantan in Brazil plans to cooperate in Phase III clinical trials for an inactivated COVID-19 vaccine candidate developed by a Chinese company.
Beijing-based Sinovac Biotech and Instituto Butantan, a leading Brazilian producer of immunobiologic products, have agreed to collaborate in Phase III clinical trials of CoronaVac, Sinovac's inactivated vaccine candidate against COVID-19.
The cooperation is expected to achieve a win-win outcome as a vaccine can help end the grim epidemic in Brazil. China, in contrast, has become less favorable as a late-stage clinical trial hub, given its smaller number of new cases.
The two parties aim to establish extensive collaboration in technology licensing, market authorization and commercialization of CoronaVac, according to an announcement Sinovac sent to the Global Times on Tuesday.
The Butantan Institute will spend 85 million reals ($17.1 million) to conduct trials on 9,000 Brazilian volunteers, São Paulo Governor João Doria said in a press conference on Thursday. Doria said that if the vaccine proved effective, it could be mass-produced in São Paulo, starting from the first half of next year, and administered to millions of Brazilians free of charge.
Liu Peicheng, a spokesperson for Sinovac, told the Global Times that the Phase III trials would only start after being approved by the health authorities in China and Brazil.
The company expects to submit a Phase IIIclinical study protocol to China's National Medical Products Administration in the near future, Sinovac said.
"The choices of locations for clinical trials depend on the current epidemic situations in host countries and estimated development trends, the willingness of partners and local governments, and researchers' clinical experience and capability," Liu said.
Confirmed COVID-19 cases in Brazil exceeded 880,000 as of Monday, according to Brazilian health authorities.
As Brazil is at the epicenter of the epidemic, it is beneficial to carry out research on the actual protective effects of vaccines against the coronavirus, which is the key to China-Brazil cooperation, Tao Lina, a Shanghai-based vaccine expert, told the Global Times on Tuesday.
CoronaVac is likely to be one of the first candidates to complete all phase trials, said Tao.
"If the Phase III clinical trials in Brazil go smoothly and on schedule, the critical data to prove efficacy of the vaccine can be obtained within two months and approval for mass production is likely by October," he said.
Sinovac announced on June 13 positive preliminary results of Phase I/II clinical trials for CoronaVac, which showed favorable immunogenicity and safety profiles.
The Phase II results showed that the vaccine induces neutralizing antibodies within 14 days. The neutralizing antibody seroconversion rate is above 90 percent.
Sinovac has started to build a plant to make 100 million doses, media reports said.
Dr. Ricardo Palacios, clinical research medical director of Instituto Butantan, said in a statement that the Chinese vaccine developer's "reliable technology is suited to being incorporated into existing public health immunization programs in Brazil."
All five types of COVID-19 vaccines in China are being developed under international cooperation with at least seven countries including Canada, the UK, the US and Germany, media reported.
Malaysia's Ministry of Science, Technology and Innovation confirmed to the Global Times in May that it is working with the Chinese Embassy in Malaysia on possible cooperation in vaccine clinical trials. A Chinese university has shown interest in being the Malaysian ministry's strategic partner in co-developing the vaccine through clinical research.
Also, the Islamabad-based National Institute of Health had an offer from Chinese vaccine developer Sinopharm to collaborate in conducting clinical trials of its inactivated vaccine in Pakistan, media said.
Unlike its technical cooperation with developed countries that are well-resourced in vaccine research like the US or the UK, China's collaboration with developing countries is mainly based on human clinical trials, said Tao, and such cooperation requires effective communications between partners.
"In theory, all six vaccines undergoing human clinical trials in China are recommended to carry out Phase III clinical trials in other countries," said Tao.
China-based vaccine maker CanSino Biologics announced its collaboration with the Canadian National Research Council on clinical trials of the recombinant vaccine in May. Further details haven't been announced.
"Given the current close ties between Canada and the US, it is possible that the Canadian side may suspend cooperation with China under US pressure aimed at a slowdown of Chinese vaccine R&D," Tao commented.
"So China's collaboration with Brazil is highly anticipated given Brazil's trust in China's research capabilities and its comprehensive strategic partnership with China," Tao added.
