The China Sinovac phase III trial in Brazil can last only three months 2020-07-10 | Instant News

CAJICA, Colombia and BEIJING – Last week Sinovac Biotech Ltd., from Beijing, announced approval by Anvisa, the Brazilian health oversight body, to begin phase III trials to test the efficacy and safety of the inactive COVID-19 vaccine developed by Sinovac Life Sciences, a Chinese subsidiary, in Latin American countries.

The milestone achieved by Sinovac in Brazil places Chinese biotech among the first developers in the race to get the SARS-CoV-2 vaccine. More than 149 research groups are racing to find solutions to this pandemic.

With Brazil hosting a phase III trial, Sinovac hopes to accelerate its development, because it is trying vaccines in a country that offers a solid regulatory framework, and there is no shortage of volunteers, given the fact that it is the second country with most COVID-19 cases which is confirmed.

“In terms of time, Brazil’s phase III system has been fairly easy and has been well developed since late 2008,” Benny Spiewak, partner at SPLaw, a law firm focusing on life sciences based in Sao Paulo, Brazil, told BioWorld.

“At present, the Ministry of Health and the institutional review board are quite active and they are quite aligned in terms of prioritizing ways to move forward with requests for clinical trial approval,” he explained.

Sinovac partnered with Butantan Institute, from Sao Paulo, Brazil, to submit approval for a phase III trial that tested vaccines, called Coronavac. Butantan is a public research institution that is recognized in Brazil for pioneering work in vaccines.

“This is a pretty brave step, if you ask me,” said Spiewak. “I understand that the structure underlying Butantan is to take an active role in developing vaccines, so having Chinese biopharma joining the effort with Butantan is not real news, because that is the type of entity that Butantan likes.”

According to Anvisa, the vaccine to be tested in Brazil is made from the inactive type SARS-CoV-2. “The proposal provides for testing 9,000 people in the country, in the states of Sao Paulo, Rio Grande do Sul, Minas Gerais, and ParanĂ¡, in addition to the Federal District. Volunteer recruitment is the responsibility of the centers that conduct research, “according to Anvisa.

“For this authorization, Anvisa analyzes data from the previous product development stage. “Nonclinical studies on animals are conducted, the results show that vaccines provide acceptable safety,” he explained.

Butantan will begin recruiting 9,000 volunteers for phase III trials this week. Volunteers will be selected from health professionals to directly treat COVID-19 patients.

“The testing process will start on July 20. Participants may not suffer from infections caused by coronavirus, they may not participate in other studies and women cannot become pregnant or plan a pregnancy within the next three months. Another limitation is that they do not have unstable disease or the need for drugs that change the body’s immune response, “Butantan explained.

Analysts such as Spiewak have noted that in the current emergency, phase III trials in Brazil can take less than a semester.

“We look forward to the time frame, for phase III vaccines, at around three to six months, which is quite accelerated, if you compare it to the others,” Spiewak said. “We know that there are certain drugs that take two and a half to five years to complete, and even in phase IV, they can take up to 10 years, because you have ongoing trials,” he added.

The accelerated approval is one of the steps taken by the Brazilian government to deal with a pandemic, which has surpassed 1.7 million cases. Even the country’s president, Jair Bolsonaro, tested positive last week for the virus.

“Unfortunately, we are in a short situation … so, choosing between accelerated reviews and safe and very conservative ones, is something we might not have the privilege of choosing now,” Spiewak said. “Achieving a balance between getting to a safe place and speeding up reviews is a very positive thing.”

According to Spiewak, phase III trials in Brazil are the most structured throughout the world. “The structure is very solid; You don’t have a lot of gray areas to discuss, in terms of post-trial supplies and other things, so this is a very relevant and safe and structured system that we have at the moment in Brazil, “he said.

Chinese trials abroad

Sinovac is not the only Chinese company conducting trials outside the borders of China. Company likes Sinopharm Group, from Shanghai, and Cansino Biologics Inc., from Tianjin China, has observed different jurisdictions to conduct phase III trials.

“We are conducting trials in the UAE and are in talks with other countries. In the future, we can conduct phase III trials in three or four more countries, “said Xiaoming Yang, chairman of Sinopharm, during a Dialogue with the Biotechnology Community webinar, organized by the Hong Kong Stock Exchange on July 6.

For his part, Xuefeng Yu, chairman and CEO at Cansino, confirmed during the same webinar the company’s intention to conduct phase III trials in several different locations throughout the world.

“We hope to move our vaccine candidates to the global phase III trials in the second half of this year, to give them to the world,” he said.

Weidong Yin, chairman, president and CEO of Sinovac, said the company was pleased with the partnership with Butantan. “[This is] “one step further to our commitment to develop vaccines for global use and for our mission to provide vaccines to eliminate human diseases,” he said.

“The approval of phase III clinical trials is a demonstration that the Sinovac and Butantan partnership is an efficient collaboration to move forward offering hope to save lives around the world,” added Dimas Covas, director of the Butantan Institute.


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