CAJICA, Colombia, and BEIJING – Last week Sinovac Biotech Ltd., of Beijing, announced the approval by Anvisa, the Brazilian health care surveillance agency, to start phase III trials to test the efficacy and safety of its inactivated COVID-19 vaccine being developed by Sinovac Life Sciences, a subsidiary of the Chinese company, in the Latin American country.

The milestone achieved by Sinovac in Brazil puts the Chinese biotech amid the first developers in the race for a SARS-CoV-2 vaccine. More than 149 research groups are competing to find a solution to the pandemic.

With Brazil becoming the host of the phase III trials, Sinovac expects to speed up its development, as it tries the vaccine in a country offering a solid regulatory framework, as well as no scarcity of volunteers, given the fact that it became the second country with most COVID-19 confirmed cases.

“In terms of timing, the Brazilian phase III system is quite straightforward and well-developed since late 2008,” Benny Spiewak, partner at SPLaw, a life sciences-focused law firm based in Sao Paulo, Brazil, told BioWorld.

“Currently, the Ministry of Health and the institutional review boards are quite active and they are quite aligned in terms of prioritizing how to move forward with requests for clinical trial approvals,” he explained.

Sinovac partnered with the Butantan Institute, from Sao Paulo, Brazil, in order to file for the approval of the phase III trials testing the vaccine, called Coronavac. Butantan is a public research institution recognized in Brazil for pioneering work in vaccines.

“It is quite a bold move, if you ask me,” Spiewak said. “I understand that the underlying structure of Butantan is to take an active role in developing a vaccine, so having a Chinese biopharma joining efforts with Butantan is not really news, since it is the type of entity that Butantan likes to put efforts with.”

According to Anvisa, the vaccine to be tested in Brazil is made from inactivated strains of 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 Paraná, in addition to the Federal District. The recruitment of volunteers is the responsibility of the centers that conduct the research,” according to Anvisa.

“For this authorization, Anvisa analyzed the data from the previous stages of product development. Nonclinical studies in animals were carried out, the results of which demonstrated that the vaccine presents acceptable safety,” it explained.

Butantan will start recruiting the 9,000 volunteers for the phase III trials this week. Volunteers will be chosen from health professionals directly taking care of COVID-19 patients.

“The testing process will begin on July 20. Participants must not have suffered an infection caused by the coronavirus, they must not participate in other studies and women cannot be pregnant or planning a pregnancy in the next three months. Another restriction is that they do not have unstable diseases or the need of medications that alter the immune response,” Butantan explained.

Analysts such as Spiewak have noted that under the current emergency circumstances, phase III trials in Brazil could last less than a semester.

“We are looking forward in terms of timelines, for the vaccine in phase III, on something around from three to six months, which is quite expedited, if you compare with other ones,” said Spiewak. “We do know that there are certain drugs that are taking two and a half to five years to be completed, and even in phase IV, they can take up to 10 years, since you have ongoing trials,” he added.

Speeding up approvals is one of the measures taken by the Brazilian government to face the pandemic, which already surpassed 1.7 million cases. Even the country´s president, Jair Bolsonaro, tested positive last week to the virus.

“Unfortunately, we are in a short blanket situation ... so, choosing between expedited review and a safe and highly conservative one, is something we may not have the privilege of opting right now,” Spiewak said. “Striking a balance between getting to a safe place and expediting the review is a very positive thing.”

According to Spiewak, phase III trials in Brazil are among the most well-structured around the world. “The structure is a very solid one; you don't have a lot of gray areas to discuss, in terms of post-trial supplies and other matters, so it is a very relevant and safe and structured system, the one that we have nowadays in Brazil,” he said.

Chinese trials abroad

Sinovac is not the only Chinese company conducting trials beyond China's borders. Companies like Sinopharm Group, of Shanghai, and Cansino Biologics Inc., of Tianjin China, have eyed 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 may conduct phase III trials in three or four more countries,” Xiaoming Yang, chairman of Sinopharm, said during the Dialogues with the Biotech Community webinar, hosted 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 intentions to conduct phase III trials in several different locations around the world.

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

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

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

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