Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
“This is very good news. However, the emergency use authorization is very limited, very strict and it seems to be very well-connected to the trial phase of the vaccines,” Benny Spiewak, partner at SPLaw, a life sciences-focused law firm based in Sao Paulo, told BioWorld.
But not all vaccine makers appear willing to go down that path. China’s Sinovac Biotech Ltd., whose Coronavac vaccine is completing phase III trials in the state of São Paulo, is among them. Rather, the company is relying on the state-owned Butantan Institute in Sao Paulo to distribute the vaccine. Sinovac has partnered with Butantan to manufacture and distribute its vaccine in the country. It has a technology transfer agreement with Butantan and will not take the emergency pathway.
“This new regulation by Anvisa is important, but Butantan will not use this requirement,” Dimas Covas, director of the Butantan Institute, told CNN Brasil on Dec. 3. “[Butantan] will apply for registration. We are already very advanced in this process."
At a press conference, Anvisa´s director, Gustavo Mendes, said the vaccine from the University of Oxford and Astrazeneca plc, AZD-1222, as well as vaccines from Sinovac, Johnson & Johnson and Pfizer Inc./Biontech SE, have the green light to apply for emergency authorization approval.
"If we observe, from the data that the vaccine has shown so far, that there is a specific population, such as the elderly or the health professionals, to which there is a clear benefit-risk balance, emergency authorization is justified,” Mendes said.
Butantan has said it is confident of the outcome of going through the regular pathway. Sinovac has already sent a million doses of Coronavac to Brazil. The vaccines are being stored in the country and will be ready for distribution as soon as Anvisa grants its marketing authorization.
At the same time, a team from Anvisa traveled to China, where it inspected Sinovac´s manufacturing plants to certify them for GMP production. The inspections in China started on Nov. 30.
“We are there in China with an extremely experienced team,” said Ronaldo Ponciano, director at Anvisa´s health inspection branch. “Together, they have over 400 international inspections. They are extremely experienced and Brazilian society can be absolutely sure that the process will proceed in the most professional way possible.”
The Brazilian team also plans to conduct GMP inspections at Wuxi Biologics, of Hangzhou, China, which is a key partner of Astrazeneca in the manufacturing of innovative biologics in China.
Inspecting Wuxi Biologic´s plants is key for President Jair Bolsonaro´s vaccine plans in Brazil. He has his hopes on the vaccine candidate being developed by Astrazeneca and the University of Oxford. Brazil’s federal government has already reserved 100 million doses of that vaccine.
“I don't see at least Sinovac and Astrazeneca asking for the emergency authorization, because they are very close to having the formal complete submissions ready,” said Spiewak in Sao Paulo. “The new emergency guidelines show that Anvisa is working hard and its internal team is becoming better prepared on a daily basis to deal with a mass vaccination program. I believe that having an emergency authorization procedure is a first step to get what we really want, which is to go to a mass vaccination.”
Meanwhile, politics continue to surround Brazil’s response to COVID-19.
Sao Paulo´s governor, Joao Doria, continues to move forward with the Chinese vaccine manufactured by Sinovac, while other states are betting on the Russian Sputnik V developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, Russia, while the federal government is putting its bets on Astrazeneca and the University of Oxford.
For its part, Pfizer and Biontech also want to get a share of the market. Pfizer Brasil, the Brazilian branch of the U.S. company, said Nov. 25 that the company started the registration process of the BNT-162b2 vaccine.
“This is an important step for the vaccine to be available in Brazil. Pfizer will make all the necessary data available for evaluation and will be in full collaboration with Anvisa so that this process runs smoothly and as quickly as possible,” said Márjori Dulcine, medical director at Pfizer Brasil. The company is not taking the emergency pathway, either, but rather the so-called “continuous submission” process designed by Anvisa for the COVID-19 vaccine.
“Whenever a company secures an emergency use, it will not be the same as securing a definitive formal approval,” Spiewak explained.
“It is very relevant, most for it to set the tone for the next steps, than for what it really is,” he said.
Brazil has recorded more than 6.5 million cases of COVID-19 and more than 175,000 deaths since the outbreak began.