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Brazil's health regulator has suspended trials of a Chinese-developed Covid-19 vaccine following a "serious adverse event" involving a volunteer recipient, according to sources cited by CNN's affiliate, CNN Brasil.
Chinese drugmaker Sinovac Biotech began Phase 3 trials of its CoronaVac in collaboration with the Brazilian Butantan Institute in Sao Paulo in late July, with an aim to recruit 130,000 volunteers. Phase 3 trials represent the final and most important testing stage before regulatory approval is sought.
The pause in testing marks a potential setback for one of China's leading vaccine candidates and comes as US drugmaker Pfizer said Monday that early data from its own coronavirus vaccine showed more than 90% effectiveness.
According to a note from Brazil's National Health Surveillance Agency, an incident reported on October 29 led to a decision to suspend the trial in order to better evaluate the data and assess the risk.
"With the study interrupted, no new volunteers can be vaccinated," read the note published by CNN Brasil late Monday.
The note did not elaborate on the specific nature of the serious event or where it took place, citing privacy concerns. The Butantan Institute said it would hold a press conference Tuesday morning local time, according to CNN Brasil.
In a statement posted online Tuesday, Sinovac said it was "confident in the safety of the vaccine," without giving a reason for the reported suspension.
"We have communicated with our Brazilian partner, the Butantan Institute, and the head of the institute believes the incident has nothing to do with the vaccine. Sinovac will continue to communicate with the Brazilian side on this matter. Work related to our clinical research in Brazil will continue to be carried out in strict accordance with GCP (Good Clinical Practice) requirements," the statement said.
A Chinese Foreign Ministry spokesman read the company's statement to reporters when asked to comment on the development at the ministry's daily press briefing Tuesday.
A Brazilian volunteer receives a coronavirus vaccine produced by Chinese company Sinovac Biotech at the Sao Lucas Hospital in Porto Alegre, southern Brazil on August 8.
Pausing a clinical trial is not unusual. In September, drug giant AstraZeneca paused global trials of its coronavirus vaccine because of an unexplained illness in one of the volunteers.
Last month, Sao Paulo Governor Joao Doria had called CoronaVac "the safest, the one with the best and most promising rates" among all the vaccines tested in Brazil, after Butantan Institute said that the vaccine had proved to be safe in a trial involving 9,000 volunteers, according to Reuters.
Sinovac is also conducting Phase 3 trials in Indonesia and Turkey. Sinovac did not immediately responded to CNN's request for further comment.
Just last month, Chinese officials and vaccine developers declared that no serious side effects had been observed or reported in the clinical trials of any of China's rapidly produced vaccines. China currently has four coronavirus vaccines in Phase 3 clinical trials, mostly conducted in developing countries across the world.
www.cnn.com
[my comment] - Just like the PPE and masks, they shipped worldwide to many countries, who had to reject and send them back, as they were deemed as being of deficient grade, faulty, and in many cases, outright fraud committed
Chinese drugmaker Sinovac Biotech began Phase 3 trials of its CoronaVac in collaboration with the Brazilian Butantan Institute in Sao Paulo in late July, with an aim to recruit 130,000 volunteers. Phase 3 trials represent the final and most important testing stage before regulatory approval is sought.
The pause in testing marks a potential setback for one of China's leading vaccine candidates and comes as US drugmaker Pfizer said Monday that early data from its own coronavirus vaccine showed more than 90% effectiveness.
According to a note from Brazil's National Health Surveillance Agency, an incident reported on October 29 led to a decision to suspend the trial in order to better evaluate the data and assess the risk.
"With the study interrupted, no new volunteers can be vaccinated," read the note published by CNN Brasil late Monday.
The note did not elaborate on the specific nature of the serious event or where it took place, citing privacy concerns. The Butantan Institute said it would hold a press conference Tuesday morning local time, according to CNN Brasil.
In a statement posted online Tuesday, Sinovac said it was "confident in the safety of the vaccine," without giving a reason for the reported suspension.
"We have communicated with our Brazilian partner, the Butantan Institute, and the head of the institute believes the incident has nothing to do with the vaccine. Sinovac will continue to communicate with the Brazilian side on this matter. Work related to our clinical research in Brazil will continue to be carried out in strict accordance with GCP (Good Clinical Practice) requirements," the statement said.
A Chinese Foreign Ministry spokesman read the company's statement to reporters when asked to comment on the development at the ministry's daily press briefing Tuesday.
A Brazilian volunteer receives a coronavirus vaccine produced by Chinese company Sinovac Biotech at the Sao Lucas Hospital in Porto Alegre, southern Brazil on August 8.
Pausing a clinical trial is not unusual. In September, drug giant AstraZeneca paused global trials of its coronavirus vaccine because of an unexplained illness in one of the volunteers.
Last month, Sao Paulo Governor Joao Doria had called CoronaVac "the safest, the one with the best and most promising rates" among all the vaccines tested in Brazil, after Butantan Institute said that the vaccine had proved to be safe in a trial involving 9,000 volunteers, according to Reuters.
Sinovac is also conducting Phase 3 trials in Indonesia and Turkey. Sinovac did not immediately responded to CNN's request for further comment.
Just last month, Chinese officials and vaccine developers declared that no serious side effects had been observed or reported in the clinical trials of any of China's rapidly produced vaccines. China currently has four coronavirus vaccines in Phase 3 clinical trials, mostly conducted in developing countries across the world.
'Serious adverse event' that led Brazil to suspend Sinovac trial has 'no relation' to coronavirus vaccine
The "serious adverse event" that led Brazil's health authorities to halt clinical trials of a Chinese-developed Covid-19 vaccine was not related to the vaccine trial itself, the director of Brazil's Butantan biomedical institute said on Tuesday.
www.cnn.com
without a single confirmed accident happened.
