Brazil stops Chinese vaccine trials after ‘serious adverse event’

WHAT YOU NEED TO KNOW:

• Brazil’s health regulator said on Monday that it ordered the halt of COVID-19 vaccine trials developed by a Chinese firm due to a serious event that occurred.
• The potential vaccine, developed by China-based company, Sinovac, is currently produced at Butantan Institute in Sao Paolo.
• Brazillian president Jair Bolsonaro had frequently expressed doubt on the vaccine’s potential.  

In a statement published through its website on Monday, Brazil National Health Surveillance Agency (ANVISA) said that clinical trials of the coronavirus candidate vaccine CoronaVac would be suspended due to what they described as an “adverse, serious event.”

Chinese biopharmaceutical company Sinovac is developing a possible vaccine, and Sao Paulo Brazil’s state-owned Butantan Institute is where the product will be produced. In their response, Butantan said that it was shocked by Anvisa’s announcement and that it would call for a media conference on Tuesday.

President Jair Bolsonaro has earlier expressed his reservation the usefulness of CoronaVac shot, which sparked controversy in the country. The president’s doubt had also stirred confusion the previous month when said he’s not in favor of the Chinese-made vaccine, adding that he will not also allow Brazilians as test pigs. The statement then was followed with an update that his health minister, Eduardo Pazuello, had given a go to procure Butantan produced CoronaVac shots.

Bolsonaro has frequently shown that his doubt over China since the 2018 campaign trail. He, however, moderated his criticism when he took office. State Gov. João Doria of Sao Paulo has come to be a political opponent and a vocal critic of the president’s handling of the pandemic.

In its post, Anvisa wrote that an event transpired on Oct. 29 has made them decide to halt the trial, without explaining details of what happened. The agency added that there would be no volunteer to be vaccinated pending the suspension of the study.

The move, however, is considered norm with vaccine and drug trials as the risk of illness to all participants is high. Taking a break from the study allows scientists to examine whether an infection is a consequence or just by accident. Two drug companies last month continued trials of their candidate COVID-19 vaccines in the U.S. after an earlier put off.

Currently, CoronaVac is undergoing tests in at least seven states in Brazil, with another federal region where Brasilia capital lies.

After last month’s confusion over the CoronaVac shot, Anvisa approved the importation of 6 million doses from China. The office announced then that the prospective vaccine would not be allowed for Brazilians pending local approval.

Health secretary of Sao Paulo state, Jean Gorinchteyn, said Monday morning that 120,000 CoronaVac shots would their international airport by November 20.

Gorinchteyn explained that they would comply with health regulations in administering the shots and they would wait for approval from Anvisa.

Sao Paulo is also getting raw material to manufacture 40 million CoronaVac shots, which is expected to arrive on November 27.

Source: AP News