SAO PAULO (AP) — Small groups of protesters gathered in Brazil’s two biggest cities Sunday to demonstrate against any mandate for the taking of a coronavirus vaccine, supporting a rejection campaign encouraged by President Jair Bolsonaro.
People assembled in downtown Sao Paulo calling for the removal of Sao Paulo state Gov. Joao Doria, who has said state residents will be required to take a vaccine, likely the one being developed by Chinese biopharmaceutical company Sinovac and the local Butantan Institute.… Read More
The Brazilian newspaper O Globo, citing unnamed sources, reported that the volunteer was in a control group that did not receive the experimental vaccine and died of covid-19. The news service G1 said the volunteer was a 28-year-old physician who treated coronavirus patients in Rio de Janeiro.
The National Health Surveillance Agency said it was informed of the volunteer’s death Monday. The agency said AstraZeneca’s international safety committee had recommended the trial continue.
Under the trial’s protocol, half the participants receive the experimental vaccine, and half receive an established meningitis vaccine that has been proved safe. The trial, like others, is overseen by an independent board that reviews all adverse events. Any severe event that might have been caused by the vaccine would trigger a pause in the study for an investigation. The trial is not paused due to the death.
A spokesman for AstraZeneca said he could not comment on individual cases in an ongoing trial, citing confidentiality requirements and clinical trial rules. But he said there were no concerns that would lead the study to pause.
“We can confirm that all required review processes have been followed,” spokesman Brendan McEvoy said. “All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study.”
Oxford confirmed that the volunteer’s death was reviewed by an independent committee.
“Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial, and the independent review in addition to the Brazilian regulator have recommended that the trial should continue,” the university said in a statement.
The trial was suspended last month after a participant developed an unexplained illness. AstraZeneca has since resumed trials in Brazil, India, South Africa, Japan and Britain. It remains on hold in the United States.
In the global race for a vaccine, Brazil, which has been battered by the disease but has a long-standing openness to vaccines, has become one of the most crucial testing grounds. The country is hosting four vaccine trials — as many as anywhere in the world.
Brazil has watched vaccine development closely as the virus continues to lash the country. The official toll is now more than 5 million infections and over 150,000 deaths, second only to the United States. But as the tests near their conclusions, the issue of vaccinating people has become just one more issue for politicians to argue over.
São Paulo Gov. João Doria has said state health workers will begin receiving a Chinese vaccine before the end of the year. Other groups will then follow. Doria has said the vaccine will be obligatory in Brazil’s most populous state.
President Jair Bolsonaro, who has spent months touting the unvetted and potentially harmful anti-malarial drug hydroxychloroquine as a coronavirus cure, has been deeply suspicious of vaccines. He says the vaccine will not be mandatory, even though a law he signed
A volunteer participating in clinical trials of the Covid-19 vaccine developed by Oxford University has died in Brazil, officials said Wednesday, though it was unclear whether he received the vaccine or a placebo.
It is the first death reported in the various coronavirus vaccine trials taking place worldwide.
However, organizers of the study said an independent review had concluded there were no safety concerns and that testing of the vaccine, developed with pharmaceutical firm AstraZeneca, would continue.
Media reports said the volunteer was a 28-year-old doctor working on the front lines of the pandemic who died of complications from Covid-19.
“All significant medical incidents, whether participants are in the control group or the Covid-19 vaccine group, are independently reviewed,” Oxford said in a statement.
“Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial, and the independent review in addition to the Brazilian regulator have recommended that the trial should continue.”
National health regulator Anvisa confirmed it had been “formally notified of the case on October 19” and had received a report on the independent review from the security and evaluation committee overseeing the study.
The D’Or Teaching and Research Institute (IDOR), which is helping organize the tests in Brazil, said the independent review process had “raised no doubts about the safety of the study, and recommended it continue.”
Oxford and AstraZeneca previously had to suspend testing of the vaccine in September when a volunteer in Britain developed an unexplained illness.
Trials resumed after British regulators and an independent review concluded the illness was not a side effect of the vaccine.
Half the volunteers in the final-stage clinical trial — a double-blind, randomized, controlled study — receive a placebo, IDOR said.
Around 8,000 volunteers have been vaccinated so far in Brazil, and more than 20,000 worldwide, it said.
Study participants must be doctors, nurses or other health sector workers who come into regular contact with the virus.
Brazilian newspaper Globo said the deceased volunteer was a young doctor who had been treating Covid-19 patients since March in the emergency rooms and intensive care units at two hospitals in Rio de Janeiro.
He graduated from medical school last year, and was in good health prior to contracting the disease, family and friends told the newspaper.