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Brazilian health authority Anvisa announced on Monday that it had suspended clinical trials of a Chinese candidate SinoVac vaccine against the novel coronavirus after a “serious adverse effect” with a volunteer, it said in a statement, without providing further details.
“After the occurrence of a serious adverse event, Anvisa determined the interruption of the clinical study of the CoronaVac vaccine. The event that occurred on 10/29 was communicated to the Agency, which decided to interrupt the study to evaluate the data observed so far and judge the risk / benefit of continuing the study. “
The category “serious adverse event” includes death, life-threatening side effects, disability or invalidity, hospitalization, or other “clinically significant events.”
“With the study discontinued, new volunteers cannot be vaccinated”the agency said, adding that “evaluate the data observed so far and judge the risk / benefit of continuity” Of the tests.
CoronaVac’s clinical trials, which involve 9,000 volunteers, came a day after US pharmaceutical giant Pfizer announced that its Covid-19 vaccine was 90% effective in testing.
The candidate vaccines from Pfizer and Sinovac are in phase 3 trials, the last phase before receiving regulatory approval.
Both are being tested in Brazil, the second most affected country by the pandemic, with more than 162,000 deaths.
CoronaVac, which is also being tested in China, Turkey, Bangladesh and Indonesia, has been the subject of a political battle in Brazil between one of its biggest supporters, São Paulo Governor João Doria, and its main political opponent, President Jair Bolsonaro, who in October prohibited its purchase.
The head of state referred to the Sinovac vaccine as “from that other country” and instead promoted the vaccine developed by the University of Oxford with the British pharmaceutical company AstraZeneca.
The Government of São Paulo teamed up with Sinovac to coordinate the last phase of clinical trials in Brazilian territory and signed a contract that included the acquisition and distribution of 46 million doses of the vaccine.
Bolsonaro, who is skeptical about the seriousness of the pandemic and declares himself anti-communist, also determined that vaccination against covid-19, which has already caused almost 156,000 deaths and more than 5.3 million infected in Brazil, will not be mandatory . .
The whole situation generated a strong controversy in the country and turned the distribution of the future vaccine into a highly politicized battle between the so-called “Bolsonarismo” and the opposition, both conservative and left.
Laboratories around the world are racing against time to develop a vaccine against the new coronavirus. There are dozens of teams testing various candidate vaccines, some are more advanced and promising, but scientists caution that none should be ready before the end of this year or even next.
According to the London School of Hygiene and Tropical Medicine (which has a graph showing the progress of the experiments) there are 259 projects and 54 are in the clinical trial phase, and 10 They are in phase III, which consists of inoculating the vaccine in thousands of volunteers to determine if it really prevents infection.
The project between Oxford University and AstraZeneca is one of the most promising, to which Pfizer and BioNTech, gives Modern, from Sanofi and GSK laboratories, from various Chinese projects, specifically from CanSinoBIO who has already obtained authorization to administer the vaccine to Chinese military personnel, CoronaVac from the SinoVac laboratory.
COVAX global platform
The COVAX mechanism is a global platform for the development of vaccines against Covid-19, with the support of the World Health Organization, for equitable access to vaccines at affordable prices.
Several countries, institutions and organizations participate, such as the European Union.
In total, according to the latest official data from October, so far 184 countries have joined the international mechanism for the purchase and distribution of vaccines: 92 low- and middle-income countries that will receive free doses and 92 “high-income” countries that will pass Covax to stock up, but they will have to pay for the doses out of their own pocket.
The pandemic has killed more than 1.25 million people worldwide
The covid-19 pandemic caused at least 1,255,803 deaths in more than 50.3 million cases of infection worldwide, according to a report by the French agency AFP.
Approximately 1 in 5 deaths occurs in the United States, the most affected country in the world, with more than 237 thousand deaths and almost 10 million cases.
With a total of 126,611 deaths, India is the third-deadliest country in the world, after the United States and Brazil, according to the Johns Hopkins University tally.
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