[ad_1]
RIO – Oxford University has received the green light to resume testing for the evaluation of the ChAdOx1 nCoV-19 vaccine, an immunizer produced in association with the pharmaceutical company AstraZeneca.
Trials around the world, including Brazil, were stopped to assess the adverse reaction in a British volunteer, and their resumption depended on the approval of an independent committee.
Sciences: The time of science is not that of political pressure for the approval of a vaccine
So far, about 18,000 volunteers have received the immunizer, which is in phase three of the research. According to the University of Oxford, it is expected that in effectiveness tests like this, some participants will have side effects, which must be evaluated on a case-by-case basis for studies to continue. The clinical trials have already gone through phases one and two, with testing for safety and production of antibodies against Covid-19.
In Brazil, the study involves 5,000 volunteers and should also be resumed, after the release of the National Health Surveillance Agency (Anvisa) and the National Research and Ethics Committee (Conep), said the Federal University of São Paulo (Unifesp) it’s a statement. , which coordinates research in the country, through the Special Immunobiological Reference Center (Crie / Unifesp).
River:Crivella announces return of cinemas and theaters with 50% capacity
So far, the statement said, 4,600 volunteers have been recruited and vaccinated, with no history of serious health complications. In Rio and Salvador, the studies are carried out and financed by the Instituto D’Or.
In a note published on Saturday morning, Anvisa said that the University of Oxford informed it about the resumption of the tests, but is still awaiting an official communication from the UK Health Authority (MHRA), responsible for the authorization.
Saint Paul: The richest neighborhoods of the capital register an increase in contagion by coronavirus
For the reactivation of the clinical study to take place in Brazil, Anvisa expects to receive, in the next few days, the request from the AstraZeneca company. In practice, the laboratory must submit the request for a new consent so that the study of the Oxford vaccine can be resumed in the country. “he said in a statement.” Anvisa reiterates that it is committed to the rapid analysis of all data. At the same time, it works to guarantee the safety of the participants in the clinical study in Brazil. “
The research was halted worldwide on September 6, according to the university, for the data to be evaluated by the independent committee and British government regulators. Routine meetings continued, but vaccination of volunteers was stopped.
Still, according to Oxford, the independent evaluation concluded that testing can be resumed.
“We cannot reveal medical information about the disease for reasons of confidentiality of the participants,” the university said in a statement. “We are committed to the safety of our participants at the highest levels of study completion and will continue to monitor safety closely.”
Brazil: Anvisa will receive data from the British agency on vaccines to analyze adverse reactions
The AstraZeneca vaccine is the main bet of the Brazilian government. In June, the Health Ministry announced an agreement with Oxford for the initial production of 30.4 million doses of the Covid-19 vaccine. The first batch was announced for December and the second in January by Bio-Manguinhos, a laboratory of Fiocruz (Fundação Oswaldo Cruz).
In August, President Jair Bolsonaro signed a provisional measure that provides for an investment of R $ 1.9 billion in the production and acquisition of the Oxford vaccine. The funds will be used for the transfer of technology, which will allow the Fiocruz laboratory to manufacture the immunizer.
“This means that we are guaranteeing the production and delivery of 100 million doses, in addition to bringing to the country the ability to use this new technology in the national industry and give sustainability to the National Immunization Program,” said the Acting Minister of Health. Eduardo Pazuello, at the MP’s signature.
The measure provides for the transfer of R $ 522.1 million to the Bio-Manguinhos structure and R $ 1.3 billion to expenses related to payments provided for in the Technological Order contract.
Hours before the news of the suspension of the tests emerged this Tuesday, Pazuello declared that the government’s forecast was to start vaccination in January 2021.
