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the clinical trials for coronavirus vaccine conducted by AstraZeneca and the University of Oxford were resumed in the UK. The action was taken after the Drug Regulatory Authority (MHRA) confirmed that it was safe to continue testing.
The announcement was made by the pharmacist on Saturday (12), six days after the trials were interrupted because a volunteer had adverse reactions.
In Brazil, the resumption of testing depends on the launch. after the formal request made by the pharmaceutical company to Anvisa (read below).
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According to the statement from the AstraZeneca company, the interruption occurred to review the safety data by independent committees. “The UK committee has completed its investigations and recommended to the MHRA that trials in the UK can be safely resumed,” the text says.
“AstraZeneca is committed to the safety of study participants and to the highest standards of conduct in clinical studies. The company will continue to work with health authorities around the world and guide itself on when further clinical trials can be resumed to Provide the vaccine in a comprehensive, equitable and non-profit manner during this pandemic, ”the company says in a statement.
In Brazil, the study that involved 5,000 participants should also be resumed, shortly after the launch of Anvisa and the National Ethics and Research Committee (Conep).
In a note, Anvisa said it was not officially communicated by MHRA, the UK health authority responsible for the release.
“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 company AstraZeneca,” the statement said.
In practice, the laboratory needs to carry out a new protocol to resume studies in Brazil.
“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 text says.
Unifesp says that in Brazil no one had complications with the Oxford vaccine
In Brazil, the research is coordinated by the Federal University of São Paulo (Unifesp). In a statement, Unifesp affirms that the volunteers “were recruited and vaccinated, without any record of serious health complications.”
“In large trials like this one, some participants are expected to be unwell and all cases must be carefully analyzed to ensure a careful safety assessment,” says Unifesp.
The university also claims to be “committed to the safety of all participants and to the highest standards of conduct in studies, ensuring the continuity of a tight security control.”
Purchase of 30 million doses
The vaccine developed by AstraZeneca, in partnership with the University of Oxford, is considered by the Brazilian government as one of the main immunization bets against Covid-19 in the country.
The Brazilian government, through the Ministry of Health and the Oswaldo Cruz Foundation (Fiocruz), signed a memorandum of understanding with AstraZeneca that provides for the purchase of 30 million doses of the vaccine, with delivery in December of this year and January of next year, and the possibility of acquiring another 70 million whether the vaccine has proven efficacy and safety.
Also, the initial agreement provides for the transfer of technology developed by the University of Oxford and the AstraZeneca laboratory for local production in Fiocruz, which the ministry expects to start in the first half of 2021, which was questioned by experts heard by Reuters due to the complexity of the technology transfer process.
Suspension for unexpected illness
The adverse reaction may not be related to the vaccine, says the infectious diseases specialist at Fiocruz
Clinical trials were suspended on Sunday (6) and announced earlier this week. It’s a standard procedure that occurs whenever an unexplained illness arises in one of the participants, the university and the company said in a note.
According to the newspaper “The New York Times”, the volunteer suffered from transverse myelitis, an inflammatory syndrome that affects the spinal cord. She, who is British, was part of the group that took the vaccine itself, not the placebo. In a statement Saturday, the company said it could not release further medical information.
On Wednesday (9) AstraZeneca President Pascal Soriot said that despite the symptoms, the diagnosis of transverse myelitis in the patient had not yet been confirmed.
Following the publication of the report, the Reuters news agency released AstraZeneca’s position reaffirming that the volunteer’s diagnosis is still pending and that, therefore, it is incorrect to link the suspension of the vaccine tests with a case of myelitis. .
Nine vaccines in the last phase of testing
In addition to the Oxford University candidate with British pharmaceutical company AstraZeneca, eight more vaccines are in the third and final phase of human testing, the last before launch.
- Janssen Pharmaceutical Companies (USA)
- Moderna / National Institute of Allergy and Infectious Diseases (USA)
- BioNTech / Fosun Pharma / Pfizer (Germany and USA)
- Sinovac (China)
- Wuhan / Sinopharm Institute of Biological Products (China)
- Beijing Institute of Biological Products / Sinopharm (China)
- CanSino Biological Inc./ Beijing Institute of Biotechnology (China)
- Gamaleya Research Institute (Russia)
