Oxford vaccine tests against Covid-19 return in Brazil this Monday, says laboratory | Vaccine

On Saturday (12), AstraZeneca announced the general resumption of testing, but did not detail the conclusions about the case of adverse effects in a volunteer.

The vaccine test was suspended worldwide last Tuesday (8), after a participant presented a health condition that could be related to the vaccine.

Scientists reported that No cause and effect relationship was found between the vaccine and the patient’s symptoms..

“Clinical trials of the coronavirus vaccine will restart in Brazil next Monday (14), after the confirmation issued by Anvisa on 09/12, that the restart is safe,” the laboratory reported.

The National Sanitary Surveillance Agency (Anvisa) received official information from the British government and the laboratory on the volunteer’s case on Saturday and that same day announced that the resumption of tests in Brazil was approved.

“After evaluating the data of the adverse event, its causality and the set of safety data generated in the study, Anvisa concluded that the benefit / risk ratio remains favorable and, therefore, the study can be resumed,” said the agency regulatory. .

The Health Ministry issued a note on Saturday about the resumption of tests in “all participating countries”, but has not confirmed the date reported by the laboratory.

“It should be noted that Pasta’s priority is the safety of all volunteers involved in the tests, which is based on the international standard of Good Clinical Practice – rigorously followed by Brazil,” the ministry said.

“The Ministry of Health also reiterates that in addition to the AstraZeneca vaccine, it also monitors more than 200 ongoing studies. The goal is to find an effective and safe solution for the cure and prevention of Covid-19. No effort will be spared to make it available. of the Brazilians “. as soon as possible, an effective vaccine, in quantity and quality to serve the population “.

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Clinical trials of the vaccine resumed in the UK on Saturday.

Temporary suspension of tests

On Tuesday (8), vaccine tests were temporarily suspended after a volunteer had an adverse reaction.

Oxford University and the AstraZeneca Laboratory did not reveal details of the case for reasons of confidentiality of the participants.

The New York Times, however, reported that the patient who suffered adverse effects had transverse myelite, an inflammatory syndrome that affects the spinal cord. The president of Anvisa mentioned the same syndrome in the interview with GloboNews.

“In these processes there is a whole issue, a confidentiality for these studies to be carried out. Even in the preservation of the people of the volunteers themselves ”, said the general director of Anvisa, Antônio Barra Torres.

“But there is no doubt, you yourself mentioned this hypothesis of transverse myelitis, this is already in the public domain,” he added, before explaining the conclusions of the independent committee.

No brazil, there were no reports of serious adverse events, according to Anvisa.

In the country, the research is coordinated by the Federal University of São Paulo, through the Reference Center for Special Immunobiologicals (Crie / Unifesp).

Anvisa says that “it will continue to monitor all adverse events observed during the study and, if any serious situation is identified with the Brazilian volunteers, it will take the appropriate measures to guarantee the safety of the participants.”

A suspension of clinical trials is standard procedure this happens whenever an unexplained illness arises in one of the participants.

“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,” Unifesp explained in a note.

Trials in Brazil and purchase of 30 million doses

HE study has already applied doses to 4,600 volunteers in Brazil and Unifesp says the volunteers “were recruited and vaccinated, without any record of serious health complications.”

The vaccine developed jointly by the University of Oxford and the pharmaceutical AstraZeneca 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 the year coming.

The document provides for the possibility of acquisition of more than 70 million if the vaccine has proven efficacy and safety.

There is a technology transfer agreement developed by the University of Oxford and the AstraZeneca laboratory for local production at Fiocruz, and the ministry is expected to start in the first half of 2021.

The deadline was questioned by experts heard by Reuters due to the complexity of the technology transfer process.

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)

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