Oxford vaccine tests resume today in Brazil
The measure was authorized by national sanitation watchdog Anvisa
Published in 14/09/2020 - 12:23 By Karine Melo - Brasília
Pharmaceutical giant AstraZeneca today (Sep. 14) is resuming the tests on the vaccine against COVID-19, known as the Oxford vaccine, in Brazil. The green light was given by the country’s national sanitation watchdog Anvisa. With tests run also in other countries, vaccination in phase three of the study was suspended last Tuesday (8) due to a reaction reported by a volunteer in the UK.
Last Saturday (12), Anvisa experts met to assess the data received from British Medicines and Healthcare Products Regulatory Agency, the Independent Security Committee ff the clinical study, and the company sponsoring the study, AstraZeneca. “After evaluating the data on the adverse event, its cause, and the set of security data generated in the study, the agency concluded that the relation benefit-risk is kept favorable, which is why the study will be allowed to resume,” the agency said in a note.
In its communication, Anvisa adds it will continue to monitor all adverse events observed during the study, and should any serious situation take place with Brazilian volunteers, it will take the applicable measures to ensure the safety of participants.
Last week, the Oswaldo Cruz Foundation (Fiocruz) signed the technological shipment contract with AstraZeneca granting the Institute of Technology in Immunobiologicals (Bio-Manguinhos/Fiocruz) acess to 100.4 million doses of the active pharmaceutical ingredient for final processing and quality control, also ensuring Fiocruz the total transfer of the technology.
Before tests had been suspended, acting Health Minister Eduardo Pazuello said on several occasions that the first doses should arrive in January 2021. The second dose is likely to become available in the second half of the next year.
In addition to the Oxford vaccine, clinical trials are being conducted in Brazil by CoronaVac, produced by Chinese laboratory Sinovac Bontech, and another vaccine developed by pharmaceutical firms Pfizer and BioNTech.
Translation: Fabrício Ferreira - Edition: Valéria Aguiar / Nira Foster
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