[ad_1]
A volunteer from the AstraZeneca / Oxford clinical trial in Brazil for the Covid-19 vaccine has died. This was reported by Reuters, taken up by the Bloomberg agency, citing the Brazilian health authority Anvisa and the federal university of Sao Paulo, which helps coordinate phase 3 of the trial in the South American country.
The volunteer had signed up for the trial but had not yet received the dose. Bloomberg reports it by citing a source close to the file.
The president of the Irbm research center in Pomezia Piero Di Lorenzo, which is collaborating with the University of Oxford for the development of a Covid 19 vaccine for Astra Zeneca, confirms the availability of the first doses for December, already announced in recent days by Prime Minister Giuseppe Conte. According to Di Lorenzo “if there are no sudden problems – he said during an interview with the Financial Lounge site – it is reasonable to think that the clinical trial phase may be complete by the end of November or beginning of December”. “After phase 3 – he continued – the balloon goes to EMA (the European Medicines Agency, ed) for possible validation”, which normally takes up to 12 months. “But these are not normal times,” explains Di Lorenzo, who remembers how the validation process has already begun.
The evaluations carried out “did not raise any concerns about the continuation of the ongoing study” for vaccine testing. This was stated by the multinational AstraZeneca, which is developing the anti-Covid vaccine in collaboration with the University of Oxford and the Irbm of Pomezia, in reference to the news – later denied – of the death of a volunteer involved in the experiment. Final Phase 3 testing of this vaccine candidate is ongoing.
“We cannot comment – says AstraZeneca – on individual cases involved in the ongoing Oxford vaccine trial, strictly adhering to the regulation of clinical trials, but we can confirm that all required verification processes have been followed.” “All significant medical events – specifies the multinational – are carefully evaluated by the clinical investigators of the trial, an independent monitoring committee and regulatory authorities. These evaluations did not give rise to concerns regarding the continuation of the ongoing study.”
REPRODUCTION RESERVED © Copyright ANSA
