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 citing a source close to the dossier.
The president of the Irbm research center of Pomezia Piero Di Lorenzo
, who collaborates with the University of Oxford for the creation of an anti Covid 19 vaccine for Astra Zeneca,
confirms the availability of the first doses by December, already announced in recent days by the president of the board Giuseppe Conte.
According to Di Lorenzo "if sudden problems do not arise - he said during an interview granted to the Financial Lounge site - it is reasonable to think that the clinical trial phase could be completed by the end of November or early December".
"After phase 3 - he continued - the ball passes to the 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 recalls how the validation procedure has already begun.
The evaluations carried out "did not lead to any concern regarding the continuation of the ongoing study"
for the trial of the vaccine.
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 currently underway.
"We cannot comment - says AstraZeneca - on individual cases involved in the ongoing experimentation of the Oxford vaccine, adhering strictly to the regulation of clinical trials, but we can confirm that all the required verification processes have been followed".
"All significant medical events - the multinational specifies - are carefully evaluated by clinical investigators of the trial, an independent monitoring committee and regulatory authorities. These evaluations did not lead to concerns in relation to the continuation of the ongoing study".