Following the death of a volunteer, Oxford will continue testing his vaccine
The British University of Oxford and the pharmaceutical company AstraZeneca will continue testing their COVID-19 vaccine despite the death of a volunteer who was participating in these trials in Brazil.
Oxford explained in a statement, picked up by the British media, that the death was the subject of a "careful assessment" which found no elements of concern about the safety of the vaccine.
"Following the independent review, in addition to the Brazilian regulator, they have recommended that the trial be continued," the university noted in its note.
Approximately half of the volunteers participating in the trials, which are also taking place in the UK or India, are given the experimental vaccine, while the rest are given a placebo.
Brazilian health authorities reported the death of one volunteer on Wednesday, although they did not specify how or whether he received the dose or a placebo.
The National Health Surveillance Agency (Anvisa), linked to the Brazilian Ministry of Health, said in a note that it was "formally informed" of the event last Monday and that it will continue its "assessment", although it confirmed that clinical trials are continuing in the country.
This potential vaccine is in phase 3 of clinical trials, the last one before receiving regulatory approval to proceed with inoculation of the population.
Last September, the University of Oxford resumed clinical trials after they were briefly interrupted by an adverse reaction in a volunteer.
Experts working on the vaccine are optimistic that it can be approved by regulators by the end of the year, allowing adults in the UK to be vaccinated by April 2021, The Times recently reported.
Just yesterday it was announced in various media agencies that "70% of the Russian population could be vaccinated in one year".
The production volume of the Russian vaccine, called 'Sputnik V', in December could reach between 5 and 6 million doses per month, which could allow 70% of the Russian population to be vaccinated in 10-12 months, announced this Wednesday Alexandre Guintsburg, director of the Russian National Research Centre for Epidemiology and Gamaleya Microbiology, where the vaccine was created.
On 9 September the third phase of clinical trials of Sputnik V began, involving 40,000 people. Outside Russia, the vaccine is being tested in Venezuela, the United Arab Emirates and Belarus. More than 40 countries have already expressed interest in obtaining the drug.
Last Monday, the director of the Russian Direct Investment Fund, Kirill Dmitriev, announced that the Sputnik V vaccine could be delivered to Latin American countries starting in December.
Sputnik V, Russia's coronavirus vaccine, was registered on 11 August in full compliance with international standards. It was created artificially, without any element of the coronavirus in its composition, and is presented in freeze-dried form, as a powder that is mixed with an excipient to dissolve it and then administered intramuscularly.
The drug uses human adenovirus technology from two different vectors, Ad26 and Ad5, for a first and second injection. However, Sputnik V does not contain live human adenoviruses, but human adenoviral vectors that are not capable of multiplying "and are completely safe for health".
Sputnik V is based on an existing two-vector vaccine platform developed in 2015 to treat Ebola, which passed all phases of clinical trials and was used to defeat the Ebola epidemic in Africa in 2017.
Previously, the results of the Phase 1 and 2 clinical trials were published in The Lancet, one of the most respected scientific journals in medicine worldwide.
In that publication, the vaccine developers note that 100% of participants developed a stable humoral and cellular immune response during phases 1 and 2 of the trials. At the same time, the level of antibodies against SARS-CoV-2 in volunteers vaccinated with Sputnik V was 1.4 to 1.5 times higher than in patients who had recovered from coronavirus.