AstraZeneca vaccine, a Brazilian volunteer died, Brazilian media: received a placebo | Brazil_Sina Finance_Sina.com

Original title: AstraZeneca vaccine, a Brazilian volunteer died, Brazilian media: received a placebo

[Texto / Red de Observadores Zhang Chenjing]According to the “Globo” of Brazil, the National Agency for Health Supervision of Brazil (ANVISA) confirmed on the 19th that last Thursday (15), a volunteer who participated in a clinical trial of the new corona vaccine died in the country. The cause of death was complications from a new coronary pneumonia. The vaccine was developed jointly by the University of Oxford and the British company AstraZeneca.

The report cited a legally valid report stating that the volunteer was not vaccinated but received a placebo. However, due to confidentiality, the Brazilian National Health Inspection Agency did not come forward to confirm the matter. Reuters quoted people familiar with the matter as saying that if the volunteer died after the vaccination, the trial would be aborted. If it is not finished, it means that the volunteer is a member of the control group for the meningitis vaccine.

After news broke of the volunteer’s death, AstraZeneca’s stock price fell more than 1% on the 21st.

“Globe” reported that the deceased volunteer was only 28 years old and was a doctor at a hospital in Rio de Janeiro. It has been fighting on the front lines of the epidemic since March of this year. At the end of July this year, he was inoculated with a drug developed jointly by the University of Oxford and AstraZeneca. In September he contracted the new corona virus. Subsequently, his condition deteriorated. He died on October 15 from complications from the new corona pneumonia. His death shocked his family members because before that he was in good health.

Brazil’s National Sanitary Inspection Agency stated that it received the death notice of the volunteer on the 19th, but the International Committee for Evaluation and Safety, which oversees the clinical trial, recommended that the trial continue. It is not clear whether the volunteer received a vaccine or a placebo in the trial. Brazil’s National Health Supervision Agency stated that it would not release further information due to medical privacy considerations.

CNN reported that the University of Oxford also stated in a statement: “Regardless of whether the volunteers are the control group or the vaccine group, all major medical incidents will be reviewed independently. Brazil is reviewing this case.” . After careful evaluation, there was no concern for the safety of clinical trials. Therefore, in addition to the Brazilian regulatory agency, the independent review board also recommended that the trial continue. “

The Federal University of Sao Paulo, which helped coordinate the late-stage clinical trials, stated that “everything is going according to plan and no volunteer has a history of serious vaccine-related complications.” A spokesperson for the university said the original plan was to recruit 10,000 volunteers. So far, 8,000 volunteers have been recruited in six Brazilian cities, they have been administered the first dose of the vaccine and many of them have also received the second dose.

A spokesman for the pharmaceutical company AstraZeneca declined to comment on the death of the volunteer, but said there was no reasonable reason to stop the clinical trial. “We strictly adhere to medical confidentiality and clinical trial regulations. What can be confirmed is that we have complied with all review procedures.”

A person familiar with the matter told Reuters that if the volunteer died after being vaccinated with the new corona vaccine, the clinical trial will be suspended, meaning that the volunteer is a member of the meningitis vaccine control group.

The Globe reported that a legally valid report showed that the volunteer was not vaccinated, but with a placebo group. However, due to confidentiality, the center responsible for the trial and the Brazilian National Health Supervision Agency did not disclose whether the volunteer had received a placebo.

Carlos Fortaleza, an epidemiologist at the State University of São Paulo, also stated that “the trial was not suspended, which indicates that the volunteer may have been vaccinated with a placebo.”

As early as September 8 this year, AstraZeneca once stopped the third phase of the global clinical trial due to a “serious side effect” experienced by a vaccinator. The volunteer’s side effect was “perforating myelitis.” This inflammation can be caused by a viral infection. In severe cases, it can cause the sensory, motor, and autonomic nervous systems of the lower extremities to lose control of the inflamed part of the spinal cord.

However, just 7 days later, AstraZeneca resumed clinical trials of the vaccine in locations other than the United States. On the 20th of this month, Reuters quoted various sources as saying that after the US Food and Drug Administration (FDA) completes its review, the US is expected to restart trials this week.

The AstraZeneca vaccine uses an adenovirus vector recombination pathway. Both Pfizer and Moderna, which have entered phase III clinical trials, adopt the RNA (ribonucleic acid) vaccine route, but those vaccines have not been approved for commercialization before.

A few days ago, Tian Baoguo, deputy director of the Department of Science and Technology for Social Development of the Ministry of Science and Technology of China, presented at a press conference that China’s vaccine research and development work is generally in a position of leadership. 13 vaccines are said to have entered clinical trials. Among them, two technical routes of inactivated vaccines and vaccines with adenovirus vectors, a total of 4 vaccines, have entered phase III clinical trials. Overall, they are progressing smoothly. So far, a total of 60,000 have been vaccinated. There were no reports of serious adverse reactions. He initially showed good security. “

According to data from Johns Hopkins University, Brazil currently has the second highest number of deaths from new coronary pneumonia in the world, surpassed only by the United States, with at least 115,000 deaths.

Editor in charge: He Zhongfu