AstraZeneca Covid 19 vaccine trial – Burning Issues – Free PDF Download

COVID 19

• There has been a death in the late-stage clinical trials of a Covid-19 vaccine being developed by University of Oxford and Swedish-British drugmaker AstraZeneca. What happened and what does this mean for the trials of the closely watched candidate, a version of which is at the forefront of India’s own Covid-19 vaccine race?

What happened and why is it important?

• A volunteer in Brazil participating in the trials for the Oxford University-AstraZeneca vaccine candidate, AZD1222, died this week, according to the country’s health surveillance agency, ANVISA. While the regulator, University of Oxford and AstraZeneca, did not elaborate further, a report by CNN Brasil states that the volunteer was a 28-year-old male living in Rio de Janeiro and had died of Covid-19 complications.
• Brazil is among the major grounds for testing Covid-19 vaccine globally, with phase 3 human trials in the country enrolling around 5,000 volunteers across the country.

Does this mean the vaccine is unsafe?

• So far, no. According to reports, the participant was not given a shot of AZD1222, which means his death was not a result of the trial vaccine.
• AstraZeneca has said that this issue, like all significant medical events, was “carefully assessed” by trial investigators, an independent safety monitoring committee and regulatory authorities.
• “These assessments have not led to any concerns about continuation of the ongoing study,” the firm has said in a statemen

What other issues have cropped up in the course of this trial?

• This may be the first reported death during this trial, but the candidate did hit a roadblock in September, when a participant in the UK reportedly given the experimental Covid-19 vaccine developed a serious adverse reaction. The trials of this vaccine were put on pause across the globe as a result.

What is the status of the trials for this candidate in India?

• Pune-headquartered Serum Institute of India (SII), which has an agreement with AstraZeneca to manufacture this vaccine for low- and middle-income countries, is currently conducting late-stage trials of the candidate in India targeting around 1,600 participants.

What other issues have cropped up in the course of this trial?

• This may be the first reported death during this trial, but the candidate did hit a roadblock in September, when a participant in the UK reportedly given the experimental Covid-19 vaccine developed a serious adverse reaction. The trials of this vaccine were put on pause across the globe as a result.

What happens to the trial in Brazil?

• Brazil’s regulator has said that the trial will continue.
• Testing would have been suspended if the participant had been given the dose of trial Covid-19 candidate. However, as it has been suggested that this person was part of the meningitis vaccine control group, there is no question of the trial running into problems as a result of this death.

What is the status of the trials for this candidate in India?

• Pune-headquartered Serum Institute of India (SII), which has an agreement with AstraZeneca to manufacture this vaccine for low- and middle-income countries, is currently conducting late-stage trials of the candidate in India targeting around 1,600 participants.

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