Phase 3 of AstraZeneca's COVID-19 vaccine trial on hold due as participant falls ill
- 4 years ago
아스트라제네카, 코로나19백신 임상3상 중단…"심각질환 발견"
Meanwhile, drug giant AstraZeneca has paused all clinical trials of the Covid-19 vaccine it's developing with Oxford university after a participant in the UK section suffered a suspected serious adverse reaction.
Earlier on Tuesday, the drugmaker joined eight other companies in signing a pledge promising they would not seek premature government approval for any Covid-19 vaccine.
Our Kim Do-yeon, has the details.
Pharmaceutical company AstraZeneca halted Phase 3 of its COVID-19 vaccine trials on Tuesday after discovering that one of the participants fell seriously ill in the process.
The company said that this is a routine measure encountering an "unexplained illness" among the participants.
The news comes while the company's vaccine, 'Oxford', is regarded as one of the strongest contenders to win the race and become the first vaccine on the market.
"Such safety event maybe detected in the Phase 3 once more people are given the vaccine it may be rare even to late stage of the vaccine development. It's hard to say when the development will be resumed it will depend on the evaluation by sponsor and independent data safety monitoring board to give the recommendation whether or not the study can resume."
Details of the symptoms are yet to be released, but, according to U.S.-based media outlet Stat News, who first broke the story, the individual will recover.
The person who fell ill is from the UK but the decision to bring research to a halt has impacted the company's trials all across the world.
In the U.S. alone, the target number of participants for Phase 3 is 30,000 across 80 sites.
While it wasn't clear which steps were taken in response to the trials being put on the hold, the recruitment process usually stops with such a decision.
This comes with AstraZeneca being one of the nine prominent pharmaceutical companies worldwide that on Tuesday local time signed a pledge to adhere to high standards of COVID-19 vaccine development.
The pledge had four specific points... to make the safety and well-being of vaccinated individuals the top priority... to adhere to high scientific and ethical standards... only submit for approval or emergency use authorization after successful Phase 3 tests... and ensure of a sufficient supply and range of vaccine options.
Other signatories include Johnson & Johnson, Pfizer, and Moderna.
Together, they called this a "historic pledge" that would free them from the political pressure they are under in the race to the first COVID-19 vaccine.
Kim Do-yeon, Arirang News
Meanwhile, drug giant AstraZeneca has paused all clinical trials of the Covid-19 vaccine it's developing with Oxford university after a participant in the UK section suffered a suspected serious adverse reaction.
Earlier on Tuesday, the drugmaker joined eight other companies in signing a pledge promising they would not seek premature government approval for any Covid-19 vaccine.
Our Kim Do-yeon, has the details.
Pharmaceutical company AstraZeneca halted Phase 3 of its COVID-19 vaccine trials on Tuesday after discovering that one of the participants fell seriously ill in the process.
The company said that this is a routine measure encountering an "unexplained illness" among the participants.
The news comes while the company's vaccine, 'Oxford', is regarded as one of the strongest contenders to win the race and become the first vaccine on the market.
"Such safety event maybe detected in the Phase 3 once more people are given the vaccine it may be rare even to late stage of the vaccine development. It's hard to say when the development will be resumed it will depend on the evaluation by sponsor and independent data safety monitoring board to give the recommendation whether or not the study can resume."
Details of the symptoms are yet to be released, but, according to U.S.-based media outlet Stat News, who first broke the story, the individual will recover.
The person who fell ill is from the UK but the decision to bring research to a halt has impacted the company's trials all across the world.
In the U.S. alone, the target number of participants for Phase 3 is 30,000 across 80 sites.
While it wasn't clear which steps were taken in response to the trials being put on the hold, the recruitment process usually stops with such a decision.
This comes with AstraZeneca being one of the nine prominent pharmaceutical companies worldwide that on Tuesday local time signed a pledge to adhere to high standards of COVID-19 vaccine development.
The pledge had four specific points... to make the safety and well-being of vaccinated individuals the top priority... to adhere to high scientific and ethical standards... only submit for approval or emergency use authorization after successful Phase 3 tests... and ensure of a sufficient supply and range of vaccine options.
Other signatories include Johnson & Johnson, Pfizer, and Moderna.
Together, they called this a "historic pledge" that would free them from the political pressure they are under in the race to the first COVID-19 vaccine.
Kim Do-yeon, Arirang News