Phase 3 clinical trials for the COVID-19 vaccine named AZD1222, developed by AstraZeneca and Oxford University, have been paused after a participant suffered suspected adverse effects.
COVID-19 trial paused as participant experienced serious spinal ailment
The COVID-19 vaccine trial participant which fell ill, leading AstraZeneca to put a voluntary hold on the late-stage global clinical trials was a woman in the UK who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, said CEO, Pascal Soriot, during a private conference call with investors on Wednesday this week.
AstraZeneca puts routine hold on all trials held globally
The Anglo-Swedish pharmaceutical giant explained in a press release yesterday that this is a routine action which needs to happen whenever there is a potentially unexplained illness in one of the trials, whilst it is investigated, to ensure the trials integrity is maintained.
Pascal Soriot, Chief Executive Officer, said:
“At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”
The woman’s diagnosis has not yet been confirmed, but she is improving and will likely be discharged from the hospital as early as today, Pascal Soriot clarified during his call with the investors reported by MSN.
AstraZeneca’s AZD1222 vaccine is the UK’s most promising vaccine candidate to date, as it was shown to trigger a robust immune response against COVID-19 in Phase I/II trials.
It’s a pause not a stop of the trials
In an LBC radio interview reported by the Guardian, the UK Secretary of State for Health and Social Care Matt Hancock stated:
“This is a normal part of a vaccine development that, when you find a problem, the system is paused while you investigate that particular problem. What it underlines is that we won’t bring forward a vaccine unless it is safe, no matter how enthusiastic I am for a vaccine.”
“This is a pause, not a stop, so I am hopeful [AstraZeneca] will be able to resume, but only if it is safe to do so”.
If the adverse reaction is vaccine-related all doses will be thrown away
AstraZeneca is one of several drug companies participating in the U.S. Government’s Operation Warp Speed program to accelerate the development of a COVID-19 vaccine.
The Director of the U.S. National Institute of Health, Francis Collins, told a Senate committee on Wednesday the trial had been halted due to a “spinal cord problem.”
Collins commented in front of the committee that the severe adverse event in the U.K. patient was transverse myelitis, a neurological disorder that causes inflammation of the spinal cord. The Director noted that if AstraZeneca’s review finds the adverse event is related to the vaccine, all the doses already manufactured will be thrown away.
But, AstraZeneca Chief Executive Officer Pascal Soriot emphasised on Wednesday’s call with investors that there had been no final diagnosis in the case and there wouldn’t be one until more tests are done, according to company spokeswoman Michele Meixell.