A global COVID-19 vaccine trial has been put on hold by major drug company AstraZeneca after a volunteer came down with what's being described as a "potentially unexplained" illness. A further statement from the pharma company went on to stress that it had voluntarily paused the trial.
The vaccine has been developed in conjunction with the University of Oxford and is one of the most closely-watched potential COVID-19 vaccines in development around the world.
The participant who triggered a global shutdown of AstraZeneca's Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker's chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.
Behind-the-scenes monitors known as the "data and safety monitoring board" in Britain paused vaccinations while alerting its safety counterparts in the USA, said Dr. Moncef Slaoui of Operation Warp Speed, the Trump administration's vaccine development program.
On the disruption of trials of Oxford University's vaccine candidate, which has been touted as a front runner, Professor Ashish Jha wrote on Twitter "We have no idea whether this is a big deal or not".
In the notice, the drug regulator mentioned that the clinical trials have been put on hold across countries where it is conducted - the U.S., the UK, Brazil and South Africa.
Oxford University said an effective vaccine could still be 12-18 months away
AstraZeneca's statement said that "in large trials, illnesses will happen by chance but must be independently reviewed to check this carefully". The pharmaceutical firm also said that the pause of the human trial would let them study the potential adverse reaction.
"We are working to expedite the review of the single event to minimise any potential impact on the trial timeline".
Clinical holds often involve pausing the recruitment of new participants and stopping dosing for existing participants, unless it is in the interest of the participants' safety to continue doing so.
AstraZeneca is one of three companies that have begun the third phase of trial, while the other two companies are Pfizer and Moderna. I remain optimistic we will have a vaccine found to be safe and effective in upcoming months.
Mexico will also work with other labs in Europe, China and Russian Federation in vaccine development projects, although AstraZeneca is the only one that has guaranteed distribution across Latin America.
Brazil's health regulator Anvisa said Tuesday that the company has informed it of trial suspension, including the one underway in the country, Reuters reported separately.
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