[ad_1]
One of the most promising Candidates for the Covid-19 vaccine, which is being developed by AstraZeneca and the University of Oxford, suspended its phase 3 trials after a patient experienced a serious adverse event. That certainly sounds like bad news for everyone who is eager to have a vaccine ASAP.
But hidden in this development is a core of good news, if you can call it that: this is exactly the kind of scientific rigor we want biopharmaceutical companies to practice, especially amid fears that the approval of a Covid-19 vaccine in the United States it may be compromised. by politics.
The Oxford vaccine has been one of the most intriguing vaccines in development. Like Bloomberg covered in your lead scientist profile, Sarah Gilbert from Oxford, stands out from the other top candidates because it doesn’t need to be stored at such a cold temperature. Others must be frozen to be transported; Oxford just needs to be cold. That could be a huge advantage, considering existing concerns on how easy any Covid-19 vaccine will be to widely distribute.
AstraZeneca / Oxford phase 3 trials began in the US in August, and have already started in the UK, Brazil and South Africa. The company planned to enroll 30,000 Americans in its trials in the United States. Phase 3 trials they are the turning point for any new therapy, large-scale trials to determine whether a drug or vaccine has a significant effect and to monitor any adverse effects in a patient population much larger than phase 1 and earlier phase, smaller 2 trials .
STAT broke the news By Tuesday night, the Oxford Phase 3 trial had been stopped due to a patient’s medical complication. A follow-up story from STAT on Thursday relayed the details of the patient’s case:
The participant who triggered the global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the UK who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, said the manufacturer’s chief executive. of medicines, Pascal Soriot. during a private conference call with investors Wednesday morning.
The woman’s diagnosis has not yet been confirmed, but she is improving and she will likely be discharged from the hospital on Wednesday, Soriot said.
The board charged with overseeing the data and safety components of AstraZeneca’s clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was established by the investment bank JP Morgan. .
STAT also learned that a previous interruption in July as a result of an adverse event from another patient turned out to be unrelated to the vaccine – the person was diagnosed with multiple sclerosis. It is a helpful reminder that a patient who develops a medical condition while participating in a clinical trial does not necessarily mean that their diagnosis is related to the vaccine under investigation.
However, as Derek Lowe, who covers drug development for the journal Science, explained, there is some reason to be concerned about what this particular adverse event means for the viability of the Oxford vaccine.
The vaccine uses a live virus, adapted from a virus found in primates, to produce an immune response to Covid-19. The neurological complication experienced by the patient, transverse myelitis, has in the past been associated with an autoimmune response after viral infections. That link has not been conclusively proven, but it is part of the existing body of research.
“I think this is indeed an event to be taken seriously,” Lowe wrote, “and I think pausing the trial to take stock of what is happening is entirely appropriate.”
That was the consensus of scientists and medical journalists after the news from Oxford.
With the world desperate for a Covid-19 vaccine, no one wants a clinical trial for a promising candidate to slow down. But such strikes are not unusual – NIH Director Francis Collins told Congress Wednesday that they were “absolutely unprecedented” – and they represent a sound scientific method.
“This type of pause usually occurs when there is an unexpected serious adverse event,” Angela Rasmussen, virologist at Columbia University, wrote on Twitter about the news. “It may not be related to the vaccine, but the important part is that this is why we test before releasing a vaccine to the general public.”
And that’s really the point. We want a rigorous process to produce a viable vaccine because, like Brian Resnick of Vox explained, many people are skeptical about whether approval of a Covid-19 vaccine will be based on good science, given President Trump’s public agitation for a vaccine to be approved as soon as possible. If too few people take a vaccine because of doubts about the process that produced it, then the pandemic will not end just because the FDA puts its seal of approval on a vaccine.
Drug manufacturers appear to be aware of this risk; Umair Irfan from Vox covered hopeful signs that companies will not give in to political pressure by speeding up their clinical review. This strike is further proof that they will truly live up to those principles.
As AstraZeneca CEO Pascal Soriot told investors according to STAT: “A vaccine that nobody wants to take is not very helpful.”
Everybody wants a vaccine as soon as possible. But science cannot rush. Oddly enough, the great caution displayed by AstraZeneca and Oxford after this adverse event is the kind of response we need to build and preserve public trust in a Covid-19 vaccine.
This story appears in VoxCare, a Vox newsletter about the latest twists and turns in the healthcare debate in America. Sign up to get VoxCare in your inbox along with more stats and health care news.
Support Vox’s explanatory journalism
Every day at Vox, our goal is to answer your most important questions and provide you and our audience around the world with information that has the power to save lives. Our mission has never been more vital than right now: to empower you through understanding. Vox’s work is reaching more people than ever, but our distinctive brand of explanatory journalism requires resources, particularly during a pandemic and economic downturn. Your financial contribution will not constitute a donation, but will allow our staff to continue offering free articles, videos and podcasts in the quality and volume that this moment requires. Consider making a contribution to Vox today.
[ad_2]
