Not good news and we don't know what the adverse reaction was. Hopefully the person makes a full recovery and the hold does not last long.
" The large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.
Clinical holds are not uncommon, and it’s unclear how long AstraZeneca’s might last. But the progress of the company’s trial — and those of all Covid-19 vaccines in development — are being closely watched given the pressing need for new ways to curb the global pandemic. There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold.
The Phase 3 trial in the U.S. aims to enroll about 30,000 participants at 80 sites across the country, according to a release last week from the National Institutes of Health. It was not immediately clear what steps were being taken at study sites across the U.S. in response to the hold. Clinical holds in ongoing studies often involve a pause in recruiting new participants and dosing existing ones, unless it’s deemed in the interest of participant safety to continue dosing.
In the statement from AstraZeneca, the company spokesperson noted that “in large trials illnesses will happen by chance but must be independently reviewed to check this carefully.” The spokesperson also said the company is “committed to the safety of our participants and the highest standards of conduct in our trials.”
if every drug that had an adverse reaction is out-there would be no drugs. some people die after taking an aspirin. there is always someone who reacts to something. People die from flue shots. Just hope it just a small fraction
As you write, all drugs have side effects. But these side effects have to be balanced against the utility of the drug.
I take ibrutinib which causes, among other things, high blood pressure for me. That side effect would be unacceptable if I was taking ibrutinib for a headache or an upset stomach. I take it for my cancer, so the utility easily outweighs the side effect.
The same is true for chemo drugs that can carry very bad side effects beyond hair loss. People are willing to lose their hair to save their lives. We would not take chemo to treat a sinus infection, the risk outweighs the utility.
Determining what side effects are acceptable for a covid vaccine is quite a difficult analysis. I am in a high risk group of getting very ill from covid, so I am willing to take more risk of a side effect. Younger people for whom covid can be like a cold may not take a vaccine with serious risk profile.
AstraZeneca is doing exactly what they are supposed to do in a phase three trial, amass further data to see if the drug is safe and effective in a larger sample size.
If the adverse event is transverse myelitis (tm), as rumored, that's a big deal. You cant write it off just by saying aspirin can kill, by that logic there would be no reason to regulate trials or drugs at all.
They are already cutting some corners to get a vaccine to market early, and I agree with that strategy. If the Oxford vaccine did cause tm, I do not know what frequency of the side effect is acceptable.
One thing hurting AstraZeneca is they are not the only game in town. As a regulatory body, I would take less risk on a vaccine if there were other ones in tandem development that might be safer.
This is another reason why vaccines can be so slow to get to market. When you have trials with 30000 people in them, you have more chance of a serious adverse event manifesting itself. You also have an increased chance of someone having a serious illness unrelated to the vaccine.
How will they know if the illness was related to the vaccine? They might never know. The first thing they do is vigorously examine the ill person and their medical background to look for other causes. They also look to see if others taking the vaccine had similar, albeit milder, reactions.
Even if the reaction turns out to be vaccine related, that doesn’t necessarily sink the vaccine. Then you have to find out how common the reaction was. If one in a hundred or even one in a thousand are getting seriously ill, that would probably disqualify the vaccine, enough people might not take it anyway. If it’s one in fifty thousand, then that probably wouldn’t stop the vaccine from going to market.
It’s a quandary for AstraZeneca and regulators. There is a lot of altruistic kumbaya messaging from pharma companies about how they are working together to save mankind. I think they are more racing each other to be first to market. This could be a real setback for AstraZeneca. Pfizer and Moderna vaccines could go to market this year if their trials go well.
Life in the business world can be very arbitrary. A random illness possibly unrelated to the vaccine could cost AstraZeneca a ton. Hopefully they can get back on track soon.
In the short term look for Moderna and Pfizer stock to go up while AstraZeneca takes a hit. They are going to be looking to jump start their trial soon. The timing is horrible for them.
“While it’s still unclear how severe and rare the adverse event may be, the finding could impact how quickly efficacy data from the U.K. trial will be available. Those data are considered integral to any bid to seek an emergency use authorization for the vaccine from the U.S. Food and Drug Administration — and potentially jeopardize President Trump’s efforts to fast-track a vaccine ahead of the November election.”
Early reports suggest transverse myelitis is the illness the person contracted. Thats not good, it is a serious illness and has been linked to other vaccines in the past, but in small numbers.
There are a lot of anti-vaccine folks in the US and many, many more on the fence about vaccines. This one event in this trial, related or not to the vaccine, could have serious implications as to whether folks would even take the Oxford vaccine if approved.
What a shame. I hope they can prove this was unrelated or very rare. Thats going to be hard to prove in the short window they have if their competitors bring a vaccine to market before them.
I hope it works out. I am supposing there are thousands of people working on this vaccine and I hope their work is not spoiled by a potentially unrelated adverse effect. Of course it is possible that it is a vaccine related effect and if it is, we need to know how common it is.
I wonder if it could be caused by the chimp adenovirus vector in the Oxford vaccine? TM has been documented to be triggered after viral infections - and perhaps a bit of chimp adenovirus isn't so harmless as we thought?
There are 9 other vaccines in some form of Phase III trial (though I think 3 of them are Chinese - no thanks!). Either way that leaves 5 more in phase II trials. The Moderna vaccine has been going a while and not had any "stops" to it. The Moderna vaccine is an mRNA vaccine with no viral vector. I belive there is another mRNA vaccine being tested, a DNA vaccine being tested and the usual sorts of vaccines being tested.
So this is disconcerting, but by no means a reason to give up on the whole process. In fact, this was the reason for coming up with so many vaccines to begin with.
And there is no reason to give up on the Oxford vaccine yet. The article quoted that the patient may be going home today.
Lots to think about, and lots to wait and see about.
China's pharmacological research and development is really taking off, even in CLL, with Zanubrutinib/Brusinka possibly having an improved side effect profile compared to other BTK inhibitors. Nearly all the world's supply of BTK inhibitors is currently made in China.
In the world of vaccine safety, transverse myelitis is one of several conditions collectively known as a serious acute neurological episode (SANE) temporally associated with vaccination. Others include Guillain-Barré syndrome and acute disseminated encephalomyelitis.
“Temporal” suggests they occasionally occur some time after vaccination, but we don’t know whether the relationship is one of cause and effect. Unfortunately, it’s not always easy to find what caused these conditions, and it’s important to look for other infections that may be associated with the diagnosis.
There are a couple of things worth noting in this case. First, in the UK branch of the trial, not all participants were receiving the AZD1222 vaccine. To ascertain its effectiveness, researchers have given a control group a type of meningococcal vaccine (MenACWY) that has already been licensed. As the trial is double-blinded, we don’t yet know whether the affected participant received the COVID-19 vaccine.
Second, AZD1222 is not a “live-attenuated” vaccine — it’s not made from live SARS-CoV-2 virus. (It does use a chimpanzee adenovirus vector, but this doesn’t replicate or cause disease in humans.) It’s not impossible the transverse myelitis — if confirmed as a diagnosis — was related to the vaccine. But it wouldn’t be possible for the vaccine to cause a COVID-19 infection, which could then spark the myelitis.
Further, phase 2 and 3 trials involve much broader populations than the young, healthy adults who typically participate in early testing. The UK trial of AZD1222 includes people 70 years and older, which naturally increases the risk of temporally associated adverse events.
It’s not a bad thing
This halt on the trial doesn’t indicate the vaccine isn’t safe — we’ll need to see further evidence before we can ascertain this.
But it does reflect robust processes for a clinical trial. In a sense, this is what phase 2 and 3 clinical trials are designed for — to pick up any potential safety issues and investigate them further.
These sort of things happen occasionally in other clinical trials too. We just don’t hear about it. There’s perhaps never been so much attention on a single clinical trial as there is on the trial of this and other potential COVID-19 vaccines.
Serious adverse events are par for the course when trialling new drugs. That we're all desperate for a vaccine makes this is news especially unwelcome, but it would be amazing, not to say suspicious, if any vaccine were to be approved without such an event.
Look at trial data for Ibrutinib 2,838 patients: grade 3+ infections 21pct, major hemorrhage 4pct. It still got approved.
Plus the big difference between a vaccine and a leukemia treatment is that you are giving the vaccine to healthy individuals. The risk vs reward factor is very different for the two situations.
The good news is that they have concluded their deliberations and investigations and decided it is safe to re-start the trial see healthunlocked.com/cllsuppo...
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