[Atlantis]

Moderna stocks, which is the US's top vaccine maker, have suffered insider sell-off for some time already, and now this, AstraZeneca, the West's top candidate for developing a Covid vaccine, is experiencing problems.

This was always likely to happen because most Western Covid vaccines under development employ new technology using messenger substances while the Russians and Chinese use traditional well-known dead virus vaccines.

Don't worry, if the West fails (again), we'll still have the Russians to come to the rescue. I guess the cold warriors would rather die of Covid than risk being poisoned by Novichok

A 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.

The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.

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.

Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.

AstraZeneca only began its Phase 3 trial in the U.S. in late August. The U.S. trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the U.K., Brazil, and South Africa.

There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death. It was also not immediately clear which clinical trial the adverse reaction occurred in, though a clear possibility is the Phase 2/3 trial underway in the U.K.

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

I bet Trump will claim that they are doing this just to prevent him getting a vaccine before the election

[Wulfschilde]

AstraZeneca is not one of the three companies being considered for possible October/early November release by the CDC though. Those companies are Phizer, Moderna and Johnson & Johnson I think.

[Atlantis]

AstraZeneca is not one of the three companies being considered for possible October/early November release by the CDC though. Those companies are Phizer, Moderna and Johnson & Johnson I think.

@Wulfschilde, I bet you didn't even know that there are countries outside the US.

[Wulfschilde]

What the does that have to do with what either of us wrote. Did you forget that you brought up Trump?

[Rich]

What the does that have to do with what either of us wrote. Did you forget that you brought up Trump?

Well these days every thread is about Trump. Even of you have thread about say particle physics where the OP doesn't mention Trump, its considered good etiquette to bring Trump in within the first few posts.

The funny thing is its the Left that's obsessed with Trump not the Right and certainly not the anti-Sharia, anti-Marxists like myself. The Liberals need to remember Kritzinger's warning. Trump has undoubtedly established himself as one of the greatest men of the twentieth first century. He's not up with the likes of Plato, Alexander, Julius Caesar St Paul, Genghis Khan or Adolph Hitler, but to so dominate the world's psychology is an utterly remarkable achievement.

I think we need to face up to the real possibility that Trump could be gone in six months. We need to recognise that Trump has become a part of all of us. We to a significant part define our identities in relation to Trump. When Trump goes its going to leave a hole in all of us. We saw a taster of this with the end of the Obama Presidency. A lot of Conservatives couldn't face a world without Obama, without that psychological anchoring point. They went into denial and started creating pathetic fantasies about Obama making himself King. We've seen similar pathetic fantasies from the Liberals on this forum, about a second Trump term, rounding up PoFo users, as if the left were facing a Germany 33 situation.

[Rancid]

I wonder what this illness is that this person got.

How would they determine that it is or is not because of the vaccine.

[Atlantis]

What the does that have to do with what either of us wrote. Did you forget that you brought up Trump?

You just confirm the fact that you know nothing about the rest of the world, but we know all about you.

Internationally, AstraZeneca was/is considered the front-runner and has already orders for more vaccines than others. As I said, Moderna seems in trouble and the other two US contenders are either using European-developed vaccines or are far behind.

But you wouldn't know that since you Yanks are so full of yourself.

[Rancid]

I wonder what sivad has to say about this news.

But you wouldn't know that since you Yanks are so full of yourself.

I think the reason people are hostile to you, is that right out of the gate you tend to come off as a total dick.

[Wulfschilde]

You just confirm the fact that you know nothing about the rest of the world, but we know all about you.

Internationally, AstraZeneca was/is considered the front-runner and has already orders for more vaccines than others. As I said, Moderna seems in trouble and the other two US contenders are either using European-developed vaccines or are far behind.

But you wouldn't know that since you Yanks are so full of yourself.

There are plenty of states outside of the US, like Japan and Essex.

[ingliz]

^

Essex is a county in the south-east of England, north-east of London.

[Atlantis]

There are plenty of states outside of the US, like Japan and Essex.

At least you have a sense of humor.

[Wulfschilde]

^

Essex is a county in the south-east of England, north-east of London.

All I know about them is that they suck.

[ThirdTerm]

The adverse reaction is transverse myelitis, an inflammation of the spinal cord, a major part of the central nervous system. Transverse myelitis interrupts the messages that the spinal cord nerves send throughout the body.

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.

The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said.

The board tasked with overseeing the data and safety components of the AstraZeneca 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 set up by the investment bank J.P. Morgan.

Soriot also confirmed that the clinical trial was halted once previously in July after a participant experienced neurological symptoms. Upon further examination, that participant was diagnosed with multiple sclerosis, deemed to be unrelated to the Covid-19 vaccine treatment, he said.

https://www.statnews.com/2020/09/09/ast ... nt-report/

[blackjack21]

I wonder what this illness is that this person got.

Autism, perhaps.

[Deutschmania]

The Oxford trial, one of the most advanced of the major global programmes to find a vaccine for Sars-CoV-2, has been paused, resulting in much speculation about why, and what this might mean for our efforts to control the pandemic. Is this a cause for concern? Unsettling as some of the headlines may seem, in my opinion we should not be unduly worried.

Vaccines are some of the most rigorously scrutinised of all healthcare products. In the UK, clinical trials of vaccines (and medicines) are overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has strict processes governing the conduct of clinical trials, which are designed to ensure that the vaccines we develop are effective and safe.

The Oxford vaccine was tested in a small randomised controlled trial during which 543 participants from five UK centres received the vaccine (with another 534 receiving a control vaccine that is already in clinical use). The study participants were followed carefully over 28 days from the time the vaccine was administered, and according to their peer-reviewed publication of the study in the Lancet in July 2020, no one developed any serious adverse events during this trial. The success of the first trial led to the current much larger UK trial, in which up to 10,560 participants are randomised to receive either the Sars-CoV-2 vaccine or a control. The study team’s website states that by mid-July more than 8,000 people had been enrolled in to this trial. As well as trials in the UK, the vaccine is being tested in Brazil, South Africa, and the US.

Running any clinical trial is an enormous responsibility. As an investigator you want to do everything you can to ensure you do not cause avoidable harm to the people participating in your study – much time, effort, and worry goes into designing trials that will detect signs of a potential issue as early as possible. I suspect the weight of this responsibility will be felt even more heavily than usual by the Oxford vaccine team, who are undertaking their work in the full glare of the international spotlight.

Once investigators have designed a study, the trial protocol is independently scrutinised by the MHRA to ensure it agrees that the study design, including the safety monitoring plan, is appropriate. The clinical trial authorisation (CTA) needed to be allowed to start a clinical trial is not issued until the MHRA is satisfied.

From a safety point of view, the current Oxford vaccine trial appears to have worked just as we would all hope, with the study being suspended to allow independent investigation of an issue that has arisen in one of the more than 8,000 participants they have enrolled so far. As well as pausing the study to allow this independent investigation to happen, the investigators have been transparent with the public about what has happened. This is to be welcomed.

Pausing clinical trials to investigate serious adverse events is not uncommon. In many ways, it is a sign of the rigorousness of the safety monitoring regime, as opposed to there being a definite problem with the vaccine or medicine being tested. Once the investigation is completed, many studies go on to restart their recruitment and successfully finish their trial without further incident. While the pausing of the Oxford vaccine trial may seem significant, I suspect very few of the many other clinical trials that have been similarly paused over the years have had such massive publicity.

The pause is happening to allow an independent investigation into whether the adverse reaction was related to the vaccine. This has not yet happened, so speculation about what might have gone on and the possible consequences is just that – speculation. It is possible that one of the thousands of study participants may have developed a serious health issue that was not known about when they were enrolled into the trial, entirely by chance. We need to allow the regulatory authorities and the study team the time they need to determine whether there is in fact an issue relating to the vaccine.

Trust is a critical element of the global effort to tackle the Covid-19 pandemic – without it we will not make the progress we need towards bringing the crisis under control. Participants in clinical trials need to be able to trust that they will not be exposed to unnecessary and unacceptable risks during the research, and we all need to be able to trust that the medicines and vaccines that emerge from the various clinical development programmes are safe and effective. Key to both these elements is the existence of a thorough regulatory process, and this appears to be working well at the moment.

We need to be patient and let the review process take its course. In the meantime, there is something we can control: our reaction to the news. There is a risk that speculation about the pausing of the Oxford vaccine trial may mean that fewer people are willing to be vaccinated against Sars-CoV-2 when a vaccine does become available, even if the investigation concludes that this event was unrelated to the trial. Jumping to conclusions erodes the trust that is so vital to making progress against this disease – and could have very real consequences down the line.

https://www.theguardian.com/commentisfree/2020/sep/10/oxford-coronavirus-vaccine-trial-covid-19-pandemic?

[Wulfschilde]

Trial is back on, the adverse reaction presumably was something else.

[wat0n]

Was he in the control group?

[Atlantis]

Was he in the control group?

No, he was given the vaccine.

The trial has resumed in the UK but is still on hold in the US, pending investigation by the regulatory agency.

[Torus34]

As the months pass, the expectation in some quarters for a miracle cure/vaccine for the Covid-19 virus will be tempered by that old bugaboo of ideologies, Reality. The time required to develop a save and effective vaccine will be what it will be, not what people wish it to be.

“The outcome of placing Ideology on one pan of a balance and Reality on the other pan is never in doubt.” On Politicians and Others, Clifton Snape. Chelm Press, 1989, South Carolina.

Regards, stay safe 'n well. Remember the Big 3: masks, hand washing and physical distancing.

[B0ycey]

As the months pass, the expectation in some quarters for a miracle cure/vaccine for the Covid-19 virus will be tempered by that old bugaboo of ideologies, Reality. The time required to develop a save and effective vaccine will be what it will be, not what people wish it to be.

Depends. Russia will have their vaccine next month. Although I doubt the West will sanction it to be used.

From my understanding the reaction was some rare spinal condition. I doubt it was related to the vaccine although I suspect it will get the anti vaxxers knickers in a twist.