NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial

Jerri-Lynn here. This is a really important piece, focusing on the legitimacy of COVI-19 vaccine trials. The writers seem to talk around the key point: that AstraZeneca not sharing the data is a bad sign. So please bear that point in mind as you read.

I post this on the same day am also linking to an article questioning whether political pressure is distorting trials for the Russian COVID-19 vaccine candidate. Readers won’t be surprised to find that political pressure may be brought to bear on U.S. and British trials as well.

I should also mention that this isn’t the only bad behaviour for which AstroZenaca stands accused. As reported Monday by Common Dreams in, ‘Outrageous’: Sanders Blasts AstraZeneca for Raising Drug Prices Despite $1.2 Billion From Taxpayers for Covid-19 Vaccine:

Bernie Sanders on Monday was among critics denouncing AstraZeneca—one of the world’s biggest and most profitable pharmaceutical corporations—for aggressively raising the prices of some of its best-selling drugs in recent months, even after it secured a more than $1 billion taxpayer handout for the development of a Covid-19 vaccine.

The Los Angeles Times reports AstraZeneca has implemented two rounds of price hikes for some of its most popular medications in 2020. In January, the U.K.-based company announced it would modestly raise prices on 13 different products. Shortly after the company’s January announcement, the coronavirus pandemic accelerated around the world. AstraZeneca subsequently instituted price hikes that were much steeper than some of its top competitors.

 “It’s outrageous for Big Pharma to use the pandemic as an opportunity to raise prices on life-saving medicine.”
—Sen. Bernie Sanders

The price of some AstraZeneca drugs has increased by up to 6%, according to an investigation by the Times and 46brookyln Research, a nonprofit group focusing on the pharmaceutical industry.

According to Pharm Exec, AstraZeneca is the world’s 11th-largest pharmaceutical company by 2019 sales. The Times reports it enjoyed over $3.6 billion in operating profits over the first half of 2020.

News of the price hikes sparked condemnation from progressive leaders and activists.

“It’s outrageous for Big Pharma to use the pandemic as an opportunity to raise prices on life-saving medicine,” Sen. Bernie Sanders (I-Vt.), who made Medicare for All—including prescription drugs—a pillar of his near-miss 2020 presidential run, tweeted on Monday. “Big drug companies don’t need more subsidies. We need to end their greed.”

***

Jerri-Lynn again. But the purpose of this crosspost is to share the important story penned by Arthur Allan and Liz Szabo, who write regularly for Kaiser Health News, and not to produce yet another jeremiad against Big Pharma.

By Arthur Allan and Liz Szabo. Originally published at Kaiser Health News

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”

Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.

“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”

The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.

Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.

Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.

If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.

A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.

Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.

The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.

More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.

In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.

Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.

“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”

Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.

FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.

It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.

Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.

“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.

AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.

But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.

“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”

The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.

“There are also potential consequences if you stop a study,” Goodman said.

If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.

“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”

Schaffner said researchers need to remember that vaccine research is unpredictable.

“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”

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29 comments

  1. PlutoniumKun

    Unfortunately, one of the biggest casualties of Covid may well be science itself. The rush to deliver a vaccine has been far too politicised and commercialised. Its very hard not to see the possibility for the pressure for an early release of an untested vaccine resulting in a disaster. The long term implications for faith in science and public health could be even worse.

    Reply
    1. voteforno6

      I’m not so sure about that – a lot of similar things happened during the influenza pandemic a hundred years ago. Science managed to recover from that.

      Reply
      1. nobody

        No it didn’t; “science” was brought to heel by the global oligarchy.

        And here we all are now, in the year of our Lord 1984.

        Reply
  2. Jessica

    My guess is that vaccine progress in the US will appear slow until Trump has conceded a lost election. Then it will seem to accelerate.
    Also, coverage of the virus crisis will soften. “US is world leader in virus deaths” will become “US is Number 8 in deaths per million”. (Both of these statements are true right now.)
    I am not supporting Trump. I just think that either he has picked enough fights with a large enough proportion of the elites to have the media lined up against him or it is all pure kayfabe and he is just playing the heel role.

    Reply
    1. Prairie Bear

      I just think that either he has picked enough fights with a large enough proportion of the elites to have the media lined up against him or it is all pure kayfabe and he is just playing the heel role.

      My guess would be the latter, although the two things aren’t necessarily mutually exclusive, and there could be other factors too. One clue will be, if a Trump loses, how vigorous will be any efforts at prosecutions of Trump et al. Millions are howling for such efforts already, but I have a feeling that it would suddenly become a matter of “look forward, not back.”

      Reply
      1. lyman alpha blob

        “Look forward, not back” has been the mantra regarding wrongdoing by the political class most of the time in the past, and has allowed many to fail upwards without consequences. But all of those politicians were in the same big club, and that club isn’t Mar-a-Lago.

        I’d put the odds of looking forward in this case at about 50/50. There are definitely some who would like to try to prosecute Trump to set an example and ensure that no boorish interlopers lacking the proper pedigree are allowed inside Club DC ever again, but then there is the question of what to prosecute Trump for that those cheerleading the prosecution are not guilty of themselves. Any prosecution would involve a lot of black pots trying to take down the kettle and I would guess there might be more than a few smaller receptacles going down as collateral damage. That would probably be the main reason for ‘looking forward’ in Trump’s case.

        Reply
    2. ShamanicFallout

      Jessica- I think I’m with you on this and could even go further as my cynicism usually gets the better of me (though judging by the truth of that Lily Tomlin quote, maybe I shouldn’t worry). I keep telling people, more tongue in cheek really, that if Biden is elected, the corona era will end; schools will be open by inauguration; air travel back; restaurants, bars open. But I think it will actually be more in line with what you are saying- the tone will change, the coverage will change. I think we can be pretty sure about that.

      Reply
  3. The Rev Kev

    When Oxford went full radio silence on the problems that that one person was experiencing, I began to wonder just what happened to that person. Auto-amputation? Spontaneous combustion? An alien bursting out of their chest? But now that it is established that it was spinal cord damage, that is worse. And the next stop after the spinal cord is the brain itself. Probably find that the subjects all signed papers where it is illegal for them to give interviews or discuss their experiences in public lest they be taken to court. I know that Australia has signed a deal with the Oxford group but I do not want to be one of the first to take that vaccine. Going by past performance, the government will probably make it so that you cannot have a job dealing with the public unless you be vaccinated and they would probably withhold social security payment as well. Gotta get those economies opened up after all.

    Reply
      1. rusti

        People strapped for cash, maybe? I was searching for the compensation amount, the US government-funded “Covid-19 Prevention Network” advertises that volunteers will be compensated, but the only quantification I could find was a Fox Business article that said volunteers could get $1100.

        I don’t think they’re forcing anyone to participate, if that’s why you have quotes around “volunteer” :) And they don’t deliberately subject anyone to the virus. According to the most recent episode of This Week In Virology, some of the companies have been trying with limited success to recruit more black volunteers. The companies need a diversity in genetic background and age for the big Phase III trials with ~30k people.

        Reply
      2. Dan from California

        I am one volunteer. I am a retired CFO who was a volunteer fire fighter and EMT back when.

        It has been frustrating to see the pandemic so badly handled by our society and I was hoping to find a way to do some good here. A lot of normal ways of helping out, such as food banks were deemed to be too risky for older volunteers. This is a way to try to do some good and the payoff may be early access to a vaccine.

        Reply
        1. AnonyMouse

          Indeed, when I encouraged my friend to go in for trials, our perspective was:

          => Risk is likely to be very low (and indeed just 1/30,000 adverse events in actuality)
          => Might get early access to COVID-19 protection
          => Would get continual monitoring + good healthcare
          => Some compensation
          => Civically-minded thing to do to help get us all out of this mess a bit quicker

          I would’ve done it myself were it not for pre-existing health conditions that bar me in the screening

          Reply
      3. AnonyMouse

        Both you and OP are off base here. I interviewed an Oxford vaccine trial volunteer who happens to be a friend of mine – there’s no embargo on them talking to the press as far as we’re aware.

        As for the volunteers, you’re compensated for your time and some for risk, you get full and regular health check-ups – which was hard to come by in the early days of the pandemic – and mostly she did it out of a sense of civic duty + wanting to help out in the midst of the crisis.

        Reply
    1. Susan the other

      So I agree Rev. And that’s because, unassociated with any sort of virus vaccine, I contracted chicken pox from my daughter when she was 5 and I was 35. She got over it in a week, no sweat. It took me several years. I had neurological damage, a slowly diminishing “temporal lobe epilepsy” and general fatigue. All of those symptoms slowly dissipated, but I considered myself lucky. And I have ever since refused to take a chicken pox vaccine. I don’t care if I get shingles – it’s better than epilepsy. And I’m willing to concede that I might be the one in 100,000. But… there are a lot of us. And this is just my immediate personal concern. My long term, societal concern is that these vaccinations are going to screw up our genetics if they mess too deeply with our mRNA system. Really. Not hysterical here. It is entirely possible. According to the stuff I have read and think I understand. I’m waiting to be patted on the head and told not to worry my cute little old self about all of this. Nagahappen – because they aren’t sure themselves.

      Reply
      1. Richard Needleman

        Susan the Other

        Consider your head patted. I have published many papers in molecular genetics. There is no mechanism whereby your ‘mRNA system’ can screw up your genetics (nor messed with by the Moderna vaccine). As a simplification, human heredity is DNA and not RNA, and mRNA depends upon your DNA.

        Now this is not to minimize your concerns, especially given your experience. But even shingles (herpes zoster) is hardly a minor thing–my wife lost an eye because of it……

        Reply
      2. oliverks

        Shingles is unpleasant, but it is also quite treatable if you get Valtrex. That stuff works amazingly quickly, and shuts down the worse part of shingles quickly.

        A possible side effect is I have never had a bad cold since having Shingles. It could be coincidental, or shingles did something, but I suspect that Valtrex may have killed some virus that was causing me to have frequent nasty colds. My colds were so bad before I had shingles, I was happy if I got the flu. Now it is the other way around.

        If that is so, it had a double benefit.

        Reply
        1. Alternate Delegate

          Valtrex is another case in point. The generic versions of valacylovir appear to be filled with crap and impurities that give some people serious headaches.

          Why? I don’t know, but it’s apparently a total coincidence that GlaxoSmithKline pushed the price of name-brand Valtrex (which doesn’t give you a headache) above $600 for 30 tablets before (acquaintance) finally said enough, and decided to just live with the terrible headaches.

          Now I see it’s over $700.

          You can eat the rich, but maybe avoid eating the pharma companies. You don’t want what’s in there.

          Reply
          1. oliverks

            Yes it is expensive but the dosing is much easier and the side effects as you mention are lower. However, I agree the price is excessive.

            Reply
      3. Alternate Delegate

        Seriously, stay away from that new shingles vaccine. Does not prevent shingles, for one. Acquaintance continues to get shingles and also now has recurrent massive hive attacks, which never happened before. The vaccine, for unexplained reasons, employs a new adjuvant based on saponins. That’s a lot of things including cacao. Can’t eat chocolate anymore without getting hives.

        Nothing against well-tested vaccines against deadly diseases.

        Under a totally for-profit health care system … that may be a thing of the past.

        Reply
      4. Sue from SoCal

        Yes, Susan the other. I understand completely. Since I have MS and another autoimmune disorder, I’m not hysterical. I’m just a paranoid old insurance lawyer. I don’t trust healthcare for profit to throw it. It won’t be me taking any vaccine that isn’t personally blessed by Anthony Fauci.

        Reply
  4. hoonose

    There are vast numbers of very high risk people all over the world just waiting for a vaccine. For example HC workers and nursing home patients. Many with multiple Covid 19 risk factors, having to shelter at home. Their risks might be much higher today from Covid 19 as compared to a modern vaccine. For instance one can review the swine flu vaccine 1976.

    https://wwwnc.cdc.gov/eid/article/12/1/05-1007_article

    Over the next year most likely we will have multiple vaccine choices, and know with some improved certainty as to whether it makes any sense to vaccinate low risk people.

    Reply
    1. ambrit

      Of equal importance is a cheap and simple test for the coronavirus. We cannot know with much certainty who is having the Dreaded Pathogen and at what intensity without a general knowledge of the scope of infection. What about the asymptomatic cases that are going untested? How large a portion of the total infected population are they? How are they being physically damaged without knowing it?
      Finally, will the vaccines produce ‘stealth’ morbidities, similar to those supposedly showing up in asymptomatic cases of the coronavirus? With the vaccine trials becoming so politicized, will the first series of vaccine campaigns be huge public beta testing programs?

      Reply
    2. tegnost

      Low risk people = those who work from home
      High risk people = those who supply those who work from home.

      Give it to congress first, and you are free to volunteer for the sake of the economy if you are so inclined

      Reply
  5. TimH

    “The price of some AstraZeneca drugs has increased by up to 6%”.

    I hate this sort of statement. “The price of every single AstraZeneca drug has increased by up to 100%” is exactly as accurate.

    Even the 6% is meaningless because the time period is not given.

    Reply
  6. Sheldon

    How to reassure the the American people:

    Any politician, local, state federal, including school boards,
    who mandates vaccination shall be the first to get the vaccine.

    U.S. Congress first.

    Reply
  7. Mummichog

    AstraZeneca is a criminal organization:
    “In 2003 federal officials announced that AstraZeneca had pleaded guilty to criminal and civil charges relating to the illegal marketing of the prostate cancer drug Zoladex. The company agreed to pay $355 million, consisting of $64 million in criminal fines, a $266 million settlement of civil False Claims Act charges, and a $25 million settlement of fraud charges relating to state Medicaid programs.”
    The rest of their lengthy Rap Sheet is at:
    https://www.corp-research.org/astrazeneca

    It speaks volumes about the Integrity of Science when the esteemed Oxford University is willing to get into bed with a criminal organization.

    It would also seem reasonable that any media reporting about AstraZeneca on these life-or-death health issues would mention AstraZeneca’s criminal history. In addition, one would expect that any AstraZeneca claims or studies would be viewed with a much more jaundiced and skeptical eye than a company without such a history.

    And AstraZeneca is not the only Pharma vaccine company with a criminal history.

    Reply

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