Astra Zeneca study failure

destriero · Sep 9, 2020

Hearing that the study participant was stricken with Hemolytic Uremic Syndrome.

destriero · Sep 9, 2020

If true, it's incredibly unlikely that the patient would have been stricken with HUS from another cause. I did grad-level biochem focused on oncology and HUS is rare and typically related to a class of alkylating agents.

HUS is fatal when chemically-induced.

destriero · Sep 9, 2020

*IF* it's HUS that study is over.

Developer · Sep 9, 2020

There is also rumor about "transverse myelitis", but not officially confirmed by Astra Zeneca

ph1l · Sep 9, 2020

Developer said:
There is also rumor about "transverse myelitis", but not officially confirmed by Astra Zeneca
More...

Confirmed according to AstraZeneca CEO to investors. But the article also says "The woman’s diagnosis has not been confirmed yet."
https://www.statnews.com/2020/09/09/astrazeneca-covid19-vaccine-trial-hold-patient-report/

Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says

By ADAM FEUERSTEIN

SEPTEMBER 9, 2020

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Pascal Soriot, the chief executive officer of AstraZeneca.WIN MCNAMEE/GETTY IMAGES
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.

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The new disclosures made by Soriot were heard by three investors participating on the call and were shared with STAT. An AstraZeneca spokesperson did not respond to an email request for further comment.

One investor on the call said Soriot’s comments were intended to reassure investors that the company was taking the possible vaccine safety event seriously, and to reverse any damage to the company’s stock price. “A vaccine that nobody wants to take is not very useful,” said Soriot.

To date, AstraZeneca’s public statements on the pause have been sparse with details. For instance, the company has not publicly confirmed that this is the second time its trials have been stopped to investigate health events among participants.

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Covid-19 Drugs and Vaccines Tracker
On Wednesday, the company issued a statement, attributed to Soriot, saying AstraZeneca would be guided by a committee of independent experts in determining when to lift the hold on the trial “so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold. Such holds are not uncommon, and it’s not clear yet how long AstraZeneca’s will last.

“To have a clinical hold, as has been placed on AstraZeneca as of yesterday, because of a single serious adverse event is not at all unprecedented,” Francis Collins, the director of the National Institutes of Health, told a Senate panel on Wednesday. “This certainly happens in any large-scale trial where you have tens of thousands of people invested in taking part, some of them may get ill and you always have to try to figure out: Is that because of the vaccine, or were they going to get that illness anyway?”

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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. 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 NIH. Phase 2/3 trials were previously started in the U.K., Brazil, and South Africa.

The vaccine — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus.

Transverse myelitis is a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems. In rare instances, vaccines have triggered cases of transverse myelitis; although it can also be caused by viral infections.
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tsznecki · Sep 10, 2020

destriero said:
If true, it's incredibly unlikely that the patient would have been stricken with HUS from another cause. I did grad-level biochem focused on oncology and HUS is rare and typically related to a class of alkylating agents.

HUS is fatal when chemically-induced.
More...

@destriero for us non bio majors or degens, could you give an indication as to which methods/studies/trials look the most promising for a vaccine? Most know the differences in the vaccine types, but we don't know how to rank them.

If its too long then just TLDR and throw tickers at us with maybe a small blurb why.

Thanks.

destriero · Sep 10, 2020

MRNA's was the most promising outside of AZN. https://www.elitetrader.com/et/threads/mrna-getting-more-money.347454/

destriero · Sep 10, 2020

Humans have never developed a Coronavirus vaccine. There are hundreds of cases of confirmed reinfections. Antibodies to COVID peak some three weeks after onset of symptoms. The best "vaccine" as it were, is antibodies developed from an active disease state, and that's not durable.

So yeah, we're fucked. The only good news is that if you survive COVID you'll likely survive next season's strain as well.

tsznecki · Sep 10, 2020

destriero said:
Humans have never developed a Coronavirus vaccine. There are hundreds of cases of confirmed reinfections. Antibodies to COVID peak some three weeks after onset of symptoms. The best "vaccine" as it were, is antibodies developed from an active disease state, and that's not durable.

So yeah, we're fucked. The only good news is that if you survive COVID you'll likely survive next season's strain as well.
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So I take it you are bullish on tech/cloud/WFH stocks then?

destriero · Sep 10, 2020

tsznecki said:
So I take it you are bullish on tech/cloud/WFH stocks then?
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Yeah, NVDA due to that confluence of factors; AMD missing on the Navi card spec, NVDA winning in Cloud, and as a hedge if it all works out and there is robust immunity from the "vaccine" (sic).