Are vaccines the light at the end of the tunnel?

[npcl]

2 hours ago, Arizona Wildcat said:

Interesting article in USA Today.  They stated that COVID vaccine will be distributed through McKesson in the US.  They certainly have a wide distribution network.

They explained the packaging for the various vaccines, shelf life one shipped and after vials are at a site to be administered.  There was a large variation from a shelf life of a couple days to a week or possibly more.

More interesting to myself was that some vaccines - think J&J - could be stored at temperatures workable for local pharmacies; while others required very low temps and to be frozen using dry ice for most retail outlets.

For vaccines requiring super cold wouldn't that be difficult in rural areas?

Locally, our county health stated they would partner with both hospitals and pharmacies to have innoculation clinics.

No discussion about a time line.

 

Drop ship over night with special containers, dry ice, and sensors to ensure that the product remained at appropriate temperature and you can reach just about anywhere pretty easily with proper coordination.  Been there, done that 15 years ago.  Easier and more common today.

Edited September 8, 2020 by npcl

[npcl]

6 hours ago, TeeRick said:

I have been involved with vaccine trials with tens of thousands of healthy volunteers.  And for pediatric vaccines even higher numbers.  In general these have taken several years to complete and analyze.  But a COVID vaccine trial looking at immune responses and hopefully correlated to protection from virus will be straight forward and the time frame will be reasonable.  There are lots of healthy volunteers, elderly, risk groups etc that really want to participate.  At least in the lead phase 3 trials that have started.  And the virus is still everywhere.  So that makes conditions for these trials very doable.

A more interesting challenge will be once the first generation vaccine comes out, trying to get participants for a second generation, improved vaccine.

[OceanCruise]

European Journal of Internal Medicine- August 25, 2020 This was a retrospective observational study:

https://www.ejinme.com/article/S0953-6205(20)30335-6/fulltext

Conclusion: "HCQ use was associated with a 30% lower risk of death in COVID-19 hospitalized patients.....our data do not discourage the use of HCQ in inpatients with COVID-19." 

[Fouremco]

7 minutes ago, OceanCruise said:

European Journal of Internal Medicine- August 25, 2020 This was a retrospective observational study:

https://www.ejinme.com/article/S0953-6205(20)30335-6/fulltext

Conclusion: "HCQ use was associated with a 30% lower risk of death in COVID-19 hospitalized patients.....our data do not discourage the use of HCQ in inpatients with COVID-19." 

I'm repeating the full conclusion below, including the important elements that you selectively chose to edit out. BTW, I would hardly consider "data do not discourage the use of HCQ" as particularly strong support for its use. 

 

Conclusions

HCQ use was associated with a 30% lower risk of death in COVID-19 hospitalized patients. Within the limits of an observational study and awaiting results from randomized controlled trials, these data do not discourage the use of HCQ in inpatients with COVID-19.

[OceanCruise]

On 9/7/2020 at 11:47 AM, markeb said:

 

Yes. I've already said that. Those were the studies that appeared to show cardiotoxicity. The dataset could not be verified, and the studies were withdrawn. The original results were more than a little surprising, and I'm much less surprised they couldn't be verified.

 

I'm not a physician. Pre-hospital intervention has not even been shown to be necessary. Ideally, you'd intervene with something with more antiviral activity than HCQ or doxy or azithromycin, but by the time you actually have a diagnosis, given the asymptomatic period, it's unclear how effective any antiviral would be; once you damage enough cells, it's about the inflammatory response.

 

The first 2-3 links on your web page went to 404 file not found when you tried to go to the primary source. One study is a very good safety study on HCQ in RA and I believe SLE. Not surprising results. No, it's shown mixed results at best that have been interpreted by those with an agenda as extremely promising. I actually tried to follow the studies out of curiosity and gave up when the references went nowhere, the, doi numbers went nowhere, and in at least one case, even the primary author went nowhere.

 

Case series with no control group are interesting at best. If they show promise, they tend to trigger actual controlled studies. The NIH multi-center study was randomized and placebo controlled. It found no benefit in hospitalized patients. That was in June. There are currently 250 clinical trials listed globally using HCQ. Many are actually placebo controlled. A few are looking at HCQ versus one or more broad-spectrum antivirals. Only a small handful have completed, and without looking at all 250 (probably less than 25 completed), I may have found one that has gone to publication, but its results are still under review.. A number have been suspended, terminated, or withdrawn for various reasons, including a drop of cases in the study area. Many of those studies with some actual scientific rigor are looking at the pre-hospital setting, but most of them won't finish for months, and won't go to publication for some time after that. 

If you click on the title links for each study from 2003 and beyond at c19study.com and click on "source" it takes you to the individual studies. I don't know why you say you can't access them. As I said, the studies show more effectiveness pre-hospital athough I just posted an Italian study that indicated reduced mortality for hospitalized patients using HCQ. RCTs and clinical trials take a lot of time so retrospective and observational studies can be useful in the meantime to help prevent thousands of unnecessary deaths. BTW, the NIH knew as far back as 2005 per this Journal of Virology article that  "Chloroquine is a potent inhibitor of SARS coronavirus". https://virologyj.biomedcentral.com/articles/10.1186/1743-422X-2-69 

There are also recent studies indicating benefits using certain steroids for hospitalized patients with later stage Covid.

https://www.wsj.com/articles/covid-19-deaths-significantly-reduced-by-use-of-steroids-analysis-says-11599055201?st=hg1ahs36assb8qq&reflink=article_email_share

[OceanCruise]

6 hours ago, TeeRick said:

OceanCruise,

This has been a highly informative vaccine thread on a cruise board and it is a topic highly relevant to the restart of cruising and the future of cruising.  While I hope that effective COVID-19 therapeutics will be developed, and there are many such drugs in development, that is not the topic here.  If you have an opinion one way or another on hydroxychloroquine as many people do, please realize that it is not our topic here.  Plenty of other places to discuss this.  Thank you and be well.

This will be my last post here on this issue. My reason for posting this info on the vaccine thread is that a vaccine that may or may not be safe (using never before used gene therapy) is not necessary if there are effective, safe therapeutics. One of the reasons that there has been resistance to HCQ is that the vaccine companies cannot fast track a vaccine through emergency use authorization (EAU) if there is an alternative therapeutic. Be careful and consider who profits from a vaccine rather than low-cost therapeutics. 

[UnorigionalName]

1 hour ago, OceanCruise said:

This will be my last post here on this issue. My reason for posting this info on the vaccine thread is that a vaccine that may or may not be safe (using never before used gene therapy) is not necessary if there are effective, safe therapeutics. One of the reasons that there has been resistance to HCQ is that the vaccine companies cannot fast track a vaccine through emergency use authorization (EAU) if there is an alternative therapeutic. Be careful and consider who profits from a vaccine rather than low-cost therapeutics. 

 

lol

[npcl]

Just heard that AstraZeneca has just put their trial on hold due to a serious side effect in one participant.  The trial is on hold for a review of the safety data and to determine if this was an event related to the study drug or to some other reason for that participant.

 

This is not unusual in large studies, depending upon the details of the side effect after all you could take any large population, do nothing to them and still have medical events occur.

[npcl]

2 hours ago, Fouremco said:

I'm repeating the full conclusion below, including the important elements that you selectively chose to edit out. BTW, I would hardly consider "data do not discourage the use of HCQ" as particularly strong support for its use. 

 

Conclusions

HCQ use was associated with a 30% lower risk of death in COVID-19 hospitalized patients. Within the limits of an observational study and awaiting results from randomized controlled trials, these data do not discourage the use of HCQ in inpatients with COVID-19.

The unwritten but assumed line is

 

This does not constitute proof of efficacy which requires the results of randomized controlled trials

[Arizona Wildcat]

2 hours ago, OceanCruise said:

This will be my last post here on this issue. My reason for posting this info on the vaccine thread is that a vaccine that may or may not be safe (using never before used gene therapy) is not necessary if there are effective, safe therapeutics. One of the reasons that there has been resistance to HCQ is that the vaccine companies cannot fast track a vaccine through emergency use authorization (EAU) if there is an alternative therapeutic. Be careful and consider who profits from a vaccine rather than low-cost therapeutics. 

Appreciate your thoughts, but as said this was a thread to discuss vaccines.  HCQ is a treatment with an "interesting" set of results.

The drug companies are working on both treatments - Sanofi at least 3 - as well as vaccines.  I find you comment that pharma is pushing vaccines because of profits out of touch.  The vaccine for COVID has sold wholesale in the $25 to $40 area for millions of doses to Canada, US, Europe, Japan etc.  The companies then will provide billions of doses to 3rd World countries.  That is a major reason Glaxo - who has a huge vaccine business - makes little money on them.

This thread is about prevention of COVID so that cruising can resume.  If a vaccine is successful a therapy or therapies that reduce the fatality rate will not be needed.  Nor will the billions spent on the lengthy hospital stays.

Edited September 8, 2020 by Arizona Wildcat

[Fouremco]

17 minutes ago, npcl said:

The unwritten but assumed line is

 

This does not constitute proof of efficacy which requires the results of randomized controlled trials

Yes, even those of us without related education or work experience can draw that conclusion from the report without difficulty.  

[ABoatNerd]

AstraZ has just halted activity due to a potential side effect "unexplained illness".

[gerelmx]

AstraZeneca pauses vaccine trial after suspected adverse event | Financial Times

https://www.ft.com/content/98fca6d4-fcd2-488c-bcfc-d47758740a1a


Sent from my iPhone using Forums

[ipeeinthepool]

1 hour ago, ABoatNerd said:

AstraZ has just halted activity due to a potential side effect "unexplained illness".

 

Not unexpected.  They will investigate to look for the cause.

[markeb]

7 hours ago, npcl said:

Just heard that AstraZeneca has just put their trial on hold due to a serious side effect in one participant.  The trial is on hold for a review of the safety data and to determine if this was an event related to the study drug or to some other reason for that participant.

 

This is not unusual in large studies, depending upon the details of the side effect after all you could take any large population, do nothing to them and still have medical events occur.

 

Yes to all. But it will take time, and due diligence, to figure out what happened and why. Won't stop them gathering data on already enrolled and vaccinated participants, (and I would think it would be unethical not to collect data on them) and could have absolutely nothing to do with the vaccine, but if they stop new vaccinations and have a biologically plausible side effect (and having now announced the hold, they're almost stuck saying what it was, which I haven't seen anywhere), the pace goes back to some version of normal for awhile...

[TeeRick]

Of course the media has grasped the AZ vaccine trial pause as a huge event to spread their version of misinformation with everything out of context.  Vaccine trials like all others always have adverse events.  Some serious, most not.  Particularly when you get to larger numbers of subjects in Phase 3.  I would be very surprised if there were no adverse events in these trials.  Medical issues happen to all of us on a daily basis and they will happen in clinical trials too.  Let's see what this means:

1) Random medical event unrelated to vaccine.  Hopefully most likely scenario and trial resumes.

2) Medical event possibly related to vaccine - becomes more likely if others in the same trial get the same event.

2a) If related to vaccine - was it caused by the SARS-CoV-2 antigen expressed (this would not be a good outcome for all vaccines being developed using that same antigen, ie, SPIKE).

2b) If related to vaccine - was it caused by the technology (adenovector approach)?

2c) if caused by the adenovector (in this AZ case chimpanzee), will it be avoided with a human adenovector (J&J, others) ?

3) Will the mRNA approaches expressing the same antigen be affected?

4) Will the purified subunit /adjuvant approach offer advantages as it is not expressed (produced) in the body?

 

Remember that many of us have expressed concerns that vaccine approaches that have not been used in humans in approved vaccines are considered 1st generation and might carry some adverse risk.  But is that risk rare and is it much less than the risk of hospitalization and death from COVID?  All of this usually plays out over many months to years in typical vaccine trials.  

 

[npcl]

11 hours ago, markeb said:

 

Yes to all. But it will take time, and due diligence, to figure out what happened and why. Won't stop them gathering data on already enrolled and vaccinated participants, (and I would think it would be unethical not to collect data on them) and could have absolutely nothing to do with the vaccine, but if they stop new vaccinations and have a biologically plausible side effect (and having now announced the hold, they're almost stuck saying what it was, which I haven't seen anywhere), the pace goes back to some version of normal for awhile...

They will continue to monitor and collect data on those already inoculated.   They will stop inoculating new patients while the hold is in place.

 

Since it is a 2 dose regimen the biggest impact might be for those that received the first dose and miss the time frame for the second. Though under some circumstances I have seen participants that have received the first dose in a trial continue to receive later doses even during a trial hold.  Don't know what they will be doing in this case.

 

At this point they will look at all of the data they have and see if any conclusion can be reached.  It really will come down to the nature of the side effect, and what the data indicates.  There are some events that occur with some frequency in the general population trial or not. Even if they cannot explain it, if it was one of those, and it is an isolated occurrence then the trial will resume.  

 

At this point all one can do is wait for them to complete their review.

[Homosassa]

The adverse illness is a case of transverse myelitis. 

 

Transverse  myelitis is associated, among other things, with viral infections and viral vaccines.  The incidence rate is low.

 

When I heard the news last night, I immediately wondered if it was Guillain Barre Syndrome which did show up with the first swine flu vaccine in 1976.

[Ken the cruiser]

7 minutes ago, Homosassa said:

The adverse illness is a case of transverse myelitis. 

 

Transverse  myelitis is associated, among other things, with viral infections and viral vaccines.  The incidence rate is low.

 

When I heard the news last night, I immediately wondered if it was Guillain Barre Syndrome which did show up with the first swine flu vaccine in 1976.

Is there a link to the article where you got this information from?

[Homosassa]

27 minutes ago, Ken the cruiser said:

Is there a link to the article where you got this information from?

Sorry, no.

 

I am still looped in on information from my years in FDA.

[Baron Barracuda]

UK patient with transverse myelitis recovering, being discharged today.

 

From Stat News

 

https://www.statnews.com/2020/09/09/astrazeneca-covid19-vaccine-trial-hold-patient-report/

Edited September 9, 2020 by Baron Barracuda

[Arizona Wildcat]

46 minutes ago, Ken the cruiser said:

Is there a link to the article where you got this information from?

There are dozens of articles - NYT, NBC News, USA Today, FT in London, Market Watch article is pasted below.  All the articles stated the same thing - transverse myelitis - and that the study is likely to resume next week or similar wording.  Other links provide info about the patient having MS as an underlying condition.

In a set of 30K patients it would be unusual NOT to have a severe adverse reaction.  

AstraZeneca AZN AZN may resume its halted trial of its COVID-19 vaccine as early as next week, the Financial Times reported, citing people familiar with the matter. The company halted the trial after the discovery of a sick participant, who contracted transverse myelitis, the report said. The trial may see further pauses, the report said, citing a person close to the process.

Edited September 9, 2020 by Arizona Wildcat

[phoenix_dream]

5 hours ago, TeeRick said:

Of course the media has grasped the AZ vaccine trial pause as a huge event to spread their version of misinformation with everything out of context.  Vaccine trials like all others always have adverse events.  Some serious, most not.  Particularly when you get to larger numbers of subjects in Phase 3.  I would be very surprised if there were no adverse events in these trials.  Medical issues happen to all of us on a daily basis and they will happen in clinical trials too. ................

 

Exactly!  Coupled with many others, this has been one of the huge issues related to this virus outbreak.  It's more about trying to grab people's attention with frightening headlines than it is about educating the public.  No wonder mental health is tanking rapidly.  Every time you turn on the news it is some new frightening headline, often blown out of proportion and/or taken out of context.  Between the politics and the virus, I am so disgusted with most all news media anymore.  It used to be a respected and valuable profession - no more.

[Homosassa]

I was curious, so I looked up the package insert for one of the common childhood vaccines.

 

Transerse myelitis is a recognized adverse event (incident rate is less than 1 %) for the vaccine, but it is also a known problem with the viral disease itself.

 

 The stopping of the Covid 19 trial due to this occurrence of tranverse myelitis is the second time the trial was stopped. It was also stopped due to another incident of transverse myelitis in July. However, the patient in that occurrence had an diagnosed case of MS.

[npcl]

1 hour ago, Homosassa said:

The adverse illness is a case of transverse myelitis. 

 

Transverse  myelitis is associated, among other things, with viral infections and viral vaccines.  The incidence rate is low.

 

When I heard the news last night, I immediately wondered if it was Guillain Barre Syndrome which did show up with the first swine flu vaccine in 1976.

That would certainly raise red flags.  With an incidence rate of less than 5 cases per million per year and the uncertainty of cause this will not be easy to clear.