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Are vaccines the light at the end of the tunnel?


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1 minute ago, TeeRick said:

Remember AZ was paused a long time in the US.  But Moderna has finished enrollment and Pfizer will soon finish too.  These trials have well defined endpoints and dates of the initial un-blinding of the data.  Unless severe adverse events happen then data goes to their medical boards for safety evaluation.  So it seems like late November to December to see what is going on with efficacy.  Not too far away.

Makes sense regarding the FDA. But with regards to AZ's worldwide Phase 3 trial, they only paused giving shots for a week in September. But, in any event, there will hopefully be good news from multiple efforts in the next month or two.

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2 minutes ago, Ken the cruiser said:

Makes sense regarding the FDA. But with regards to AZ's worldwide Phase 3 trial, they only paused giving shots for a week in September. But, in any event, there will hopefully be good news from multiple efforts in the next month or two.

Fingers and Toes crossed!

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2 hours ago, TeeRick said:

Here is the article.  Severe COVID patients hospitalized with pneumonia.  More likely in men. Possibly a way to genetically determine in advance who is most at risk for severe COVID disease and get these folks vaccinated asap.  Learning a lot daily. 

https://science.sciencemag.org/content/370/6515/eabd4585

Interesting read.

 

If testing is not readily available, I wonder if a history of progressing rapidly from mild URIs to pneumonia could be used as an indicator.

 

Side note: This thread has made me pull out my immunology text (how can it be from fifty years ago ???!!!!) to brush up on my basics.

 

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1 hour ago, Ken the cruiser said:

So based on these rolling submissions, could it be possible some more advanced Phase 3 trials have already reached the required "minimum" infection counts allowing them to at least "peak behind the curtain" to see who received the vaccine versus the placebo, to start to determine efficacy rates among other things? If I recall AstraZeneca started their early Phase 3 trial in late June. 

Pfizer CEO in the earnings call has indicated that the dmsb has not done a interim look at the data. So at least in Pfizers case the answer is no. if the dmsb has not looked then they certainly would not have reached the case numbers yet.

 

This is counter to earlier statements in August and September when they said they expected data by the end of October.

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1 hour ago, TeeRick said:

Remember AZ was paused a long time in the US.  But Moderna has finished enrollment and Pfizer will soon finish too.  These trials have well defined endpoints and dates of the initial un-blinding of the data.  Unless severe adverse events happen then data goes to their medical boards for safety evaluation.  So it seems like late November to December to see what is going on with efficacy.  Not too far away.

 

The dmsb does more than just look at adverse events.

 

there are interim data views by the dmsb that look at efficacy.  The intent is that in those views a trial might be unblinded and potentially stopped if the interim data is either very very good, as well as if the data is bad. in either case it would trigger ethics considerations about continuing the trial.

 

The dmsb is the only group that gas access to unbounded data such that they can take these looks at defined periods.

 

 

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50 minutes ago, Homosassa said:

 

Side note: This thread has made me pull out my immunology text (how can it be from fifty years ago ???!!!!) to brush up on my basics.

 

 

50 years!?!?! The field has progressed light years since then. I bet wikipedia has more relevant information than that textbook.

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1 hour ago, UnorigionalName said:

 

50 years!?!?! The field has progressed light years since then. I bet wikipedia has more relevant information than that textbook.

True. But the basics remain the same. I wanted to brush up on complement fixation.

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55 minutes ago, Homosassa said:

True. But the basics remain the same. I wanted to brush up on complement fixation.

Hi,

Yes, most of the basics remain the same but the fine details

and the timelines have shortened greatly. I am totally amazed at how

fast they can do stuff now. When I was cloning and sequencing

novel human genes 35 years ago it took about one year to

sequence one gene! At that time the first complete human

genome took 10 years to sequence and cost $10 billion. As I mentioned

in an earlier post they were able to completely sequence 500

severe covid patients in a very short time period. AMAZING!

It now cost under a $1000 to have your complete genome

sequenced!! This MAY? be a fast method (although expensive)

to determine if you will have severe covid if infected. I'm sure simple

rapid inexpensive tests (PCR, Autoantibody screen, DNA sequencing

etc) will be used in the future to determine and taylor individual

covid treatments. 

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hi there, just dropping in to report my experiences so far in the phase 3 Pfizer trials

 

Received my first shot on Friday around 4...  after a very long day of many pokes, swabs & paperwork, & lots of waiting.

 

I have an app on my phone to do self reporting of any symptoms...

 

No reactions at all until Sunday evening, body aches....  then Monday morning, woke with slight headache, which progressed to a slight fever, chills, body aches, sore throat building over the afternoon, all, very, very mild.... 100% better today.  

 

I am only reporting what I was told....  they are very hopeful that sometime in December they will have enough data to "unblind" the study, & vaccinate all who received the placebo,  this is not guaranteed at this time...again, only what we were told.   

 

I go back for my second shot on November 12th....

 

Any more detailed questions I'd be happy to answer if I can.  

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2 hours ago, cruise kitty said:

hi there, just dropping in to report my experiences so far in the phase 3 Pfizer trials

 

Received my first shot on Friday around 4...  after a very long day of many pokes, swabs & paperwork, & lots of waiting.

 

I have an app on my phone to do self reporting of any symptoms...

 

No reactions at all until Sunday evening, body aches....  then Monday morning, woke with slight headache, which progressed to a slight fever, chills, body aches, sore throat building over the afternoon, all, very, very mild.... 100% better today.  

 

I am only reporting what I was told....  they are very hopeful that sometime in December they will have enough data to "unblind" the study, & vaccinate all who received the placebo,  this is not guaranteed at this time...again, only what we were told.   

 

I go back for my second shot on November 12th....

 

Any more detailed questions I'd be happy to answer if I can.  

The FDA Vaccine advisory committee during the October 22 meeting was pushing for continuing the trial after the Initial efficacy review and leaving the trial arms intact to determine immunity response. So there might be some pushback about vaccinating those that received placebo until a later date.

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10 hours ago, cruise kitty said:

hi there, just dropping in to report my experiences so far in the phase 3 Pfizer trials

 

Received my first shot on Friday around 4...  after a very long day of many pokes, swabs & paperwork, & lots of waiting.

 

I have an app on my phone to do self reporting of any symptoms...

 

No reactions at all until Sunday evening, body aches....  then Monday morning, woke with slight headache, which progressed to a slight fever, chills, body aches, sore throat building over the afternoon, all, very, very mild.... 100% better today.  

 

I am only reporting what I was told....  they are very hopeful that sometime in December they will have enough data to "unblind" the study, & vaccinate all who received the placebo,  this is not guaranteed at this time...again, only what we were told.   

 

I go back for my second shot on November 12th....

 

Any more detailed questions I'd be happy to answer if I can.  

 

Just add my experience participating in the Novavax phase 3 trial.......

 

first session last Tuesday. All very slick and well organised. Vital signs checked, then exam from doc, followed by vaccination. I was in and out in around 90 minutes.

Here we are 9 days on and no adverse affects whatsoever. Back in a couple if weeks for second shot.

I was told that if an approved vaccine became available I would be notified by team and free to go get it.

Edited by zanderblue
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Putin being somewhat honest speaking about production issues with the Sputnik vaccine.  Remember this is a human Adeno vector approach similar to others in development across the US, EU and China.  The AZ/Oxford vaccine he mentions is a monkey adenovector version.

 

https://www.reuters.com/article/us-health-coronavirus-russia-putin/putin-says-equipment-a-problem-in-production-of-russian-covid-19-vaccines-idUSKBN27E21X

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19 hours ago, cruise kitty said:

hi there, just dropping in to report my experiences so far in the phase 3 Pfizer trials

 

Received my first shot on Friday around 4...  after a very long day of many pokes, swabs & paperwork, & lots of waiting.

 

I have an app on my phone to do self reporting of any symptoms...

 

No reactions at all until Sunday evening, body aches....  then Monday morning, woke with slight headache, which progressed to a slight fever, chills, body aches, sore throat building over the afternoon, all, very, very mild.... 100% better today.  

 

I am only reporting what I was told....  they are very hopeful that sometime in December they will have enough data to "unblind" the study, & vaccinate all who received the placebo,  this is not guaranteed at this time...again, only what we were told.   

 

I go back for my second shot on November 12th....

 

Any more detailed questions I'd be happy to answer if I can.  

cruise kitty,

 

Did they give you any instructions concerning best practices for avoiding Covid?

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6 minutes ago, nocl said:

cruise kitty,

 

Did they give you any instructions concerning best practices for avoiding Covid?

They probably told cruise kitty not to cruise😀.

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1 hour ago, nocl said:

cruise kitty,

 

Did they give you any instructions concerning best practices for avoiding Covid?

 

Anyone not following our laws in CA & LA county was not getting anywhere near that clinic.   

 

But yes, our 30 odd page page waiver included CDC guidelines... luckily our rules here are stricter.  

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6 hours ago, cruise kitty said:

 

Anyone not following our laws in CA & LA county was not getting anywhere near that clinic.   

 

But yes, our 30 odd page page waiver included CDC guidelines... luckily our rules here are stricter.  

thank you

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50 minutes ago, gerelmx said:

This is exactly why the ten minute tongue swab being developed here NOW is imperative. A test that can scan for coronavirus with near immediate results in a hand held unit - just imagine 🤔 And before you ask - 

 

“In an Australian first, UTS scientists have used novel optical technology to design a highly sensitive saliva test for the SARS-CoV-2 virus antigens, or viral protein fragments. The test can deliver a positive result in under 15 minutes.

The rapid antigen test collects saliva in a cartridge placed in an existing hand-held device, first developed by Perth company Alcolizer for illicit drug testing. Customised iStrip technology measures the viral load in the saliva sample, even at very low levels, and displays the result on the instrument’s small screen.” 

 

Source: https://www.uts.edu.au/news/health-science/spot-coronavirus-test-within-spitting-distance

 

Edited by Porky55
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32 minutes ago, Porky55 said:

Could this CDC decision hurry the release of vaccines along?

 

https://www.cruisecritic.com.au/news/5687/

 

No CDC has absolutely nothing to do with the drug approval process.  The process is already moving as quickly as possible.  The limiting factor is the rate of symptom occurrence in the trial populations.

Edited by nocl
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2 hours ago, nocl said:

No CDC has absolutely nothing to do with the drug approval process.  The process is already moving as quickly as possible.  The limiting factor is the rate of symptom occurrence in the trial populations.

Shame 🤔

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