J&J starting 'bridging' trials for Covid Vaccine approval in India.

[BacktoCricaddict]

@sandeep @Clarke @coffee_rules

@gattaca

The Vox video does a really good job of explaining efficacy.  

 

Typically:

• They take, 30,000 - 40,000 volunteers with proper representation of the demographic. 
• Half get placebo.  Half get the vaccine.  Some trials do 1:2 (1 placebo:2 vaccine)
• This is the key:  They do not infect the volunteers with the virus.  They let them go and monitor them until a pre-determined # of positives is reached for each trial.  Moderna's predetermined number was 95, Pfizer was 151 (I think).  
• Then they see how many Covid positives came from each group.  In Moderna's case, 90 out of 95 positive cases came from placebo group.  Thus 94.5% efficacy.  

With J&J's trials being done closer to peak CoViD in the US, the same endpoint strategy likely led to less efficacy numbers.  

 

Also, C_R, the J&J vaccine is not just a cold virus.  Instead, they take the DNA that codes for the SARS CoV2 spike protein and insert it into the DNA of the cold virus.  So, the cold virus is a vehicle.  Once inside the person, the body makes the spike protein, the immune system recognizes it as foreign and forms an immune response.  

Edited April 11, 2021 by BacktoCricaddict

[sandeep]

38 minutes ago, BacktoCricaddict said:

@sandeep @Clarke @coffee_rules

@gattaca

The Vox video does a really good job of explaining efficacy.  

 

Typically:

• They take, 30,000 - 40,000 volunteers with proper representation of the demographic. 
• Half get placebo.  Half get the vaccine.  Some trials do 1:2 (1 placebo:2 vaccine)
• This is the key:  They do not infect the volunteers to the virus.  They let them go and monitor them until a pre-determined # of positives is reached for each trial.  Moderna's predetermined number was 95, Pfizer was 151 (I think).  
• Then they see how many Covid positives came from each group.  In Moderna's case, 90 out of 95 positive cases came from placebo group.  Thus 94.5% efficacy.  

With J&J's trials being done closer to peak CoViD in the US, the same endpoint strategy likely led to less efficacy numbers.  

 

Also, C_R, the J&J vaccine is not just a cold virus.  Instead, they take the DNA that codes for the SARS CoV2 spike protein and insert it into the DNA of the cold virus.  So, the cold virus is a vehicle.  Once inside the person, the body makes the spike protein, the immune system recognizes it as foreign and forms an immune response.  

 

 

And that's why people throwing around the efficacy % as some sort of evaluation of the vaccine's effectiveness is just simply wrong.  But that is the result of stupid foolish 'summary' reporting on science and studies, driven by headline pressure and a failure to prioritize accurate information.

 

And yet, how many reasonably intelligent folks have fallen into this trap.  In fact my 70 yr old uncle in MA, skipped his vaccine appointment a month ago, because he was 'suspicious' of J&J vaccine, and said I want the other one.  I had a 2 hour argument with him, but the damage was done, and now his appt is April 23rd, instead of being vaccinated in early march.  Just plain foolish.   

Edited April 11, 2021 by sandeep

[BacktoCricaddict]

1 hour ago, sandeep said:

many reasonably intelligent folks

The problem is that we are not hard-wired for reasoned decision-making and risk analysis. If an ancient human in the forest assumed that the rustling he heard was the wind and not a predator, he would be right 9 out of 10 times, but the one time he is wrong would be the last time he gets to apply logic.  

 

Even today, although we live in the safest of times, our reflexive fear instinct drives most of our thinking, and disinformation campaigners take full advantage.  

 

 

Edited April 11, 2021 by BacktoCricaddict

[coffee_rules]

@BacktoCricaddict when I quoted efficacy it was from Janssen website and Yale’s comparison. It shows least among all. The comparative trial data was assumed even by yale, O didn’t bother to read it before agreeing to get vaccinated. I was like anything will do as appointment availability is sparse. You get what you get and you don’t get upset

 

I read this good tidbit on AMA

 

Don’t compare the three vaccines

“Don’t get caught up necessarily on the numbers game, because it’s a safe and effective vaccine and what we need is to have as many effective vaccines as possible,” said Dr. Irons. Rather than focusing on efficacy rates, “accept the fact that now you have three highly effective vaccines.”

“These vaccines have not been tested head to head, so it’s impossible to do a really accurate comparison,” she said. “What matters most is … they are all effective at preventing the most severe COVID outcomes, including hospitalization and death.”

[BacktoCricaddict]

Just now, coffee_rules said:

@BacktoCricaddict when I quoted efficacy it was from Janssen website and Yale’s comparison. It shows least among all. The comparative trial data was assumed even by yale, O didn’t bother to read it before agreeing to get vaccinated. I was like anything will do as appointment availability is sparse. You get what you get and you don’t get upset

 

I read this good tidbit on AMA

 

Don’t compare the three vaccines

“Don’t get caught up necessarily on the numbers game, because it’s a safe and effective vaccine and what we need is to have as many effective vaccines as possible,” said Dr. Irons. Rather than focusing on efficacy rates, “accept the fact that now you have three highly effective vaccines.”

“These vaccines have not been tested head to head, so it’s impossible to do a really accurate comparison,” she said. “What matters most is … they are all effective at preventing the most severe COVID outcomes, including hospitalization and death.”

Not everybody will go in and dig deeper like you did.  When scientists report the data, they can only report what they see and then explain the results in the research paper.  But the headlines only mention 95, 94, 72.  And readers go:  Chalo, mere ko 95 waala hi chahiye.    

[sandeep]

23 hours ago, BacktoCricaddict said:

But the headlines only mention 95, 94, 72.  And readers go:  Chalo, mere ko 95 waala hi chahiye.    

Exactly.  Its so goddam frustrating to hear educated folks talk like that.  

[BacktoCricaddict]

7 minutes ago, sandeep said:

Exactly.  Its so goddam frustrating to hear educated folks talk like that.  

Education without statistics is like Shyam w/o Radha.  Ranjha w/o Heer.  Dhoni w/o Raina. Incomplete ....

[ravishingravi]

5 hours ago, sandeep said:

Exactly.  Its so goddam frustrating to hear educated folks talk like that.  

 

I think you overestimate education. In fact, illiterate people more often end up ask more valid questions. Even the "term" efficacy, I am not sure many are aware of at this point. J & J is good one for sure, all considered.

[ravishingravi]

What is shocking and also predictable is that all these innovations are coming out of or driven by USA ? No wonder Aliens only prefer to talk to them. 

 

The importance of research and R & D. Also, makes on wonder, if the social health care in Europe, can encourage these kind of R & D innovation. Gives a different perspective for sure. 

[gattaca]

6 hours ago, ravishingravi said:

What is shocking and also predictable is that all these innovations are coming out of or driven by USA ? No wonder Aliens only prefer to talk to them. 

 

The importance of research and R & D. Also, makes on wonder, if the social health care in Europe, can encourage these kind of R & D innovation. Gives a different perspective for sure. 

 

Europe has socialist policies it makes them lazy and the birth rates now falling all the immigrants in Europe are from poor countries are interested in producing more kids for benefits. 

[gattaca]

12 hours ago, BacktoCricaddict said:

Education without statistics is like Shyam w/o Radha.  Ranjha w/o Heer.  Dhoni w/o Raina. Incomplete ....

Only knock on J and J is its efficacy against new strains in South Africa and UK compared to Pfizer and Moderna. But at least it should give a chance. 

[coffee_rules]

Six rare cases of blood clots associated with J&J.

 

What will India do? People here are happy with FDA and EMA approvals for usage in India

Edited April 13, 2021 by coffee_rules

[BacktoCricaddict]

4 million doses administered.  6 cases of blood clots.  

[rkt.india]

35 minutes ago, BacktoCricaddict said:

4 million doses administered.  6 cases of blood clots.  

They need to check what other ailments those 6 have. There might be some correlation.  They might have certain condition that may have led to this side effect.

[coffee_rules]

2 minutes ago, rkt.india said:

They need to check what other ailments those 6 have. There might be some correlation.  They might have certain condition that may have led to this side effect.

Yes, it is important to study such cases to avoid large scale impact when extrapolated over a large populace 

[rising]

The problem here if their Vaccine does well they would selling first to more developed countries but if they are Vaccine or having issues they are  more likely to  give push in  countries like India and all  this vaccines coming  out  in India are similar type which is a issue , I think Australia didn't wanted go for this as they already has Astraza and felt they were too similar  

[cowboysfan]

5 hours ago, rkt.india said:

They need to check what other ailments those 6 have. There might be some correlation.  They might have certain condition that may have led to this side effect.

all women.its serious but they should not have halted the vaccines as the incidence is 1 in a million.even FDA approved drugs have higher fatal problems than that.

[BacktoCricaddict]

50 minutes ago, cowboysfan said:

all women.its serious but they should not have halted the vaccines as the incidence is 1 in a million.even FDA approved drugs have higher fatal problems than that.

Delicate balancing act.  As it is, vaccine hesitancy is at an all-time high based on fearmongering and unwillingness/inability to assess risk posed by the vaccine vs risk posed by CoViD-19.   By pausing and re-assessing, some of the fears are being allayed right away.  This is a 50.5 - 49.5 kind of vote.  

[BacktoCricaddict]

US lifts pause on J&J vaccine.

https://apnews.com/article/health-science-business-europe-coronavirus-vaccine-839bf6a7c857b25df04078402b4d7b8a?utm_campaign=SocialFlow&utm_medium=AP&utm_source=Twitter

 

U.S. health officials lifted an 11-day pause on COVID-19 vaccinations using Johnson & Johnson’s single-dose shot on Friday, after scientific advisers decided its benefits outweigh a rare risk of blood clot.

The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized.

But ultimately Friday, federal health officials decided that J&J’s one-and-done vaccine is critical to fight the pandemic — and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.

The Centers for Disease Control and Prevention said the J&J vaccine has important advantages for some people who were anxiously awaiting its return. And the Food and Drug Administration updated online vaccine information leaflets for would-be recipients and health workers, so that shots could resume as early as Saturday.

[ravishingravi]

15 out of 8 million. For godsake.