Vaccine Trials

[Montecfo]

It seems strange a vaccine announcement would come on a financial TV network.

The financial people watch this very closely for economic impact and stock prospects. Futures up sharply today.

 

[MichaelB]

The financial people watch this very closely for economic impact and stock prospect.

I understand that. When I was a wee lad in the corporate world our CEO explained one morning the difference between conflict of interest and the appearance of conflict. He was very clear on the need to meet both standards.

The news, from Pfizer and Moderna, is very encouraging. It would be more so if they were releasing hard data for peer and industry scrutiny.

There is a snippet of potential good news from the Moderna announcement. From the NYT

Natalie E. Dean, a biostatistician at the University of Florida, said an important finding was that the vaccine appeared to prevent severe disease. Pfizer did not release information about disease severity when reporting its results.

 

[Aerides]

The Moderna one seems to overcome the Pfizer logistical issues. It requires only -20c to store (same as the chicken pox vaccine), and it can be stored up to 30 days. So PCPs and pharmacies will be able to store and deliver.

The Pfizer one with -70 was going to need new super-freezers at most hospitals to do it. And it only lasts for 5 days.

They are both quoting over 90%.

 

[Dawg52]

Moderna will win in the long term due to the easier storage requirement? Just a guess.

Short term, both will be distributed.

Great news there will be 2 vaccines available. Hopefully sooner rather than later.

 

[ivinsfan]

As to #4, I think Old people who are out and about, taking care of their own business, should be vaccinated before those in a facility. The facility people are already locked down, quarantined, and protected to a fare-thee-well. The independent Old have no such protection, especially if they don't have someone to do their shopping and so on,

This is not true our state MN is still having 20-24 nursing home deaths a day.

 

[garyt]

Just heard and found a NY Times article says Pfizer announced it's vaccine with German drugmaker BioNTech is 90% effective. Found post at:
https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html


Some of the news:


"The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said."


"Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this month, after it has collected the recommended two months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people, company executives have said."

Somebody help me understand. They say they vaccine is 90% effective. Yet from what I understand it's considered unethical to just expose someone to the virus so they don't do that. Basically they just let people go about their lives and after a time they see how many got the virus. If 10% of the people got the virus it's considered 90% effective? But what if those people happen to have just been very careful? Do they send them out with instructions not to wear masks and take other precautions? Are these people all working, going to restaurants, etc? I bet if the people on this forum were tested we'd likely have a better than 90% effective rate if none of us got any vaccine just because it seems the majority here are taking more precautions then the population at large.
The US just hit 11 million cases of covid. Let's say it's really 3 times that to account for people who never got tested. That's 33 million cases or about 10% of the population for an "effective rate" of 90% for NO vaccine.
I'm just trying to understand the testing protocol of the vaccine manufacturers. Is 90% really anywhere near 90%? Now if they actually exposed the test subjects to the virus and only 10 % got the virus then I could see where 90% wouls be a true number. What am I missing?

 

[ivinsfan]

Somebody help me understand. They say they vaccine is 90% effective. Yet from what I understand it's considered unethical to just expose someone to the virus so they don't do that. Basically they just let people go about their lives and after a time they see how many got the virus. If 10% of the people got the virus it's considered 90% effective? But what if those people happen to have just been very careful? Do they send them out with instructions not to wear masks and take other precautions? Are these people all working, going to restaurants, etc? I bet if the people on this forum were tested we'd likely have a better than 90% effective rate if none of us got any vaccine just because it seems the majority here are taking more precautions then the population at large.
The US just hit 11 million cases of covid. Let's say it's really 3 times that to account for people who never got tested. That's 33 million cases or about 10% of the population for an "effective rate" of 90% for NO vaccine.
I'm just trying to understand the testing protocol of the vaccine manufacturers. Is 90% really anywhere near 90%? Now if they actually exposed the test subjects to the virus and only 10 % got the virus then I could see where 90% wouls be a true number. What am I missing?

This is going to give you a headache and ruin your day. Realize no one has these answers now or anytime soon.

 

[Montecfo]

This is going to give you a headache and ruin your day. Realize no one has these answers now or anytime soon.

At least not now. And this is typical for a vaccine. Most of us have never been interested in sufficient detail to understand the sausage-making. But this is how they do it.

 

[gerntz]

It seems strange a vaccine announcement would come on a financial TV network.

I saw it on local news at 6am CST.

 

[gerntz]

This morning got 2 interviews with Scott Gottlieb on CMBC, he just commented on Moderna news. Available at
https://www.cnbc.com/video/2020/11/...d-pandemic-in-2021.html?&qsearchterm=gottlieb


Interesting answer on the future of vaccines, said he suspects it will be annual at least for a few years and reformulations will reduce the restrictions on cold storage and perhaps to a single dose. Said they bypassed all the nice features in a race to get a vaccine out. Now they will have time to go back and do the kind of things they would have normally spent another year to work on.



For those that have watched him over past months, note he is almost showing a smile.

Pfizer stock down this morning and Moderna is up. I would have expected both to be up. Go figure

Not only will vaccines improve but so will treatments. IMO the picture of C-19 will be completely different - way way improved - in 2022.

 

[gerntz]

I suspect the ultimate winner might be a single shot vaccine or even an oral one.

But we need more details on effectiveness. Are the effectiveness rates of Moderna and Pfizer really comparable? What exactly was prevented by each?

Did those who got sick have milder symptoms?

Pfizer claimed over 90% effectiveness. Moderna claims 94.something %. Are those numbers statistically different?

We'd like more details of course, but these results seem way sufficient to move full ahead for protection. Any delays will cost more lives imo. I think we can assume more details will become available over months.

I suspect there'll be 10 or more vaccine choices in the next 3-5 years.

 

[skipro33]

Somebody help me understand. They say they vaccine is 90% effective. Yet from what I understand it's considered unethical to just expose someone to the virus so they don't do that.

I read a report that said they used volunteers and actually infected those with the vaccine to test it. I can't find it right now and it may now even be suppressed news, but that's what I read. I even saw an interview of someone who had volunteered as to what it was like to get the injection after the vaccine.

Found this from the NIH;
After the second injection, the team evaluated how well the vaccine provoked an immune response against SARS-CoV-2.

I would take that to mean the virus was introduced so the immune response could be evaluated.

 

[ivinsfan]

I read a report that said they used volunteers and actually infected those with the vaccine to test it. I can't find it right now and it may now even be suppressed news, but that's what I read. I even saw an interview of someone who had volunteered as to what it was like to get the injection after the vaccine.

Found this from the NIH;
After the second injection, the team evaluated how well the vaccine provoked an immune response against SARS-CoV-2.

I would take that to mean the virus was introduced so the immune response could be evaluated.

I think it means they do a blood anti-body check for covid.

It's not ethical to expose someone to live COVID.

 

[garyt]

I read a report that said they used volunteers and actually infected those with the vaccine to test it. I can't find it right now and it may now even be suppressed news, but that's what I read. I even saw an interview of someone who had volunteered as to what it was like to get the injection after the vaccine.

Found this from the NIH;
After the second injection, the team evaluated how well the vaccine provoked an immune response against SARS-CoV-2.

I would take that to mean the virus was introduced so the immune response could be evaluated.

Interesting ,thanks. That seems like the only way to really test a vaccine.

 

[REWahoo]

Good grief...

 

[cathy63]

Somebody help me understand. They say they vaccine is 90% effective. Yet from what I understand it's considered unethical to just expose someone to the virus so they don't do that. Basically they just let people go about their lives and after a time they see how many got the virus. If 10% of the people got the virus it's considered 90% effective? But what if those people happen to have just been very careful? Do they send them out with instructions not to wear masks and take other precautions? Are these people all working, going to restaurants, etc? I bet if the people on this forum were tested we'd likely have a better than 90% effective rate if none of us got any vaccine just because it seems the majority here are taking more precautions then the population at large.
The US just hit 11 million cases of covid. Let's say it's really 3 times that to account for people who never got tested. That's 33 million cases or about 10% of the population for an "effective rate" of 90% for NO vaccine.
I'm just trying to understand the testing protocol of the vaccine manufacturers. Is 90% really anywhere near 90%? Now if they actually exposed the test subjects to the virus and only 10 % got the virus then I could see where 90% wouls be a true number. What am I missing?

No, people who've been vaccinated are still supposed to follow the same precautions as everyone else. The test subjects are supposed to be a cross section of the population by age, race, gender, etc. Some have frontline jobs where they normally experience high exposure, some are leading more isolated lives. Some are carefully following mask mandates, others are not. They are divided into two groups and half get the vaccine while the other half get a placebo. Nobody receiving or giving the shots knows which ones are placebos and which ones are vaccines.

The theory is that if the vaccine is 0% effective, then once there have been 100 cases among the test subjects, ~50 will be in the placebo group and ~50 will be in the vaccine group. These people were randomly assigned to groups and the groups are large enough that the number of people exposed in each group should be about the same. Since they're saying that the test so far shows 94% effectiveness, that means that among the first 100 cases, 3 were in the vaccine group and 97 were in the placebo group. If you expected 50 people to get sick, and only 3 actually got sick, you prevented 94% of the infections.

 

[JoeWras]

Somebody help me understand. They say they vaccine is 90% effective. Yet from what I understand it's considered unethical to just expose someone to the virus so they don't do that. Basically they just let people go about their lives and after a time they see how many got the virus. If 10% of the people got the virus it's considered 90% effective? But what if those people happen to have just been very careful? Do they send them out with instructions not to wear masks and take other precautions? Are these people all working, going to restaurants, etc? I bet if the people on this forum were tested we'd likely have a better than 90% effective rate if none of us got any vaccine just because it seems the majority here are taking more precautions then the population at large.
The US just hit 11 million cases of covid. Let's say it's really 3 times that to account for people who never got tested. That's 33 million cases or about 10% of the population for an "effective rate" of 90% for NO vaccine.
I'm just trying to understand the testing protocol of the vaccine manufacturers. Is 90% really anywhere near 90%? Now if they actually exposed the test subjects to the virus and only 10 % got the virus then I could see where 90% wouls be a true number. What am I missing?

OK, this is why they get a wide, diverse range of volunteers. You will have careful people, you will have people who don't follow any rules.

The 90% comes from a comparison with placebo group.

In the Moderna study, 90 people got the disease in the placebo group. Only 5 got it in the vaccinated group. That's where they can determine efficacy.

In a way, the recent surge of cases nationwide is good for the studies because they are finally reaching the numbers they need to do analysis. The studies absolutely depend on people getting the virus! The best outcome is all of them are in the placebo group. The Moderna study was darn near that.

Sucks if you are in the study and got the placebo, right? But it is necessary.

 

[ivinsfan]

No, people who've been vaccinated are still supposed to follow the same precautions as everyone else. The test subjects are supposed to be a cross section of the population by age, race, gender, etc. Some have frontline jobs where they normally experience high exposure, some are leading more isolated lives. Some are carefully following mask mandates, others are not. They are divided into two groups and half get the vaccine while the other half get a placebo. Nobody receiving or giving the shots knows which ones are placebos and which ones are vaccines.

The theory is that if the vaccine is 0% effective, then once there have been 100 cases among the test subjects, ~50 will be in the placebo group and ~50 will be in the vaccine group. These people were randomly assigned to groups and the groups are large enough that the number of people exposed in each group should be about the same. Since they're saying that the test so far shows 94% effectiveness, that means that among the first 100 cases, 3 were in the vaccine group and 97 were in the placebo group. If you expected 50 people to get sick, and only 3 actually got sick, you prevented 94% of the infections.

If this is true I don't have a ton of confidence in the effective number.

 

[JoeWras]

I would take that to mean the virus was introduced so the immune response could be evaluated.

No. See other discussions above.

 

[JoeWras]

If this is true I don't have a ton of confidence in the effective number.

Why? That's the way studies are done. It is a very sound approach.

 

[cathy63]

I read a report that said they used volunteers and actually infected those with the vaccine to test it. I can't find it right now and it may now even be suppressed news, but that's what I read. I even saw an interview of someone who had volunteered as to what it was like to get the injection after the vaccine.

Found this from the NIH;
After the second injection, the team evaluated how well the vaccine provoked an immune response against SARS-CoV-2.

I would take that to mean the virus was introduced so the immune response could be evaluated.

Deliberately exposing someone to a disease they've been vaccinated for is called a challenge trial. I think the news you saw was about the U.K. planning to start that type of trial soon. It was covered pretty extensively in U.S. media last month as well, but here's the BBC article: https://www.bbc.com/news/health-54612293

The test for immune response is just an antibody blood test. If it's negative before the vaccine and positive afterwards, that's an indication that the vaccine is getting your body to generate antibodies so that if you ever were exposed to the virus your immune system would already be trained to fight it off.

 

[JoeWras]

Deliberately exposing someone to a disease they've been vaccinated for is called a challenge trial. I think the news you saw was about the U.K. planning to start that type of trial soon. It was covered pretty extensively in U.S. media last month as well, but here's the BBC article: https://www.bbc.com/news/health-54612293

The test for immune response is just an antibody blood test. If it's negative before the vaccine and positive afterwards, that's an indication that the vaccine is getting your body to generate antibodies so that if you ever were exposed to the virus your immune system would already be trained to fight it off.

Right. The challenge trial is different than what is going on now. These are important to help evaluate vaccines head to head, among other reasons. It takes a lot of guts to volunteer for those!

 

[explanade]

These are preliminary results.

They will reach another milestone in the number of infected and then submit for EUA based on that.

Good news about Moderna is that 11 of the infected had severe disease and they were all in the placebo group..


I think people are also looking for actual antibody and T cell titers as far as data.

 

[P.S.]

I am asking why you would think that something that is injected into the body will be more tolerable to people who won't even wear a mask which is an act that requires no such injection of a foreign substance into one's body?


.

GOOD NEWS!: b/c people are adaptable.
They learn and are constantly evolving. When humans see the relevance to themselves personally (eg. self or a loved one adversely affected), they take appropriate action (eg. heeding cancer screening, or avoiding phishing emails, or complying with a vax). In those isolated communities that refuse measles vax, there’s nothing like a tiny outbreak to motivate previously non-vax-ers.

Further good news: literally 100’s of different SARS CoV2 vax in the pipeline, and the spec’s of Moderna’s already sound better than PFE. Maybe eventually an intranasal one time spray will become available. With all the money being thrown at this, how about a slow release gummy, which surely can’t be that offensive (ok, prob not).

 

[Popeye]

It seems strange a vaccine announcement would come on a financial TV network.

Look at it from the CEO’s perspective. Who would you give the interview? One of the networks running weekly stories about how you make too much money and how your company is the spawn of satan? Or would you go with a financial guy you know and have had sensible discussions with over the years? Eventually you go to the big mainstream networks but you don’t give them the scoop. He’ll likely be on one or more of the morning shows next Sunday.