Pfizer and BioNTech COVID Vaccine has 90% efficacy first look at data

[TeeRick]

I found this of interest.  I did not know about this.  The third leg of the stool that has rights to this particular COVID vaccine.  Pfizer,  BioNTech and Fosun International in China.  They bought an equity share of BioNTech earlier this year and have rights to this mRNA vaccine in China.  I am not saying there is anything wrong with this but there will be a demand for manufactured doses split amongst these partners for sure.

 

https://asia.nikkei.com/Spotlight/Coronavirus/Investors-applaud-Fosun-role-in-promising-Pfizer-COVID-vaccine

[Arizona Wildcat]

4 hours ago, TeeRick said:

I found this of interest.  I did not know about this.  The third leg of the stool that has rights to this particular COVID vaccine.  Pfizer,  BioNTech and Fosun International in China.  They bought an equity share of BioNTech earlier this year and have rights to this mRNA vaccine in China.  I am not saying there is anything wrong with this but there will be a demand for manufactured doses split amongst these partners for sure.

 

https://asia.nikkei.com/Spotlight/Coronavirus/Investors-applaud-Fosun-role-in-promising-Pfizer-COVID-vaccine

FWIW Earlier this year Forum bought Gland Pharma for about $1B USD.  Gland was a leader in injectables.  Presume this will mean another source of the Pfizer vaccine.

[mimbecky]

I can’t access the full article and am not sure if this is valid or not but...

https://www.newscientist.com/article/2259821-pfizer-covid-19-vaccine-may-not-need-to-be-kept-at-70c-after-all/

 

[LGW59]

5 hours ago, TeeRick said:

I found this of interest.  I did not know about this.  The third leg of the stool that has rights to this particular COVID vaccine.  Pfizer,  BioNTech and Fosun International in China.  They bought an equity share of BioNTech earlier this year and have rights to this mRNA vaccine in China.  I am not saying there is anything wrong with this but there will be a demand for manufactured doses split amongst these partners for sure.

 

https://asia.nikkei.com/Spotlight/Coronavirus/Investors-applaud-Fosun-role-in-promising-Pfizer-COVID-vaccine

Never trust a three legged stool.

[cl.klink]

On 11/9/2020 at 8:32 AM, Arizona Wildcat said:

The 90% efficacy is super.  The T response suggesting lasting effectiveness also super.

The reality is FDA approval in second half of December.  Very limited vaccine for those most at risk possible this year.  2 doses.  Gottlieb suggested mid 2021 for the majority to be able to be vaccinated with 2 doses.  

 

 

I'll take it

-Joel

[TeeRick]

15 hours ago, mimbecky said:

I can’t access the full article and am not sure if this is valid or not but...

https://www.newscientist.com/article/2259821-pfizer-covid-19-vaccine-may-not-need-to-be-kept-at-70c-after-all/

 

It is stored at -70C but it is likely stable for a few days(?) at refrigerator temperatures once thawed.  They are doing a lot of work on stability studies according to their public statements and presentations.  

[TeeRick]

16 hours ago, Arizona Wildcat said:

FWIW Earlier this year Fosun bought Gland Pharma for about $1B USD.  Gland was a leader in injectables.  Presume this will mean another source of the Pfizer vaccine.

Fosun also owns Sinopharm which is testing an inactivated SARS-CoV-2 whole virus vaccine in clinical trials.  It seems that quite a few of these Chinese pharma concerns are tied together.

https://www.thelancet.com/journals/lanpsy/article/PIIS1473-3099(20)30832-X/fulltext

[Arizona Wildcat]

2 hours ago, TeeRick said:

Fosun also owns Sinopharm which is testing an inactivated SARS-CoV-2 whole virus vaccine in clinical trials.  It seems that quite a few of these Chinese pharma concerns are tied together.

https://www.thelancet.com/journals/lanpsy/article/PIIS1473-3099(20)30832-X/fulltext

Obviously supply is not going to be an issue.  That various Pharma are interconnected good news.

[odysee]

Not looking for argumentations here, just trying to understand.  I read a while ago that due to ethical reasons they could not test the vaccines being developed with the “live virus””, ie they could not willingly expose or infect trial persons with Virus, but would have to wait for accidental or coincidal exposures.  So this would mean test result are pure chance as nobody can guarantee that both groups (the ones with real vaccine and the placebo group) would be accidentally exposed to same number and same load of infected persons ?

Do I see this wrong ?

[TeeRick]

3 minutes ago, odysee said:

Not looking for argumentations here, just trying to understand.  I read a while ago that due to ethical reasons they could not test the vaccines being developed with the “live virus””, ie they could not willingly expose or infect trial persons with Virus, but would have to wait for accidental or coincidal exposures.  So this would mean test result are pure chance as nobody can guarantee that both groups (the ones with real vaccine and the placebo group) would be accidentally exposed to same number and same load of infected persons ?

Do I see this wrong ?

No that is basically correct.  So the rule of chance is minimized in these cases by doing very large and diverse trials and multiple demographics.  That is why you cannot really say anything about efficacy and longer term safety issues in the initial (smaller) Phase 1 and Phase 2 trials.  They would not stand up statistically speaking.  The Phase 3 trials in this case have 10's of thousands of subjects and are "powered" (designed mathematically) to be statistically significant.  It is somewhat more complicated but trying to give a straight forward answer.  Does that help?

[odysee]

Yes it confirms that I have not misunderstood.  Unfortunately it also confirms my reservations about the vaccine’s possible effectiveness.  
But I will remain hopeful that this or next vaccines can get us out of this miserable situation and back to life as it was before. 

[Arizona Wildcat]

23 minutes ago, odysee said:

Not looking for argumentations here, just trying to understand.  I read a while ago that due to ethical reasons they could not test the vaccines being developed with the “live virus””, ie they could not willingly expose or infect trial persons with Virus, but would have to wait for accidental or coincidal exposures.  So this would mean test result are pure chance as nobody can guarantee that both groups (the ones with real vaccine and the placebo group) would be accidentally exposed to same number and same load of infected persons ?

Do I see this wrong ?

Some numbers always helps me.

Think of a group of 40 people.  Half vaccinated.  The odds today suggest that 1 at most would be exposed and infected with Covid through their regular daily activities.  Thus no logical meaning.

As Rick said change to a group of say 40000 with an infection rate of 1/2% - remember in a study each patient is repeatedly tested and almost 100% of cases, asymptomatic included, will be detected.  Thus around 200 should  be ultimately infected of the people in the study - 100 with placebo and 100 with vaccine.  If after 2 months the number infected is 10X with placebo (say 50 and 5) then you can infer the vaccine prevented 45 cases or 90%.

[nocl]

34 minutes ago, odysee said:

Yes it confirms that I have not misunderstood.  Unfortunately it also confirms my reservations about the vaccine’s possible effectiveness.  
But I will remain hopeful that this or next vaccines can get us out of this miserable situation and back to life as it was before. 

the studies are designed to give the results statistical significance. the studies also make sure that the two arms are balanced both by geography and demographics to minimize the chance that those influence results. for example to make sure you do not have more placebo arm patients in a high risk area that vaccine treated patients.

 

the designing of trials is a science in itself and the study designs are reviewed and approved not only by the company but also by regulatory authority (in this case multiple regulatory authorities) as well as an independent data monitoring and safety board. once the results come in the data is analyzed to make sure that there are no anomalies that have skewed the results. Reviewed by the dmsb, the company and the regulatory authorities.

 

[TeeRick]

19 hours ago, odysee said:

Yes it confirms that I have not misunderstood.  Unfortunately it also confirms my reservations about the vaccine’s possible effectiveness.  
But I will remain hopeful that this or next vaccines can get us out of this miserable situation and back to life as it was before. 

But it should actually make you much more comfortable really to get a vaccine that is effective in a 40,000 person trial.  That comes directly from the field of mathematics called Probability and Statistics.  I hope you can access a safe and effective vaccine soon wherever you live.  we are all hoping for that!  Be safe.

[emmas gran]

The guy from BioNtech was just on the BBC news and said it will be next Fall/Winter before the vaccine takes full effect. Summer will be better but we have to think next Fall at the earliest 

 

Liz

[TeeRick]

Another look at the data for this vaccine pushed the efficacy to 95% with no safety issues of concern.  Looking at EUA to the FDA in a few days.

 

https://apnews.com/article/pfizer-covid-19-shot-95-percent-9d71455cfce0ff047dee4df873ec1023

[mom says]

3 hours ago, TeeRick said:

Another look at the data for this vaccine pushed the efficacy to 95% with no safety issues of concern.  Looking at EUA to the FDA in a few days.

 

https://apnews.com/article/pfizer-covid-19-shot-95-percent-9d71455cfce0ff047dee4df873ec1023

And even better news (to me) is that it appears to be effective for all us at risk seniors

[TeeRick]

14 hours ago, mom says said:

And even better news (to me) is that it appears to be effective for all us at risk seniors

Yes and the AZ/Oxford vaccine just published Phase 2 Clinical data (in Lancet) showing robust immune responses in elderly adults too.  Not Phase 3 efficacy data yet but perhaps coming by year end.

[mimbecky]

4 hours ago, TeeRick said:

Yes and the AZ/Oxford vaccine just published Phase 2 Clinical data (in Lancet) showing robust immune responses in elderly adults too.  Not Phase 3 efficacy data yet but perhaps coming by year end.

Hope so.  I recently read that J&J may not have phase 3 data until late January or early February.

[Caymus88]

Just had a visit to my doctor.

he said this vaccine is projected to be effective for 6 to eight months.

SO does this mean a booster every 6 or 8 months?

[TeeRick]

1 minute ago, Caymus88 said:

Just had a visit to my doctor.

he said this vaccine is projected to be effective for 6 to eight months.

SO does this mean a booster every 6 or 8 months?

To be honest, I don't know your doctor but I am guessing that he/she is just speculating.  There is no data yet on the longevity of the immune responses from these vaccines.  So it is wait and see.  It is possible that future boosters might be required or even a slightly different version of the vaccine yearly (like flu vaccines).  On the other hand maybe not- maybe just the initial two doses will be fine.  Nobody knows yet.  

[markeb]

7 hours ago, TeeRick said:

Yes and the AZ/Oxford vaccine just published Phase 2 Clinical data (in Lancet) showing robust immune responses in elderly adults too.  Not Phase 3 efficacy data yet but perhaps coming by year end.

 

It would be the ultimate irony to go from nothing to having discussions of one of the FDA's most obscure terms: noninferiority...

 

It wouldn't surprise me if one or more of the vaccines performs differently in different age groups, and it wouldn't surprise me if they don't. But there could be a perception that a 90% effective vaccine, for example, is inferior to a 95% effective vaccine, and that could be meaningless in the real world, and might be judged noninferior by the different regulatory authorities around the world.

 

I'm going to go with the glass being mostly full, here, though!

[TeeRick]

17 hours ago, markeb said:

 

It would be the ultimate irony to go from nothing to having discussions of one of the FDA's most obscure terms: noninferiority...

 

It wouldn't surprise me if one or more of the vaccines performs differently in different age groups, and it wouldn't surprise me if they don't. But there could be a perception that a 90% effective vaccine, for example, is inferior to a 95% effective vaccine, and that could be meaningless in the real world, and might be judged noninferior by the different regulatory authorities around the world.

 

I'm going to go with the glass being mostly full, here, though!

My glass is 95% full.😀

[verizon]

Thanks for the Vaccines.

RCL is up 5.20 today.

First time above 80 again since March low.