The New Normal

[tirolski]

I have a feeling that Moderna is having to scramble more than Pfizer in order to pull together all the documentation required to complete the BLA submission. Pfizer has far more experience with the regulatory process than Moderna. Probably has more staff that could be pulled onto the project.

Pfizer got huge by merging and buying other companies as many do.
And have much more experience what it takes for an FDA and EMA approval(s) than the much smaller Germany’s BioNTech.
But BioNTech is the “Holder" of the recent approval(s) of Comirnaty both here and in Europe for some reason(s).
Go figure, I can’t.
Folks in the US of A have been offshoring Pharma stuff for years.

 

[Brownski]

Pfizer got huge by merging and buying other companies as many do.

They had to do something with all the boner pill money- might as well buy the competition I guess.

 

[tirolski]

They had to do something with all the boner pill money- might as well buy the competition I guess.

When I was in Italy and went up to Tirol one Sunday to look for the place where the grand folks were from I stoped in the village at the hotel next to the closed information center.
The only one who spoke English of the owners was the son.
He told me he bought Pfizer stock cause of the little blue pill.
We did discuss other topics.
They served great gelato.
Want to go back.

 

[MarzNC]

Pfizer got huge by merging and buying other companies as many do.
And have much more experience what it takes for an FDA and EMA approval(s) than the much smaller Germany’s BioNTech.
But BioNTech is the “Holder" of the recent approval(s) of Comirnaty both here and in Europe for some reason(s).
Go figure, I can’t.
Folks in the US of A have been offshoring Pharma stuff for years.

Probably made regulatory approval a bit easier in Europe because BioNTech was the filing company. Got it in Dec 2020.

As noted, Pfizer has been around and multi-national for a long time. Founded in 1849 by a couple of immigrants from Germany. Has probably always had an international outlook. The company I worked for does contract work for pharma/biotech companies and was founded by a professor who came from the UK. That made his interest in having connections and offices outside the U.S. very strong even when there were only a few dozen employees. When I joined there were about 40 people in NC and 1 in London. Seemed to work considering it grew to 17,000 employees worldwide in about 10 years.

The FDA requires efficacy trials done in the U.S. while European regulatory agencies probably want trials done in European countries. A U.S. patent only lasts 17 years, that the start date isn't when FDA approval is given. The sooner there is regulatory approval somewhere in the world, the sooner a company starts bringing in revenue after years of research.

 

[tirolski]

The sooner there is regulatory approval somewhere in the world, the sooner a company starts bringing in revenue after years of research.

Yup. But why do the approval(s) go BioNTech?

 

[MarzNC]

Yup. But why do the approval(s) go BioNTech?

Just guessing, but since BioNTech is focused on the mRNA approach, could be that the thinking was that they would get along better with the European regulators (EMA). Like Moderna, BioNTech had more reason to make the COVID-19 vaccine development a top priority for pretty much everyone in the company. Presumably Pfizer had to keep other drug development going at the same time that work for the pandemic vaccine was proceeding.

I've paid more attention to news about Moderna partially because it's simpler to follow one company instead of an international partnership. Wading through the Pfizer website is not worth the effort.

BioNTech - Wikipedia

en.wikipedia.org

December 4, 2021

Here are 5 things to know about BioNTech and the married couple behind the COVID-19 vaccine developed with Pfizer

Co-founded by Turkish-German scientists Uğur Şahin and his wife Özlem Türeci, BioNTech is now worth $25 billion.

www.marketwatch.com

 

[tirolski]

Wading through the Pfizer website is not worth the effort.

Here’s their agreement.
It’s in legalese.
Pfizer owns a licensing agreement.
BioNTech knows the mRNA technology and it’s manufacture better.
Pfizer knows how to make drug product, has distribution and marketing network(s) and deeper pockets,

https://www.sec.gov/Archives/edgar/data/1776985/000119312520195911/d939702dex1045.htm

 

[wonderpony]

Cornell has moved to yellow alert.. Move in was last week. 98% of undergrads are vaccinated. Sigh.

 

[MarzNC]

Cornell has moved to yellow alert.. Move in was last week. 98% of undergrads are vaccinated. Are these breakthrough cases, or the remaining unvaccinated 2%? Enquiring minds still want to know.

Given that everyone is being tested regardless of whether or not they have any symptoms, sounds like there are breakthrough cases among the students. For Aug. 20-26, the total number of positive test was 60 and most were students. Percent Positive was 0.33% since most tests were required as part of the surveillance approach and not based on someone having symptoms or thinking there was close contact.

The infections that started after students moved in were probably from social activities, not work or classes. Presumably some infections started before students made it to Ithaca and were undetected. When did classes start?

I noted the extra comment about "Greek houses" as part of the recommendation that students living off-campus mask indoors.

Cornell announcement, August 27, 2021
" . . .
While the number of cases is concerning, we want to emphasize that our system is working. Virtually all of our students are fully vaccinated; as such, it is the case that those who are infected will almost all be vaccinated. And as has been seen across the country, the vaccine is proving effective in preventing severe illness — the vast majority of our identified cases are asymptomatic or experiencing only mild symptoms and would likely not have been identified were it not for our extensive testing program. Importantly, the knowledge gained from our testing program also provides us with information as to where infections are occurring; to date, these are overwhelmingly associated with informal social events and activities and are not linked to organized university events.
. . ."

 

[wonderpony]

It' s only the students who are being tested regularly at the moment. I am not sure if that includes grad students. Of course, I could read for comprehension.

I kind of wonder if the email is a warning to the students to start behaving or go back to zoomland. And, the statement that there were no transmissions in the classroom is misleading, IMO. I have a grad student who was exposed while being a TA. Thankfully, the distancing and masking last year kept her safe.