[Airline] Rebound Tied Directly To Vaccine
#51
Banned
Joined APC: Apr 2014
Posts: 1,291
I see an opportunity there !! 🤣🤣
#53
Actually influenza deaths are much lower in the USA. See below. Typically we see less than 10k a year and typically less than 5k. Not to long ago, CDC policy was changed to report influenza with pneumonia deaths together. I'm not going to get into wha.
From April 12, 2009 to April 10, 2010, CDC estimated there were 60.8 million cases (range: 43.3-89.3 million), 274,304 hospitalizations (range: 195,086-402,719), and 12,469 deaths (range: 8868-18,306) in the United States due to the (H1N1)pdm09 virus. These are real numbers with a poor vaccine that year. The trivalent vaccine that year actually completely missed with the quadravalent giving a small response for that H1N1 strain.
.
From April 12, 2009 to April 10, 2010, CDC estimated there were 60.8 million cases (range: 43.3-89.3 million), 274,304 hospitalizations (range: 195,086-402,719), and 12,469 deaths (range: 8868-18,306) in the United States due to the (H1N1)pdm09 virus. These are real numbers with a poor vaccine that year. The trivalent vaccine that year actually completely missed with the quadravalent giving a small response for that H1N1 strain.
.
An excerpt:
while I don’t disagree with your 2009-2010 numbers, that was an abnormally LOW year, not a high one. At least by comparison to the last decade.
https://www.cdc.gov/flu/about/burden/index.html
#54
Steps for j and j..
1.. refine lead antigen to promote immunological response.
2.. finalize formula and delivery platform
2.. perform carc and mutagenic studies
2.. Perform animal clinical studies
September
3... phase 1 in human clinical study.. small scale
3.. manufacturing and engineering studies
3.. compile data, submissions to FDA
3.. laboratory work
December or January
4.. initiate phase 2a and 2b in human clinical studies... large scale
4... finalize final formula and delivery platform
4.. stability and shipping studies.
4.. manufacturing
4... laboratory work..
4.. compile data and submit to fda.
Maybe next year sometime
5. Large scale phase 3 concurrent with limited approval..
.. this would be how much of the population will start receiving the vaccine ahead of a formal approval.
5.. manufacturing
5... laboratory work..
5.. compile data and submit to fda.
6.. final FDA approval
7.. broad release of the vaccine
7.. collect post approval safety and efficacy data
This is all a very, very, very very advanced timeline. One little hiccup in any step could doom the vaccine and your basically starting from zero.
A few more are close but j and j has the resources. Merk and Sanofi Aventis would be my other bets as they have very good vaccine and manufacturing abilities with very large scientific knowledge banks.
Vaccines are tough to develop. Coronavirus vaccines are difficult, and fingers crossed one is effective soon.
1.. refine lead antigen to promote immunological response.
2.. finalize formula and delivery platform
2.. perform carc and mutagenic studies
2.. Perform animal clinical studies
September
3... phase 1 in human clinical study.. small scale
3.. manufacturing and engineering studies
3.. compile data, submissions to FDA
3.. laboratory work
December or January
4.. initiate phase 2a and 2b in human clinical studies... large scale
4... finalize final formula and delivery platform
4.. stability and shipping studies.
4.. manufacturing
4... laboratory work..
4.. compile data and submit to fda.
Maybe next year sometime
5. Large scale phase 3 concurrent with limited approval..
.. this would be how much of the population will start receiving the vaccine ahead of a formal approval.
5.. manufacturing
5... laboratory work..
5.. compile data and submit to fda.
6.. final FDA approval
7.. broad release of the vaccine
7.. collect post approval safety and efficacy data
This is all a very, very, very very advanced timeline. One little hiccup in any step could doom the vaccine and your basically starting from zero.
A few more are close but j and j has the resources. Merk and Sanofi Aventis would be my other bets as they have very good vaccine and manufacturing abilities with very large scientific knowledge banks.
Vaccines are tough to develop. Coronavirus vaccines are difficult, and fingers crossed one is effective soon.
The fed can waive some of that, and expedite some more of it. Some of it can be worked in parallel. As you mentioned, you can do volume production in advance of approval, and I believe Fauci said the Fed will help underwrite the financial risk.
Some of the timeline is economic in nature (ie don't commit money to step B until you know step A is good) and some is bureaucratic. But this is a national emergency, leadership can accept some risk to expedite a solution. That risk will be balanced with the risks of allowing ongoing economic disaster, and decisions made at the appropriate times.
#55
Gets Weekends Off
Joined APC: Oct 2018
Posts: 564
Disagree. Did you even LOOK at the url I posted?
An excerpt:
while I don’t disagree with your 2009-2010 numbers, that was an abnormally LOW year, not a high one. At least by comparison to the last decade.
https://www.cdc.gov/flu/about/burden/index.html
An excerpt:
while I don’t disagree with your 2009-2010 numbers, that was an abnormally LOW year, not a high one. At least by comparison to the last decade.
https://www.cdc.gov/flu/about/burden/index.html
Yes I'm very aware at the new way the cdc calculates influenza cases, hospitalizations, and vaccination effectiveness. In a previous life before aviation I was a fly on the wall here. See the quoted text below. This change in public policy was a complete 180 by the CDC and HHS. This was after the h1n1 pandemic of 2009 which the numbers were highlighted in a previous post. The reason for this is way beyond the scope of this builtin board, of which I would be happy to take off line. As I highlighted earlier, all deaths, both influenza, pneumonia and "others" are plugged into the current model. 2009 is the last year that many scientist consider good data and this is hotly debated in the scientific community.
Of which usually in the USA, relatively less positive flu cases that lead to death are in the data. Usually less than 10k and mostly less than 5k people with a positive flu test die. I wonder if the CDC will change the current influenza model now as it's actually causing quite a bit of controversy.
Currently the directive from the CDC is all deaths counted as a Covid death require a positive covid19 positive test. This may change and individual states have their own protocols.
"CDC uses a mathematical model to estimate the numbers of influenza illnesses, medical visits, hospitalizations, and deaths in the United States, (1-4) as well as, the impact of influenza vaccination on these numbers. The methods used to calculate the burden of influenza have been described previously (1-2). More recently, the same model was adopted to estimate influenza-associated deaths in the United States. This methodology has been used to retroactively calculate influenza burden, including deaths, going back to 2010."
#56
Gets Weekends Off
Joined APC: Oct 2018
Posts: 564
I've worked in bio med mfg., and am professionally familiar with that process. It was harder in my day, computer modelling has come a very long way since then.
The fed can waive some of that, and expedite some more of it. Some of it can be worked in parallel. As you mentioned, you can do volume production in advance of approval, and I believe Fauci said the Fed will help underwrite the financial risk.
Some of the timeline is economic in nature (ie don't commit money to step B until you know step A is good) and some is bureaucratic. But this is a national emergency, leadership can accept some risk to expedite a solution. That risk will be balanced with the risks of allowing ongoing economic disaster, and decisions made at the appropriate times.
The fed can waive some of that, and expedite some more of it. Some of it can be worked in parallel. As you mentioned, you can do volume production in advance of approval, and I believe Fauci said the Fed will help underwrite the financial risk.
Some of the timeline is economic in nature (ie don't commit money to step B until you know step A is good) and some is bureaucratic. But this is a national emergency, leadership can accept some risk to expedite a solution. That risk will be balanced with the risks of allowing ongoing economic disaster, and decisions made at the appropriate times.
I have a lot of faith in Fauci.. I've met him several times and he's one of those people that when your in their presence, your completely blown away.
#57
#58
Anti-Vaxx Discussion
MOD INPUT: We're done with anti-vaxx discussion. That stuff is inappropriate here, especially in the middle of the largest medical crisis in the last century.
Feel free to discuss COVID vaccination.
Feel free to discuss COVID vaccination.
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