Vaccine Development Summary
#231
We support a wide selection of other folks (not old...whatever age range you think that is).
I would like to continue life going forward without supporting a broad range of folks that HAVE proven to be and will continue to be non-productive, by choice. Not going to happen though.
I would like to continue life going forward without supporting a broad range of folks that HAVE proven to be and will continue to be non-productive, by choice. Not going to happen though.
Fundamental nature of humanity that the young have to care for the old (and the very young).
#232
you really believe older (whatever age you are alluding to) don’t have to go to work for the most part? Current Economic trends and lost retirements have dictated otherwise. My public observations also indicate otherwise.
#233
During the covid emergency I would be OK with extra social security for old folks who need to stay home... neither age nor covid is their fault.
#234
Moderna reports good results in phase 1, including in older folks.
Specifically safety and anti-body production were reported, not efficacy in the real world (later tests cover that).
https://www.reuters.com/article/us-h...-idUSKBN26K3KE
Specifically safety and anti-body production were reported, not efficacy in the real world (later tests cover that).
https://www.reuters.com/article/us-h...-idUSKBN26K3KE
#235
Moderna reports good results in phase 1, including in older folks.
Specifically safety and anti-body production were reported, not efficacy in the real world (later tests cover that).
https://www.reuters.com/article/us-h...-idUSKBN26K3KE
Specifically safety and anti-body production were reported, not efficacy in the real world (later tests cover that).
https://www.reuters.com/article/us-h...-idUSKBN26K3KE
From the article:
In at least two cases, however, volunteers had severe reactions.
One developed a grade three fever, which is classified as 102.2 degrees Fahrenheit (39°C) or above, after receiving the lower vaccine dose. Another developed fatigue so severe it temporarily prevented daily activities, Anderson said.
One developed a grade three fever, which is classified as 102.2 degrees Fahrenheit (39°C) or above, after receiving the lower vaccine dose. Another developed fatigue so severe it temporarily prevented daily activities, Anderson said.
And then there is the logistics problem for the new technology:
https://www.fiercepharma.com/manufac...-question-cold
Drugmakers on the hunt for a COVID-19 vaccine have promised massive supply rollouts in the coming months if their candidates pass regulators' scrutiny. But promises and results are very different things: for two highly touted mRNA-based shots, storage concerns could derail those plans.
A pair of frontrunner mRNA-based COVID-19 vaccines from Moderna and Pfizer could run into supply logistics issues over the ultra-cold storage needs for both shots, SVB Leerink analysts said in a pair of client notes Thursday.
Citing discussion at a CDC advisory committee meeting Wednesday, analysts pointed out that experts expressed concern that the temperatures required to store mRNA vaccines were "severely limiting" to distributors' ability to ship the shots and to clinics' ability to administer them to a wide swath of patients.Pfizer and BioNTech's mRNA hopeful, dubbed BNT162b2, specifically raised eyebrows: The vaccine reportedly needs to be held in storage at -94° Fahrenheit, and will last for only 24 hours at refrigerated temps between 35.6° and 46.4°. Meanwhile, most protein subunit vaccines—the type being developed for COVID-19 by Sanofi and Novavax, among others—can be held at refrigerated temps for months, analysts said.
Given those constraints, the analysts argued that Pfizer's shot could only be used at certain hospitals and clinics with the proper equipment, and would require "intensive one-day vaccination events at such sites ... (that would) cover a fraction of the healthy population."
In a statement, Pfizer argued that its vaccine could be stored at refrigerated temps for up to 2 days, instead of the 24 hours cited by analysts. The drugmaker has also developed shipping containers using dry ice that it believes will solve some shipping worries.
"We are confident of our capability to deliver and store doses to the destination's governments designate, according to product shipping and storage requirements," a spokeswoman said.
Despite similar storage issues, Moderna is pursuing stability data showing its vaccine, mRNA-1273, can be stored at -4° Fahrenheit—which would be a big leg up over Pfizer's candidate. On a Wednesday call with investors, Moderna CTO Juan Andres said the -4° mark was a "very normal storage condition" comparable to home freezers.
"Of course, industrial, well-monitored freezers for pharmaceuticals will be used for storage and shipment, Andres said. "The point here is that the infrastructure is widely available, and we do not need special equipment to use our vaccine."
In the meantime, though, Moderna is likely to pursue an emergency use approval with cold-storage requirements similar to Pfizer's—and analysts said Moderna's eventual advantage over its rival might not be much of an advantage given the range of competitors in the hunt.
"We note that storage/distribution temperature may be less of an advantage–and may in fact still be substantially inferior to non-mRNA competitors utilizing a protein sub-unit approach with much more permissive storage conditions," analysts wrote.
The ability to successfully distribute their vaccines will come as a big challenge for both companies, which have promised hundreds of millions of doses within months if an approval comes through.
A pair of frontrunner mRNA-based COVID-19 vaccines from Moderna and Pfizer could run into supply logistics issues over the ultra-cold storage needs for both shots, SVB Leerink analysts said in a pair of client notes Thursday.
Citing discussion at a CDC advisory committee meeting Wednesday, analysts pointed out that experts expressed concern that the temperatures required to store mRNA vaccines were "severely limiting" to distributors' ability to ship the shots and to clinics' ability to administer them to a wide swath of patients.Pfizer and BioNTech's mRNA hopeful, dubbed BNT162b2, specifically raised eyebrows: The vaccine reportedly needs to be held in storage at -94° Fahrenheit, and will last for only 24 hours at refrigerated temps between 35.6° and 46.4°. Meanwhile, most protein subunit vaccines—the type being developed for COVID-19 by Sanofi and Novavax, among others—can be held at refrigerated temps for months, analysts said.
Given those constraints, the analysts argued that Pfizer's shot could only be used at certain hospitals and clinics with the proper equipment, and would require "intensive one-day vaccination events at such sites ... (that would) cover a fraction of the healthy population."
In a statement, Pfizer argued that its vaccine could be stored at refrigerated temps for up to 2 days, instead of the 24 hours cited by analysts. The drugmaker has also developed shipping containers using dry ice that it believes will solve some shipping worries.
"We are confident of our capability to deliver and store doses to the destination's governments designate, according to product shipping and storage requirements," a spokeswoman said.
Despite similar storage issues, Moderna is pursuing stability data showing its vaccine, mRNA-1273, can be stored at -4° Fahrenheit—which would be a big leg up over Pfizer's candidate. On a Wednesday call with investors, Moderna CTO Juan Andres said the -4° mark was a "very normal storage condition" comparable to home freezers.
"Of course, industrial, well-monitored freezers for pharmaceuticals will be used for storage and shipment, Andres said. "The point here is that the infrastructure is widely available, and we do not need special equipment to use our vaccine."
In the meantime, though, Moderna is likely to pursue an emergency use approval with cold-storage requirements similar to Pfizer's—and analysts said Moderna's eventual advantage over its rival might not be much of an advantage given the range of competitors in the hunt.
"We note that storage/distribution temperature may be less of an advantage–and may in fact still be substantially inferior to non-mRNA competitors utilizing a protein sub-unit approach with much more permissive storage conditions," analysts wrote.
The ability to successfully distribute their vaccines will come as a big challenge for both companies, which have promised hundreds of millions of doses within months if an approval comes through.
https://www.thepharmaletter.com/arti...s-for-covid-19
We still need a Plan B.
#236
There isn't one for the airlines, other than wait for people to decide to fly again. It will happen eventually, airlines will really market their safety measures and the low risk, and people will eventually have an unavoidable need to fly or get sufficiently tired of not having access to most of the world. Who knows how long that will take? Longer than the airlines can afford to bleed though.
#237
Two “serious reactions” from an n of 40 is 5%. There are 95 million US citizens over 55. 95 million times five percent is nearly five million people, and if 5 million people have “severe reactions” the likelihood is that at least 10% of those five million would have very severe reactions. That’s a half million people.
And then there is the logistics problem for the new technology:
https://www.fiercepharma.com/manufac...-question-cold
https://www.thepharmaletter.com/arti...s-for-covid-19
https://www.fiercepharma.com/manufac...-question-cold
https://www.thepharmaletter.com/arti...s-for-covid-19
If it turns out to be expensive, then this vaccine might be superseded by others which are easier to handle. But if it's one of the first out of the gate, they'll just deal with logistics initially.
Also... to get people to take a flu shot, you have to make it convenient (work site, every corner drug store, every doctors office). But for covid, most folks would be willing to drive a bit further if necessary to get to a central vaccination site if log requirements dictated that.
#238
From the article:
Two “serious reactions” from an n of 40 is 5%. There are 95 million US citizens over 55. 95 million times five percent is nearly five million people, and if 5 million people have “severe reactions” the likelihood is that at least 10% of those five million would have very severe reactions. That’s a half million people. And if the resulting immunity wanes as quickly as with most Coronaviruses, it’s very possible they would need boosters every six months.
And then there is the logistics problem for the new technology:
https://www.fiercepharma.com/manufac...-question-cold
https://www.thepharmaletter.com/arti...s-for-covid-19
We still need a Plan B.
Two “serious reactions” from an n of 40 is 5%. There are 95 million US citizens over 55. 95 million times five percent is nearly five million people, and if 5 million people have “severe reactions” the likelihood is that at least 10% of those five million would have very severe reactions. That’s a half million people. And if the resulting immunity wanes as quickly as with most Coronaviruses, it’s very possible they would need boosters every six months.
And then there is the logistics problem for the new technology:
https://www.fiercepharma.com/manufac...-question-cold
https://www.thepharmaletter.com/arti...s-for-covid-19
We still need a Plan B.
#239
Moderna going for EMERGENCY approval
"November 25 is the time we will have enough safety data to be able to put into an emergency use authorization file that we would send to the FDA," Bancel said, adding that an approval wouldn't be expected until late first quarter or early second quarter of 2021.
The timeline matches up with what public health experts have previously laid out, which is that a vaccine could be found to be safe and effective by the end of the year at the earliest but widespread distribution wouldn't occur until further into 2021.
One of the frontrunners to develop a safe vaccine first, Moderna earlier in the month said it was slowing its trial enrollment to ensure it was representing disproportionately affected minority groups but later added it could have enough data by November to know if its vaccine candidate works.
The timeline matches up with what public health experts have previously laid out, which is that a vaccine could be found to be safe and effective by the end of the year at the earliest but widespread distribution wouldn't occur until further into 2021.
One of the frontrunners to develop a safe vaccine first, Moderna earlier in the month said it was slowing its trial enrollment to ensure it was representing disproportionately affected minority groups but later added it could have enough data by November to know if its vaccine candidate works.
That is going to seriously complicate efforts to make any vaccine mandatory.
#240
This isn’t about me, it’s about society putting all their eggs in one basket, a basket that has never before been able to successfully carry that much or that quickly. HopIng is great, but hope isn’t a plan.
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