Are vaccines the light at the end of the tunnel?

[D C]

9 hours ago, K.T.B. said:

 

This Thursday Pfizer meets with the FDA to apply for an EUA and Moderna does the same on December 17th.  No idea about AstraZeneca.

 

By the way, excellent article about the vaccines here:  https://www.msnbc.com/opinion/covid-vaccine-almost-here-here-s-what-you-should-know-n1250269

 

Wasn't the application filed a week or so ago??

The inability of these people to pull-ahead a meeting and schedule something immediately (or near) upon the application isn't very comforting for how the rollout will proceed. 

[markeb]

22 minutes ago, D C said:

 

Wasn't the application filed a week or so ago??

The inability of these people to pull-ahead a meeting and schedule something immediately (or near) upon the application isn't very comforting for how the rollout will proceed. 

 

The meeting was scheduled to allow the FDA staff and the advisory committee to review what is almost certainly thousands of pages of data. You don't do that in a day.

[cangelmd]

14 minutes ago, D C said:

 

Wasn't the application filed a week or so ago??

The inability of these people to pull-ahead a meeting and schedule something immediately (or near) upon the application isn't very comforting for how the rollout will proceed. 

I think they are working frantically on the data. They look at everything, not just the data, they go over the manufacturing processes, in this case probably the storage and shipping, recrunch the numbers, evaluate for different age groups.

 

If it makes you feel better, I work in healthcare and we have already ordered our first round of doses, through the public health department. They are proceeding in a very organized fashion, requiring hospitals to prove they have the capacity to store the vaccine correctly and have an admin plan so that no doses are wasted.

 

Moving to opinion, I think the hope at the health department is get healthcare workers, nursing home residents and staff, first responders and, yes, prisoners and people who work in prisons, all vaccinated with the Pfizer vaccine, with the idea that by then Moderna vaccine will be available and it can go out to the less defined and "controlled" groups in the community, probably through pharmacies. If for some reason the Moderna is significantly delayed, I think the backup plan may involved mass vaccinations with the help of the larger hospitals in cities, and the public health department focusing on rural areas and underserved areas - we have many counties with no hospital or no hospital that could manage the Pfizer vaccine. Drive through vaccination, just like the drive through testing - or more likely parking lot vaccines, so the driver can recover if necessary.

[D C]

7 hours ago, lyndarra said:

I heard today on ABC that the initial supply by Pfizer is 100 million doses and that the offer of a follow up order was declined by the US government. This would mean that 50 million will vaccinated and everyone else will now have to wait for supply from elsewhere or if/when Pfizer receives another order which it can fill sometime in the future after other countries' orders. Did I understand it correctly?

That's actually better than I had expected.   50 million covers everyone over 65.  of course, there will be the health care workers as well in that initial wave.

 

The issue will be the rollout to "essential" people since there is no accepted definition of what that means. Giving a vaccine to a healthy 25 year old grocery store cashier would make no sense. 

[sandancer]

4 hours ago, nomad098 said:

 

According to a post on CC somebody is faking test results now to be able to fly.

People have broken the rules before, lied on the health declarations and probably a lot worse things.

Throwing someone overboard is not socially acceptable but it happens.

 

Our local airport is offering COVID tests for £99 for travellers to ensure they can take their flight. If the airlines insisted that this was the only test result they would accept then the fakes would be useless. However, I can understand that some people would not want this added expense and the airlines would not want to lose the business. It’s a difficult one alright. 

[ECCruise]

3 minutes ago, D C said:

That's actually better than I had expected.   50 million covers everyone over 65.  of course, there will be the health care workers as well in that initial wave.

 

The issue will be the rollout to "essential" people since there is no accepted definition of what that means. Giving a vaccine to a healthy 25 year old grocery store cashier would make no sense. 

Health care workers: approximately 20,000,000

First responders, other similar essential: Over 2,000,000

Nursing home residents:  Over 1,500,000

Other essential employees:  Unknown but 87,000,000 total, including older and with comorbidities.

 

Long time before everyone over age of 65 is inoculated. 

 

[markeb]

22 minutes ago, D C said:

That's actually better than I had expected.   50 million covers everyone over 65.  of course, there will be the health care workers as well in that initial wave.

 

The issue will be the rollout to "essential" people since there is no accepted definition of what that means. Giving a vaccine to a healthy 25 year old grocery store cashier would make no sense. 

 

 

Edited:  Oops. Did the math twice. It's 100 million doses or 50 million people!

Edited December 8, 2020 by markeb
Math too early in the morning...

[D C]

2 minutes ago, markeb said:

 

50 million doses at 2 doses per person. That's 25 million people with either the Pfizer or Moderna vaccines (and most of the others behind them).

The post I quoted said 100m doses, so 50m people.  Haven't verified that though .

[emmas gran]

Interesting article re mixing different brands of vaccine from BBC website

 

UK scientists are planning trials to see if giving people two different types of Covid vaccine, one after the other, might give better protection than two doses of one jab.

This mix-and-match approach can go ahead only if another jab is approved by regulators, as has already happened with the Pfizer/BioNTech vaccine.

The head of the UK's vaccine task force said trial designs were being prepared.

The news comes as the NHS starts its Covid mass vaccination programme.

A 90-year-old woman, Margaret Keenan, has become the first person to be given the Pfizer/BioNTech vaccine as part of the rollout across the UK.

Ms Keenan, who is originally from Enniskillen, said: "I feel so privileged to be the first person vaccinated against Covid-19. It's the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year."

Strong immune response

That vaccine, given as two doses a few weeks apart, offers up to 95% protection against Covid-19 illness, according to data.

Although that is a very impressive figure, experts want to explore whether the immune response can be strengthened further and made more durable with a mix-and-match "heterologous boost" approach.

Kate Bingham, who chairs the vaccine task force, said: "It's an established process.

"It's not being done because of supplies."

There is another Covid jab that could soon be approved by regulators - the Oxford/AstraZeneca vaccine.

This works in a slightly different way to the Pfizer jab which could make it a good companion for pairing, say scientists.

The Pfizer vaccine uses a small amount of genetic code from the pandemic virus to teach the body how to fight off an infection, while the Oxford one is a genetically modified virus that has been altered so it won't cause infection but does carry information on how to beat Covid.

The idea is to give people a shot of the Pfizer vaccine followed by a dose of the Oxford one a few weeks later or vice versa, rather than two doses of the same vaccine.

The hope is that it will make the immune system produce two responses

 

 

[markeb]

3 minutes ago, D C said:

The post I quoted said 100m doses, so 50m people.  Haven't verified that though .

 

Yep. Fixed the post. Don't try to do math on your second cup of coffee when you didn't sleep well the night before. It's 50 million people.

[D C]

8 minutes ago, ECCruise said:

Health care workers: approximately 20,000,000

First responders, other similar essential: Over 2,000,000

Nursing home residents:  Over 1,500,000

Other essential employees:  Unknown but 87,000,000 total, including older and with comorbidities.

 

Long time before everyone over age of 65 is inoculated. 

 

Hopefully that list is rationalized prior to distribution.  

 

The objective is to stop people from dying, right?  Give it to those most likely to die, and those who are most likely to transmit it to that group.   

 

Prioritizing every healthcare worker makes no sense.  There are surely those involved in the direct care for the vulnerable, or are likely to come into contact with or treat patients with COVID.  Vaccinate them first.  Those with minimal patient contact don't belong in that first group imho. 

 

 

[D C]

3 minutes ago, markeb said:

 

Yep. Fixed the post. Don't try to do math on your second cup of coffee when you didn't sleep well the night before. It's 50 million people.

And that's just dividing by 2!  Better drink a lot more coffee if you intend to do any calculus today!  😄

[markeb]

1 minute ago, emmas gran said:

Interesting article re mixing different brands of vaccine from BBC website

 

Honestly, I wouldn't hold my breath on this. Maybe in the UK, but in the US, until the products are individually licensed as tested in the clinical trials (same product twice for the most part), I can't imagine any of the commercial companies putting their product into another trial to test this. If it doesn't work as expected, you suddenly have to explain what's considered spurious data, and that may set you back months.

 

It's entirely possible it will work; it's been done with other vaccine candidates in pre-clinical trials and shown a lot of promise. But it's a horrible regulatory strategy at this point.

[Homosassa]

1 hour ago, markeb said:

 

The meeting was scheduled to allow the FDA staff and the advisory committee to review what is almost certainly thousands of pages of data. You don't do that in a day.

Glad to see your and Cagelmd's responses. I was just taking a deep breath accompanied by an eye roll upon reading the post above yours.

 

As a retired FDA reviewer (devices and drugs), I can state that the FDA personnel have been working nonstop to review the data and preparing summaries for the advisory panel members to review before they meet.

 

I sometimes wonder if those that post such comments would also ask a surgeon to take shortcuts on a needed surgery to speed up the time necessary to do a good job.

[markeb]

1 minute ago, Homosassa said:

Glad to see your and Cagelmd's responses. I was just taking a deep breath accompanied by an eye roll upon reading the post above yours.

 

As a retired FDA reviewer (devices and drugs), I can state that the FDA personnel have been working nonstop to review the data and preparing summaries for the advisory panel members to review before they meet.

 

I sometimes wonder if those that post such comments would also ask a surgeon to take shortcuts on a needed surgery to speed up the time necessary to do a good job.

 

And they've only got a week to get ready for the next meeting.

 

I know they've been doing rolling submissions, but that's still got to be a mountain of material to go through!

[K.T.B.]

9 hours ago, lyndarra said:

I heard today on ABC that the initial supply by Pfizer is 100 million doses and that the offer of a follow up order was declined by the US government. This would mean that 50 million will vaccinated and everyone else will now have to wait for supply from elsewhere or if/when Pfizer receives another order which it can fill sometime in the future after other countries' orders. Did I understand it correctly?

 

No Pfizer vaccine in the US until at least June, mostly July.

 

Wonderful. /sarcasm

[markeb]

2 minutes ago, K.T.B. said:

 

No Pfizer vaccine in the US until at least June, mostly July.

 

Wonderful. /sarcasm

 

Initial 100 million doses from Pfizer once approved or granted an EUA (probably already on hand). No additional doses until summer.

[ECCruise]

1 hour ago, D C said:

Hopefully that list is rationalized prior to distribution.  

 

The objective is to stop people from dying, right?  Give it to those most likely to die, and those who are most likely to transmit it to that group.   

 

Prioritizing every healthcare worker makes no sense.  There are surely those involved in the direct care for the vulnerable, or are likely to come into contact with or treat patients with COVID.  Vaccinate them first.  Those with minimal patient contact don't belong in that first group imho. 

 

 

I only commented because you said 50 million doses were enough for all those over 65, like they should be prioritized.

All health care workers have the chance to interact with COVID positive patients, not just those directly responsible for their care.  The point is to vaccinate them so they are available for care for all types of illness, not just COVID.  

[Ken the cruiser]

1 hour ago, cangelmd said:

I think they are working frantically on the data. They look at everything, not just the data, they go over the manufacturing processes, in this case probably the storage and shipping, recrunch the numbers, evaluate for different age groups.

 

If it makes you feel better, I work in healthcare and we have already ordered our first round of doses, through the public health department. They are proceeding in a very organized fashion, requiring hospitals to prove they have the capacity to store the vaccine correctly and have an admin plan so that no doses are wasted.

 

Moving to opinion, I think the hope at the health department is get healthcare workers, nursing home residents and staff, first responders and, yes, prisoners and people who work in prisons, all vaccinated with the Pfizer vaccine, with the idea that by then Moderna vaccine will be available and it can go out to the less defined and "controlled" groups in the community, probably through pharmacies. If for some reason the Moderna is significantly delayed, I think the backup plan may involved mass vaccinations with the help of the larger hospitals in cities, and the public health department focusing on rural areas and underserved areas - we have many counties with no hospital or no hospital that could manage the Pfizer vaccine. Drive through vaccination, just like the drive through testing - or more likely parking lot vaccines, so the driver can recover if necessary.

Makes a lot of sense, especially since the Moderna vaccine has a much lower cold storage requirement that Pfizer's and can be easily accommodated in more rural areas.

 

Moderna has said that its vaccine needs to be frozen too, but only at minus 20 Celsius, more like a regular freezer.

 

Why Moderna And Pfizer Vaccines Have Different Cold Storage Requirements : Shots - Health News : NPR

[K.T.B.]

16 minutes ago, markeb said:

 

Initial 100 million doses from Pfizer once approved or granted an EUA (probably already on hand). No additional doses until summer.

 

Yeah, MSNBC, which is where I got the info, was wrong when I posted that.  Stephanie Rhule just corrected that about 10 minutes ago.  

[Ken the cruiser]

Here's some more good news for those folks first in line to get the first dose of the Pfizer vaccine.

 

The Pfizer vaccine calls for two doses, three weeks apart. In November, Pfizer said early results from its Phase 3 clinical trials appeared to be 95 percent effective in preventing symptomatic Covid-19.

The new information shows it has benefits even after the first dose, with an effectiveness of more than 50 percent about a week later. What's more, the effectiveness seems to be the same across all age groups, racial and ethnic minorities, and people with underlying conditions, such as obesity, diabetes and high blood pressure.

 

FDA: Pfizer's Covid-19 vaccine safe and effective after one dose (nbcnews.com)

Edited December 8, 2020 by Ken the cruiser

[D C]

5 minutes ago, ECCruise said:

I only commented because you said 50 million doses were enough for all those over 65, like they should be prioritized.

All health care workers have the chance to interact with COVID positive patients, not just those directly responsible for their care.  The point is to vaccinate them so they are available for care for all types of illness, not just COVID.  

Healthcare workers don't all have an EQUAL chance of interacting with covid patients, and we are not at a point where there is a widespread shortage of healthcare workers due to them being ill with covid.   Thus the prioritization to those most critical to in a first wave.

 

1st goal: Stop people from dying

 

And yes, 50 million is enough for everyone over 65 in the USA.  The acceptance rate won't be 100%.  if we assume a very good 60% acceptance, that's 30 million for 65+ and 20 million doses for others.  Damn good start in my book. 

[mimbecky]

I also read about the US not purchasing more doses of Pfizer when we had the chance- damn shame that is for sure.  I can see the same happening with Moderna as we only purchased 100 million of those as well.  Looks like most of us will be getting AstraZeneca IF it is effective.  Not sure I like the chimpanzee thing but my thoughts aren't based in science.  Just seems a bit wiggy. 

 

Edited December 8, 2020 by mimbecky

[Crazy planning mom]

6 minutes ago, mimbecky said:

I also read about the US not purchasing more doses of Pfizer when we had the chance- damn shame that is for sure.  I can see the same happening with Moderna as we only purchased 100 million of those as well.  Looks like most of us will be getting AstraZeneca IF it is effective.  Not sure I like the chimpanzee thing but my thoughts aren't based in science.  Just seems a bit wiggy. 

 

 

[Crazy planning mom]

Just now, Crazy planning mom said:

 

Jim Cramer on CNBC is very positive on J & J.

 

https://www.cnbc.com/2020/12/08/coronavirus-live-updates.html