Vaccine distribution - Printable Version

Vaccine distribution - Printable Version

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RE: lex24 - Goose - 12-15-2020

(12-15-2020, 03:57 AM)Snorlax94 Wrote: Wow -- a miracle?? a Miracle??

Only one vaccine has been approved in the US, and that is Pfizer's, and "Pfizer did not accept federal funding to help develop or manufacture the vaccine, unlike front-runners Moderna and AstraZeneca...In an interview on Sunday, Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said, “We were never part of the Warp Speed,” adding, “we have never taken any money from the U.S. government, or from anyone.”" (NYTimes)

So how can Trump be responsible for this "miracle" if the Pfizer vaccine was not part of Warp Speed?

lex24 - lex24 - 12-15-2020

(12-15-2020, 09:36 AM)Goose Wrote: te="Snorlax94" pid='301356' dateline='1608029865']

Wow -- a miracle?? a Miracle??

Only one vaccine has been approved in the US, and that is Pfizer's, and "Pfizer did not accept federal funding to help develop or manufacture the vaccine, unlike front-runners Moderna and AstraZeneca...In an interview on Sunday, Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said, “We were never part of the Warp Speed,” adding, “we have never taken any money from the U.S. government, or from anyone.”" (NYTimes)

So how can Trump be responsible for this "miracle" if the Pfizer vaccine was not part of Warp Speed?

One think that did happen that many would regard as a "miracle" is that the FDA allowed the companies that were developing COVID-19 vaccines to submit their data packages piecemeal instead of as a single submission. This undoubtedly provided a significant speed-up in the time to deliver the EUA, probably two months or even more. That is a "big deal" IMHO. No question Pfizer benefited from this. Should Trump get credit for that? I suspect not, because that is really outside his job description, but it may be the FDA was predisposed to do this by executive influence.

Unlike many, I think the "credit" for the rapid development of the COVID-19 belongs almost entirely to industry. The state of the art had improved to the point faster development was possible. The governments of the world placing orders and paying "down payments" (in effect) to accomplish at-risk manufacturing was certainly useful too. Pfizer knew they were going to sell at least X million doses before they really had anything even close to ready. That makes investing heavily in a product a lot easier to justify. "The vaccine Viagra built."

Moderna and Lonza is a different case. Moderna probably didn't have the money to pay their CM. They probably needed Warp Speed money to have any hope of a scale-up and technology transfer happen.
[/quote]

THIS IS MY REPLY:

I guess I deleted too slowly. But as I didn’t; go back and look at what was being said in May. “Miracle” wasn’t my comment. It was an “expert” on CNN. The drumbeat at that time was that there was little to no chance of having a vaccine ready by end of year. And then the comment was - and furthermore we won’t trust it (that was VP elect Harris’s comment. Paraphrased.).

Snorlax, I wasn’t suggesting then or now that this gives the guy some sort of a pass for all his bad handling messaging etc. Just a thought that maybe, just maybe on this one he got it right by pushing the message forward. Trump was talking about a vaccine being ready by end of year a hell of a long time before anybody else was pushing it hard and getting lambasted for it. Just a campaign ploy..

OK he deserves getting lambasted in general because he lies for breakfast and for a host of other reasons. I certainly get that. But on this one it actually got done. So on that end I think he deserves some credit. That’s all I’m saying.

By the way I deleted the post because right after I posted, Trump came out with his “we’ve just begun to fight” comment after the electoral college voted. And frankly at that stage I didn’t want to say anything even remotely positive. Without violating Terry’s rule (oh what the hell you can violate Terrys rule when it comes to Trump, people do it all the time) what he’s doing now and what those Republicans that are following him are doing is beyond shameful.

RE: Vaccine distribution - BostonCard - 12-15-2020

Yes, Donald Trump does get credit for the speed of approval. In order to show efficacy of the vaccines, enough volunteers needed to get COVID-19 to make it possible to see a difference between placebo and vaccinated groups. Were it not for the surge in cases this fall, we would probably still be waiting for cases to accrue.

Seriously, though, the viral genome was available in January. The first patient was dosed with the Moderna vaccine March 16, 63 days from sequencing to phase 1 dosing. The phase 1 results were available in July, four months from the first patient being dosed; the first patient in the phase 2 trial was dosed in May (before the final phase 1 results were available). I can't find when the first phase 3 patient was enrolled in the trial, but the trial had accrued all 30,000 patients by October 22. The first interim result was announced Nov. 16, and the EUA will likely be granted this week.

I don't think people appreciate just how quickly that was done. Just to give you an idea, a typical FDA review takes six months from submission of the complete package of data, which itself takes about 6 months to generate from the end of a phase 3 trial. The fastest that a vaccine was developed from identification of the virus to approval before COVID-19 was 4 years (mumps). The general consensus (and I endorsed this consensus) was that the fastest it could be done, if everything broke correctly, was 12 - 18 months (with 18 being more realistic than 12). The combination of effort, luck, and yes, support from the administration, allowed this to happen in less than 11 months from sequence to EUA. Maybe he offered no value of a replacement President, and this was such a no-brainer that even Ted Cruz or Hillary Clinton, had either of them won in 2016, would have gotten us to a vaccine as fast or faster. Alas, neither of them are President, so we don't get to find out (but if they had been president and pursued the policies and gotten us the vaccine this fast, I would be offering them credit).

BC

RE: Vaccine distribution - Goose - 12-15-2020

(12-15-2020, 10:21 AM)BostonCard Wrote: I don't think people appreciate just how quickly that was done. Just to give you an idea, a typical FDA review takes six months from submission of the complete package of data, which itself takes about 6 months to generate from the end of a phase 3 trial.

IMHO this was the largest single contribution the Government made to expediting the vaccine. This is the one area where them "doing the right thing" was critical, and they did. However, I am not aware that POTUS had anything to do with the administrative decision to allow incremental submissions. If he did, isn't that undue interference in the FDA operations?

Quote:The fastest that a vaccine was developed from identification of the virus to approval before COVID-19 was 4 years (mumps). The general consensus (and I endorsed this consensus) was that the fastest it could be done, if everything broke correctly, was 12 - 18 months (with 18 being more realistic than 12). The combination of effort, luck, and yes, support from the administration, allowed this to happen in less than 11 months from sequence to EUA. Maybe he offered no value of a replacement President, and this was such a no-brainer that even Ted Cruz or Hillary Clinton, had either of them won in 2016, would have gotten us to a vaccine as fast or faster. Alas, neither of them are President, so we don't get to find out (but if they had been president and pursued the policies and gotten us the vaccine this fast, I would be offering them credit).

BC

I think this is a difference of emphasis. Doing something a "generic" president would probably have done is like a "meets" review. Is that "credit"? Probably a definition. Thus my comment about a LOM. You don't get a LOM for just doing your job. In the "Warp Speed" case, doing your job as POTUS is mostly not getting in the way IMHO.

RE: Vaccine distribution - Genuine Realist - 12-15-2020

(12-15-2020, 12:03 PM)Goose Wrote:
(12-15-2020, 10:21 AM)BostonCard Wrote: I don't think people appreciate just how quickly that was done. Just to give you an idea, a typical FDA review takes six months from submission of the complete package of data, which itself takes about 6 months to generate from the end of a phase 3 trial.
IMHO this was the largest single contribution the Government made to expediting the vaccine. This is the one area where them "doing the right thing" was critical, and they did. However, I am not aware that POTUS had anything to do with the administrative decision to allow incremental submissions. If he did, isn't that undue interference in the FDA operations?

Quote:The fastest that a vaccine was developed from identification of the virus to approval before COVID-19 was 4 years (mumps). The general consensus (and I endorsed this consensus) was that the fastest it could be done, if everything broke correctly, was 12 - 18 months (with 18 being more realistic than 12). The combination of effort, luck, and yes, support from the administration, allowed this to happen in less than 11 months from sequence to EUA. Maybe he offered no value of a replacement President, and this was such a no-brainer that even Ted Cruz or Hillary Clinton, had either of them won in 2016, would have gotten us to a vaccine as fast or faster. Alas, neither of them are President, so we don't get to find out (but if they had been president and pursued the policies and gotten us the vaccine this fast, I would be offering them credit).

BC
I think this is a difference of emphasis. Doing something a "generic" president would probably have done is like a "meets" review. Is that "credit"? Probably a definition. Thus my comment about a LOM. You don't get a LOM for just doing your job. In the "Warp Speed" case, doing your job as POTUS is mostly not getting in the way IMHO.

I repeat my thought that it is way too early to attempt to write history, or make judgments.

It happened while Trump was in office, and he clearly was invested to some degree in the effort. That's about it.

RE: Vaccine distribution - dabigv13 - 12-16-2020

Vaccinated. Currently being observed for 15 minutes to make sure no side effects.

It was the most painless vaccine I have received. Will update if I develop any side effects, though I typically have not had any with prior vaccinations so I don't expect much.

RE: Vaccine distribution - Snorlax94 - 12-16-2020

(12-16-2020, 01:44 PM)dabigv13 Wrote: Vaccinated. Currently being observed for 15 minutes to make sure no side effects.

It was the most painless vaccine I have received. Will update if I develop any side effects, though I typically have not had any with prior vaccinations so I don't expect much.

Cool, glad to hear you feel well.

Thank you for sharing your experience, please keep us posted.

RE: Vaccine distribution - BostonCard - 12-16-2020

(12-16-2020, 01:44 PM)dabigv13 Wrote: Vaccinated. Currently being observed for 15 minutes to make sure no side effects.

It was the most painless vaccine I have received. Will update if I develop any side effects, though I typically have not had any with prior vaccinations so I don't expect much.

Great to hear, and hope everything goes well. You should start having some degree of immunity in 10 days, but of course should wait until after the second shot to consider yourself immune (and of course, 95% is not 100% so you should continue to take common sense precautions).

Note that the pain during the injection depends on two things, the nurse's skill and the adjuvants used in the vaccine, not the vaccine itself.

BC

RE: Vaccine distribution - M T - 12-17-2020

This is the day that the Moderna vaccine was to be reviewed. Really? I've seen nothing about it. Guess it isn't news.

Here is the FDA's page of background materials on Moderna. The meeting is apparently in session, and you can tune into it from that page.

Moderna's package is here. The graph of effectiveness is on slide 27.

RE: Vaccine distribution - M T - 12-17-2020

I don't think this was mentioned here before...

As you know, the interval between the Pfizer doses is 21 days, while the interval between the Moderna doses is 28 days.

The question is, what if you don't get your 2nd dose on the appointed day?

OWS's Dr. Slaoui indicated that normally, the longer time between two doses, the better the effectiveness. However, the longer the time between them, the more likely that you might get the illness in that time.

So, if you are quarantining (for exposure, vs isolating for having COVID) when your 21 days is due for a 2nd Pfizer shot, my understanding is you probably are fine to wait until you can safely get your 2nd shot. (Always, talk to your physician for health advice)

I have not heard any official position on what to do about the 2nd dose if you get COVID after the 1st shot but before the 2nd shot. I expect that was covered in the FDA approval, and I'm sure your health agency will know what to do and will advise you.

RE: Vaccine distribution - Goose - 12-17-2020

(12-17-2020, 12:20 PM)M T Wrote: I don't think this was mentioned here before...

As you know, the interval between the Pfizer doses is 21 days, while the interval between the Moderna doses is 28 days.

The question is, what if you don't get your 2nd dose on the appointed day?

OWS's Dr. Slaoui indicated that normally, the longer time between two doses, the better the effectiveness. However, the longer the time between them, the more likely that you might get the illness in that time.

So, if you are quarantining (for exposure, vs isolating for having COVID) when your 21 days is due for a 2nd Pfizer shot, my understanding is you probably are fine to wait until you can safely get your 2nd shot. (Always, talk to your physician for health advice)

I have not heard any official position on what to do about the 2nd dose if you get COVID after the 1st shot but before the 2nd shot. I expect that was covered in the FDA approval, and I'm sure your health agency will know what to do and will advise you.

I don't think we know what the immunity profile is if the booster is given at different times, or if it is not given at all. There is evidence of immunity after 10 days from the Pfizer vaccine, but no profile after 21 days because everybody in the trial got a booster. No trial has been done with other delays AFAIK, and no trial has been done with no booster AFAIK. Will such trials happen? I doubt it in the short term and in the long term it may be impossible because there won't be enough disease.
The 300 lb gorilla is how long does immunity last with the 21 day booster? Naturally, we can't know yet. Hopefully at least a year, but we don't know.

RE: Vaccine distribution - M T - 12-17-2020

(12-17-2020, 12:35 PM)Goose Wrote:
(12-17-2020, 12:20 PM)M T Wrote: I don't think this was mentioned here before...

As you know, the interval between the Pfizer doses is 21 days, while the interval between the Moderna doses is 28 days.

The question is, what if you don't get your 2nd dose on the appointed day?

OWS's Dr. Slaoui indicated that normally, the longer time between two doses, the better the effectiveness. However, the longer the time between them, the more likely that you might get the illness in that time.

So, if you are quarantining (for exposure, vs isolating for having COVID) when your 21 days is due for a 2nd Pfizer shot, my understanding is you probably are fine to wait until you can safely get your 2nd shot. (Always, talk to your physician for health advice)

I have not heard any official position on what to do about the 2nd dose if you get COVID after the 1st shot but before the 2nd shot. I expect that was covered in the FDA approval, and I'm sure your health agency will know what to do and will advise you.
I don't think we know what the immunity profile is if the booster is given at different times, or if it is not given at all. There is evidence of immunity after 10 days from the Pfizer vaccine, but no profile after 21 days because everybody in the trial got a booster. No trial has been done with other delays AFAIK, and no trial has been done with no booster AFAIK. Will such trials happen? I doubt it in the short term and in the long term it may be impossible because there won't be enough disease.
The 300 lb gorilla is how long does immunity last with the 21 day booster? Naturally, we can't know yet. Hopefully at least a year, but we don't know.

Agree about the gorilla. However, neither Moderna nor Pfizer graphs seemed to have any more incidence in the vaccine group at the end of their trials than at the mid-point.

I just took a look at the Moderna numbers. About 8% (1100) of each of the placebo & real medicine groups did not get their 2nd dose. Maybe that was for cause, but maybe there is some hint of data there. (Actually, there are very weak numbers. Based on 2 cases in the vaccine group and 4 in the placebo group, the estimate of efficacy of 1 dose is 43%, but the 95%CI is -300% to 95%)

The Moderna numbers separate from the placebo at about 12-14 days after first dose.

I haven't looked at all the Moderna numbers, but the one that I'd like to understand better is one number among those that withdrew from the study. 17 withdrew from the vaccine group due to "physician decision" while only 2 withdrew for that reason from the placebo group.

RE: Vaccine distribution - BostonCard - 12-17-2020

The vaccine advisory council recommended approval of the Moderna vaccine for adults 18 and older.

https://www.vox.com/2020/12/17/22180356/moderna-covid-19-vaccine-approved-fda-emergency-use-pfizer

The vote was unanimous this time (with one abstention).

BC

RE: Vaccine distribution - dabigv13 - 12-17-2020

For those interested, 24 hours later only side effects are slight sore arm and a mild headache last night that resolved with a tylenol. Supposedly the 2nd dose you can get more side effects since the immune system is already primed from the first one.

For the second dose, I booked an appointment three weeks after the first one, but I could've scheduled up to 4 weeks later and they said it shouldn't be an issue.

RE: Vaccine distribution - dabigv13 - 12-20-2020

New CDC ACIP guidance on vaccine distribution. The new 1b designation now is for 75+, and "frontline" essential workers.

This is a change, previously 1b was all essential workers, and 1c was 65+.

[Image: Epsd-Mh-TXIAAgh-W.jpg]

I think this is a good change. A pure age based approach has a lot to recommend it- first, age is by far the biggest determinate of mortality from covid 19. With a limited resource, doing it like the UK, 85+, then 80+, then 75+, seems the quickest way to cut down deaths. Age is more difficult to fudge than a subjective measure of "essential" or "frontline", which as we saw at Stanford Hospital may not be applied in a way that seems fair.

But healthy older folks can also more likely sequester at home. Police, grocery store workers, teachers, etc. cannot, and are more likely to be further vectors of transmission. Cutting off the transmission chains could lead to a quicker end to the worst of the pandemic, and relieve stress on the healthcare system and allow a more functional society sooner. These workers are also more likely to be poorer and minorities, and spread it into their communities, which have born the worst of the pandemic by far.

I think these updates are a fair compromise. It still adds up to 49 million people, (and the lobbying to determine who is really frontline and essential will be intense), which will likely take a few months to vaccinate, but it would be a big big step forward I think if it can be accomplished.

Also note these are just guidelines. States will make their own plans. I would like to see California try to follow this closely though.

The whole CDC presentation is good to scroll through. Glad to see they are keeping to their lab lunch meeting/ morning resident didactics powerpoint aesthetic standard.

https://cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-20/02-COVID-Dooling.pdf…

RE: Vaccine distribution - BostonCard - 12-20-2020

(12-17-2020, 08:53 PM)dabigv13 Wrote: For those interested, 24 hours later only side effects are slight sore arm and a mild headache last night that resolved with a tylenol. Supposedly the 2nd dose you can get more side effects since the immune system is already primed from the first one.

For the second dose, I booked an appointment three weeks after the first one, but I could've scheduled up to 4 weeks later and they said it shouldn't be an issue.

Good to hear your experience (at least for the first dose) wasn't too bad.

On the priority list, there's a fair bit of debate as to whether it is better to vaccinate the people at highest risk for death or the people at highest risk for transmission. The logic for vaccinating the former is that by doing so you cut the morbidity and mortality of the virus the fastest. The logic for vaccinating the latter is that if you cut down transmissions it prevents not only the vaccinated from getting COVID-19, but also the the unvaccinated, by removing vectors for transmission. While this makes sense in theory, in practice it is hard to figure out who the transmission vectors are going to be reliably, so I think it makes the most sense just to vaccinate the highest risk people, at least early.

BC

RE: Vaccine distribution - chrisk - 12-20-2020

Enforcing the priorities on front-line workers will be an interesting challenge.

How do you flush out a Uber driver who drives a few hours a week when you have tens of millions 65+ waiting to be vaccinated?

lex24 - lex24 - 12-20-2020

(12-20-2020, 11:39 AM)BostonCard Wrote:
(12-17-2020, 08:53 PM)dabigv13 Wrote: For those interested, 24 hours later only side effects are slight sore arm and a mild headache last night that resolved with a tylenol. Supposedly the 2nd dose you can get more side effects since the immune system is already primed from the first one.

For the second dose, I booked an appointment three weeks after the first one, but I could've scheduled up to 4 weeks later and they said it shouldn't be an issue.

Good to hear your experience (at least for the first dose) wasn't too bad.

On the priority list, there's a fair bit of debate as to whether it is better to vaccinate the people at highest risk for death or the people at highest risk for transmission. The logic for vaccinating the former is that by doing so you cut the morbidity and mortality of the virus the fastest. The logic for vaccinating the latter is that if you cut down transmissions it prevents not only the vaccinated from getting COVID-19, but also the the unvaccinated, by removing vectors for transmission. While this makes sense in theory, in practice it is hard to figure out who the transmission vectors are going to be reliably, so I think it makes the most sense just to vaccinate the highest risk people, at least early.

BC

Haven’t read much on the debate. Tough call. When they were talking about this, my thought was that it makes more sense to vaccinate those with highest transmission rate first. Logically that seems the best way to slow the spread. But I wonder how much ICU rates played into this. I suspect that it is the elderly and those with comorbidities that are mostly ending up in the ICUs. If so, that provides another reason for vaccinating those with the higher morbidity rates first.

RE: Vaccine distribution - M T - 12-20-2020

(12-20-2020, 10:24 AM)dabigv13 Wrote: New CDC ACIP guidance on vaccine distribution. The new 1b designation now is for 75+, and "frontline" essential workers.

This is a change, previously 1b was all essential workers, and 1c was 65+.

slides
....

https://cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-20/02-COVID-Dooling.pdf…

Note that although the slide name includes "December 2020", the doses expected to be distributed in 2020 will not cover all of group 1a.

The 202M in 1a-c is more than the number of courses in the original 100M courses. But, another purchased 100M doses from Moderna will push us to 150M courses. We are still way short.

Curious that they didn't put population numbers for group 2.

I see no recommendation about seropositive people to be delayed until later.

The CDC recommendations leaves out caretakers (aides or family members who take care of high-risk individuals).
It includes teachers (4+M if only including K-12 teachers, =13.3% of 30M "frontline essential"), including those where school districts are closed, and includes 24yo teachers. It does not pay attention to the timing of any vaccination relative to their work year. (While the NASEM uses "K-12 teachers", the CDC uses "teachers", which I wonder if that will include Nick Saban and David Shaw.

The CDC recommendations are quite a bit different than the NASEM framework (slide 9).

The CDC "essential workers" listed here is not the same as "essential workers" earlier in the year. Maybe they will define it the same, but their examples are not inclusive. Note that the entire entertainment industry (including pro sports) is not included (nor was it in the US concept of essential industry).

The CDC's graph on p16 is, IMO, distorted because "all deaths" includes an extra 20% (Feb. & March) of months of all-cause deaths when there were almost no COVID deaths. It would look different if it was of, say, June to Dec. 16.

Slide 39 "Example of phase 1 ..." is distorted because (1) it uses doses rather than courses, (2) it estimates all 24M 1a plus many 1b are vaccinated within 6 weeks, when vaccination requires 2 doses 3 or 4 weeks apart. So, they require 48M doses before the first dose allocated for 1b. Even at their 10M doses/week, the chart doesn't properly show when those two doses are given.

These recommendations ignore which groups have any safety data of the vaccines (it includes pregnant females; 16-18yo; those who already had noticeable COVID).

RE: lex24 - chrisk - 12-20-2020

(12-20-2020, 03:39 PM)lex24 Wrote:
(12-20-2020, 11:39 AM)BostonCard Wrote:
(12-17-2020, 08:53 PM)dabigv13 Wrote: For those interested, 24 hours later only side effects are slight sore arm and a mild headache last night that resolved with a tylenol. Supposedly the 2nd dose you can get more side effects since the immune system is already primed from the first one.

For the second dose, I booked an appointment three weeks after the first one, but I could've scheduled up to 4 weeks later and they said it shouldn't be an issue.

Good to hear your experience (at least for the first dose) wasn't too bad.

On the priority list, there's a fair bit of debate as to whether it is better to vaccinate the people at highest risk for death or the people at highest risk for transmission. The logic for vaccinating the former is that by doing so you cut the morbidity and mortality of the virus the fastest. The logic for vaccinating the latter is that if you cut down transmissions it prevents not only the vaccinated from getting COVID-19, but also the the unvaccinated, by removing vectors for transmission. While this makes sense in theory, in practice it is hard to figure out who the transmission vectors are going to be reliably, so I think it makes the most sense just to vaccinate the highest risk people, at least early.

BC

Haven’t read much on the debate. Tough call. When they were talking about this, my thought was that it makes more sense to vaccinate those with highest transmission rate first. Logically that seems the best way to slow the spread. But I wonder how much ICU rates played into this. I suspect that it is the elderly and those with comorbidities that are mostly ending up in the ICUs. If so, that provides another reason for vaccinating those with the higher morbidity rates first.

There are more than 30 million aged 65-74. Putting them in the 3rd group makes the 2nd group more manageable and gets the most essential front-line workers vaccinated sooner. That should help with the reopening of the schools.