The Vaccine Thread

[JennyD]

I listened to some of the hearing today.  The audio cut out at one point.  "Pfizer?  Pfizer, we can't hear you.  Pfizer?  Pfizer?  [several garbled minutes]  Pfizer, please switch to your backup audio." 

It was the most 2020 thing ever.

 

[JennyD]

3 hours ago, Ausmumof3 said:

Disappointing 

The University of Queensland Vaccine trial has been abandoned after it caused people to return false positive results for HIV

https://www.abc.net.au/news/2020-12-11/uq-csl-coronavirus-vaccine-trial-to-be-abandoned/12973656

This is very disappointing.  From the NYT Vaccine Tracker:

According to early reports, the trouble appears to lie in the way the researchers designed the vaccine. If spike proteins are not anchored to a coronavirus, they can unfold. Antibodies to the unfolded spike protein may not work against folded proteins on real viruses. So the researchers made a small change to the protein, creating a little clamp at one end to hold the molecule in its proper shape. Unfortunately, the clamp is similar to a protein on HIV, which can lead the immune system to make HIV-like antibodies. People who volunteered for the vaccine trial tested positive on HIV antibody tests, even though they were perfectly healthy. 

[Ausmumof3]

Just now, JennyD said:

This is very disappointing.  From the NYT Vaccine Tracker:

According to early reports, the trouble appears to lie in the way the researchers designed the vaccine. If spike proteins are not anchored to a coronavirus, they can unfold. Antibodies to the unfolded spike protein may not work against folded proteins on real viruses. So the researchers made a small change to the protein, creating a little clamp at one end to hold the molecule in its proper shape. Unfortunately, the clamp is similar to a protein on HIV, which can lead the immune system to make HIV-like antibodies. People who volunteered for the vaccine trial tested positive on HIV antibody tests, even though they were perfectly healthy. 

Yes so disappointing for the researchers and people who had volunteered for the testing.  It’s not anything real wrong with vaccine in itself but obviously not being able to reliably test for HIV is not good.

[JennyD]

1 minute ago, Ausmumof3 said:

Yes so disappointing for the researchers and people who had volunteered for the testing.  It’s not anything real wrong with vaccine in itself but obviously not being able to reliably test for HIV is not good.

I wonder how long the trial participants will test positive for HIV?  Hopefully they'll keep tracking them even though the vaccine has been abandoned.

[Ausmumof3]

“Key exclusion criteria included a medical history of Covid-19, treatment with immunosuppressive therapy, or diagnosis with an immunocompromising condition.“

 

from the Nejm article.  I have only skim read but don’t see any mention of the exclusion of people with severe allergies unless that comes under the umbrella of immunocompromising condition somehow.

I also don’t see the mention of Bells Palsy (4 cases mentioned in the FDA report) or appendicitis (higher rates in the vaccine group although very unlikely to be related to the vaccine). 
 

overall though it sounds really good!

[Ausmumof3]

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext
 

official study from Astra Zeneca as well.

one other potential problem mentioned on Coronacast is that if the half dose whole dose issue relates to people developing antibodies against the adenovirus not the covid spike booster shots might not be effective if they are required in a year or two.  

 

[BeachGal]

22 hours ago, Corraleno said:

Yes, legally they can be vaccinated regardless of immigration status. This page happens to be written by lawyers in Texas, but most of the info would be equally applicable in any state.

https://texaslawhelp.org/article/immigrant-rights-and-healthcare-access-during-covid-19

However, one of the major concerns about the vaccine database developed by the current administration is that the information collected (name, address, birthdate, and ethnicity) may be shared with ICE, so I would encourage any undocumented person who wants to be vaccinated to (1) find out of their state is sharing this data with the federal government (some states say they will not comply) and if so, (2) perhaps seek legal advice regarding the accuracy of the information they choose to provide when they are vaccinated.

Thank you. Yes, I believe he’s worried about supplying information about himself for that reason. He has two young kids here who are US citizens but he is not. 

[Laura Corin]

Lack of staff and vaccination.  This is sure to be an issue elsewhere,  particularly in places that are struggling to deal with virus peaks at the same time

https://www.theguardian.com/society/2020/dec/11/gp-practices-england-opt-out-covid-vaccine-rollout?CMP=Share_AndroidApp_Other

[Ausmumof3]

Astra Zeneca are going to trial combining their vaccine with the Russian Sputnik V vaccine for the second dose.  Both use adenovirus vectors and its thought by using vaccines with different adenoviruses for the second round it will get around the problem where the body forms antibodies against the adenovirus and so doesn’t get the covid spike immunity from the second dose.

https://www.businessinsider.com.au/astrazeneca-oxford-vaccine-russia-sputnik-combined-shot-2020-12?amp&r=US&IR=T

[Ausmumof3]

1 minute ago, Laura Corin said:

Lack of staff and vaccination.  This is sure to be an issue elsewhere,  particularly in places that are struggling to deal with virus peaks at the same time

https://www.theguardian.com/society/2020/dec/11/gp-practices-england-opt-out-covid-vaccine-rollout?CMP=Share_AndroidApp_Other

How many GPs would have the required freezer storage facilities?  Or would that be less important provided they got stocks daily?  But yes staffing will be a problem.  I believe we have some training going on to try to deal with that.  Will see what I can find tomorrow.

In Aus we have a lot of immunisation clinics.  One is next to our local library.  I wonder how common that approach to immunisation is in other countries.  (It’s within a couple of minutes of a major hospital).

[vonfirmath]

35 minutes ago, Ausmumof3 said:

How many GPs would have the required freezer storage facilities?  Or would that be less important provided they got stocks daily?  But yes staffing will be a problem.  I believe we have some training going on to try to deal with that.  Will see what I can find tomorrow.

In Aus we have a lot of immunisation clinics.  One is next to our local library.  I wonder how common that approach to immunisation is in other countries.  (It’s within a couple of minutes of a major hospital).

 

HEB, our local grocery store that has already shone in pandemic planning and overcoming logistical challenges, has announced they will be part of distributing the vaccine.

https://www.msn.com/en-us/news/us/once-available-h-e-b-will-join-other-health-systems-in-distributing-covid-19-vaccine/ar-BB1bDuBm

[TravelingChris]

39 minutes ago, Ausmumof3 said:

How many GPs would have the required freezer storage facilities?  Or would that be less important provided they got stocks daily?  But yes staffing will be a problem.  I believe we have some training going on to try to deal with that.  Will see what I can find tomorrow.

In Aus we have a lot of immunisation clinics.  One is next to our local library.  I wonder how common that approach to immunisation is in other countries.  (It’s within a couple of minutes of a major hospital).

I believe I read that the vaccine can be out of the super cold freezer for a day or so.  It would have to unfreeze after all to go into our bodies.

As to the immunization clinics-in the US, most people get immunizations at pharmacies.  And in most parts of the US, there are a lot of pharmacies.  We also have various public health clinics- I know that before school starts, there are some vaccination clinics set up.  Plus doctors often have them too.

When I got sick in Canada (pneumonia),  I had to go to a stand alone medical practice that took private patients since I am not Canadian and not in their medical system.  We were in Toronto and the clinic I went to was primarily set up for people to get immunizations (which they had to pay for - I think these may have been things like yellow fever, etc for travel or special purposes which is why they weren't covered but I am really not sure).

[Not_a_Number]

47 minutes ago, vonfirmath said:

 

HEB, our local grocery store that has already shone in pandemic planning and overcoming logistical challenges, has announced they will be part of distributing the vaccine.

https://www.msn.com/en-us/news/us/once-available-h-e-b-will-join-other-health-systems-in-distributing-covid-19-vaccine/ar-BB1bDuBm

I do like HEB...

[Pen]

3 hours ago, Ausmumof3 said:

How many GPs would have the required freezer storage facilities?  Or would that be less important provided they got stocks daily?  But yes staffing will be a problem.  I believe we have some training going on to try to deal with that.  Will see what I can find tomorrow.

In Aus we have a lot of immunisation clinics.  One is next to our local library.  I wonder how common that approach to immunisation is in other countries.  (It’s within a couple of minutes of a major hospital).

I haven’t encountered immunization clinics like that in countries I have lived in - but perhaps they were there and I did not know since I wasn’t at that life stage.

I think the type vacccine needing super cold freezing is likely to be most useful in dense population urban areas where there are facilities that can do that and where lots of people can get to such a facility.

I have heard that NYC is likely to get it first in US which, if true, makes some sense as it should have lots of people who can get to where ever they decide to do the vaccinations — and also facilities that could manage the freezing. 
 

It also makes sense in terms of dense population urban centers allowing for rapid spread.  
 

 

 

[Pawz4me]

3 hours ago, Ausmumof3 said:

How many GPs would have the required freezer storage facilities?  Or would that be less important provided they got stocks daily?  But yes staffing will be a problem.  I believe we have some training going on to try to deal with that.  Will see what I can find tomorrow.

In Aus we have a lot of immunisation clinics.  One is next to our local library.  I wonder how common that approach to immunisation is in other countries.  (It’s within a couple of minutes of a major hospital).

The Pfizer vaccine vials can be kept at regular refrigerator temperatures for five days. I would think that most primary care providers and pharmacies have refrigerators, since quite a few common medications need to be kept cold.

[JennyD]

2 hours ago, Pen said:

I have heard that NYC is likely to get it first in US

I think it's supposed to be shipped everywhere at once -- states, territories, and a few federal agencies like the VA and the Bureau of Prisons.  I saw a detailed chart somewhere about all of this but of course have no recollection of where I saw it.   Then, of course, the states decide how to allocate it among population centers.

I listened to a very interesting interview last week with someone from CVS about vaccine distribution.  The plan, at least, is for a lot of us to ultimately get our vaccines at chain pharmacies.

Edited December 11, 2020 by JennyD

[TravelingChris]

I  have to say that I am super frustrated by the FDA and it's bureaucracy.  Why can't we move as fast as Canada and UK?  I was already frustrated that the panel was delayed so long but what in the world is the hold up now? Approve it!!!!! The panel voted and said it was fine.  Let's go!!!!!

And the Moderna vaccine is having its panel hearing next week,

[Not_a_Number]

3 minutes ago, TravelingChris said:

I  have to say that I am super frustrated by the FDA and it's bureaucracy.  Why can't we move as fast as Canada and UK?  I was already frustrated that the panel was delayed so long but what in the world is the hold up now? Approve it!!!!! The panel voted and said it was fine.  Let's go!!!!!

And the Moderna vaccine is having its panel hearing next week,

The conservative approach does have benefits if you're worried about side effects (as we all should be.) See thalidomide... 

I do hope it'll get approved soon, though. 

[Dmmetler]

27 minutes ago, JennyD said:

I think it's supposed to be shipped everywhere at once -- states, territories, and a few federal agencies like the VA and the Bureau of Prisons.  I saw a detailed chart somewhere about all of this but of course have no recollection of where I saw it.   Then, of course, the states decide how to allocate it among population centers.

I listened to a very interesting interview last week with someone from CVS about vaccine distribution.  The plan, at least, is for a lot of us to ultimately get our vaccines at chain pharmacies.

CVS here has what looks like a refrigerated trailer (the kind semis pull) parked outside and has for several days. I’m wondering if they’re doing tests to see how cold it can get. (They also are set up for drive through COVID tests, and do both rapid and PCR). 

[wathe]

Some frontline HCW and longterm care staff in Toronto and Ottawa will be getting theirs on Tuesday!  I shall have to wait a little longer, but probably only a matter of a few weeks, maybe less.

 

[Pen]

43 minutes ago, JennyD said:

I think it's supposed to be shipped everywhere at once -- states, territories, and a few federal agencies like the VA and the Bureau of Prisons.  I saw a detailed chart somewhere about all of this but of course have no recollection of where I saw it.   Then, of course, the states decide how to allocate it among population centers.

I listened to a very interesting interview last week with someone from CVS about vaccine distribution.  The plan, at least, is for a lot of us to ultimately get our vaccines at chain pharmacies.

could be

there was a press briefing recently which I did not watch

I figure I am in this group and so not much for me personally to get on top of currently:

 

“What about people not in any of those groups?

The reality is that you should expect to wait. The top US infectious disease expert, Dr. Anthony Fauci, told Good Morning America in November that he expects "the ordinary citizen" should be able to get a vaccine by April, May or June 2021.

“

[RootAnn]

I saw two signs on the front doors of a Walgreens (pharmacy/store like CVS) today. One said, "We don't do Covid tests at this location." The other said, "No vaccines available yet." So they must already be getting lots of questions about vaccinations.

[TravelingChris]

1 hour ago, Not_a_Number said:

The conservative approach does have benefits if you're worried about side effects (as we all should be.) See thalidomide... 

I do hope it'll get approved soon, though. 

But they aren't holding it up to see what is happening in Britain and Canada and I have no idea how drugs were tested or approved in the late 50s.  

As it is, with many drugs currently on the market, they found very harmful side effects after they were approved.  One group of DMARDS for rheumatological diseases, for example, was found to cause blood clots but not in the initial testing- which most likely was a similar number to the vaccine testing. Now there is a warning about it and I am always warning people on Facebook not to take it if anyone in their family has had a blood clot..

An antibiotic that was around for decades was found to cause heart problems and particularly if used in conjunction with some other drugs and that wasn't found until 10 years after my sister died of a heart attack. There are now warnings about that too.

A lot of times, since the side effect is quite rare, it doesn't appear until tens of thousands or hundreds of thousands or even millions have taken something.  There still are no warnings about calcium channel blockers even though if you have a certain gene, your blood pressure will go up instead of down when you take one that is used for bp.  Or another weird thing that also happened to me with calcium channel blockers and not listed on side effects was lactation.  

All medications and vaccines come with some risk.  I happen to think that the risk of COVID is worse.  And the reason I really want them to be rolling out the vaccine is because of what is happening in the hospitals- they are having to try to get retired staff to return, people are working crazy hours per week, etc.  

[Not_a_Number]

1 hour ago, wathe said:

Some frontline HCW and longterm care staff in Toronto and Ottawa will be getting theirs on Tuesday!  I shall have to wait a little longer, but probably only a matter of a few weeks, maybe less.

 

Yay!!

[Not_a_Number]

Just now, TravelingChris said:

But they aren't holding it up to see what is happening in Britain and Canada and I have no idea how drugs were tested or approved in the late 50s.  

Are they reviewing the data? What are they doing?

[JennyD]

1 hour ago, Dmmetler said:

CVS here has what looks like a refrigerated trailer (the kind semis pull) parked outside and has for several days. I’m wondering if they’re doing tests to see how cold it can get. (They also are set up for drive through COVID tests, and do both rapid and PCR). 

You're in TN, right?  I am as well, and TN is one of the 'dry run' states, so I bet you're right.

[Ausmumof3]

https://www.statnews.com/2020/12/02/how-society-can-make-the-most-of-covid-19-vaccines/?utm_content=buffer46024&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic
 

This is a good explanation of what some of the delays may be.

[Ausmumof3]

4 minutes ago, Not_a_Number said:

Are they reviewing the data? What are they doing?

The article I linked suggested the idea is to have a massive extremely fast roll out of the first round, in about 48 hours.  They might be delaying a bit to get the logistics in place for that?

I also have to admit I wonder if they’re trying to slow up the Pfizer slightly so the Moderna vax is ready to go soon after.

[Corraleno]

2 hours ago, TravelingChris said:

I  have to say that I am super frustrated by the FDA and it's bureaucracy.  Why can't we move as fast as Canada and UK?  I was already frustrated that the panel was delayed so long but what in the world is the hold up now? Approve it!!!!! The panel voted and said it was fine.  Let's go!!!!!

Granting an Emergency Use Authorization for a brand new vaccine that has not gone through the full normal approval process should be more than just a rubber stamp of the manufacturer's data. There are 20 people on the FDA's Vaccines and Related Biological Products Advisory Committee, and they need to coordinate the schedules of all those people, plus the relevant people from Pfizer, so they can not only meet (virtually in this case) to question the manufacturer, but also telecast that meeting to the American public. The committee raised some significant questions that I would absolutely want answered before an EUA was granted 

The primary objection of the committee (four of whom voted against authorization) had to so with approving the vaccine for 16 & 17 year olds, as several members felt that Pfizer did not have enough data in that age group — only 153 out of 44,000 participants. They urged the FDA to only authorize it for ages 18 and up, not 16 and up as requested by Pfizer. So that may be one issue that the FDA is debating before granting full approval. Other issues the FDA are looking at are safety concerns for pregnant and nursing mothers and those with a history of severe allergic reactions; they may be deciding exactly how the EUA should be worded with respect to those issues.

Another concern that was raised by multiple committee members was what to do about participants in the placebo group. Some members wanted the study to continue and to remain blinded as long as possible in order to gather more data, but others, including Pfizer, felt that it would be unethical to insist that the "brave volunteers" who agreed to participate in the study should be forced to remain at higher risk by not getting the vaccine. They also argued that many participants who suspected they were in the placebo group would get vaccinated once it was available to them, which would invalidate the study data anyway. One member suggested that all 44,000 participants should get two more shots, with the vaccine group getting a placebo and the placebo group getting the vaccine, but Pfizer said that was not logistically feasible. 

So there really are significant issues that need to be discussed and hammered out, and it's not a matter of just saying "94% efficacy looks great, let the vacinations commence." I have no idea how many people are involved in the approval process in the UK or Canada, but I don't think a delay of a few days is an unreasonable price to pay for the increased transparency of the process, including public broadcasting of the entire meeting of the advisory committee. In a country with a huge number of antivaxxers spreading lies and misinformation, that level of transparency is probably a necessity — at least no one can claim that the vaccine was approved in secret by Deep State operatives paid off by Big Pharma and Bill Gates.

[Dmmetler]

2 hours ago, JennyD said:

You're in TN, right?  I am as well, and TN is one of the 'dry run' states, so I bet you're right.

Not only that, Pfizer has a facility here, so even if they aren't manufacturing the vaccine, it would make sense for us to be one of the places they're going to test distribution. 

[TravelingChris]

25 minutes ago, Corraleno said:

Granting an Emergency Use Authorization for a brand new vaccine that has not gone through the full normal approval process should be more than just a rubber stamp of the manufacturer's data. There are 20 people on the FDA's Vaccines and Related Biological Products Advisory Committee, and they need to coordinate the schedules of all those people, plus the relevant people from Pfizer, so they can not only meet (virtually in this case) to question the manufacturer, but also telecast that meeting to the American public. The committee raised some significant questions that I would absolutely want answered before an EUA was granted 

The primary objection of the committee (four of whom voted against authorization) had to so with approving the vaccine for 16 & 17 year olds, as several members felt that Pfizer did not have enough data in that age group — only 153 out of 44,000 participants. They urged the FDA to only authorize it for ages 18 and up, not 16 and up as requested by Pfizer. So that may be one issue that the FDA is debating before granting full approval. Other issues the FDA are looking at are safety concerns for pregnant and nursing mothers and those with a history of severe allergic reactions; they may be deciding exactly how the EUA should be worded with respect to those issues.

Another concern that was raised by multiple committee members was what to do about participants in the placebo group. Some members wanted the study to continue and to remain blinded as long as possible in order to gather more data, but others, including Pfizer, felt that it would be unethical to insist that the "brave volunteers" who agreed to participate in the study should be forced to remain at higher risk by not getting the vaccine. They also argued that many participants who suspected they were in the placebo group would get vaccinated once it was available to them, which would invalidate the study data anyway. One member suggested that all 44,000 participants should get two more shots, with the vaccine group getting a placebo and the placebo group getting the vaccine, but Pfizer said that was not logistically feasible. 

So there really are significant issues that need to be discussed and hammered out, and it's not a matter of just saying "94% efficacy looks great, let the vacinations commence." I have no idea how many people are involved in the approval process in the UK or Canada, but I don't think a delay of a few days is an unreasonable price to pay for the increased transparency of the process, including public broadcasting of the entire meeting of the advisory committee. In a country with a huge number of antivaxxers spreading lies and misinformation, that level of transparency is probably a necessity — at least no one can claim that the vaccine was approved in secret by Deep State operatives paid off by Big Pharma and Bill Gates.

Yes, I know but actually all those issues should have been hammered out today.   I think AusMom may be onto something that they don't want Pizer to be way ahead of the game of Moderna.  

The severe allergies could be easily dealt with by recommending that people with severe allergies pre-dose with Benadryl and also get their shot in a doctor's office, clinic or hospital where there are medical personnel who can deal with any anyphalcoid reaction.

Since 16 and 17 year olds won't be vaccinated until at least the health care workers and front line responders are vaccinated, there is a few months time when we can decide on their vaccinations.  Also I think since the 16 and 17 year olds are getting as sick as the 18year olds, and in almost all cases, except where weight is concerned and drugs are given by weight, 16 and 17 year olds get adult doses.

[Corraleno]

45 minutes ago, TravelingChris said:

Yes, I know but actually all those issues should have been hammered out today.   I think AusMom may be onto something that they don't want Pizer to be way ahead of the game of Moderna.  

The severe allergies could be easily dealt with by recommending that people with severe allergies pre-dose with Benadryl and also get their shot in a doctor's office, clinic or hospital where there are medical personnel who can deal with any anyphalcoid reaction.

Since 16 and 17 year olds won't be vaccinated until at least the health care workers and front line responders are vaccinated, there is a few months time when we can decide on their vaccinations.  Also I think since the 16 and 17 year olds are getting as sick as the 18year olds, and in almost all cases, except where weight is concerned and drugs are given by weight, 16 and 17 year olds get adult doses.

But the EUA has to specify whether the vaccine is authorized for 16 & 17 year olds or not —  even if the FDA chooses to revise that later, they still have to make a decision one way or the other, right now, before they can issue the EUA. And the advisory board did not agree on the recommendation, and several voted against approval of the EUA as written because of those objections.

So does the FDA err on the side of caution and only authorize it for ages 18 and up, or do they give Pfizer what they want over the objections of multiple scientific and medical experts on the advisory board? If they don't authorize it for 16 & 17 year olds, does that mean Pfizer has to resubmit the EUA? The issue is further complicated by the fact that Moderna is not asking for authorization for under-18s, they are doing a separate trial for ages 12-18. So should Pfizer's vaccine  be approved for 16 & 17 yr olds, despite the fact that Pfizer provided virtually no data on this age group, while Moderna's is only authorized for 18 & up?

I don't understand what anyone thinks the FDA would get from purposely delaying approval of Pfizer's vaccine until Moderna's is approved. How does that benefit the FDA? How would it benefit anyone in either the current administration or the incoming administration to delay vaccine distribution? Do people think Moderna is bribing people in the FDA?

[TravelingChris]

21 minutes ago, Corraleno said:

But the EUA has to specify whether the vaccine is authorized for 16 & 17 year olds or not —  even if the FDA chooses to revise that later, they still have to make a decision one way or the other, right now, before they can issue the EUA. And the advisory board did not agree on the recommendation, and several voted against approval of the EUA as written because of those objections.

So does the FDA err on the side of caution and only authorize it for ages 18 and up, or do they give Pfizer what they want over the objections of multiple scientific and medical experts on the advisory board? If they don't authorize it for 16 & 17 year olds, does that mean Pfizer has to resubmit the EUA? The issue is further complicated by the fact that Moderna is not asking for authorization for under-18s, they are doing a separate trial for ages 12-18. So should Pfizer's vaccine  be approved for 16 & 17 yr olds, despite the fact that Pfizer provided virtually no data on this age group, while Moderna's is only authorized for 18 & up?

I don't understand what anyone thinks the FDA would get from purposely delaying approval of Pfizer's vaccine until Moderna's is approved. How does that benefit the FDA? How would it benefit anyone in either the current administration or the incoming administration to delay vaccine distribution? Do people think Moderna is bribing people in the FDA?

No.  But Moderna was developed with Govt Money and Pfizer was not.  And I have no objections at all if they say 18+ and tell Pfizer to also do a study with 12-17. But the latest news is that they have already decided to approve it and first shots should be Monday.

[Not_a_Number]

2 minutes ago, TravelingChris said:

No.  But Moderna was developed with Govt Money and Pfizer was not. 

And does the panel of people approving this actually benefit from Moderna being first or not? I really have no idea what's happening inside the bureaucracy, but you'd have to show that this is plausibly affecting the process. 

Edited December 12, 2020 by Not_a_Number

[Not_a_Number]

2 hours ago, Corraleno said:

Granting an Emergency Use Authorization for a brand new vaccine that has not gone through the full normal approval process should be more than just a rubber stamp of the manufacturer's data. There are 20 people on the FDA's Vaccines and Related Biological Products Advisory Committee, and they need to coordinate the schedules of all those people, plus the relevant people from Pfizer, so they can not only meet (virtually in this case) to question the manufacturer, but also telecast that meeting to the American public. The committee raised some significant questions that I would absolutely want answered before an EUA was granted 

The primary objection of the committee (four of whom voted against authorization) had to so with approving the vaccine for 16 & 17 year olds, as several members felt that Pfizer did not have enough data in that age group — only 153 out of 44,000 participants. They urged the FDA to only authorize it for ages 18 and up, not 16 and up as requested by Pfizer. So that may be one issue that the FDA is debating before granting full approval. Other issues the FDA are looking at are safety concerns for pregnant and nursing mothers and those with a history of severe allergic reactions; they may be deciding exactly how the EUA should be worded with respect to those issues.

Another concern that was raised by multiple committee members was what to do about participants in the placebo group. Some members wanted the study to continue and to remain blinded as long as possible in order to gather more data, but others, including Pfizer, felt that it would be unethical to insist that the "brave volunteers" who agreed to participate in the study should be forced to remain at higher risk by not getting the vaccine. They also argued that many participants who suspected they were in the placebo group would get vaccinated once it was available to them, which would invalidate the study data anyway. One member suggested that all 44,000 participants should get two more shots, with the vaccine group getting a placebo and the placebo group getting the vaccine, but Pfizer said that was not logistically feasible. 

So there really are significant issues that need to be discussed and hammered out, and it's not a matter of just saying "94% efficacy looks great, let the vacinations commence." I have no idea how many people are involved in the approval process in the UK or Canada, but I don't think a delay of a few days is an unreasonable price to pay for the increased transparency of the process, including public broadcasting of the entire meeting of the advisory committee.

Thanks, Corraleno. I didn't see your comment before posting right above, but I really appreciate the detailed breakdown. 

 

Quote

In a country with a huge number of antivaxxers spreading lies and misinformation, that level of transparency is probably a necessity — at least no one can claim that the vaccine was approved in secret by Deep State operatives paid off by Big Pharma and Bill Gates.

No one SHOULD claim, you mean, lol. Of course they'll claim it anyway... 

Edited December 12, 2020 by Not_a_Number

[TravelingChris]

15 minutes ago, Not_a_Number said:

And does the panel of people approving this actually benefit from Moderna being first or not? I really have no idea what's happening inside the bureaucracy, but you'd have to show that this is plausibly affecting the process. 

I am not saying that they are holding up Pfizer to make Moderna first.  But maybe because Pfizer had manufacturing problems which caused them to be able to deliver only half what they expected,, maybe they know in order to vaccinate the front liners and emergency workers that they really need to have both done fast and close together--- as Corraleno mentioned about the having a truly public hearing on the vaccine was also a nod to try to mitigate the anti-vaccer complaints-well having a good supply of vaccines (both of them) to start vaccinating all the health staff at these hospitals and all the emergency responders who are picking up the sick COVID people may be part of their thinking.  

[catz]

I was wondering what was going on behind the scenes with coolers and distribution mechanisms.  Plenty of moving parts involved and this administration hasn't always been the most prepared and forward thinking as things come down the line.  

I have a friend in HC that was told by her employer to expect to have the opportunity to be vaccinated before the year is out.  

[Ausmumof3]

1 hour ago, Not_a_Number said:

And does the panel of people approving this actually benefit from Moderna being first or not? I really have no idea what's happening inside the bureaucracy, but you'd have to show that this is plausibly affecting the process. 

There’s some legitimate reasons to want them to roll out at a similar time.  People are less likely to sign up for a trial where they may get a placebo if they know they can get a working vaccine.  People can opt out of existing trials to seek the working vaccine.  I think the trial for moderna vaccine is probably past the stage where that’s an issue.

 

Theres also drawbacks to a vaccine being rolled out in a very staggered way (more potential for the virus to evolve around the vaccine and become resistant.  The possibility that if they vaccine only prevents not disease and you vaccinate aged care and health care workers before you do their patients there’s the risk they become super spreaders).  
 

[Ausmumof3]

https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19
 

looks like it’s official?  

[TravelingChris]

Yes it is .  YEAH

[Shoeless]

Thank God. I really want this mess to end so I can hug my people again. 

[mom2scouts]

3 hours ago, TravelingChris said:

No.  But Moderna was developed with Govt Money and Pfizer was not.  And I have no objections at all if they say 18+ and tell Pfizer to also do a study with 12-17. But the latest news is that they have already decided to approve it and first shots should be Monday.

Pfizer is already starting a study with 12-17 year olds. The son who was in the trial asked if his little sister wanted to participate because they are looking for more participants in the 12-17 age group. I would really like to find out if my son got the vaccine or not.

[Corraleno]

I'm disappointed that that they approved it for "16 & older," given that Pfizer provided so little data on that age group. I hope it doesn't set a precedent for future approval of vaccines and medical treatments in minors when only one-third of one-percent of study participants were under 18. According to Pfizer's own website, they only have 366 12-15 year olds enrolled in the current children's study, so I hope that is only a preliminary number and not the number they feel is adequate for demonstrating safety and efficacy in children.

I'm also somewhat concerned that the EUA does not include any restrictions or even recommendations regarding use in pregnant and nursing women, despite the fact that Pfizer has not even completed animal studies on that yet. 

But yay for HCWs and the elderly being able to get vaccines next week (in theory anyway).

ETA: You can read the full letter of authorization here.

Edited December 12, 2020 by Corraleno

[TravelingChris]

19 minutes ago, Corraleno said:

I'm disappointed that that they approved it for "16 & older," given that Pfizer provided so little data on that age group. I hope it doesn't set a precedent for future approval of vaccines and medical treatments in minors when only one-third of one-percent of study participants were under 18. According to Pfizer's own website, they only have 366 12-15 year olds enrolled in the current children's study, so I hope that is only a preliminary number and not the number they feel is adequate for demonstrating safety and efficacy in children.

I'm also somewhat concerned that the EUA does not include any restrictions or even recommendations regarding use in pregnant and nursing women, despite the fact that Pfizer has not even completed animal studies on that yet. 

But yay for HCWs and the elderly being able to get vaccines next week (in theory anyway).

ETA: You can read the full letter of authorization here.

Elderly are not getting it.  We won't even be getting enough to cover all the HCW and the emergency people at first.

Because if just general elderly were getting it, I would be getting it.  General elderly are down the line.  It is HCW and emergency responders, then elderly assistance places and nursery places, and then it is third group is elderly and high risk people, then it is 18-30 yo, and then the last group is the 31-to whatever age they cut off for elderly and who didn't have risk factors.  Since they decided to let 16 and 17 year olds get it- I suppose they will be in the young and stupid group (they get it before older but not elderld and not high risk because they are the main spreaders of COVID>

[mathnerd]

1 hour ago, TravelingChris said:

Elderly are not getting it.  We won't even be getting enough to cover all the HCW and the emergency people at first.

Because if just general elderly were getting it, I would be getting it.  General elderly are down the line.  It is HCW and emergency responders, then elderly assistance places and nursery places, and then it is third group is elderly and high risk people, then it is 18-30 yo, and then the last group is the 31-to whatever age they cut off for elderly and who didn't have risk factors.  Since they decided to let 16 and 17 year olds get it- I suppose they will be in the young and stupid group (they get it before older but not elderld and not high risk because they are the main spreaders of COVID>

I read an article a little while ago where the author was musing if the "social butterflies" should be the first to get the vaccine as that would take care of the main spreaders of covid. If I find the link, I will come back and post it here.

ETA: Found it:

Who gets priority when Covid-19 shots are in short supply? Network theorists have a counterintuitive answer: Start with the social butterflies.

https://www.wired.com/story/covid-19-vaccine-super-spreaders/?utm_source=twitter&utm_medium=social&utm_brand=wired&utm_social-type=owned

Edited December 12, 2020 by mathnerd

[Corraleno]

28 minutes ago, TravelingChris said:

Elderly are not getting it.  We won't even be getting enough to cover all the HCW and the emergency people at first.

Because if just general elderly were getting it, I would be getting it.  General elderly are down the line.  It is HCW and emergency responders, then elderly assistance places and nursery places, and then it is third group is elderly and high risk people, then it is 18-30 yo, and then the last group is the 31-to whatever age they cut off for elderly and who didn't have risk factors.  Since they decided to let 16 and 17 year olds get it- I suppose they will be in the young and stupid group (they get it before older but not elderld and not high risk because they are the main spreaders of COVID>

I don't know about Alabama, but more than 10,000 elderly nursing home residents in Oregon will be among the first in the state to receive the vaccine next week. That is in line with CDC recommendations that list front-line HCWs and nursing home residents as equal priority in Phase 1a. 

I can't find anything on the CDC website that says 18-30 year olds should get higher priority than 55-64 year olds — do you have a link for that? Given that the Pfizer and Moderna vaccines provoked a strong immune response in older people, which is unusual for a vaccine, combined with the fact that the US only ordered enough of those vaccines for less than a third of the population, I hope they don't "spend" those vaccines on 18-30 yr olds while 55-64 year olds, whose risk of death is much higher, end up not only waiting longer but getting a less effective vaccine for their age group.

[Corraleno]

1 hour ago, mathnerd said:

I read an article a little while ago where the author was musing if the "social butterflies" should be the first to get the vaccine as that would take care of the main spreaders of covid. If I find the link, I will come back and post it here.

ETA: Found it:

Who gets priority when Covid-19 shots are in short supply? Network theorists have a counterintuitive answer: Start with the social butterflies.

https://www.wired.com/story/covid-19-vaccine-super-spreaders/?utm_source=twitter&utm_medium=social&utm_brand=wired&utm_social-type=owned

That's a really interesting approach, but it seems like it would only work with a vaccine that is known to prevent transmission, and we don't have data on that for Pfizer and Moderna. We do know they are highly effective in reducing severe illness and death, and that they are unusually effective in the elderly, who also have the highest risk for hospitalization and death, so it makes sense (to me) to prioritize that population with these specific vaccines.

It seems like the CDC are recommending a hybrid approach that attempts to both protect the most vulnerable and target likely network nodes, with HCWs (high contact) and nursing home residents (high risk) given priority in phase 1A, then essential workers (high contact) in phase 1B, and over-65/comorbidities (high risk) in phase 1C.

Not sure I agree that my 18 yr old daughter should be higher priority (as an "essential worker") than my 85 yr old parents with a long list of comorbidities, but I guess we'll see how that plays out.

The network approach might be a smart way to handle vaccination of college students if vaccines are still limited by the time college starts in the fall (although I certainly hope that everyone who wants the vaccine will have access by then).

[Ausmumof3]

2 hours ago, mathnerd said:

I read an article a little while ago where the author was musing if the "social butterflies" should be the first to get the vaccine as that would take care of the main spreaders of covid. If I find the link, I will come back and post it here.

ETA: Found it:

Who gets priority when Covid-19 shots are in short supply? Network theorists have a counterintuitive answer: Start with the social butterflies.

https://www.wired.com/story/covid-19-vaccine-super-spreaders/?utm_source=twitter&utm_medium=social&utm_brand=wired&utm_social-type=owned

Except if it doesn’t prevent transmission.  In which case that strategy could be an outright disaster.

[Pawz4me]

5 hours ago, TravelingChris said:

Elderly are not getting it.  We won't even be getting enough to cover all the HCW and the emergency people at first.

Because if just general elderly were getting it, I would be getting it.  General elderly are down the line.  It is HCW and emergency responders, then elderly assistance places and nursery places, and then it is third group is elderly and high risk people, then it is 18-30 yo, and then the last group is the 31-to whatever age they cut off for elderly and who didn't have risk factors.  Since they decided to let 16 and 17 year olds get it- I suppose they will be in the young and stupid group (they get it before older but not elderld and not high risk because they are the main spreaders of COVID>

I believe most--or at least many--states are setting their own order of priority, so it's not possible to make blanket statements as if the whole country will be vaccinated in the same order following CDC recommendations.

[mom31257]

My dd is an RN in Tennessee. She just had the opportunity to volunteer for the Phizer vaccine. She thinks she will get it on the 20th.