Are vaccines the light at the end of the tunnel?

[TeeRick]

Well this is a fine kettle of fish as the expression goes.  Any sign of misleading or just inaccurate company statements on the vaccine data prior to review and publication gives all COVID vaccines a black eye.  There is a basic mistrust of big pharma companies  and this situation does not help.  This has so far has been a great story (from Pfizer, J&J, Moderna).  The AZ vaccine has perceived problems but reported a very good clinical outcome yesterday.  Now this!  Possibly this might effect an EUA in the USA.

 

https://www.nbcnews.com/news/world/astrazeneca-covid-vaccine-trial-data-prompts-concern-federal-agency-says-n1261789

[markeb]

10 minutes ago, TeeRick said:

Possibly this might effect an EUA in the USA.

 

You think?

 

How do you do something like this? This is a major multi-billion dollar multinational corporation. After yesterday's news, I was ready to relax and say they've got this. And less than a day later???

 

You can argue the US doesn't actually need this vaccine, but the world certainly does. And the world has to believe in it!

[D C]

39 minutes ago, TeeRick said:

Well this is a fine kettle of fish as the expression goes.  Any sign of misleading or just inaccurate company statements on the vaccine data prior to review and publication gives all COVID vaccines a black eye.  There is a basic mistrust of big pharma companies  and this situation does not help.  This has so far has been a great story (from Pfizer, J&J, Moderna).  The AZ vaccine has perceived problems but reported a very good clinical outcome yesterday.  Now this!  Possibly this might effect an EUA in the USA.

 

https://www.nbcnews.com/news/world/astrazeneca-covid-vaccine-trial-data-prompts-concern-federal-agency-says-n1261789

 

Other than a "may have", there is nothing in that article that even suggest what the problem is, but it's an inflammatory article nonetheless.   Looks mostly like the media trying to find some dirty laundry. 

[D C]

12 hours ago, markeb said:

Google it. None of them had COVID; they tested positive on PCR to SARS-CoV-2, probably to come back to Hawaii. The news articles all treat a positive PCR and COVID-19 as the same thing. 
 

They’re really bad, and I really don’t want to link them here. 

Interesting.  After reading one story on the 3 cases, I'm inclined to believe that it's a situation of test error and false-positives rather than actual positives.   Two of the cases were a pair of travelling companions.  The odds of any given person being infected post-vaccine is small enough.  The odds that of the people with actual positives also happen to be companions seems like it would be exceptionally small.   I hope they followed up with additional testing to verify the positives and assess any viral load. 

[markeb]

1 minute ago, D C said:

Interesting.  After reading one story on the 3 cases, I'm inclined to believe that it's a situation of test error and false-positives rather than actual positives.   Two of the cases were a pair of travelling companions.  The odds of any given person being infected post-vaccine is small enough.  The odds that of the people with actual positives also happen to be companions seems like it would be exceptionally small.   I hope they followed up with additional testing to verify the positives and assess any viral load. 

 

Glad you found it. Probably understand my hesitance to post it, I hope...

[Fouremco]

12 hours ago, d9704011 said:

My understanding is that it’s more like a loan.  The US will ‘give’ Canada 1.5M doses now with the expectation that Canada will replace them in Q2 and/or Q3 when Canada receives shipments of AZ vaccine.

That's my understanding as well. I've quoted the lead paragraph from this article: https://www.ctvnews.ca/health/coronavirus/canada-finalizing-deal-with-u-s-for-1-5m-doses-of-the-astrazeneca-vaccine-1.5352524

 

OTTAWA -- Canada is finalizing a deal with the United States, which if agreed to would see 1.5 million doses of the AstraZeneca vaccine sent to Canada as early as by the end of the month, under a loan agreement.

 

Lead paragraph from another link: https://globalnews.ca/news/7704507/canada-us-astrazeneca-covid-vaccine/

 

The United States plans to send roughly 4 million doses of AstraZeneca‘s COVID-19 vaccine that it is not using to Mexico and Canada in loan deals with the two countries, bowing to pressure to share vaccine with its allies.

[TeeRick]

Here is the latest from Anthony Fauci who was interviewed today on Good Morning America and asked about the AZ vaccine and other related vaccine and COVID questions.  I would encourage those concerned or confused about the current AZ vaccine situation to watch this. 

 

https://www.goodmorningamerica.com/news/video/fauci-discusses-concerns-oxfordastrazeneca-vaccine-data-76626319

[markeb]

Just seen on LinkedIn: Now hiring. Director of Public Relations. Ability to reconcile press releases and government regulatory data submittals required...

 

Not yet. Maybe soon.

[TeeRick]

1 hour ago, D C said:

 

Other than a "may have", there is nothing in that article that even suggest what the problem is, but it's an inflammatory article nonetheless.   Looks mostly like the media trying to find some dirty laundry. 

According to Dr. Fauci the vaccine's independent DSMB notified him directly and the NIH NIAID that the press release from AZ yesterday described efficacy data that might have been a bit outdated.  He is asking AZ and their DSMB to get together and review everything and re-issue a corrected press release if necessary.  The vaccine overall is very likely safe and still highly efficacious.  He said no matter what AZ says, rest assured that the FDA vaccine advisory committee will thoroughly review everything before making the recommendation to the FDA to approve an EUA.   For those of you particularly in countries where the AZ vaccine has been already approved, this communication misstep or AZ SNAFU or  whatever you want to call it hopefully will be ironed out to your satisfaction.  

Edited March 23, 2021 by TeeRick

[Fouremco]

13 minutes ago, TeeRick said:

Here is the latest from Anthony Fauci who was interviewed today on Good Morning America and asked about the AZ vaccine and other related vaccine and COVID questions.  I would encourage those concerned or confused about the current AZ vaccine situation to watch this. 

 

https://www.goodmorningamerica.com/news/video/fauci-discusses-concerns-oxfordastrazeneca-vaccine-data-76626319

Excellent interview, thanks for posting. As a potential AZ recipient in the weeks ahead, it's good to have a better understanding of this latest hiccup. 

[John182]

15 minutes ago, TeeRick said:

I would encourage those concerned or confused about the current AZ vaccine situation to watch this

I could not agree more. What on earth were AZ thinking of by releasing a press statement based upon a subset of the data. Who the heck vets what the PR guys send out. My inside source is actually more upset that the University's own press release repeated AZ's release parrot fashion. One unhappy scientist right now.

[Arizona Wildcat]

22 minutes ago, John182 said:

I could not agree more. What on earth were AZ thinking of by releasing a press statement based upon a subset of the data. Who the heck vets what the PR guys send out. My inside source is actually more upset that the University's own press release repeated AZ's release parrot fashion. One unhappy scientist right now.

Agree.  AZ included data thru the 2/17 date at which the trial end point was reached.  AZ and reviewers then spent a month assembling the data into a presentation.  So far so good.

In that month there obviously was additional data being received from those in the study.  That data was not included in the press release.

Anything significant happen to effect the study outcome happen during that time?  Not that my AZ friend is aware of.

Should a short summary of that more recent data be included in the press release?  Absolutely.

The stupid part of this is ALL data will be included in the FDA review including future data up to the time of the review.

Inexcusable error by PR department and whomever reviews press releases.

 

[TeeRick]

3 minutes ago, Arizona Wildcat said:

Agree.  AZ included data thru the 2/17 date at which the trial end point was reached.  AZ and reviewers then spent a month assembling the data into a presentation.  So far so good.

In that month there obviously was additional data being received from those in the study.  That data was not included in the press release.

Anything significant happen to effect the study outcome happen during that time?  Not that my AZ friend is aware of.

Should a short summary of that more recent data be included in the press release?  Absolutely.

The stupid part of this is ALL data will be included in the FDA review including future data up to the time of the review.

Inexcusable error by PR department and whomever reviews press releases.

 

Yes a completely avoidable error and tarnished reputation of the vaccine and company and university too.  But I do believe that the vaccine is highly efficacious and safe. It has been used in millions already.  The US trial data will all come out. And the FDA will review all of the data.

[Ken the cruiser]

10 hours ago, markeb said:

I'm fighting a drug induced insomnia tonight/this morning. Good news: Had my second Pfizer last Thursday. Massive COVID arm on Friday! Otherwise fine, and it's gone. Bad news: One of my drugs is a steroid that is associated with insomnia, and some adrenergic "spillover". So I'm not sleepy and aggressively irritable. Great internet combination... 

 

A polite suggestion to the crowd: We're at 155 pages and approaching 4000 replies. And going. And mostly relevant and polite. If you haven't noticed, Anne locked a couple of threads today that got out of control. I'm not a moderator or host on this board; do some of that in another life. But if I can politely suggest that those of us (and that includes me; I can be guilty) that have been here from July can try to bite our tongues and only engage once or not at all when something we think is blatantly stupid gets posted, and let it go after that. Sometimes the poster actually has a legitimate question and they deserve a legitimate, usually not too technical (absolutely right is probably the enemy of not wrong and understandable) reply, and there have been a few people I thought were trolling that ultimately ended up as good contributors to the thread. And the true trolls can just be ignored and let the thread flow around them.

 

But, eventually, arguing, even if you really are right, is just going to escalate, and I'm very happy that @Host Anne and @Host Jazzbeauhave cleaned up the aisle on occasion and let the thread itself ride.

 

I have no enforcement authority. You are free to ignore this post, and if you feel like it, me. But it's been a good discussion, I think both for those of us who are geeks on some part of this whole topic, and for CC members just looking for information, or even to be told the information doesn't exist.

 

And thanks to Ken for starting this. I'm pretty sure you had no idea where this would go when you posed a seemingly simple and innocent question in July!

 

Cheers.

First off, we're so happy you were able to get your second shot without too many side effects other than a sore arm and insomnia. But, yes, this thread has been quite the ride and I use much of the positive knowledge I've gained to "lecture" the folks I meet, to include my neighbors, friends and HCWs, to get the vaccine as soon as they can. But it's amazing how many people I talk with, which is really not all that many because we mostly hang out here on the farm, that try to sidestep getting the vaccine. That's when the "old sarge" in me comes out to give them a little guidance and leadership based mostly on the info we've received on this thread. Whether my visionary thoughts work or not to get them closer to getting the vaccine, that's their call. But since I'm an old guy now, they at least have the patience to listen to what I have to say. 😉

 

But I agree, hopefully folks will continue to contribute to this thread in a positive way until it's time to finally put this all behind us and start cruising again from our US ports. That's my hope anyway as one of the many sitting over here in the peanut gallery. 🙃

[mayleeman]

44 minutes ago, Ken the cruiser said:

hopefully folks will continue to contribute to this thread in a positive way until it's time to finally put this all behind us and start cruising again

 

I look forward to reading that this thread has been closed because no one has needed to read it for over a month!

[nocl]

17 hours ago, markeb said:

 

I think this is a very real risk. It seems beyond unlikely that there will be fertility issues, or  teratogenicity, etc., but to fully address that, you're going to need longer term studies. And with what's become a fairly common decision to delay children until later in life, a lot of the US population faces infertility, so demonstrating a difference between vaccinated and unvaccinated people (not easy, but easier to postulate mechanisms for women), I get it. And I'm not sure there's been much of a effort to address that.

 

And cangelmd's discussion of hourly and contract HCWs really highlights the other issue; if you're self-employed, or hourly with limited benefits, losing two days of work following the vaccine could be financially devastating. And there's a decent group of folks who are essentially on "call-back" status, so if they don't work today, there's no guarantee they'll be called back to work tomorrow. Especially for a lot of long term care workers (I don't want to use the term unskilled, because that's not accurate; they're just not licensed health care providers).

 

I would like to see a lot more engagement, NOT "education", with those groups to understand their concerns and see what can be done to address them. And not assume that the collective 'we' knows the answers!

I would have to disagree with you on one part.  While there needs to be engagement to determine concerns, part of that process does involve education about what is done as part of the review process.  Once that information is exchanged then one can see what additional concerns remain.

 

For some people additional information will alleviate some of their concerns.  For others no amount of information will do that.

 

Not sure why you are saying that it is a very real risk. I have not found any signs of either any hints or signals of reproductive impact from any of the 3 vaccines.  Or for that matter any  mechanism of action that lead one to expect such.  Certainly if there was one it would have been 1. discussed in the vaccine advisory board meeting, 2. would have required studies specifically to test the signal prior to approval.  Have you seen anything in the literature?

 

Also not sure why you are talking about long term fertility studies.  As far as I can tell the FDA (they did not when I was there and I cannot find any reference that they have added such a requirement since then) does not normally require long term fertility studies on any drugs, unless there is some indication that there might be an impact found during pre-clinical testing. They also would if something were to pop up in the adverse event data base, but to be honest, I cannot think of or find any cases in a literature search of any that has occurred outside of drugs and devices that are specifically marketed in that space (fertility drugs, contraceptives, etc.) since the current drug approval practices were put in place (post thalidomide).   Do you know of any?

 

The following link is to the guidance for  Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Discussion on reproductive toxicity studies are in section IX, pages 17 and 18.

 

https://www.fda.gov/media/71542/download

 

 

 

The guidance to industry on reproductive and developmental toxicities - integrating study results  is available if anyone wants to get some idea how this is looked at during drug development and approval.

 

https://www.fda.gov/media/72231/download

 

The following is the guidance for drug labeling.

 

Pregnancy, Lactation, and Reproductive Potential: 2 Labeling for Human Prescription Drug and Biological Products — 3 Content and Format Guidance for Industry

 

https://www.fda.gov/media/90160/download

[nocl]

3 hours ago, TeeRick said:

Well this is a fine kettle of fish as the expression goes.  Any sign of misleading or just inaccurate company statements on the vaccine data prior to review and publication gives all COVID vaccines a black eye.  There is a basic mistrust of big pharma companies  and this situation does not help.  This has so far has been a great story (from Pfizer, J&J, Moderna).  The AZ vaccine has perceived problems but reported a very good clinical outcome yesterday.  Now this!  Possibly this might effect an EUA in the USA.

 

https://www.nbcnews.com/news/world/astrazeneca-covid-vaccine-trial-data-prompts-concern-federal-agency-says-n1261789

AZ has handled their COVID vaccine trials like they have never done this before.  This is mind boggling. Especially following after their earlier missteps.

 

I think if it came to true medical need in the US, the FDA would not grant the EUA because by the time it gets to the Vaccines Advisory Board the US should have a sufficient supply of the existing vaccines.  The statute does require that there be an unmet medical need for approval of an EUA, independent of the merits of the product itself.

 

However, if the US FDA were not to approve the EUA, I think that it would cast such a shadow over the AZ vaccine in the rest of the world where it has been approved and in use that it would set back the first round of vaccine distribution by months or even a year. That puts the FDA in an interesting position.

[markeb]

5 minutes ago, nocl said:

Not sure why you are saying that it is a very real risk. I have not found any signs of either any hints or signals of reproductive impact from any of the 3 vaccines.  Or for that matter any  mechanism of action that lead one to expect such.  Certainly if there was one it would have been 1. discussed in the vaccine advisory board meeting, 2. would have required studies specifically to test the signal prior to approval.  Have you seen anything in the literature?

 

Also not sure why you are talking about long term fertility studies.  As far as I can tell the FDA (they did not when I was there and I cannot find any reference that they have added such a requirement since then) does not normally require long term fertility studies on any drugs, unless there is some indication that there might be an impact found during pre-clinical testing. They also would if something were to pop up in the adverse event data base, but to be honest, I cannot think of or find any cases in a literature search of any that has occurred outside of drugs and devices that are specifically marketed in that space (fertility drugs, contraceptives, etc.) since the current drug approval practices were put in place (post thalidomide).   Do you know of any?

 

Misplaced modifiers, or paragraph breaks, or not enough context on the reply.

 

The real risk I was talking about is the vaccine crowd being viewed as overly dogmatic. Which could push hesitant people further away. That's what I was replying to, but probably should have hit an enter key, or quoted more of his post, where he was discussing young women's concerns with the vaccine and their own fertility. The rest of that was in his OP, but I'm trying not to quote entire posts. So you lost context in my reply. I really don't think there's much risk of any of those effects, but there needs to be human engagement to address people's concerns. Which I think was the fear in the truncated post I was quoting.

 

I wasn't thinking licensure studies; I suspect you'd see any effects, which I again don't expect; in long term epidemiological studies. The old case report, case study, retrospective study type thing. Anything simple to see would have popped up by now, and as you say would have most likely shown up in pre-clinical studies.

 

Tried to be efficient and lost context!

[nocl]

Yesterday the county in which I live lowered the age to 50 from 65.  I registered with the county and checked several of the pharmacy sites. Came up empty.  Checked the Albertson's site 3 more times during the day.  At 10:15 last night some openings popped up and I am now schedule for my first injection at 2:15 today.  It helps to keep checking the pharmacy sites you never know when they will add more appointments.

[TeeRick]

3 hours ago, Fouremco said:

Excellent interview, thanks for posting. As a potential AZ recipient in the weeks ahead, it's good to have a better understanding of this latest hiccup. 

The latest today from Health Canada pertaining to the AZ vaccine.

https://www.usnews.com/news/top-news/articles/2021-03-23/canada-recommends-astrazeneca-vaccine-despite-us-criticism-of-trial-data

 

[TeeRick]

Here is where many states stand on the dates of opening up vaccine availability to all.  My state (PA) does not even make the list.  Biden promised all states starting May 1.  

https://www.cnn.com/2021/03/23/health/covid-19-vaccine-eligible-to-all-states-timeline-wellness/index.html

 

A CNN analysis of state health departments has found that Covid-19 vaccination eligibility is anticipated to open to people 16 and older in certain states by the following timeline:

• March 25: Georgia
• March 29: Oklahoma, Texas, Ohio, North Dakota
• March 31: Indiana
• April 1: Montana
• April 5: Connecticut, Michigan, Tennessee
• April 9: Missouri
• April 12: Illinois
• April 19: Maine, Vermont, Massachusetts, Rhode Island
• April 26: Idaho
• April 27: Maryland
• April, no set date: New Mexico, Virginia, Iowa
• May 1: Wisconsin, Oregon, South Dakota
• May 3: South Carolina
• May or later: California, Nebraska, Kansas, Hawaii, New Hampshire, Delaware

 

[TeeRick]

Here is a good news COVID vaccine story.  

 

https://www.cnbc.com/2021/03/23/navajo-nation-reports-no-new-coronavirus-cases-deaths-for-the-first-time-in-six-months-.html

[ECCruise]

28 minutes ago, TeeRick said:

Here is where many states stand on the dates of opening up vaccine availability to all.  My state (PA) does not even make the list.  Biden promised all states starting May 1.  

https://www.cnn.com/2021/03/23/health/covid-19-vaccine-eligible-to-all-states-timeline-wellness/index.html

 

A CNN analysis of state health departments has found that Covid-19 vaccination eligibility is anticipated to open to people 16 and older in certain states by the following timeline:

• March 25: Georgia
• March 29: Oklahoma, Texas, Ohio, North Dakota
• March 31: Indiana
• April 1: Montana
• April 5: Connecticut, Michigan, Tennessee
• April 9: Missouri
• April 12: Illinois
• April 19: Maine, Vermont, Massachusetts, Rhode Island
• April 26: Idaho
• April 27: Maryland
• April, no set date: New Mexico, Virginia, Iowa
• May 1: Wisconsin, Oregon, South Dakota
• May 3: South Carolina
• May or later: California, Nebraska, Kansas, Hawaii, New Hampshire, Delaware

 

And in some of those states it is already de facto open to everyone 16+ (or 18+ depending on vaccine supplier) depending on county.  Here in NC, we've had counties open to everyone for weeks because they cannot distribute the vaccine supply they have been allocated.  Same thing in parts of Tennessee, which shows an April 5 opening.

[nocl]

On 3/23/2021 at 7:56 AM, TeeRick said:

According to Dr. Fauci the vaccine's independent DSMB notified him directly and the NIH NIAID that the press release from AZ yesterday described efficacy data that might have been a bit outdated.  He is asking AZ and their DSMB to get together and review everything and re-issue a corrected press release if necessary.  The vaccine overall is very likely safe and still highly efficacious.  He said no matter what AZ says, rest assured that the FDA vaccine advisory committee will thoroughly review everything before making the recommendation to the FDA to approve an EUA.   For those of you particularly in countries where the AZ vaccine has been already approved, this communication misstep or AZ SNAFU or  whatever you want to call it hopefully will be ironed out to your satisfaction.  

Unfortunately I just saw a report that used the term cherry picking of the data to get better efficacy numbers. Not a good sign.

 

I think at this stage its not going to be clear until the FDA does its analysis.  Where as some other country regulatory authorities accept the analysis generated by the companies, the FDA always goes back to all of the raw data, and does its own analysis.  That is why there is the delay between the EUA filing and the meeting of the Vaccines Advisory Board. It does not depend upon the company provided analysis.  That should answer any questions that exist.

[wrk2cruise]

NC this week also changed the distribution to counties from being population based to now be based on % unvaccinated.   I support this as long as there is demand, however I worry that it will cause more doses to be left on the shelf as it seems to be counties with more resistance to taking the vaccine.