Florida Looking to Push Back Against CDC

[kazu]

1 hour ago, CruiserBruce said:

And the issue Canada is now raising,  which hasn't even happened in Canada, was resolved 10 days ago in Europe. Maybe a bit late to the party...

 

The whole thing is a mish mash as far as I am concerned.  First this vaccine wasn’t recommended for people over 65 because it hadn’t been tested enough in that age group and now they want to give it to those 55 and older?

 

It’s the new report hat has them worried (not previously out when Europe resolved it as I understand it) but no matter what, I am tired of the yo yo on this vaccine.  https://apple.news/ARKs3YhTISS2xK1_BEZXrRw

 

With all the back and forth, I suspect few will have faith in it.  I know I am leery as is DH (and he has a medical background).  It’s frustrating.

 

 

[idiebabe]

42 minutes ago, CruiserBruce said:

AstraZeneca HASN'T APPLIED for authorization in the US. CDC doesn't grant authorization if you don't apply.

49 minutes ago, CruiserBruce said:

AstraZeneca HASN'T APPLIED for authorization in the US. CDC doesn't grant authorization if you don't apply.

 

However, AZ is approved in over 50 countries. And the issue Canada is now raising,  which hasn't even happened in Canada, was resolved 10 days ago in Europe. Maybe a bit late to the party...

 

Apologize if I didn’t go into detail.  From what I read AZ kept saying they were ready to seek the Approval but  kept putting it off and putting off and the FDA said they had not completed the necessary U.S. Trials. Then AZ said they were completed, all looked good, etc. and were setting the stage for seeking Emergency Use.    Right after that The National Institute of Allergy and Infectious Diseases who Dr. Fauci is with came out questioning and raising concerns about outdated data submitted by AZ, etc.  There’s  been a lot of questions about this Vaccine, questions of AZ’s transparency,  and then the issue with the Blood Clots, etc. which has since been resolved.   

 

Even if it’s a great Vaccine all the negative coverage of this Vaccine makes people uneasy about taking it.  
 

 

[nocl]

2 hours ago, CruiserBruce said:

AstraZeneca HASN'T APPLIED for authorization in the US. CDC doesn't grant authorization if you don't apply.

 

However, AZ is approved in over 50 countries. And the issue Canada is now raising,  which hasn't even happened in Canada, was resolved 10 days ago in Europe. Maybe a bit late to the party...

CDC doesn't grant authorization even if they did apply.  The FDA is the Agency that reviews and approves drugs, including vaccines.  Once the FDA approves a vaccine than CDC gets involved with the distribution of it.

[nocl]

6 hours ago, idiebabe said:

Hopefully, that will change for Canadians.  I heard on the News this morning that Biden is sending to Canada and Mexico the AstraZeneca Doses that our FDA won't give the "Emergency Use" approval for  here in the U.S.

 

My "open" State is now at the point of opening up Vaccinating 16 yrs and older on Wednesday and all three Vaccines are readily available (Pfizer, Moderna and J&J).

Considering that AZ has not applied for an EUA in the US yet.  I would not say that the FDA won't give.  Only that it is not currently approved in the US. After all we don't know what the FDA will do once it actually receives an application from AZ.

[CruiserBruce]

43 minutes ago, idiebabe said:

Apologize if I didn’t go into detail.  From what I read AZ kept saying they were ready to seek the Approval but  kept putting it off and putting off and the FDA said they had not completed the necessary U.S. Trials. Then AZ said they were completed, all looked good, etc. and were setting the stage for seeking Emergency Use.    Right after that The National Institute of Allergy and Infectious Diseases who Dr. Fauci is with came out questioning and raising concerns about outdated data submitted by AZ, etc.  There’s  been a lot of questions about this Vaccine, questions of AZ’s transparency,  and then the issue with the Blood Clots, etc. which has since been resolved.   

 

Even if it’s a great Vaccine all the negative coverage of this Vaccine makes people uneasy about taking it.  
 

 

As @nocl correctly stated, its FDA approval, not CDC, that is required. .

 

Secondly,  the issue historically is the US with AZ has been the "half dose" issue, where a couple thousand people in the testing phase accidentally got a half first dose, and actually had a BETTER reaction than those that got a full dose. Other countries have approved it anyway, but the US required additional study on this topic.

 

The blood clot problem has occurred extremely rarely. I have seen 1 case per million doses, or less. Yes, not good if you are that one case, but statistically minute. As Europe has cleared it, I wonder why Canada needs more study. 

 

AZ provided more data when challenged about the age of its data. Not sure why this happened...certainly not a smart action by AZ.

 

I agree this is not a good look for AZ, and is hurting them in the court of public opinion,  where understanding statistics is, at best, an elective course. The US has committed to 300 million doses...I suspect we will be donating them elsewhere. 

[john2003]

I have to assume our Public Health people got a newer concerning bit of data. That is their job and I think they have pretty good antennas. I doubt they are late for any party. Time will tell.

[nocl]

2 hours ago, CruiserBruce said:

As @nocl correctly stated, its FDA approval, not CDC, that is required. .

 

Secondly,  the issue historically is the US with AZ has been the "half dose" issue, where a couple thousand people in the testing phase accidentally got a half first dose, and actually had a BETTER reaction than those that got a full dose. Other countries have approved it anyway, but the US required additional study on this topic.

 

The blood clot problem has occurred extremely rarely. I have seen 1 case per million doses, or less. Yes, not good if you are that one case, but statistically minute. As Europe has cleared it, I wonder why Canada needs more study. 

 

AZ provided more data when challenged about the age of its data. Not sure why this happened...certainly not a smart action by AZ.

 

I agree this is not a good look for AZ, and is hurting them in the court of public opinion,  where understanding statistics is, at best, an elective course. The US has committed to 300 million doses...I suspect we will be donating them elsewhere. 

A bit more info.

 

There are a couple of problems with AZ's original data set 

 

1. You mentioned the quality control issue that resulted in half doses

2. The demographics did not enough over 65 in the trial population 

3. Their initial data set was the result of a meta analysis of different trials and protocols.  The FDA tends to frown on meta-analysis. They sometimes accept them but they are not considered to be the best way to submit data.

 

It is my belief that all three impacted the need for a large scale US trial

 

I have a dislike for the media and their use of blood clots as a description of the safety issue.  Yes there are blood clots, but they are blood clots caused by Thrombocytopenia (according to a paper out of Norway).  Would like to see the actual data to see if the comparisons are to blood clots or bloods clots caused by Thrombocytopenia.  The incidence of thrombocytopenia in the US is about 3.3 per 100,000.  But the incidence of blood clots with thrombocytopenia is rarer.

 

According to media reports a University in Germany has found the mechanism of action causing the thrombocytopenia related clots.  I keep looking for a paper to come out on the subject.

 

 

In 10+ years with FDA and 10+ years in the pharmaceutical industry I have never seen an event like the one with AZ doing a press release that was not based upon the full data set and then have the Data and Safety Board call them out.

 

They have been acting like it is amateur hours in their clinical and  regulatory affairs departments. Something one would not expect from a major pharmaceutical company, even though vaccines are not their normal line of business.

Edited March 30, 2021 by nocl

[KirkNC]

8 hours ago, nocl said:

They have been acting like it is amateur hours in their clinical and  regulatory affairs departments. Something one would not expect from a major pharmaceutical company, even though vaccines are not their normal line of business.

A bit surprising but given the already existing vaccine hesitancy, it’s a deal killer for AZ.  Too many red flags. 

[fatcat04]

1 hour ago, KirkNC said:

A bit surprising but given the already existing vaccine hesitancy, it’s a deal killer for AZ.  Too many red flags. 

Yes, and now I understand better the vaccine hesitancy in Europe. Thank you for the excellent explanation @nocl

[LewiLewi]

On 3/28/2021 at 9:58 AM, CruiserBruce said:

My thought as well. I wonder if Florida has done the arrangements with cruise lines required by the CDC to resume sailing. Like plans for receiving sick patients from a ship. Or is it their contention that, by "following the science" they don't have to do those, and the CDC is overreaching. That would be an interesting argument. 

I live in Flori duh. DeSantis has gone against all good scientific recommendations as to how to contain and mitigate this virus. He has banned mask mandates, opened bars and gyms way too soon, and we have many elderly people who still cannot get a vaccination because appointments are not available. 
I will be happy to wait for the time that the CDC feels that sailing is safe again. I would not be happy to be in another Princess cruise situation.

[kangforpres]

From Cruise Hive today-

https://www.cruisehive.com/the-biggest-test-for-cruise-lines-is-yet-to-come/48607

 

-Paul

[Gracie115]

59 minutes ago, kangforpres said:

From Cruise Hive today-

https://www.cruisehive.com/the-biggest-test-for-cruise-lines-is-yet-to-come/48607

 

-Paul

 

Interesting...thanks for posting the link.

[fatcat04]

1 hour ago, kangforpres said:

From Cruise Hive today-

https://www.cruisehive.com/the-biggest-test-for-cruise-lines-is-yet-to-come/48607

 

-Paul

fta:

"In a show of how uninformed the Director is on the cruise industry, the CDC director sent out a tweet at the start of March to avoid cruise ship travel in Asia.

Cruise travel is not available to US guests in Asia; travel to most Asian nations is impossible without good reason, and the cruises that are sailing have had a perfect record since they sailed three months ago."

 

Goodness. This isn't very reassuring that the CDC is up to speed on the state of cruising. The Director's Q and A with Sen Murkowski (who I thought was very respectful and asked good questions, no gotcha nonsense) was equally uninspiring. I know cruising isn't on the front burner per se but being accurate and knowledgable should come with the job description of Director. Maybe she was just having an off day?

[Cruise NH]

15 hours ago, nocl said:

Considering that AZ has not applied for an EUA in the US yet.  I would not say that the FDA won't give.  Only that it is not currently approved in the US. After all we don't know what the FDA will do once it actually receives an application from AZ.

 

My husband and I were in the AZ trial conducted here in the US.  When we got the opportunity for one of the approved vaccines we talked to the clinic to get 'unblinded' from the study.  I got the placebo but my husband got the real thing.  He went ahead and got the Moderna vaccine anyway, chiefly because AZ wasn't approved here in the US.  Also we have concerns, listed by many here, of how the company has been releasing data and the credibility of that data.  

 

We've already had to use our cards as proof of vaccination in order to meet with the Border Patrol (in another state) and get our Global Entry approval so it worked out good.

 

My husband felt a little guilty getting 'two' vaccines but I'm so glad he did.  AZ may be far off from getting US approval.

[Heartgrove]

Unreal! Making a big-to-do about the CDC Director warning about cruising in Asia? Take the time to read the CDC website on Travel Notices. There is a notice for most any country in the world listed. Too many to count. Yet there probably aren't US travelers currently traveling that need to be concerned about the majority listed.

[nocl]

6 hours ago, KirkNC said:

A bit surprising but given the already existing vaccine hesitancy, it’s a deal killer for AZ.  Too many red flags. 

If it were AZ or no vaccine I would come down on the AZ side.  The biggest issue I have with the AZ vaccine is not the safety issue, but instead its poor performance against B.1.351 in South Africa.

 

In the US where we have 3 approved, including the J&J one shot vaccine with what appears to be plenty of supply I would lean against it.

[tinaincc]

On 3/26/2021 at 7:57 PM, rkacruiser said:

 

The uptick in cases seems to be starting.  

 

The Chairman of CCL, who was friends with the 45th President of the United States, reportedly had conversations with him about the condition of the cruising industry.  If that report is true, it surely didn't make any difference.  

 

 

I wish the conversation would shift to hospitalizations vs cases. Cases (in younger populations under 60) plus vaccinations are getting us to herd immunity. 

[nocl]

1 hour ago, Cruise NH said:

 

My husband and I were in the AZ trial conducted here in the US.  When we got the opportunity for one of the approved vaccines we talked to the clinic to get 'unblinded' from the study.  I got the placebo but my husband got the real thing.  He went ahead and got the Moderna vaccine anyway, chiefly because AZ wasn't approved here in the US.  Also we have concerns, listed by many here, of how the company has been releasing data and the credibility of that data.  

 

We've already had to use our cards as proof of vaccination in order to meet with the Border Patrol (in another state) and get our Global Entry approval so it worked out good.

 

My husband felt a little guilty getting 'two' vaccines but I'm so glad he did.  AZ may be far off from getting US approval.

Any reaction from the second?  

 

He is truly a pioneer in undiscovered territory since taking two different vaccines since there have not been any trials on safety with two different vaccines.

[kazu]

18 minutes ago, tinaincc said:

I wish the conversation would shift to hospitalizations vs cases. Cases (in younger populations under 60) plus vaccinations are getting us to herd immunity. 

 

The young are being hospitalized with the new variant.  

Cases do not equal herd immunity.  If someone catches the virus, there immunity is very short lived.  

[Cruise NH]

1 hour ago, nocl said:

Any reaction from the second?  

 

He is truly a pioneer in undiscovered territory since taking two different vaccines since there have not been any trials on safety with two different vaccines.

He had the normal side effects, slight headache and a sour arm.  He’s fine.

 

 I have to think that the 2/3 of the trial participants who got the actual AZ vaccine in the trial did the same as my husband and got one of the approved ones when it was available.  

[ontheweb]

1 hour ago, Heartgrove said:

Unreal! Making a big-to-do about the CDC Director warning about cruising in Asia? Take the time to read the CDC website on Travel Notices. There is a notice for most any country in the world listed. Too many to count. Yet there probably aren't US travelers currently traveling that need to be concerned about the majority listed.

And Asia does not want us from the USA or the rest of the world. The Japanese have already said no foreign tourists will be allowed to attend the Olympics this summer (already postponed from last summer.)

[KirkNC]

2 hours ago, nocl said:

If it were AZ or no vaccine I would come down on the AZ side.  The biggest issue I have with the AZ vaccine is not the safety issue, but instead its poor performance against B.1.351 in South Africa.

 

In the US where we have 3 approved, including the J&J one shot vaccine with what appears to be plenty of supply I would lean against it.

Honestly I have only seen headlines on it.  We have one Moderna shot already with another in ten days so it’s more of a academic issue for us.

[KirkNC]

This HBO documentary will not help convince CDC.

 

https://www.thedailybeast.com/hbos-the-last-cruise-captures-how-a-covid-infested-cruise-ship-devolved-into-class-warfare?source=entertainment&via=rss

 

 

[idiebabe]

FYI in case anyone missed this!  It's a little over an hour long but worth watching! 

 

https://youtu.be/K-3nv-ycs7E

 

[Cruise NH]

34 minutes ago, KirkNC said:

This HBO documentary will not help convince CDC.

 

https://www.thedailybeast.com/hbos-the-last-cruise-captures-how-a-covid-infested-cruise-ship-devolved-into-class-warfare?source=entertainment&via=rss

 

 

 

Thanks for posting this link.  I don't have HBO, wish I did.  We were on the QM2 during this time happily sailing along.  We heard about it but I don't know if it was us or how the media played it but we thought the Japanese government were being germaphobes at first.  It seemed like such an isolated incident at the time.