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6 hours ago, D C said:

 

So you're saying they made a best guess, but we have no idea how the decision was actually made internal to those organisations, correct?

 

Are you talking about the company or the regulatory authority?

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7 hours ago, ontheweb said:

If I could impose on your expertise. It seems to me the Pfizer and Moderna (which we have had) are similar (as opposed to the Johnson & Johnson) vaccines. Yet one recommends 3 weeks and the other 4 weeks. Is this because those are the only parameters they tested in their trials, or would they normally test different ones to see which made more sense?

 

We actually had our second vaccinations 38 days later instead of the 28 we were originally scheduled due to the transportation problem that caused our site not to have the vaccine in mid February. Can we assume that this 10 day difference really should not make a difference in our protection despite the Moderna 4 week recommendation?

It is because that is how they constructed the trials.

 

Usually in phase 1.  They test the study drug in healthy volunteers to look for safety issues.  In phase two they usually look as dose response.  I have not seen or have access to that data, but usually in those trials they will try different doses and different time periods and see what appears to have the best effect.  That will then be the basis for the phase III large trial.  

 

In this case I expect that they did not do as wide a range of possibilities that one might normally do because they did not want to take any more time than they had too.

 

The FDA will base the label on the information from the clinical trials.  After a drug is approved companies will often do post market studies to expand the approve label.  These may look at different doses, different time frames, etc.

 

The FDA and CDC both say two additional weeks is fine so there was enough information in the trials for that widening of the time.  I expect that if it was tested they could probably widen it even more.  But the FDA will not without data coming from an appropriately designed and executed clinical trial

 

So no problem at all.

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On 3/20/2021 at 11:12 AM, koolZip said:

If it's a choice between believing a ophthalmologist (who set up his own accrediting board to get accredited) and a renowned expert in infectious diseases, I'm going to go with the expert.

The expert who said a year ago there was no need for masks? The expert who said we may never shake hands again? That expert? Yeah I will go with the eye doctor. 

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15 hours ago, wowzz said:

The decision in the UK to increase the gap from 4 weeks to 12 weeks was based on the advice of medical specialists.

As can be seen from all the data, the decision was obviously the correct one,  with hundreds of lives saved as a result. Lockdown in the UK is being relaxed, whereas in much of Europe the reverse is the case.

 

Yes, but as I said earlier if the gap has not been tested, then it is a guess that there will not be an issue, it may be an educated guess by educated professionals but still a guess.  Odds are it will work out as in some vaccine is better than no vaccine, but it is still untested.  At least as far as any published clinical trials go.

 

That is why when there was a similar discussion in the US the FDA and CDC stuck with what they had information for.

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1 minute ago, farmermd said:

The expert who said a year ago there was no need for masks? The expert who said we may never shake hands again? That expert? Yeah I will go with the eye doctor. 

At the time when that was stated they were 

 

1. still basing the approach on SARS and influenza management methods 

2. The number of cases were still very low in the US, the recommendation was made prior to the first, as we now know, relatively small peak.

3. There was a shortage of PPE and the medical establishments who were operating in a high virus environments needed all they could get.  Any masks available to the public were hand made. It was a time when construction companies were donating their N95 masks to local hospitals.

 

 

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9 hours ago, beg3yrs said:

Thanks for sharing that. I find it interesting that the director told the mayor the guidelines would be released "soon". She was questioned by a congressional committee about a week ago and said the same thing. She dodged multiple questions regarding a more specific time period as soon could mean just about anything as it's a relative term.

 

Also, during that hearing she demonstrated a relative lack of knowledge about the process of getting the guidelines (technical instructions) released as she said they were in an "inter-agency review" process. When pressed she demonstrated she really had no idea which agencies were involved.

 

This tells me she wasn't properly prepared by her staff for the hearing. In my experience when that happens things don't go well for the staff afterwards. However, a week later still saying "soon" without providing a more specific time-frame doesn't bode well to me. Somewhere out there should be a schedule for getting the document reviewed, approved and issued.

It’s out now......

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1 hour ago, farmermd said:

The expert who said a year ago there was no need for masks? The expert who said we may never shake hands again? That expert? Yeah I will go with the eye doctor. 

You mean the eye doctor wouldn’t wear a mask and got infected ?  Not for me !

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1 hour ago, Ombud said:

Getting vaccinated Wednesday!! Its my turn. Talked with 2 sisters: 1 just made her (& DH) appointment / the other insists the vaccine gives you bells palsy (😅🤣😂) and it's illegal to require vaccine or negative test to fly to Hawaii. I hope she gets stopped by TSA instead of getting there & being turned back

OMG, they are REALLY strict. There was a couple on news who had both vaccine doses, then had a PCR test (both negative) at CVS 72 hours ahead but was processed at a lab that wasnt on thier approved list and when they landed in Hawaii they had to quarantine or

 fly back home. They flew back home.

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2 hours ago, Ombud said:

Getting vaccinated Wednesday!! Its my turn. Talked with 2 sisters: 1 just made her (& DH) appointment / the other insists the vaccine gives you bells palsy (😅🤣😂) and it's illegal to require vaccine or negative test to fly to Hawaii. I hope she gets stopped by TSA instead of getting there & being turned back


No shoes, no shirt, no vaccine = no service. 😉😉😉😉

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9 hours ago, D C said:

 

So you're saying they made a best guess, but we have no idea how the decision was actually made internal to those organisations, correct?

 

A best guess in terms that the effect of the extended period has not been proven by the appropriate tests or trials.

 

I have been in companies and participated in discussions involving the use of the data in developing clinical trial designs as well as participated in decisions about the preparation of the information contained within drug submission.

 

On the FDA side the rule has been pretty much if it is not proven by appropriates trials and tests that it does not go into the label.  Same as with this.

 

Cannot say how the other regulatory authorities made their decisions. But it was probably by their equivalent of FDA's Vaccines Advisory Boards.  Who knows upon what information they might have based that on because such information, including the decision making process, has not been made public as far as I can find.

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47 minutes ago, PrincessLuver said:

True.....Florida is a Covid joke!

Turn off CNN, or whatever other fake news you are seeing.  Spent two months in FL this winter and it was far from a joke.  It was safe and about as near normal as things can be these days.  Folks wear masks in public and there was high demand for vaccinations.  Even though I am a regular visitor and do not live there, I am getting tired of the mostly unfounded dumping on Florida. 

 

You want Covid jokes?  Try checking out Ontario where the current situation is exposing the fragility of our healthcare system/infrastructure, which most were blissfully unaware of.

 

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2 hours ago, nocl said:

At the time when that was stated they were 

 

1. still basing the approach on SARS and influenza management methods 

2. The number of cases were still very low in the US, the recommendation was made prior to the first, as we now know, relatively small peak.

3. There was a shortage of PPE and the medical establishments who were operating in a high virus environments needed all they could get.  Any masks available to the public were hand made. It was a time when construction companies were donating their N95 masks to local hospitals.

 

 

You can say this a million times. Some will never get it. 

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7 minutes ago, nocl said:

Cannot say how the other regulatory authorities made their decisions. But it was probably by their equivalent of FDA's Vaccines Advisory Boards.  Who knows upon what information they might have based that on because such information, including the decision making process, has not been made public as far as I can find.

PRECISELY.  I cannot find it either.  I have also requested the medical/science basis for a huge extension here in Ontario (16 week gap!!!!) and it's all crickets.  I asked three levels of government to respond, including the group that made the change.  The MSM seems to just take the decision at face value with little questioning of it.  I think it was largely based on shortage of vaccines and they did include a rider that given good supply, then the gap should be as close as possible to the published guidelines.  The Canadian NACI is having to review their idea not long after releasing it and are expected to modify at least for at-risk groups.

 

 

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3 hours ago, nocl said:

It is because that is how they constructed the trials.

 

Usually in phase 1.  They test the study drug in healthy volunteers to look for safety issues.  In phase two they usually look as dose response.  I have not seen or have access to that data, but usually in those trials they will try different doses and different time periods and see what appears to have the best effect.  That will then be the basis for the phase III large trial.  

 

In this case I expect that they did not do as wide a range of possibilities that one might normally do because they did not want to take any more time than they had too.

 

The FDA will base the label on the information from the clinical trials.  After a drug is approved companies will often do post market studies to expand the approve label.  These may look at different doses, different time frames, etc.

 

The FDA and CDC both say two additional weeks is fine so there was enough information in the trials for that widening of the time.  I expect that if it was tested they could probably widen it even more.  But the FDA will not without data coming from an appropriately designed and executed clinical trial

 

So no problem at all.

Thank you for answering my questions.

 

I'm happy to see that our 38 day Moderna gap due to weather related distribution problems did not take us out of the FDA and CDC approved time frame.

 

If I am understanding you correctly, more time frames might have been tested except for "Warp Speed". What the UK and Canada are doing might be ok, or might not as it has not really been tested.

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4 hours ago, Ombud said:

Getting vaccinated Wednesday!! Its my turn. Talked with 2 sisters: 1 just made her (& DH) appointment / the other insists the vaccine gives you bells palsy (😅🤣😂) and it's illegal to require vaccine or negative test to fly to Hawaii. I hope she gets stopped by TSA instead of getting there & being turned back

Well the data did show a signal of increased risk for bells palsy.  The normal incidence of bells palsy is 15 to 30 per 100,000. Based upon the size of the trial and the monitoring period one would have expected 1-2 cases in the treated population. Between the Pfizer and Moderna trials there were 7 in the treated population and 1 in the placebo groups.  That would imply a higher than normal risk, but still very very low.  May be 100 to 200 cases per 100,000 population per year at worst.  Not much of a concern considering that it usually self resolves.

 

Much lower odds than dying from Covid19 in the unvaccinated population.

Edited by nocl
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Just now, ontheweb said:

Thank you for answering my questions.

 

I'm happy to see that our 38 day Moderna gap due to weather related distribution problems did not take us out of the FDA and CDC approved time frame.

 

If I am understanding you correctly, more time frames might have been tested except for "Warp Speed". What the UK and Canada are doing might be ok, or might not as it has not really been tested.

I would not say because of warp speed.  After all Pfizer was doing their development on the own dime and technical part of Warp Speed.  I would say that it was more a matter of finding the shortest period that they were happy with taking into the phase 3 trial because they did not want to wait any longer than they had two for phase 1/2 results.

 

It might be ok, it probably is ok, but have not seen anything that proves it is ok.

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38 minutes ago, Steelers36 said:

 

 

You want Covid jokes?  Try checking out Ontario where the current situation is exposing the fragility of our healthcare system/infrastructure, which most were blissfully unaware of.

 


yes, even. After a December/January province wide stay at home lockdown, we in Ontario are there again tomorrow. - lockdown for 28 more days. Too many varients spreading with all the travelling, & mobility. I don’t see this as a joke. 
 

be safe, be kind, be responsible. 

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7 minutes ago, dog said:


yes, even. After a December/January province wide stay at home lockdown, we in Ontario are there again tomorrow. - lockdown for 28 more days. Too many variants spreading with all the travelling, & mobility. I don’t see this as a joke. 
 

be safe, be kind, be responsible. 

The situation is not a joke - agreed.  But the people making the decisions are - IMHO.  I could go into details, but this isn't the place for it.  Let me just say that the worst areas have been in a lockdown for sometime and has not had much impact, so extending it everywhere is hardly guaranteed to make a big impact.

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7 minutes ago, Steelers36 said:

The situation is not a joke - agreed.  But the people making the decisions are - IMHO.  I could go into details, but this isn't the place for it.  Let me just say that the worst areas have been in a lockdown for sometime and has not had much impact, so extending it everywhere is hardly guaranteed to make a big impact.

Wonder why.  Slow move to vaccinate those under 70!  
my  experience went fairly smoothly but I had trouble with the “I am not a robot” form & even with an appointment I stood in line 40 minutes before checking in

 

cannot complain. I appreciate the way things are done here. 

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9 hours ago, nocl said:

 

Cannot say how the other regulatory authorities made their decisions. But it was probably by their equivalent of FDA's Vaccines Advisory Boards.  Who knows upon what information they might have based that on because such information, including the decision making process, has not been made public as far as I can find.

In Canada the regulator is Health Canada and they have authorized the vaccines with the dose intervals as per the clinical trials ie Pfizer 3 weeks, Moderna 4 weeks and AstraZeneca 4 to 12 weeks.

 

 It is a national  advisory body of experts (called NACI) that has said extending to 16 weeks for all the covid 2 dose vaccines was ok if required because of short supply. They said their advice is based on real world evidence coming out of primarily the UK. The provinces (who have jurisdiction over the delivery of health care) have decided to follow the advice of NACI and use the 16 weeks interval.
 

NACI is now reviewing data from a new study about vaccine effectiveness for the very elderly and others (like cancer patients) and have said they may revise their recommendation.

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5 hours ago, voljeep said:

Florida is merely letting Florida adults make adult decisions with adult consequences, risks, and rewards

 

nothing more

nothing less

Those who make the decision not to get vaccinated will not be cruising for the foreseeable future regardless of what that governor says. Cruise lines will not be willing to take the risk 

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5 minutes ago, memoak said:

Those who make the decision not to get vaccinated will not be cruising for the foreseeable future regardless of what that governor says. Cruise lines will not be willing to take the risk 

now 8 weeks past our 2nd shots ( Pfizer ) - and will sign up immediately if a "booster" is needed

 

still wearing masks

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