AstraZeneca Report Success with Vaccine

[A&L_Ont]

15 minutes ago, Dinglebert said:

It is also my thought.  I was responding to a specifc point.

 

I thought so as well.  I was just giving the positive of any vaccination VS none at all. You and I can see that, but not everyone would think the same way.🙂

[ace2542]

50 minutes ago, A&L_Ont said:

 

To further your comment that I put in bold; the US is currently allowing people in who have had no vaccinations.  

 

IMO I think they will happy to allow anyone who has been vaccinated, over allowing entrance to someone who has not.

Those people are U.S CITIZENS who have the RIGHT to enter the United States and actually cannot be denied even by presidential order I believe. Or at bare minimum U.S green card holders but not foreign tourists. And I agree with your statement they probably will allow all vaccines to be used. It would be a very costly decision in terms of money and jobs not to.

[ace2542]

1 hour ago, Dinglebert said:

Fair point. Personally my main concern is that we have a safe and effective solution.  If the US don't want to allow people in because they have had a different vaccine that they will allow then thats their decision.  There are plenty of other countries in the world who will want my holiday money.

 

 

In terms of cruising a good number of routes and ships denied might be denied to you. IF for some reason you are unable to enter the United States you will be very hard pushed to cruise the Caribbean as the cruises nearly all leave from either Miami, New York or Fort Lauderdale and or visit San Juan Puerto Rico. Canada will be impossible because they all cruise from New York or Boston.  Ok you might be able to do the Queen Mary to Halifax and fly home from Montreal or Toronto. Mexico and South America are off the table as well because they go from New Orleans or LA. Oh and you can forget a Transatlantic as well in most cases.

[A&L_Ont]

1 minute ago, ace2542 said:

Those people are U.S CITIZENS who have the RIGHT to enter the United States and actually cannot be denied even by presidential order I believe.

 

Yes you are right, US citizens are allowed entry no matter their situation.

 

However there are ways that citizens of other countries can enter the US right now.  They are supposed to quarantine, however from what I have read the US is barely doing contact tracing let alone quarantine checking.  Some might go about their quarantine properly and others will head out to the general public without a care in the world.

 

 

[ace2542]

1 minute ago, A&L_Ont said:

 

Yes you are right, US citizens are allowed entry no matter their situation.

 

However there are ways that citizens of other countries can enter the US right now.  They are supposed to quarantine, however from what I have read the US is barely doing contact tracing let alone quarantine checking.  Some might go about their quarantine properly and others will head out to the general public without a care in the world.

 

 

You have to quarantine for 14 days in an approved countries before travelling to the U.S. There are not that many approved countries. A good number of countries including UK,Ireland and all of Europe i believe are banned by the presidential proclamation of March.

 

And anyone caught violating that quarantine will be DEPORTED and banned for 10 YEARS from returning.

[A&L_Ont]

6 minutes ago, ace2542 said:

Canada will be impossible because they all cruise from New York or Boston.  Ok you might be able to do the Queen Mary to Halifax and fly home from Montreal or Toronto....

 

Oh and you can forget a Transatlantic as well in most cases.

 

Canada has extended its ban on cruise ships with overnight accommodations for over 100 until Feb. 28, 2021.  I see this ban being extended until the cases have dropped dramatically around the world, within Canada, and a vaccine has been made widely available to the general public. As it stands we have had enough of a spike the last few months that cruises will be one of the last things to return to normal. 

 

For all of those factors to fall into place I can't see it happening by midyear of 2021, if at all next year.

[orville99]

3 hours ago, boscobeans said:

And of course the world must wait until December 10th for the F.D.A. to convene and THEN AND ONLY THEN begin examining the application,..??? 

 

Not exactly. The data has already been delivered to the FDA and the independent review panel. They will take the next two weeks to pour over the data and then on 12/9-12/10 they will meet to discuss their individual findings and take a vote whether to tell the FDA to proceed with the EUA or to kick the whole study back for more data. The FDA can then either take the committee's recommendation or reject it based on their own review of both the data and the committees findings.

 

SOP for any new drug approval by the FDA.

[orville99]

4 hours ago, ace2542 said:

This could cause a lot of problems in the world. The CDC has no intention of approving it under any circumstances I don't think. But in UK it will probably be approved and distributed. Which again raises my question will vaccined persons be allowed into the U.S after vaccination with this if not approved by CDC.

For starters, the CDC has no role in the approval of vaccines (or any other drugs) in the U.S., that is the sole purview of the FDA. The FDA will review and approve or reject any new drug application based solely on its own merits. The relative efficacy of competing drugs doesn’t enter into their decision process. 

[ace2542]

Just now, orville99 said:

For starters, the CDC has no role in the approval of vaccines (or any other drugs) in the U.S., that is the sole purview of the FDA. The FDA will review and approve or reject any new drug application based solely on its own merits. The relative efficacy of competing drugs doesn’t enter into their decision process. 

I think the FDA might reject this as it has had bad press like the Johnson vaccine. Just a feeling I have. Be interesting if they do or if they are swayed by political pressure. They could reject all 3 vaccines for USA leaving America in a right pretty pickle.

[orville99]

2 minutes ago, ace2542 said:

I think the FDA might reject this as it has had bad press like the Johnson vaccine. Just a feeling I have. Be interesting if they do or if they are swayed by political pressure. They could reject all 3 vaccines for USA leaving America in a right pretty pickle.

The press on both the AZ and J&J vaccines has not been bad in any way. Pauses in clinical trials are both expected and routine, and happen with virtually any new drug in a double blind placebo-controlled study. Not sure how the pauses were presented in the U.K. press, but they have never been portrayed in a negative light in the U.S. press. 

[ace2542]

10 minutes ago, orville99 said:

The press on both the AZ and J&J vaccines has not been bad in any way. Pauses in clinical trials are both expected and routine, and happen with virtually any new drug in a double blind placebo-controlled study. Not sure how the pauses were presented in the U.K. press, but they have never been portrayed in a negative light in the U.S. press. 

No they just had house speaker saying that UK drug regulations are not up to U.S standards. Ergo UK developed vaccine is not up to U.S standards?

[orville99]

19 minutes ago, ace2542 said:

No they just had house speaker saying that UK drug regulations are not up to U.S standards. Ergo UK developed vaccine is not up to U.S standards?

I personally would not take anything said by a U.S. politician as fact. I doubt she could even tell you which agency actually has approval authority in Europe or the U.K. The EMA and FDA are on the same page, and those two agencies are the ones that approve drugs, not a politician from California. BTW, the U.S. gave AZ $1.2Bn to pre-purchase 300 million doses of the vaccine once it is approved. 

 

I would be more concerned with the fact that the AZ clinical trials have only enrolled ~3,000 people in the U.K.,and ~8,000 in Brazil so they may not have sufficient data to meet the level of statistical validity that either the EMA or the FDA require.

Edited November 23, 2020 by orville99

[Tree_skier]

2 minutes ago, orville99 said:

I doubt she could even tell you which agency actually has approval authority in Europe or the U.K.

I doubt she was actually sober when she made the comments.

[ace2542]

There is some talk that the FDA WILL NOT approve the vaccine for use in the United States. That is why the share price did what it did.

[A&L_Ont]

4 minutes ago, ace2542 said:

There is some talk that the FDA WILL NOT approve the vaccine for use in the United States. That is why the share price did what it did.

There are billions of other people around the world that would be willing to take this vaccine so their stock will be fine. 
 

As for the US not willing to accept it, the bigger challenge will be getting enough people in America to take any of the Covid Vaccines. 

[not-enough-cruising]

18 hours ago, ace2542 said:

I think the FDA might reject this as it has had bad press like the Johnson vaccine. Just a feeling I have. Be interesting if they do or if they are swayed by political pressure. They could reject all 3 vaccines for USA leaving America in a right pretty pickle.

Again you persist in commenting on USA federal processes (from the UK) but seem to have no idea of how the system works. 
There is nothing particularly peculiar about the AZ application, “quirky dosing” isn’t all that rare. The J&J product appears to be on track and headed to FDA EUA process shortly after the 1st of the year. 

[ace2542]

12 minutes ago, A&L_Ont said:

There are billions of other people around the world that would be willing to take this vaccine so their stock will be fine. 
 

As for the US not willing to accept it, the bigger challenge will be getting enough people in America to take any of the Covid Vaccines. 

As maybe but in terms of entering the United States I don't think the percentage of vaccinated Americans will matter that much. Perhaps the U.S will NOT accept the AstraZeneca vaccine for entry to the country as it has not been approved by FDA?. And other vaccines for that matter. Then again maybe they will. But IF they don't, imagine trying to get people to take 2 different Covid vaccines even if it is safe to do so.

 

And FWIW I notice Dinglebert has not replied to my response about how many countries he could not cruise to IF unable to enter America.

[livingonthebeach]

26 minutes ago, A&L_Ont said:

There are billions of other people around the world that would be willing to take this vaccine so their stock will be fine. 
 

As for the US not willing to accept it, the bigger challenge will be getting enough people in America to take any of the Covid Vaccines. 

 

In a recent Gallup poll, only 58% of Americans were willing to take the Covid vaccine.  I believe 70% is needed to reach Hurd immunity, so this is indeed going to be a challenge. 

[ace2542]

24 minutes ago, not-enough-cruising said:

Again you persist in commenting on USA federal processes (from the UK) but seem to have no idea of how the system works. 
There is nothing particularly peculiar about the AZ application, “quirky dosing” isn’t all that rare. The J&J product appears to be on track and headed to FDA EUA process shortly after the 1st of the year. 

Then why all the talk on yahoo news and other sites for that matter saying it won't get approved by the FDA?. Is that no approval period of a vaccine that does 70% when others claim 95% so it is not need? Or approval will come at some point but just not at the same time a Pfizer and the others. But in terms of having U.S approval further down the line. What is the point when the U.S marketplace has at least 3 other vaccines in it with order books for hundreds of millions of doses. That is why the stock price reacted the way it did.

Edited November 24, 2020 by ace2542

[ace2542]

1 minute ago, livingonthebeach said:

 

In a recent Gallup poll, only 58% of Americans were willing to take the Covid vaccine.  I believe 70% is needed to reach Hurd immunity, so this is indeed going to be a challenge. 

That has increased from 41%. or 37% which is the lowest it was.

[orville99]

1 minute ago, livingonthebeach said:

 

In a recent Gallup poll, only 58% of Americans were willing to take the Covid vaccine.  I believe 70% is needed to reach Hurd immunity, so this is indeed going to be a challenge. 

Agree, but there is a difference between willing and needing, and governmental leverage to influence need is quite common. Back when smallpox was raging, we in the U.S. were not mandated to get the vaccine, and a significant number of people (me included) were not willing to get it. That changed when my career required me to travel outside the U.S. While I was not required to get the vaccine before I left the U.S. for Europe, I was prohibited from re-entering the U.S. without a proof of vaccination. No one is mandated to get any vaccine in the U.S., but students in public school systems in the U.S. aren't allowed to go back to school unless they have them. You may not be required to have a Covid vaccination in order to travel outbound (state-to-state, or internationally), but you may have to have proof of vaccination before you can you return.

[orville99]

13 minutes ago, ace2542 said:

Then why all the talk on yahoo news and other sites for that matter saying it won't get approved by the FDA?. Is that no approval period of a vaccine that does 70% when others claim 95% so it is not need? Or approval will come at some point but just not at the same time a Pfizer and the others. But in terms of having U.S approval further down the line. What is the point when the U.S marketplace has at least 3 other vaccines in it with order books for hundreds of millions of doses. That is why the stock price reacted the way it did.

The only place less likely to have valid information on anything than a U.S. politician, is a U.S. social media site. You do realize that Yahoo "news" merely aggregates whatever is floating around on the rest of the social media world. There is absolutely no validity to any claim that the FDA will or will not approve any investigational medication. Data are data, and data will ultimately make the decision, not Yahoo or a political hack.

 

BTW, the U.S. has $1.2Bn (300 million doses) of the AZ vaccine on its order books, so if and when the data show that the vaccine meets the efficacy threshold (>50%) and safety threshold, it will be just as approvable by ths FDA as any other that meets those thresholds.

Edited November 24, 2020 by orville99

[ace2542]

35 minutes ago, orville99 said:

Agree, but there is a difference between willing and needing, and governmental leverage to influence need is quite common. Back when smallpox was raging, we in the U.S. were not mandated to get the vaccine, and a significant number of people (me included) were not willing to get it. That changed when my career required me to travel outside the U.S. While I was not required to get the vaccine before I left the U.S. for Europe, I was prohibited from re-entering the U.S. without a proof of vaccination. No one is mandated to get any vaccine in the U.S., but students in public school systems in the U.S. aren't allowed to go back to school unless they have them. You may not be required to have a Covid vaccination in order to travel outbound (state-to-state, or internationally), but you may have to have proof of vaccination before you can you return.

How is that legal a U.S Citizen CANNOT be denied entry to the country under any circumstances?. They will just have to quarantine for 14 days upon returning.  It will be interesting to see how the Qantas decision affects the American industry. And what about the U.S colleges I can imagine them at least trying to insist upon vaccine to access campus if they can. And if schoolkids have to have the vaccine and as you say then the  parents will probably get it as well.

Edited November 24, 2020 by ace2542

[Smiles1984]

There seems to be a slight blurring here on whether the US will approve a certain vaccine for use within its borders and whether they will accept a non-US citizen vaccinated with it for entry into the country. 

 

Authorising a vaccine for use is decided by a number of factors, whether it works, whether it produces side effects, how expensive it is, and whether or not the politician signing the form (or a member of their family/a friend/babysitter etc) makes any money from it.

 

Allowing visitors from another country based on whether they have had a particular vaccine will be decided by whether the vaccine works, and whether there is anything to be lost/gained by antagonising the country in question.

 

 

[livingonthebeach]

49 minutes ago, orville99 said:

Agree, but there is a difference between willing and needing, and governmental leverage to influence need is quite common. Back when smallpox was raging, we in the U.S. were not mandated to get the vaccine, and a significant number of people (me included) were not willing to get it. That changed when my career required me to travel outside the U.S. While I was not required to get the vaccine before I left the U.S. for Europe, I was prohibited from re-entering the U.S. without a proof of vaccination. No one is mandated to get any vaccine in the U.S., but students in public school systems in the U.S. aren't allowed to go back to school unless they have them. You may not be required to have a Covid vaccination in order to travel outbound (state-to-state, or internationally), but you may have to have proof of vaccination before you can you return.

 

I believe it’s also possible to mandate vaccinations on a State level, however many States are unwilling to do so.