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-   -   Pfizer vaccine approved in the UK (https://www.talkofthevillages.com/forums/current-events-news-541/pfizer-vaccine-approved-uk-313641/)

jimjamuser 12-03-2020 01:36 PM

Quote:

Originally Posted by Arctic Fox (Post 1869101)
The annual flu vaccine is a generic, based on the previous year's, and has mixed results depending on how close it matches the actual virus. Since the flu shot varies little from the previous year's version, it is largely assumed that it will be safe to use.

That for Coronavirus has had to be designed from scratch. Not only does this take longer, but more testing is needed for safety before it can be generally released for use.

The major part of the "delay" in releasing drugs is the safety testing, and this is a trade-off between the risks and the benefits. Since the benefits of an effective Coronavirus vaccine are huge, it is considered worthwhile to take a bigger risk that there might be more adverse effects to its use, rather than spending years reducing this risk (and losing the benefits).

Medical scientists began preparing for the generic type of CV (not just CV-19) 3 or 4 years ago. The China wet markets were a CV Pandemic waiting to happen. That is the REASON why they were able to get vaccines for COVID-19 faster than other disease vaccines. Then after some "pulling of teeth" with China, China gave the US and the world the new DNA print of CV-19. Then world-wide SCIENCE went into gear.

jimjamuser 12-03-2020 01:40 PM

Quote:

Originally Posted by noslices1 (Post 1869105)
Moderna submitted their info to the FDA a week or so ago, but the FDA said they will meet and discuss their vaccine on December 10th. Haven’t they heard that we are in a PANDEMIC? What’s the holdup?

Hold onto your water. What happened to so many on this forum calling CV a "hoax". Suddenly it is not a hoax and everyone wants a cure IMMEDIATELY. In June it was a hoax....now it is an emergency. How shortsighted can we be?

graciegirl 12-03-2020 01:42 PM

I will go first in line.

I have always tried to be careful and considered and to seek the best professional opinions for our daughters congenital heart condition and related medical issues. I am somewhat of a picky person about medical care.

We three are satisfied that as soon as we get the go ahead signal from Dr. Joseph Rizzi, our GP here in The Villages, we will get the shot or shots.

Please do what your good sense tells you to do. But PLEASE do not be diverted by conspiracy theories or political Bovine emissions. They come in all forms and I AM TIRED OF IT.

jimjamuser 12-03-2020 01:46 PM

Quote:

Originally Posted by jbrown132 (Post 1869111)
It’s very clear that the FDA does no feel that time is of the essence. Their attitude is so what if another 50 or 100 thousand people die. Based on what I have been reading they knew back in September and early October that this vaccine worked. The phase three trial involved thousands more than they would normally have used in a trial of this nature so they new it’s efficacy rate was over 90%. Based on these facts one can only conclude that it is purely politics. Maybe other big pharmaceutical companies (big money) do not want it approved so they can catch up. Whatever the reason, it is embarrassing for a vaccine that was produced in this country to be approved in another country before it is approved here. The UK is not some backward country. They have excellent scientists there who would not release this if they thought it was a danger to their population. Let’s face it, we all know the reason but to keep this non political I will not mention it. Yesterday I heard that FDA can not meet until next week to discuss this. I mean there is only a pandemic going on so what’s the rush. This is pathetic, politics over lives, how sad.

This 1st CV vaccine was designed and produced in Germany by a company started by 2 Muslim men.

jimjamuser 12-03-2020 01:50 PM

Quote:

Originally Posted by JanetMM (Post 1869131)
Thank you for that link. That article was very informative and answered many of the questions or comments that have been in this and other threads and articles.

Keep in mind that for a long time the FDA has often been slower to approve new meds than most European countries including the UK. This is something I have noticed for decades. I don’t know if that is good or if it’s bad but it really isn’t a political statement of THIS time period. It’s some thing that’s been happening for a long time.

Hope everyone stays safe.

Yes, good post. It is standard protocol. Not at all POLITICAL!

kenoc7 12-03-2020 01:52 PM

Quote:

Originally Posted by Byte1 (Post 1868922)
I read today that the Pfizer Covid 19 vaccine has been approved in the UK. Apparently, it can't be approved here until the panel (death panel?) meets later this month, so they can discuss whether or not it is safe for the U.S. I am sure that someone is going to post on here that they feel it is necessary for the wait. Sorry, but to me it sounds like the delay is political and not science when our leader demands that it be released and the powers that be smile and say it won't be allowed to be released until they say it can be released.

I wonder if those that consistently say that "other" countries are handling the virus better than us, will change their minds and begin to defend those that are hindering the release of the vaccine to the populace. Maybe those "important" folks that are holding it up under pretense of having a full calendar, are waiting for the death toll numbers to peak at a certain level?

I wonder if Pfizer being able to start distributing the vaccine overseas will impact the ability to provide sufficient amounts to the U.S. when the death panel finally meets and decides to allow our folks to obtain protection from the virus.

Just a few thoughts. Red tape and politics seem to be the norm in this country when it comes to any progress in pharmaceuticals.

The delay isn't political; it is the time necessary for the panelists to study the mountain of data and reach conclusions about safety and efficacy. Just stop with the stupid conspiracy theories, please.

Velvet 12-03-2020 01:53 PM

Quote:

Originally Posted by jimjamuser (Post 1869332)
This 1st CV vaccine was designed and produced in Germany by a company started by 2 Muslim men.

Maybe Allah blessed those 2 guys, vaccine... what a gift to the world!

jimjamuser 12-03-2020 01:54 PM

Quote:

Originally Posted by Uncle Pepe (Post 1869187)
I was told by someone that the reason the UK has the Pfizer vaccine first is that it was developed in cooperation with Oxford in England.

No. The Oxford vaccine is the Astra Zenica vaccine. It has a 60 or 70% efficacy.

jimjamuser 12-03-2020 01:56 PM

Quote:

Originally Posted by dtennent (Post 1869189)
Let's separate the press releases from a company from the actual technical data coming out of the research and trials. The FDA has a system whereby independent scientists review the submitted data which is not a trivial matter. Taking a few weeks for this process to run its course to ensure a safe and effective vaccine seems prudent to me. Yes I know that people are dying. However, in the past, people have suffered greatly when the process has been short circuited.

Exactly correct, good post.

jimjamuser 12-03-2020 01:58 PM

Quote:

Originally Posted by Bonnevie (Post 1869201)
I used to be a pharmaceutical sales rep. I can remember a drug, Oraflex, made by Eli Lilly. Approved in Britain before the US. had to be taken off the market less than a month after it was marketed. It had a host of side effects not seen until widespread use. Britain banned it first due the the side effects being seen. Seldane, an antihistamine only lasted about a year. there are many others. With the planned use in the entire population, I am glad they are taking every precaution in checking the findings.

Yes, logical - good post!

jimjamuser 12-03-2020 02:05 PM

Quote:

Originally Posted by dewilson58 (Post 1869235)
When do the right drug makers meet with the FDA.
:MOJE_whot:
(sorry, had to)

Yes. A comma or other punctuation might be HELPFUL for that post. Thank you, Mr. Helpful.

jimjamuser 12-03-2020 02:09 PM

Quote:

Originally Posted by Win1894 (Post 1869250)
Each sovereign nation has the responsibility to review on its own terms, by its own standards, and by its own regulatory agency any application for a market approval of a new drug (vaccine) in that nation. The main component of that review is the clinical study conducted by the drug sponsor. Many other factors are involved in that review process such as the indications, contraindications, warnings and cautions, all this sometimes refered to as the IFU (indications for use) and labelling for the drug. None of this has anything to do with 'death panels'. The primary issues for the FDA are the safety and efficacy of the new drug. All these factors can be different in each country so both the date of submission of the sponsor's application and the length of time for review can be significantly different. None of this is a political matter. After regulatory approval the distribution and sequence of treatment will be conducted mostly a logical order based primarily on the sponsor's ability to manufacture and supply the vaccine.

That was extremely informative! And I believe that the Winchester 1894 was the rifle that won the West - very historic reference!

jimjamuser 12-03-2020 02:14 PM

Quote:

Originally Posted by Larry chappel (Post 1869264)
Here is what I know. My brother-in-laws daughter is a Micro Biologist and she says they haven't even got a vaccine for the H1N1 Virus yet much less an effective one for Covid. Take at your own risk.

Right now, that is NOT the nearly universal conclusion of the World's Medical Scientists.

Joe V. 12-03-2020 02:20 PM

Quote:

Originally Posted by jimjamuser (Post 1869341)
That was extremely informative! And I believe that the Winchester 1894 was the rifle that won the West - very historic reference!

Get educated. The Winchester 1873 was the rifle which held the title of "Won the West". The west was "won" by 1894.

The 1894 model Winchester was acclaimed to be one of the most famous and best hunting rifles of all times.

jimjamuser 12-03-2020 03:49 PM

Quote:

Originally Posted by Joe V. (Post 1869343)
Get educated. The Winchester 1873 was the rifle which held the title of "Won the West". The west was "won" by 1894.

The 1894 model Winchester was acclaimed to be one of the most famous and best hunting rifles of all times.

Thanks, I appreciate getting educated.

jbrown132 12-03-2020 04:30 PM

Quote:

Originally Posted by cherylncliff (Post 1869219)
Pfizer and their German partner are not part of Operation Warp Speed. They did not take any federal money but are self funded. The FDA has a legal responsibility to review and approve all drug marketing in the US to assure safety and efficacy.

They did take hundreds of millions to start stock piling the drug so once it is approved they can release it immediately.

Byte1 12-03-2020 05:09 PM

Quote:

Originally Posted by jimjamuser (Post 1869317)
1st a fact : the Phizer vaccine was developed in Germany by a company run by 2 Muslim men. Phizer bought into their company because Phizer has the distribution capacity................ Now, as to the quote, " our leader demands it to be released". America was not built by ANY one man (or woman). America has leaders in Medical Science that lead and decide when and IF any vaccine or medicine is READY to be unleashed upon the whole US population. No Real Estate developer is qualified to make medical Science proclamations, sorry.... the American Food and Drug Administration is the BEST in the world. They have the best reputation. No thinking American would like to lose that World honor. We need to retain all our possible honors and top-rankings that we can because they have been slipping away rapidly. The world has STOPPED holding the US in high esteem. It must be built back - a too hasty, unscrutinized interference in vaccine protocols would hurt the good US Medical reputation.

As to the quote, "Important folks are holding it up under the pretense of having a FULL CALENDAR" .........THAT IS not the reason for CAUTION. SAFETY is the reason for CAUTION. Only Pfizer and their insiders have had eyes on their own data. That is NOT good enough! Pfizer is in a hurry and in a competition and MIGHT(?) have cut corners on safety. That is why experts outside of Pfizer need to look at the DATA. It is quality control of the life or death kind. There are over 4 separate vaccines on the horizon. If this 1st one available (Pfizer) were to develop problems during its rollout period, then the ANTI-vaccinators will control the media narrative and that COULD(?) blow any nationwide HERD immunity. Nobody wants that to happen. The US can easily wait a few more weeks to encourage vaccine confidence!

Why does a person's religion need to be relevant to the subject? Does Muslim or Christian matter when discussing medicine?
So, you feel that a few hundred/thousand deaths is OK in exigent circumstances? Maybe they could just issue some more masks that are the "cure all?"
America is not held in "high esteem?" I haven't lived overseas for a few years, but I did live half my life overseas and do not agree. We are held in VERY HIGH esteem, even though there are many countries that are jealous of spoiled Americans that take our great nation of Freedom and Liberty for granted. All of the other nations emulate us in many different aspects, such as clothing, cultural music, motor vehicles and movies. But, I can understand how some would think different here in the modern and liberal world. We are constantly bombarded by the media and Hollywood by those that take advantage of all America's got to offer but turn around and disparage it every chance they get. Those that want power must make the minions feel like they NEED their leadership. I won't expound on that further because I do not wish to make this a political thread and have it removed. Some on here insist on making everything political in an attempt to shut it down.

I am all for being careful with medicines when they are created, BUT this one has been tested and tested again and again by many thousands of subjects. Whether the FDA has had sufficient time to review the documentation, I do not know. However, I am not the one that believes that the world is about to end without a miracle. I am not the one that is running amok yelling "the end is near, or the sky is falling." The UK is issuing the vaccine, period. Maybe the FDA is making it political, or maybe not. Hopefully, no one is making it political. All I know is that there are several well tested vaccines out there and there a lot of scared folks out there that need something now. Personally, I don't care if the vaccine comes out next year or the year after. I am not worried about myself. I have lived a good life and do not allow fear to rule my life.
Unlike a couple on here, I do not push the negative. Rather I enjoy the positive and feel that most others do also.

jimjamuser 12-03-2020 06:10 PM

Quote:

Originally Posted by Byte1 (Post 1869377)
Why does a person's religion need to be relevant to the subject? Does Muslim or Christian matter when discussing medicine?
So, you feel that a few hundred/thousand deaths is OK in exigent circumstances? Maybe they could just issue some more masks that are the "cure all?"
America is not held in "high esteem?" I haven't lived overseas for a few years, but I did live half my life overseas and do not agree. We are held in VERY HIGH esteem, even though there are many countries that are jealous of spoiled Americans that take our great nation of Freedom and Liberty for granted. All of the other nations emulate us in many different aspects, such as clothing, cultural music, motor vehicles and movies. But, I can understand how some would think different here in the modern and liberal world. We are constantly bombarded by the media and Hollywood by those that take advantage of all America's got to offer but turn around and disparage it every chance they get. Those that want power must make the minions feel like they NEED their leadership. I won't expound on that further because I do not wish to make this a political thread and have it removed. Some on here insist on making everything political in an attempt to shut it down.

I am all for being careful with medicines when they are created, BUT this one has been tested and tested again and again by many thousands of subjects. Whether the FDA has had sufficient time to review the documentation, I do not know. However, I am not the one that believes that the world is about to end without a miracle. I am not the one that is running amok yelling "the end is near, or the sky is falling." The UK is issuing the vaccine, period. Maybe the FDA is making it political, or maybe not. Hopefully, no one is making it political. All I know is that there are several well tested vaccines out there and there a lot of scared folks out there that need something now. Personally, I don't care if the vaccine comes out next year or the year after. I am not worried about myself. I have lived a good life and do not allow fear to rule my life.
Unlike a couple on here, I do not push the negative. Rather I enjoy the positive and feel that most others do also.

" and feel that most others do also"..........I can feel the NEED expressed here. The need to feel that they are among friends and "like-minded", "like-thinking", "good people". It feels all warm and comfortable when a person can parrot the same thoughts as their friends and co-workers. And all can, in concert, expel out the SAME propaganda. "Hate the Eurasians, love Big Brother" !!!!!!

Kenswing 12-03-2020 06:13 PM

Quote:

Originally Posted by jimjamuser (Post 1869402)
" and feel that most others do to"..........I can feel the NEED expressed here. The need to feel that they are among friends and "like-minded", "like-thinking", "good people". It feels all warm and comfortable when a person can parrot the same thoughts as their friends and co-workers. And all can, in concert, expel out the SAME propaganda. "Hate the Eurasians, love Big Brother" !!!!!!

What in the world are you talking about?

And again, three times as many posts as the next highest poster. Why do you consistently try to dominate every thread you post in?

Joe V. 12-03-2020 06:14 PM

Quote:

Originally Posted by Kenswing (Post 1869405)
What in the world are you talking about?

And again, three times as many posts as the next highest poster. Why do you consistently try to dominate every thread you post in?


He thinks quantity makes up for loss of quality.

stanley 12-03-2020 06:19 PM

Quote:

Originally Posted by Joe V. (Post 1869407)
He thinks quantity makes up for loss of quality.

And obviously it does not.

chet2020 12-03-2020 06:54 PM

Generally the FDA takes 6-10 months to approve a drug or vaccine once they receive the clinical trial data from the pharma company. Approval for the coronavirus vaccine is taking place quite quickly by FDA norms. They'll get criticized whether they approve it too fast or too slow.

Velvet 12-03-2020 07:20 PM

Hope they work on it efficiently. Two people are dying every minute. You can count the time they take in number of lives.

Aloha1 12-03-2020 09:03 PM

Quote:

Originally Posted by Villages Kahuna (Post 1869179)
The reasons for the delay in the U.S. has been extensively explained in both newspapers as well as TV. The delay won’t be anywhere near as long as asserted by this poster.

THIS POST IS POLITICAL AND SHOULD BE REMOVED!

Why did you post then if you want your post removed??

John41 12-03-2020 09:55 PM

Quote:

Originally Posted by dtennent (Post 1869189)
Let's separate the press releases from a company from the actual technical data coming out of the research and trials. The FDA has a system whereby independent scientists review the submitted data which is not a trivial matter. Taking a few weeks for this process to run its course to ensure a safe and effective vaccine seems prudent to me. Yes I know that people are dying. However, in the past, people have suffered greatly when the process has been short circuited.

So the UK short circuited the process and we can expect their vaccinated citizens to start dropping like flies according to you.

stanley 12-03-2020 10:00 PM

Quote:

Originally Posted by John41 (Post 1869463)
So the UK short circuited the process and we can expect their vaccinated citizens to start dropping like flies according to you.

One never knows, now do one?

OhioBuckeye 12-03-2020 10:39 PM

Ohiobuckeye
 
Quote:

Originally Posted by Byte1 (Post 1868922)
I read today that the Pfizer Covid 19 vaccine has been approved in the UK. Apparently, it can't be approved here until the panel (death panel?) meets later this month, so they can discuss whether or not it is safe for the U.S. I am sure that someone is going to post on here that they feel it is necessary for the wait. Sorry, but to me it sounds like the delay is political and not science when our leader demands that it be released and the powers that be smile and say it won't be allowed to be released until they say it can be released.

I wonder if those that consistently say that "other" countries are handling the virus better than us, will change their minds and begin to defend those that are hindering the release of the vaccine to the populace. Maybe those "important" folks that are holding it up under pretense of having a full calendar, are waiting for the death toll numbers to peak at a certain level?

I wonder if Pfizer being able to start distributing the vaccine overseas will impact the ability to provide sufficient amounts to the U.S. when the death panel finally meets and decides to allow our folks to obtain protection from the virus.

Just a few thoughts. Red tape and politics seem to be the norm in this country when it comes to any progress in pharmaceuticals.

If it’s not safe they wouldn’t put it out there yet. Where’s the line, I want to be the 1st one in line!

dtennent 12-03-2020 10:53 PM

Quote:

Originally Posted by John41 (Post 1869463)
So the UK short circuited the process and we can expect their vaccinated citizens to start dropping like flies according to you.

That is clearly not what I said. I appreciate the honest give and take when done with facts. In this case, Great Britain did approve the vaccine very quickly. Other European nations have criticized Great Britain for their haste.

EU criticises '''hasty''' UK approval of COVID-19 vaccine | Reuters

As noted in a previous post, Great Britain has quickly approved previous medicines that were later shown to have serious side effects. BTW, this is not a matter of British scientists vs US scientists, but rather the approval process.


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