Talk of The Villages Florida - Pfizer vaccine approved in the UK

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

Quote:

Originally Posted by graciegirl (Post 1868935)

I heard on the local news yesterday that it would be released here on the fifteenth and today I heard from the same local news that it would be the tenth of December to Health workers and first responders and then to those in long term care.

The same news reported that Governor Desantis has a million doses on order for Florida.

Wrong drug makers meet with FDA on the 15th. That’s not when it gets distributed.

Quote:

Originally Posted by Byte1 (Post 1868944)

It was reported on TV that the panel would meet on the 10th to decide IF the vaccine would be released. It has to be "approved" before they will allow it to be disseminated. In my opinion, if it was already approved there would be no reason to wait until the 10th for it to be shipped. I am just basing my opinion on the information that the media is putting out there. I have also heard that the vaccine is going to be released to the public on the 10th or the 15th. If that is true, then why not now? I assume that they have to get approval before they can commit to inoculating.

They want to be free of liability as consumers have no idea what they have compounded the vaccine with. Cant sue if you get sick.

Quote:

Originally Posted by KRM0614 (Post 1869231)

Wrong drug makers meet with FDA on the 15th.

When do the right drug makers meet with the FDA.
:MOJE_whot:
(sorry, had to)

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.

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.

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.

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.

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Originally Posted by RoadToad (Post 1869221)

A million doses for 21 million population. Hmmm ..E

Does anyone know if that is 1 million doses for 1 million (actually 2 million as you need 2shots) or enough for 500,000? That is a difference. It will be some time before the majority of the population is vaccinated.

Quote:

Originally Posted by RoadToad (Post 1869221)

A million doses for 21 million population. Hmmm ..

The million doses is the first wave. Try Google, it will help you

The UK is not alone

Quote:

Originally Posted by Two Bills (Post 1868940)

Wife and I are top of list for early vacination, just after nursing homes and care staff.
Then it is us over 80's and front line staff in hospitals.
Think they are starting with the oldies in case it all goes wrong, and the vacinated start dropping like flies.
It is going to be a logistical nightmare, but UK governments are very good at creating nightmares, so no one will be holding their breath waiting!!

The UK good at spreading nightmares......so there are none here !!!! At 75 years old we have to change our whole life because of some selfish folk spreading the virus.. and this is not a nightmare !!!!!

Quote:

Originally Posted by Byte1 (Post 1868922)

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!

Quote:

Originally Posted by PugMom (Post 1869090)

ok., idk how accurate this is, but i overheard a druggist @ Walgreens tell a customer they expected the doses in by Dec., 15th.

1st doses go to hospital staff and nursing homes.

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.

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?

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.

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.

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!