Pfizer vaccine approved in the UK
 

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.

I really don't have an opinion as to why the delay with the FDA panel. Still, given the depth of this crisis and the extraordinary measures taken by the manufactures and Operation Warp Speed to get a vaccine available, one has to wonder why not meet right away and get it done. I'm assuming that they did "rolling review" during the process like Britain did.

My thoughts also.

The vaccine to be used in the UK will be manufactured in Belgium, so the USA should not be adversely affected.

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.

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!!

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.

March 30: HHS announced $456 million in funds for Johnson & Johnson's (Janssen) candidate vaccine
April 16: HHS made exit disclaimer icon up to $483 million in support available for Moderna's candidate vaccine
May 21: HHS announced up to $1.2 billion in support for AstraZeneca's candidate vaccine,
July 7: HHS announced $450 million in funds to support the large-scale manufacturing of Regeneron's COVID-19 investigational anti-viral antibody treatment, REGN-COV2
July 7: HHS announced $1.6 billion in funds to support the large-scale manufacturing of Novavax's vaccine candidate
July 22: HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate.
ETC, ETC, ETC...........
From: HHS.gov website

They did a remarkable job making the vaccine in record time and having it ready for distribution.

I would think they are still reviewing the results of the tests and upon completion good to go.

The major drawback with the Pfizer vaccine is that it has to be stored at very low temperatures so, until it is approved for use, it is not feasible to produce large amounts in advance. Once approved, they should be able to ramp up production.

You are correct and Pfizer has developed a “just in time logistics network” to facilitate rapid distribution of the vaccine. This was a major advantage of Operation Warp Speed which provided guarantees to companies for preplanning distribution. The issue of storage has been mitigated by using cold storage containers with dry ice and normal hospital refrigeration to hold the vaccine temporarily. The complete logistics are listed below.

Pfizer is working closely with the U.S. government, including state officials, on vaccine distribution, and we are very grateful for their partnership.
Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than
165 countries. Pfizer manufactures more than 200 million doses of Pfizer vaccines annually and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year.
Our track record gives us confidence in our ability to quickly scale, manufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the United States and Europe. We have experience working with customers with different infrastructures in all markets.
During the initial stage, our contracts are with governments, and we will be providing doses according to their preferred channel and designated vaccination locations, subject to regulatory authorization or approval. We seek to work with governments to support distribution to their defined priority groups, and we anticipate that points of vaccination will vary but may include hospitals, outpatient clinics, community vaccination locations and pharmacies.
We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Our distribution is built on a flexible, just-in-time system, which will ship the frozen vials to the point of vaccination.
In the U.S., our distribution approach will be to largely ship from our Kalamazoo, Michigan site direct to the point of use (POU). We also will use our existing distribution centers in Pleasant Prairie, Wisconsin.
We will be utilizing road and air modes of transportation in the United States, where we expect to be able to get product to any POU within a day or two.
We also have developed packaging and storage innovations to be fit for purpose for the range of locations where we believe vaccinations will take place. We have specially designed,
temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions of -70°C±10°C for up to 10 days. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations.
We will utilize GPS-enabled thermal sensors with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen.
Once a POU receives a thermal shipper with our vaccine, they have three options for storage:
- Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months.
- Refrigeration units that are commonly available in hospitals. The vaccine can be stored for five days at refrigerated 2-8°C conditions.
- The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage.
After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8°C storage conditions for an additional five days, for a total of 20 days. Once thawed and stored under 2-8°C conditions, the vials cannot be re-frozen or stored under frozen condition
The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure.
For additional questions, please visit our COVID-19 hub at Coronavirus disease (COVID-19) Facts, News & Information | Pfizer

“These advisory panels are not necessary for an emergency use authorization”.

“Unlike regulators in the U.K. and some other countries, however, the FDA has not taken the data for the new vaccines on a rolling basis.”

U.K. approves Pfizer’s Covid-19 vaccine, putting pressure on FDA

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

I love your tag line at the end. Be Happy !

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).

December 10
 

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?

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.

Totally agree. Not a time for conspiracy theories.

With a population of over 300 million in the USA, (over 21 million in FL) the vaccine coming in the next few weeks/months is a drop in the bucket, but a good start. Wear your mask & wash your hands in the meantime.

People are dying everyday without covid 19. Remember thalidomide?

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.

I think many pharmaceutical companies are afraid of rushing to vaccinate too quickly because the United States is such a litigious society. If they rush and it’s not tested enough and people die from the vaccine they will be sued by a lot of people if not even the government. The United Kingdom is not as litigious and so they can go through testing more quickly. The pharma companies are not in fear of multi billion dollar lawsuits.

The number of lawsuits after thalidomide just showed these companies they better test and test and test or they could pay the price.

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!

More info
 

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.

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.

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.

I see your worthy debate on this. I, me, Grace Helene, an old woman with no degrees in science, have carefully, every day read about this vaccine journey, I read about it from valid sources in newspapers and I heard first hand from a person who was involved in the clinical trials and I watched when the trials were stopped and saw them start again and I know that Pfizer and Moderna have the ability to protect us more than 90% and Astra Zenica is lower, but more than 70%. I know that one vaccine was tested with more than 70,000 in the test group. Some got the vaccine and some got placebos.

I watched when people gathered here in a large group and wondered if infection would increase afterward and it appeared not to. I have had a million questions and tried to find the answers from science. I was very frustrated that there were so many to me foolish arguments and unfounded conspiracy figures.

I have tried to separate what is really happening from what people are telling us is happening.

I hope they get it here fast and refrigerate it carefully and that someone will invite us three to be vaccinated. Soon.

That is what I want for Christmas.

Pfizer said their quick development of a vaccine had nothing to do with Warp Speed. That sounds logical...It’s all about the BILLIONS of dollars world-wide to be made from getting out a vaccine to be sold across our planet!!!!!

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.

Wow ...
 

A million doses for 21 million population. Hmmm ..

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

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.

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

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.

Vaccine
 

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.

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.

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

The UK is not alone
 

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 !!!!!

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!

1st doses go to hospital staff and nursing homes.