[Byte1]

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.

[npwalters]

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.

[Byte1]

Originally Posted by npwalters

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.

[Arctic Fox]

Originally Posted by Byte1

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.

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

[graciegirl]

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.

[Two Bills]

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!!

[Byte1]

Originally Posted by graciegirl

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.

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.

[Byte1]

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

[Stu from NYC]

Originally Posted by John41

It’s a fact that Operation Warp Speed provided incentives worldwide to produce a Covid 19 vaccine
and now there two available in record time. It’s a model of how to effectively deal with a pandemic and should be publicized not hidden away.

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.

[Arctic Fox]

Originally Posted by Byte1

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.

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.

[Arctic Fox]

Covid vaccine: What does UK vaccine approval mean for US? - BBC News

Originally Posted by Arctic Fox

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

[Altavia]

“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

[PugMom]

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

[Greg L]

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