Why Pfizer’s ultra-cold COVID-19 vaccine will not be at the local pharmacy any time soon

[snoop1130]

Why Pfizer’s ultra-cold COVID-19 vaccine will not be at the local pharmacy any time soon

By Carl O'Donnell

 

A person walks past the Pfizer Headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. REUTERS/Carlo Allegri

 

NEW YORK (Reuters) - Work to distribute the experimental COVID-19 vaccine developed by Pfizer Inc and BioNTech SE is gearing up after the companies announced successful interim data earlier on Monday, but it will not be coming to local pharmacies for the general public any time soon.

 

The data, which sent U.S. stocks to record highs [.N], showed that the two companies' experimental vaccine is 90% effective at preventing COVID-19. They are still awaiting data on safety, which could come later this month.

 

Pfizer and BioNTech need to get regulators to sign off on the shot before it can start shipping vaccines to those considered most in need by government. Healthcare workers and people living in nursing homes will likely top that list.

 

But the vaccine's complex and super-cold storage requirements are an obstacle for even the most sophisticated hospitals in the United States and may impact when and where it is available in rural areas or poor countries where resources are tight.

 

The main issue is that the vaccine, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below.

 

"The cold chain is going to be one of the most challenging aspects of delivery of this vaccination," said Amesh Adalja, senior scholar at Johns Hopkins Center for Health Security.

 

"This will be a challenge in all settings because hospitals even in big cities do not have storage facilities for a vaccine at that ultra-low temperature."

 

Indeed, one of the most prestigious U.S. hospitals, the Mayo Clinic in Rochester, Minnesota, said it does not currently have that capability.

 

"We're talking about a vaccine that needs storage at minus 70 or 80. That's a tremendous logistical issue not only in the U.S. but outside the Western world," said Dr Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic.

 

"We're a major medical center and we don't have storage capacity like this. That will be true for everybody. This is a logistical obstacle."

 

Pfizer spokeswoman Kim Bencker said the company was working closely with the U.S. government and state officials on how to ship the vaccine from its distribution centers in the United States, Germany and Belgium around the globe.

 

The detailed plan includes using dry ice to transport frozen vaccine vials by both air and land at their recommended temperatures for up to 10 days, she said.

 

ON ICE

 

State and local healthcare providers are responsible for storing and administering vaccines once delivered.

 

They can be kept in an ultra-low temperature freezer for up to six months, or for five days at 2-8 degrees C – a type of refrigeration commonly available at hospitals, Bencker said.

 

The Pfizer storage units can also be refilled with ice for up to 15 days, she said.

 

But shots will spoil in around five days at normal refrigeration temperatures of slightly above freezing. BioNTech CEO Ugur Sahin told Reuters the companies are analyzing if they can extend that for two weeks.

 

The vaccine of Moderna Inc, which is working on a vaccine based on similar technology, does not need to be stored at such a low temperature.

 

Other vaccines including ones from Johnson & Johnson and Novavax Inc can be stored at 2-8 degrees C, the temperature of a regular refrigerator.

 

EXPANSION

 

Northwell Health, a major hospital system in New York, is expanding its ultra-cold storage capacity. Although it is possible to deploy the vaccine before it spoils, Northwell Chief Pharmacy Officer Onisis Stefas said the hospital decided the freezer access would ensure a smooth rollout.

 

The cold storage requirements could impede Pfizer’s ability to reach rural healthcare systems and nursing homes, or less wealthy nations, which may not have the funds for the refrigeration units, experts said.

 

"If Pfizer’s is the only vaccine to be authorized in the next few months, we do worry about equity when it comes to spreading it to rural areas,” said Claire Hannan, executive director at the Association of Immunization Managers, a lobbying group for local public health officials who handle vaccines.

 

Ultra-cold freezer supplies are already limited as hospitals scramble to stock up, Stefas said.

 

Some states have said they have a shortage of ultra-cold freezers, according to public documents that states filed with the U.S. Centers for Disease Control.

 

New Hampshire has purchased extra ultra-cold freezers and like other states is lobbying the Trump administration for additional funds, the documents show.

 

California has also said ultra-cold freezer supplies are limited and roughly half of the states’ health departments are looking in to purchasing or leasing additional cold storage supplies.

 

It has proposed building a distribution network of ultra-cold freezers, including mobile vaccination clinics, to reach underserved areas around the state. California said it will not provide vaccine supplies to facilities without adequate cold-storage capabilities.

 

Without the extra equipment, doctors will have a dilemma: store vaccines in standard refrigerators and deploy all 975 doses in each Pfizer vaccine container in less than five days or restock them with dry ice and open them only twice a day to extend the vaccines’ life span, Hannan said.

 

"I think it will be difficult, but based on the task and how important it is, people will do the best to their ability to make that happen," Stefas said.

 

-- © Copyright Reuters 2020-11-10

 

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[keith101]

5 minutes ago, snoop1130 said:

experimental vaccine is 90% effective at preventing COVID-19.

Not good enough they need to be 100% effective to be any good for everybody .

[Blumpie]

8 minutes ago, keith101 said:

Not good enough they need to be 100% effective to be any good for everybody .

Nonsense.

90 percent is a pipe dream that they had no idea they could attain.

Its a dream result - 60 to 70 percent would be excellent.

Please, stop spreading your prison planet nonsense online.  

[ukrules]

The -80 degree C is the major issue here.

 

There is one that requires nothing like this, it's the one known as ChAdOx1 during development, I can't recall offhand what temperature it requires but it's nothing like the extreme -80 C.....

 

[tgw]

time to buy stocks of manufacturers of such equipment.

Edited November 10, 2020 by tgw

[impulse]

16 minutes ago, tgw said:

time to buy stocks of manufacturers of such equipment.

 

By the time we read about stuff like this, the news is already built into that stock price.  Probably already oversubscribed, with early entrants ready to dump their stock and take their profits.

 

[Pattaya46]

25 minutes ago, tgw said:

time to buy stocks of manufacturers of such equipment.

 

Other upcoming vaccines may not have this constraint...

[tgw]

9 minutes ago, impulse said:

 

By the time we read about stuff like this, the news is already built into that stock price.  Probably already oversubscribed, with early entrants ready to dump their stock and take their profits.

 

on that kind of indirect information, the effect is much slower, especially if you choose manufacturers with a local market.

 

the market doesn't react as fast as a commodities market reacts to war in the middle east or a draught.

Edited November 10, 2020 by tgw

[rabas]

1 hour ago, ukrules said:

The -80 degree C is the major issue here.

 

There is one that requires nothing like this, it's the one known as ChAdOx1 during development, I can't recall offhand what temperature it requires but it's nothing like the extreme -80 C.....

ChAdOx1 seems to be a standard virus vector vaccine.  The new mRNA vaccine  is a piece of raw mRNA code in a nano lipid ball.

 

You would think if man can create custom mRNA codes to program your cells and pack it into nano lipid balls, they could figure out how to work at dry ice temperatures.  It may be more a bureaucracy and logistics problem:

 

Work on COVID-19 Vaccine Distribution is “Mind-Bogglingly Complex”

 

But molecularly programmable nano lipid balls are OK....

[thaibeachlovers]

10 hours ago, keith101 said:

Not good enough they need to be 100% effective to be any good for everybody .

Do you know of ANY vaccine that is 100% effective?

[DDBKK]

1 hour ago, thaibeachlovers said:

Do you know of ANY vaccine that is 100% effective?

He doesn't even know where he left his shoes last night. (Hint: likely beside the front door...)

[shdmn]

11 hours ago, keith101 said:

Not good enough they need to be 100% effective to be any good for everybody .

90% is considered quite good.  A lot of people were hoping for something that is at least 60% effective. I don't think 100% is realistic for any vaccine.

Edited November 10, 2020 by shdmn

[Proboscis]

12 hours ago, rabas said:

 

 

You would think if man can create custom mRNA codes to program your cells and pack it into nano lipid balls, they could figure out how to work at dry ice temperatures.  It may be more a bureaucracy and logistics problem:

 

 

It is an engineering problem mixed in with a pharma problem. Either they find a neat engineering solution to keeping the shots at the ultra low temperature or they find a way of tweaking the vaccine so that it does not have to be kept at such ultra low temperatures. Neither have to do really with bureaucracy or logistics.

[sawadee1947]

19 hours ago, keith101 said:

Not good enough they need to be 100% effective to be any good for everybody .

Compared to a quote of around 60-70% concerning masles...... 90% with the German vaccine is brilliant. 

Flu injection will give you only around 30-50% effectiveness. 

 

 

 

[cormanr7]

2 hours ago, sawadee1947 said:

Compared to a quote of around 60-70% concerning masles...... 90% with the German vaccine is brilliant. 

Flu injection will give you only around 30-50% effectiveness. 

 

 

 

Indeed, no vaccine is 100% effective. But people overlook another major factor: an efficacy of 90% (the accuracy of which is questionable as we talk about very small numbers) would be great IF everyone was vaccinated (in the shorter time this is not feasible anyway so will likely be restricted to certain risk groups).  If, however, 50% refuses to do so, it will only reduce the number of deaths. 

    The cold storage requirements for the Pfizer stuff present a further hurdle, in Germany for instance there is now talk of setting up a few specialized centres with the proper facilities. You will be unlikely to get a jab at your local doctor. In developing countries with limited facilities the transport/storage will likely be a major hurdle. 

[RPCVguy]

It is good news that a vaccine is at this point of use, but the complications as to the ultra freezing and the specificity of the portion of the virus that the mRNA trains the immune system to block IS NOT AS STABLE as other portions of the virus. This entire segment of the 1 hr show is good , but to go directly to the temperature and mRNA issues, you can fast forward to the 24½ minute mark. Better, the transcription of the video is included in the link.
Pfizer Raises Hope for Vaccine, But Many Questions Remain

Edited November 11, 2020 by RPCVguy
link needed to be added

[sawadee1947]

1 hour ago, cormanr7 said:

however, 50% refuses to do so, it will only reduce the number of deaths. 

This is the task of Govt and scientists to convince people for vaccination. We need around 60%, not even more for herd immunity. 

[Elkski]

ArticIe said -70 degrees not -80 this is important.  Dry ice sublimes at  -78c.    Dr Faucci always said 70% effective would be wonderful combined with a high % uptake  but he worried about  vaccine deniers. 

Making  a refrigerator that cools to this  temperature is complicated and expensive.  It requires a large amount of energy, the supporting equipment is big and heavy.   Its not so easy to whip up  these things in 2-3 months.    

 

[thaibeachlovers]

On 11/11/2020 at 4:14 PM, Proboscis said:

It is an engineering problem mixed in with a pharma problem. Either they find a neat engineering solution to keeping the shots at the ultra low temperature or they find a way of tweaking the vaccine so that it does not have to be kept at such ultra low temperatures. Neither have to do really with bureaucracy or logistics.

My farmer friend reminded me that semen for artificial insemination of cows is kept below -70 C. That aspect is probably not a serious problem for the vaccine. He takes the semen containers in the back of his car to where they are needed.

[thaibeachlovers]

19 hours ago, Elkski said:

ArticIe said -70 degrees not -80 this is important.  Dry ice sublimes at  -78c.    Dr Faucci always said 70% effective would be wonderful combined with a high % uptake  but he worried about  vaccine deniers. 

Making  a refrigerator that cools to this  temperature is complicated and expensive.  It requires a large amount of energy, the supporting equipment is big and heavy.   Its not so easy to whip up  these things in 2-3 months.    

 

Perhaps they need to ask the cattle artificial insemination people in NZ how to do it. They've been transporting semen at under -70 C for many years. It's not even a big deal.

[Expat Brad]

On 11/10/2020 at 7:12 PM, keith101 said:

Not good enough they need to be 100% effective to be any good for everybody .

No vaccine is 100% effective. This one will be no different, or any other for that matter!!!

[Elkski]

On 11/12/2020 at 1:04 AM, thaibeachlovers said:

Perhaps they need to ask the cattle artificial insemination people in NZ how to do it. They've been transporting semen at under -70 C for many years. It's not even a big deal.

haha,, you made my point.  Breeding a  bull with 15,000$ semen is important.  But a 5kg 1 cu ft  dry oce shipping box is much different than these  drugs. they  are being packed by the pallet.. In fact each drug company has specs on pallet size and weight, how many doses per truck or shipping container. etc.

[Kadilo]

On 11/10/2020 at 1:56 PM, impulse said:

 

By the time we read about stuff like this, the news is already built into that stock price.  Probably already oversubscribed, with early entrants ready to dump their stock and take their profits.

 

True say. If you track Pfizer’s share price it’s hardly budged since the announcement. In fact it was higher in 2018/19. 

Edited November 13, 2020 by Kadilo

[shdmn]

On 11/11/2020 at 4:19 AM, Elkski said:

ArticIe said -70 degrees not -80 this is important.  Dry ice sublimes at  -78c.    Dr Faucci always said 70% effective would be wonderful combined with a high % uptake  but he worried about  vaccine deniers. 

Making  a refrigerator that cools to this  temperature is complicated and expensive.  It requires a large amount of energy, the supporting equipment is big and heavy.   Its not so easy to whip up  these things in 2-3 months.    

 

I have read both -70 and -80.  I think -70 is ok but -80 is better.  I also read that it can last a few days in special shipping containers with dry ice and can then be stored in a normal refrigerator for a few days before it goes bad.  So it sounds feasible that it can be transported around the world and used as long as it's done right away.

[RPCVguy]

On 11/14/2020 at 9:13 PM, shdmn said:

I have read both -70 and -80.  I think -70 is ok but -80 is better.  I also read that it can last a few days in special shipping containers with dry ice and can then be stored in a normal refrigerator for a few days before it goes bad.  So it sounds feasible that it can be transported around the world and used as long as it's done right away.

Shipping around the world has an issue of dry ice being a hazardous substance aboard airplanes... probably because as air pressure goes down the dry ice sublimates. Start the article with this reminder, -70ºC = -94ºF.
This article by CBS News goes into many of the specifics as to storage time issues:
Distributing Pfizer's vaccine will be a "logistical nightmare"
Some of the main hurdles listed are:

• Pfizer's shipping boxes, packed with specially formulated dry ice and containing between 1,000 and 5,000 vaccine doses each, can only be opened twice a day for less than three minutes at a time while maintaining temperature standards.

• Even so, the deep-freeze suitcases only hold their cool for 10 days. And the clock starts ticking when they are sealed, which for U.S. shipments will be at one of two Pfizer facilities, in either Kalamazoo, Michigan, or Pleasant Prairie, Wisconsin.

• Pfizer's vaccination requires two doses 21 days apart, making it more complicated to deliver the required number of treatments with doses going to waste. 

[balo]

Forget this vaccine from Pfizer, there is already a new traditional vaccine on it's way that can be stored in a normal fridge.  And that vaccine will be very important to distribute to all the poorer countries in Africa, Asia etc.  Also it's more than 90% effective. 
 

Edited November 17, 2020 by balo

[mommysboy]

Sadly, the Pfizer and Moderna vaccines just to not lend themselves to mass inoculation programs.  Maintaining the integrity of a conventional 'cold chain' is challenge enough, but these vaccines require 'a frozen chain'.

 

Too perfect.  We need something that works in practice.

[GroveHillWanderer]

On 11/10/2020 at 7:12 PM, keith101 said:

Not good enough they need to be 100% effective to be any good for everybody .

There are no vaccines or medicines that are 100% effective.

 

If that were the level of efficacy required for use, there would be no medicines in use anywhere in the world.

[GroveHillWanderer]

On 11/14/2020 at 9:13 PM, shdmn said:

I have read both -70 and -80.  I think -70 is ok but -80 is better.

The actual figure is -70°C, plus or minus 10°. So either -70 or -80 is within the required range.

[GroveHillWanderer]

On 11/18/2020 at 5:57 AM, balo said:

Forget this vaccine from Pfizer, there is already a new traditional vaccine on it's way that can be stored in a normal fridge.  And that vaccine will be very important to distribute to all the poorer countries in Africa, Asia etc.  Also it's more than 90% effective. 
 

Probably more than one, if they pan out successfully. The Oxford/AstraZeneca vaccine and two others mentioned in the article (Johnson & Johnson and Novavax vaccines) can all be stored at 2-8°C, the temperature of a regular refrigerator.