As companies prepare to deliver on dosage commitments by the end of 2020, concerns about vaccine storage and distribution are weighing on expectations of vaccines from Pfizer (PFE) and Bioentech (BNTX) in unprecedented global demand.
With data released next week and the possibility of allowing emergency use by the end of the year, how to ensure the integrity of the vaccines once they arrive at their sites – and who will receive the first dose. Mostly unaware
The companies announced the use of a freezer, which can hold the vaccine for up to six months, in a release in September.
With plans to build a “freezer farm” of the same size in Wisconsin, Mitch., There are currently more than 300 freezer plants in Kalamazoo, Milachi. The Michigan plant can hold 100 million doses, and company officials believe that’s enough to keep the dose needed for shipment.
“We don’t expect to sit on a dose,” said Tanya Alcorn, vice president of Pfizer’s biopharma global supply division.
In a recent interview with Yahoo Finance, he also noted that the company has ongoing stabilization studies to see if vaccines can stay in freezers longer without being wasted.
The vaccines will be moved from freezers to innovative shipping boxes, with continuous GPS tracking. Monitoring was accredited by the Federal Aviation Administration to keep the temperature under control at their place of use.
Instead of relying on the federal government’s delivery process, the company delivers the vaccine directly to the health system and other priority recipients using shipping companies FedEx and UPS. Shipping containers use dry ice, which can be replaced, to maintain an ultra-cold temperature of -70 સે C for 15-days.
Despite its independent plans, the company has found itself in a tense situation with the federal government’s coalition of defense agencies, Operation Speed Speed (OWS), to ensure smooth production and delivery of vaccines.
Pfizer President Albert Borla has repeatedly highlighted the company’s investment in vaccine research and development. With the exception of Pfizer and Bioentech, all other vaccine companies have accepted some level of federal funding for their candidates.
In an update on Friday, President Donald Trump claimed that companies are part of the OWS and take credit for the positive results announced earlier this week.
But the company has maintained the government’s ખરીદી 1.95 billion purchase order, with supplementary materials such as syringes, to be shipped from OWS to vaccine locations.
In a statement Friday, Pfizer said: “Pfizer is proud to be one of the various vaccine manufacturers participating in Operation Operation Rap Speed as a potential COVID-19 vaccine supplier. When Pfizer reached an advanced purchase agreement with the US government, the company did not accept large funding. Pfizer’s Covid-19 vaccine development and production costs are fully self-funded. “
The company also noted that it has invested close to 2 2 billion at its own risk, and is willing to bear the cost.
Pfizer is working with OWS to ensure that once authorized or approved, the vaccine can reach those in need as soon as possible, the company said.
Monitoring of vaccine vessels
GPS Lcorn said most FAA-accredited monitoring devices provide temperature data only after arrival, as using GPS devices is a new strategy for Pfizer.
To monitor this shipment, Pfizer is setting up a supply chain control tower that will ensure real-time monitoring, as well as the ability to intervene if a shift in temperature is detected to prevent spoilage of vaccines.
Once the shipment reaches its destination, it is up to the end user to maintain the integrity of the vaccine. While few recipients are prone to cold storage, Alcorn notes that a 15-day window for shipping boxes and five days of vaccine in the refrigerator is sufficient to maintain its integrity, avoiding extreme-cold temperatures.
Investing in a unique infrastructure and distribution strategy for technology (mRNA) that has never been approved is not cheap. But money is not a problem, and long-term impact is not a problem.
“We haven’t thought about what’s next … If we’re going to buy too many freezers, we’re going to buy too many.”
The company is also working on a form of vaccine that does not require an ultra-cold chain.
A spokesperson told Yahoo Finance, “Pfizer and Bioentech are actively exploring the lifilized (powered) presentation of the BNT162B2, which we expect will be more stable in the refrigerator temperature than the current stable liquid formulation.”
“Pfizer plans to bring this formulation to market by 2022 to meet the potential needs of patients.”
Until then, the company is also trying to be eco-friendly with reusable shipping boxes. Pfizer does not expect many recipients to do so, but they can call a number so Pfizer can arrange to pick up and return the selected ones. It’s a simple process, Elcorn said.
But if the dose is not used in time, it can be wasted.
While the first phase of delivery will target health care workers and the most vulnerable populations, the federal government recently increased the number of places where Americans can get vaccinated by partnering with pharmacies across the country.
Pharmacies designed for vaccine delivery
While state and local governments are concerned about how to accept and distribute supplies, pharmacies are considering direct shipments in the same way they do for flu campaigns.
The U.S. Department of Health and Human Services previously announced a federal partnership with pharmacy chains CVS (CVS) and VG Grains (WBA) for the administration of vaccines in nursing homes and then the general population.
Adding to the breadth of options for Americans, HHSA announced more than a dozen sites, such as pharmacies; Retail and grocery stores such as Kroger (KR), Writ Aid (RAD), Publics, Walmart (WMT); And independent pharmacies such as Amerisource Bergen’s Good Neighbor Pharmacy Network.
“It’s a pretty elegant approach that expands the net broadly,” said Brian Nightingale, president of Emersource Bergen (ABC) Good Neighbor Pharmacy Network.
Amerisource Bergen is concerned about being eligible for direct dosing. Its network of about 5,000,000 pharmacies is located in urban and rural areas, providing key demographic information among the epidemic-underworld population. While urban sites may have sufficient volume, rural sites do not, so Nitrangel wonders if those sites will be unsuitable for receiving doses.
Naitengle told Yahoo Finance that independent pharmacists have long-standing ties to their communities, resulting in more vaccine uptake than larger chains.
It is expected that this trend will continue even with the COVID-19 vaccination.
About 40% of all independent pharmacies serve a population of less than 20,000, with the majority serving less than 50,000 people. And more than 90% of all pharmacists have said they are ready or interested in vaccine administration.
But if the volume in rural areas is too low to justify shipment costs by the end of Pfizer, Nightingale said, residents in rural areas may have to wait until a less expensive vaccine arrives.
“Five days in the fridge isn’t all that much. What is the minimum number of doses sent? ”Said Nitengal. “Pfizer will not send five doses in expensive dry-ice containers. So we assume there will be at least an order. “
That’s why, he said, vaccines are likely to be expected in the temperature range in rural zones.
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