Concerns about vaccine storage and distribution amid unprecedented global demand weighed on the prospect of a vaccine from Pfizer (PFE) And BioNTech (BNTX) – even as companies prepare to meet dose delivery commitments by the end of 2020.
With the data set to be released next week and permission to use in emergencies will likely be granted by the end of the year, and how to ensure the safety of vaccines once they reach their destination – and who will receive the first doses is largely unknown.
The companies disclosed the used freezers, which can keep the vaccine for six months. In a presentation in September.
There are currently more than 300 freezers at a plant in Kalamazoo, Michigan, with plans to establish an equal-sized “freezer farm” in Wisconsin. The Michigan plant can hold 100 million doses, and company executives believe they’re enough to hold the doses needed for shipping.
“We don’t expect to be sitting on doses,” said Tania Alcorn, vice president of global supplies of biopharmaceuticals at Pfizer.
In a recent interview with Yahoo Finance, she also indicated that the company has ongoing stability studies to see if vaccines can stay in freezers for longer without spoiling.
Vaccines will be transported from freezers to innovative shipping boxes with continuous monitoring of the Global Positioning System (GPS) approved by the Federal Aviation Administration to ensure continued temperature control to the point of use.
Instead of relying on the federal government distribution process, the company delivers vaccines directly to health systems and other priority recipients using FedEx and UPS shippers. Shipping containers use dry ice, which can be replaced, to keep extremely cold temperatures of -70 ° C for up to 15 days.
Despite its independent plans, the company found itself in a tense position with Operation Warp Speed (OWS), the federal government’s coalition of health agencies and the Department of Defense, to ensure that the vaccine was produced and delivered smoothly.
Pfizer’s president, Albert Burla, has repeatedly highlighted the company’s investment in vaccine research and development. Other than Pfizer and BioNTech, all other vaccine companies have accepted some level of federal funding for their candidates.
In a Friday update, President Donald Trump claimed that the companies were part of the OWS and took credit for the positive results unveiled earlier in the week.
But the company maintains the $ 1.95 billion government purchase order, which is a purchase order, along with complementary materials such as syringes that will be sent to vaccine sites from OWS.
Pfizer said in a statement on Friday: “Pfizer is proud to be one of many vaccine manufacturers involved in Operation Warp Speed as a potential coronavirus vaccine supplier. While Pfizer reached a pre-purchase agreement with the United States government, the company did not accept funding. BARDA. Development and manufacturing costs for Pfizer’s COVID-19 vaccine were completely self-funded. “
The company also indicated that it has invested nearly $ 2 billion on its own responsibility and is willing to continue bearing the costs.
“Pfizer is working with OWS to ensure that the vaccine, once approved or approved, can reach those who need it most as quickly as possible,” the company said.
Monitor shipments of the vaccine
The use of GPS devices is a new strategy for Pfizer, Alcorn said, because most FAA-approved monitors only provide temperature data after arrival.
To monitor these shipments, Pfizer is setting up a supply chain control tower that ensures real-time monitoring, as well as the ability to intervene if any temperature change is detected to avoid spoiling vaccines.
Once shipments reach their destination, it’s up to the end user to keep the vaccine safe. While few recipients likely have cold storage, Alcorn noted that the 15-day window for shipping boxes and the ability of the vaccine to keep five days safe in the fridge, is sufficient to avoid the extremely cold temperatures.
Investing in a unique infrastructure and distribution strategy for mRNA technology that has never been approved is not cheap. But money wasn’t an issue, and the long-term effect wasn’t an issue.
“We haven’t considered the next step … if we over-buy on freezers, we’re over-buying,” said Alcorn.
The company has also started working on a form of vaccine that does not require a super cold chain.
“Pfizer and BioNTech are exploring a lyophilized (powered) presentation of BNT162b2, which we expect may be more stable in refrigerator temperatures than the current frozen liquid formulation,” said a Yahoo Finance spokesperson.
“Pfizer is looking to bring this formulation to market to meet patient needs by 2022.”
Until then, the company is also trying to go green with reusable shipping boxes. Pfizer doesn’t expect many recipients to do this, but they can call a number so Pfizer can arrange to pick up and return the boxes. It’s an easy process, Alcorn said.
But if the duo is not used in time, they may end up getting lost.
While the first phase of deliveries will target health care workers and the most vulnerable populations, the federal government recently expanded the number of sites where Americans can get the vaccine by partnering with pharmacies across the country.
Pharmacies are preparing to distribute vaccines
While state and local governments Remain worried On how to further accept and distribute supplies, pharmacies are set up to receive direct shipments the same way they handle flu campaigns.
The U.S. Department of Health and Human Services previously announced a federal partnership with pharmacy chains CVS (CVSWalgreensWBA) To give vaccines in nursing homes and, accordingly, the general population.
In addition to the array of options available to Americans, HHS has announced more than a dozen other locations, such as pharmacies; Retail and grocery stores like Kruger (KR), Rite Aid (Rad(, Publix, Walmart)WMT); And independent pharmacies like AmeriSource Bergen’s Good Neighbor pharmacy network.
It’s a very elegant approach that extends the grid very broadly, ”said Brian Nightingale, president of AmeriSource Bergen’sABCGood neighborhood pharmacies network.
AmeriSource Bergen is concerned that he will be eligible to receive doses directly. Its network of nearly 5,000 pharmacies is located in both urban and rural areas, serving the main demographics amid the pandemic – the underserved population. While urban sites may have sufficient volume, rural locations are not, which leads Nightengale to question whether these locations will be ineligible to receive doses.
Nightengale told Yahoo Finance that independent pharmacists have had long-term relationships in the communities they serve, which has resulted in increased vaccine uptake compared to the larger chains.
It’s a trend that he predicts will stand up to COVID-19 vaccines as well.
About 40% of all independent pharmacies serve fewer than 20,000 people, with the majority serving fewer than 50,000 people, according to Nightengale. More than 90% of pharmacists said they are ready or interested in administering the vaccine.
But if the volume in rural areas is too low to justify the shipping cost from Pfizer’s end, Nightingale said residents in rural areas may have to wait for a less expensive vaccine to be shipped to them.
“The five days in the refrigerator aren’t that much. What’s the minimum number of doses that can be charged?” Nightengale said. Pfizer will not ship five doses in expensive dry ice containers. So we expect there to be a minimum order.
This, he said, is why rural areas are likely to hold fast to vaccines in their usual temperature ranges.
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