Concerns over vaccine storage and distribution amid unprecedented global demand are weighing on the anticipation of a vaccine from Pfizer (PFE) and BioNTech (BNTX) — even as the companies prepare to fulfill commitments of dose delivery by the end of 2020.
With data set to be released in the coming week and an emergency use authorization likely to be granted by the end of the year, how to ensure the integrity of the vaccines once they’ve reached their destinations — and who will receive the first doses remains largely unknown.
The companies revealed the freezers being used, which can keep the vaccine for six months, in a presentation in September.
More than 300 freezers are currently at a plant in Kalamazoo, Mich., with plans to create an equally-sized “freezer farm” in Wisconsin. The Michigan plant can hold 100 million doses, and company executives believe that is sufficient to hold the necessary doses for shipment.
“We don’t expect to be sitting on doses,” said Tanya Alcorn, vice president of Pfizer’s Biopharma Global Supply division.
In a recent interview with Yahoo Finance, she also noted that the company has ongoing stability studies to see if the vaccines can remain in the freezers for longer without spoiling.
The vaccines will be moved from the freezers to innovative shipping boxes with continuous GPS monitoring approved by the approved by the Federal Aviation Administration to ensure the temperature remains controlled to their point of use.
Rather than rely on the federal government’s distribution process, the company is directly delivering vaccines to the health systems and other priority recipients using shipping companies FedEx and UPS. The shipping containers use dry ice, which can be replaced, to maintain the ultra-cold temperature of -70 degrees Celsius for up to 15 days.
Despite its independent plans, the company has found itself in a tense situation with Operation Warp Speed (OWS), the federal government’s coalition of health agencies and the Department of Defense, to ensure a smooth vaccine production and delivery process.
Pfizer’s President Albert Bourla 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 an update on Friday, President Donald Trump claimed the companies were part of OWS and took credit for positive results revealed earlier in the week.
But the company maintains the government’s $1.95 billion purchase order is just that, a purchase order, along with the supplemental materials like syringes that will be sent to vaccine sites from OWS.
In a statement Friday, Pfizer said, “Pfizer is proud to be one of various vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID-19 vaccine. While Pfizer did reach an advanced purchase agreement with the U.S. government, the company did not accept BARDA funding. Pfizer’s COVID-19 vaccine development and manufacturing costs have been entirely self-funded.”
The company also noted it has invested close to $2 billion at its own risk, and is prepared to continue to bear costs.
“Pfizer is working with OWS to ensure that once authorized or approved, the vaccine can reach those in most need as quickly as possible,” the company said.
Monitoring vaccine shipments
Using GPS devices is a new strategy for Pfizer, since most FAA-approved monitoring devices provide temperature data only after arrival, Alcorn said.
To monitor these shipments, Pfizer is setting up a supply chain control tower that will ensure real-time monitoring, as well as the ability to intervene if any shift in temperature is detected to avoid spoiling the vaccines.
Once the shipments arrive at their destination, it is up to the end-user to maintain the vaccine’s integrity. While few recipients are likely to have cold storage, Alcorn noted that the 15-day window for the shipping boxes and the vaccine’s ability to maintain its integrity for five days in a refrigerator, is sufficient to avoid ultra-cold temperatures.
The investment into a unique infrastructure and distribution strategy for a technology (mRNA) that has never been approved is not cheap. But money hasn’t been a problem, and long-term impact hasn’t been an issue.
“We haven’t thought about what’s next...if we overbought on freezers, we overbought,” Alcorn said.
The company is also starting work on a form of the vaccine that doesn’t require the ultra-cold chain.
“Pfizer and BioNTech are actively exploring a lyophilized (powered) presentation of BNT162b2, which we anticipate might be more stable at refrigerator temperatures than the current frozen liquid formulation,” a spokesperson told Yahoo Finance.
“Pfizer is looking to bring this formulation to market to meet patients’ needs potentially by 2022.”
Until then, the company is also trying to be eco-friendly with the reusable shipping boxes. Pfizer doesn’t anticipate many recipients will do so, but they can call a number so that Pfizer can arrange for the boxes to be picked up and returned. It’s an easy process, Alcorn said.
But if the doses aren’t used up in time, they could end up being wasted.
While the first phase of deliveries will target health care workers and the most vulnerable populations, the federal government recently expanded the number of locations that Americans could get the vaccine by partnering with pharmacies across the country.
Pharmacies gearing up for vaccine distribution
While state and local level governments remain concerned about how to accept and further distribute supplies, pharmacies are being primed to take on direct shipments in the same way they do for flu campaigns.
The U.S. Health and Human Services Department had previously announced a federal partnership with pharmacy chains CVS (CVS) and Walgreens (WBA) to administer vaccines in nursing homes and, subsequently, the general population.
Adding to the breadth of options for Americans, HHS announced more than a dozen more sites, such as pharmacies; retail and grocery stores such as Kroger (KR), Rite Aid (RAD), Publix, Walmart (WMT); and independent pharmacies such as Amerisource Bergen’s Good Neighbor Pharmacy network.
“Its a pretty elegant approach that does broaden the net quite widely,” said Brian Nightengale, president of Amerisource Bergen’s (ABC) Good Neighbor Pharmacy network.
Amerisource Bergen is worried about being eligible to receive doses directly. Its network of about 5,000 pharmacies is located in both urban and rural areas, catering to key demographics amid the pandemic — underserved populations. While the urban sites may have enough volume, rural sites do not, leading Nightengale to wonder if those sites will be ineligible to receive doses.
Nightengale told Yahoo Finance that independent pharmacists have long-standing relationships in communities they serve, which has resulted in higher vaccine uptake when compared to larger chains.
Its a trend he anticipates will stand with the COVID-19 vaccinations as well.
About 40% of all the independent pharmacies serve populations of less than 20,000, with a majority serving areas of less than 50,000 people, according to Nightengale. And more than 90% of all pharmacists have said they are ready to or interested in administering the vaccine.
But if the volume at rural locations is too low to justify the cost of shipment from Pfizer’s end, Nightengale said the residents in rural areas may have to wait until a less-costly vaccine can be shipped to them.
“It’s isn’t so much the five days in the fridge. What’s the minimum number of doses that can be shipped?” Nightengale said. “Pfizer is not going to be shipping five doses in expensive dry-ice containers. So we anticipate there will be a minimum order.”
Which is why, he said, rural zones will likely have to hold out hope for the vaccines in the usual temperature ranges.
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