(Updated 7 P.M. ET, Dec. 17, 2020 with quote from Disaster Accountability Project.
U.S. officials say they are working with pharmaceutical companies to increase manufacturing capacity and production of COVID vaccines as the pace of order fulfillment to states picks up.
Another 886 hospitals and other administration sites are scheduled to receive their first shipments of the lifesaving drug Thursday, with long-term care facilities being added to the distribution list the next two days, Operation Warp Speed officials said during a press conference Wednesday.
Some unexpected hiccups, however, underscore why Operation Warp Speed, the public-private partnership on vaccine logistics led by the departments of Defense and Health and Human Services, is holding some safety stock from the first allocation to states.
Each insulated box that leaves the Pfizer (NYSE: PFE) plant in Portage, Michigan, or its freezer farm in Pleasant Prairie, Wisconsin, contains five trays of 195 vials and is packed with dry ice to keep the temperature at minus 70 degrees Celsius. It also has a Bluetooth-enabled temperature probe and GPS locator that feeds readings into a sophisticated computer system at the OWS command center in Washington.
Four trays of Pfizer vaccine had temperature excursions as FedEx and UPS drivers were about to deliver them and were pulled back, Army Gen. Gus Perna, chief operating officer for OWS, said.
Logisticians at the control tower noticed that the temperature had gotten colder, to more than minus 80 degrees C, in Pfizer shipments that arrived at two separate California locations. The drivers were immediately contacted to turn around and dispatchers immediately sent out two replacement shipments.
“We locked those trays down, working with FedEx and UPS. They never left the truck,” Perna said.
In Alabama, two trays were received at one location with the same temperature anomaly — a reading of minus 92 degrees C.
“We were able to stop and quarantine the vaccine, get a replacement shipment immediately to Alabama and now we’re just working through the forensics to determine if the vaccine is still good,” Perna said. “We’re working with the FDA, CDC and Pfizer to determine if that anomaly is safe or not, but we were taking no chances.”
OWS is holding back 500,000 doses from the initial batch of Pfizer vaccines to cover any supply chain contingencies that may arise. Winter weather, for example, could pose a challenge to on-time deliveries in the Northeast on Thursday.
Officials plan to increase how much vaccine they allocate each week as they become more confident in the manufacturing and distribution process, and lessons learned in the early states help in that regard, Perna has said.
On Tuesday, OWS allocated 2 million additional doses of Pfizer vaccine for delivery to jurisdictions next week as the logistics operation picks up its cadence and expands its distribution network.
Long-term health care facilities in Ohio and Connecticut will begin receiving shipments on Friday and Saturday, followed by Florida and West Virginia. By Monday, more than 1,100 nursing homes will have been covered and the number will continue to expand.
The Centers for Disease Control and Prevention is collaborating with 19 pharmacy chains to administer the vaccine by about mid-January, initially to priority populations, as doses become more available. Eventually, more than 70,000 CVS and Walgreen pharmacy facilities alone will receive vaccines.
The intense delivery tempo will pause on Christmas and New Year’s Day, except for any emergency distribution that might be required if there are unexpected delays leading up to those Friday holidays. Packing at plants and distribution centers will resume the following day and vaccines will start the day after that, just as every week is supposed to unfold, Perna said.
Reinforcements could be on their way as soon as this Sunday if the Food and Drug Administration as expected approves Moderna Inc.’s (NASDQ: MRNA) vaccine for emergency use on Friday. An advisory panel is meeting Thursday and is expected to give a favorable recommendation after early data showed the drug was 95% effective.
OWS has allocated 5.9 million doses of the Moderna vaccine for the initial distribution wave, double the amount released for Pfizer’s vaccine, which will go to more than 3,200 sites in the first few days.
The availability of a new vaccine from Moderna will also allow planners to expand distribution to more rural areas, Perna said. The fact that the drug only needs to be at normal refrigerated temperatures for up to 30 days makes it easier for rural facilities, many of which don’t have special deep freezers, to handle.
Officials plan to deliver 20 million Moderna doses by the end of the month.
Last week, the government exercised an option to purchase an additional 100 million doses from Moderna.
Pumping up supply
Meanwhile, officials are trying to help vaccine makers accelerate production.
Moncel Slaoui, Operation Warp Speed’s chief medical adviser, said he and Perna recently met with AstraZeneca and Johnson & Johnson (NYSE: JNJ) to discuss how to further optimize their supply chains.
J&J has closed recruitment for phase 3 trials of its Janssen Pharmaceuticals vaccine and could assess its efficacy by next month, with doses potentially available by February or March. AstraZeneca (NASDQ: AZN) is also progressing with its phase 3 trial and could have a readout in February.
The government also continues to add significant capacity to Moderna’s manufacturing capability, utilizing the military’s procurement skills to source materials and equipment, as well as build extra facilities where needed.
The U.S. Army Corps of Engineers is working with Catalent Inc., Moderna’s outsourced fill-finish facility, and Emergent BioSolutions Inc., which provides bulk production, to add scale to their operations, officials said.
But the first priority is getting Pfizer to increase its production capacity, Slaoui said. Pfizer last month cut in half its shipment forecast for this year after experiencing supply chain problems sourcing ingredients.
“Now that they’ve identified what production challenges they’ve got, we’ve been working with them on what assistance is appropriate for us to provide in order for us to secure additional doses,” HHS Secretary Alex Azar said.
The U.S. prepurchased 100 million doses of Pfizer vaccine and is negotiating a follow-on order. Azar and Slaoui pushed back against criticism the U.S. could have to wait for Pfizer to fulfill orders from other countries because the government didn’t commit to more volume earlier.
OWS has been closely engaged in the development and manufacturing of five vaccines, including Moderna’s, but has a more arm’s-length deal with Pfizer under which it was guaranteed the right to purchase the vaccine if it was approved by the FDA.
“And that means, to date, we’ve had less visibility into their manufacturing processes, manufacturing capacities, their locations, supplies, raw material issues and supply chain management than we do with, say, a Moderna or AstraZeneca or Johnson & Johnson,” Azar said.
“So part of our ongoing discussions is to remediate that and get better visibility into what they’re doing and what challenges they are facing, because they’ve made significant commitments to us and others.”
Slaoui added that it didn’t make sense to bulk up on an unproven drug.
“We built a portfolio of vaccines and took them into development to make sure that at least one of them makes it to the finish line. And if more than one makes it to the finish line we can accrue and accumulate vaccine doses faster than if we were relying on a single provider,” he said.
Ben Smilowitz, founder and executive director of the Disaster Accountability Project and SmartResponse.org, a nonprofit started after Hurricane Katrina, says the White House should invoke the Defense Production Act to expand production.
“The vaccines may have been produced at warp speed. However production is, at best, a slow jog due to the lack of leadership from the top,” he said in a statement. “The U.S. government is not treating this disaster with the urgency needed. Quit waiting for a deal and use Defense Production Act to the fullest extent possible.”
Late Monday, the FDA said the Pfizer vials may contain extra doses than originally thought, potentially increasing the supply from 100 million to 120 million doses through March. The company originally said the vials can vaccinate five people, but further analysis shows there is enough drug to administer six or seven injections.