Moderna Inc.’s (NASDQ: MRNA) COVID-19 vaccine could be shipped as early as Sunday, but to five times as many distribution points as Pfizer Inc.’s (NYSE: PFE) product is heading to in its initial wave, according to federal officials.
But maintaining adequate safety stock is a key consideration in both cases.
A Food and Drug Administration advisory panel is expected Thursday to recommend emergency use authorization for Moderna’s vaccine after clinical trials showed it to be 95% effective. If decision-makers follow the same pattern as last week for Pfizer’s vaccine, the agency could approve the drug for public use on Friday, followed by packing temperature-controlled boxes on Saturday and shipping by truck and air on Sunday.
Moderna’s drug is scheduled to go to 3,285 U.S. distribution points compared to 636 locations for Pfizer, Army Gen. Gus Perna, the head of Operation Warp Speed, said during a news conference Monday.
On Friday, the Department of Health and Human Services purchased an additional 100 million doses of COVID-19 vaccine from Moderna, providing continuous delivery through the end of June.
FedEx Express (NYSE: FDX) and UPS (NYSE: UPS) package cars delivered the first shipments of Pfizer’s vaccine early Monday morning and within hours frontline medical workers at hospitals and research centers were being immunized, the first sign of hope for many after nine months of constant combat against the coronavirus.
Express carriers are scheduled to reach 425 administration sites Tuesday and 66 Wednesday. Follow-on orders for the Pfizer vaccine will result in another 581 shipments through the rest of the week.
“It was the initial push that we were fully driving and now we are starting our drumbeat of continuous execution of vaccine,” Perna said.
Under the Operation Warp Speed plan, states identify the dosing sites or storage locations where the drugs should be delivered and the quantities for each, based on their allocation.
Pfizer’s vaccine requires two doses three weeks apart to achieve immunity. The company is shipping 2.9 million doses in the first wave and another 2.9 million doses closer to second-shot administration, with Perna ordering 500,000 doses held in reserve in case of unforeseen contingencies.
“This is about making sure we’re prepared to mitigate situations. As our process matures, both in manufacturing and distribution, the safety stock will go down significantly,” Perna told reporters. “Vaccine sitting on the shelf is not effective. We’re just taking prudent steps to ensure people have access to first and second dose and … everyone across the U.S. gets fair and equitable distribution.”
What could go wrong?
Perna said shipments could be delayed by anything from a simple address problem to weather to a delivery truck or aircraft being involved in an accident.
The OWS computer system that is tracking every supply chain aspect of the vaccine campaign is so sensitive that it won’t properly read Fort Collins, Colorado, if the address is entered as Ft. Collins or if there is an extra space in a hyphenated city.
Everything is meticulously tracked from production to delivery. “We’ve created a steady drumbeat so it’s a predictable execution and the right people are in the right place at the right time to prepare and deliver the vaccine,” Perna said.
Moderna’s vaccine also requires two shots spread out over four weeks. The first batch of Moderna vaccines will contain about 12 million doses, with half being shipped the first week and the remainder scheduled around the second shot. Shipping will follow a similar timeline as the Pfizer rollout this week, with order fulfillment spaced out over several days.
One reason there is more Moderna vaccine in the pipeline at the outset is that the Pfizer vaccine was the first candidate through clinical trials and ready for regulatory review. Perna said he had to decide the logistics plan for the initial rollout in mid-November to allow as much time as possible for planning, based on how much medicine was available at the time, adding he won’t make final allotment decisions based on estimates.
“I didn’t have to snap the chalk line for 10 days later for Moderna, so they’ve accumulated more vaccine,” he said. “But we catch up in the following allocations and cadence so we can ensure a [consistent] flow.”
Operation Warp Speed, led by the departments of Defense and Health and Human Services, will only release vaccine doses once the FDA has approved them. The manufacturers are required to submit certificates of analysis for each drug product lot at least 48 hours prior to distribution. The certificate includes results for each quality control test performed on the final production lot.
Another difference between the Pfizer and Moderna distribution relates to the role of logistics providers and ancillary supplies. Pfizer is packaging and shipping its own vaccine because of its special ultra-cold temperature requirements, with FedEx and UPS handling the transportation from the warehouse docks. UPS, meanwhile, is separately delivering the ancillary kits of syringes, needles, alcohol swabs and diluent for mixing, which will get married up at dosing sites.
In Moderna’s case, McKesson Corp., the government’s centralized logistics coordinator, is responsible for kitting the vaccine and the ancillary supplies to go out together.