By Jennifer Smith
Federal officials are taking a page from the playbook used
during the H1N1 pandemic in plans to speed vials of Moderna Inc.'s
Covid-19 vaccine to thousands of locations if the shot is cleared
for use by U.S. regulators.
The U.S. rollout plan for the Moderna vaccine and any others
authorized after that relies on McKesson Corp., one of the world's
largest drug wholesalers, as a go-between to manage the shipment of
shots as well as syringes and other supplies needed for
inoculations.
The strategy contrasts with Pfizer Inc.'s distribution effort
for the vaccine it developed with partner BioNTech SE. To cut down
on time in transit, Pfizer is shipping that vaccine, which must be
kept at ultralow temperatures, directly to hospitals and public
health organizations, which are preparing the doses for use with
supply kits McKesson is shipping separately.
A Food and Drug Administration advisory panel recommended
Thursday that Moderna's Covid-19 vaccine be cleared for broad use,
setting the stage for the agency to grant an expected emergency-use
authorization Friday.
The distribution plan developed by the federal Operation Warp
Speed program is to have the Moderna vaccine shipped from
manufacturing sites to McKesson distribution centers for staging
with the supply kits. FedEx Corp. and United Parcel Service Inc.
are to deliver the vaccines to sites designated by 64 U.S. states,
territories and other jurisdictions.
Irving, Texas-based McKesson is the nation's largest middleman
for seasonal-flu shots and distributed the H1N1 vaccine during that
pandemic in 2009 and 2010.
The Covid-19 vaccine effort is several orders of magnitude
larger, however, involving hundreds of millions of doses that must
be shipped under strict temperature requirements in one of the
largest mass mobilizations in decades. The Centers for Disease
Control and Prevention is managing centralized distribution through
an existing contract option with McKesson.
"We've been working to scale up the infrastructure necessary to
be ready to distribute approved vaccines as soon as they are
available," McKesson Chief Executive Brian Tyler said in a Nov. 3
earnings call.
"Based on the volumes that we've been given and projections, we
have quickly been engaged in standing up some new facilities, both
for the vaccine distribution and for the kitting and frankly for
just some storage," Mr. Tyler said. "It's a big effort...but
something that we've successfully done in the past."
Those facilities include two new cold-chain sites outside
Memphis, Tenn., and Louisville, Ky. Future sites will be brought
online to meet anticipated demand, a McKesson spokeswoman said.
"The framework is largely the same as what was used for the H1N1
distribution," said Julie Swann, a professor and head of the
industrial and systems engineering department at North Carolina
State University in Raleigh, N.C., who advised the CDC during the
H1N1 pandemic.
The government sets the vaccine allocations around the U.S. Each
state or jurisdiction decides where those doses will go, the order
is sent to McKesson, "and it gets shipped out the door," said Dr.
Swann.
As with H1N1, initial delivery of the shots to inoculation
sites, local distribution hubs and big retail pharmacy networks
involved in the vaccination program will be handled by commercial
shipping companies, mostly the major parcel carriers. "They do this
every day, and have systems for shipping vaccines," she said.
The Moderna vaccine doesn't require the ultracold temperatures
needed to keep the Pfizer vaccine stable.
Unlike the Pfizer and BioNTech shot, Moderna's can be maintained
at minus 4 degrees Fahrenheit, or minus 20 degrees Celsius, which
most home or medical freezers can achieve. Most pharmaceutical
distribution companies also can ship and store products at that
temperature, Moderna says.
Plans call for the prospective Moderna vaccine to be shipped to
3,285 sites -- more than five times as many as those receiving the
Pfizer shot -- because the government has had more time to plan its
rollout, Gen. Gustave Perna, chief operating officer of Operation
Warp Speed, the federal government's coronavirus vaccine program,
said in a briefing Monday.
Moderna expects to produce 20 million finished doses in the U.S.
this month. The doses will ship from manufacturing sites to a
"fill-finish" facility where the vaccine is put into vials and
packaged for distribution. Somerset, N.J.-based
pharmaceutical-services contractor Catalent Inc. has said it is
working with Moderna to perform fill-finish work at its facility in
Bloomington, Ind.
From there, the Moderna shots are to be handed off to McKesson.
The distributor's RxCrossroads unit will move the vaccine by truck
to its third-party logistics facility, then move the shots to
dedicated Covid-19 vaccine distribution centers, the McKesson
spokeswoman said. McKesson will oversee delivery to hospitals and
other sites, primarily via FedEx and UPS.
Relying on one company to manage distribution for an effort of
this scale and complexity carries some risk. "It will be an
extraordinary challenge for one company to oversee vaccinations of
more than 300 million people through one distribution network,"
retired U.S. Navy Admiral James Stavridis wrote in a Fortune
magazine commentary last month.
The Covid-19 vaccination push is about three to four times
bigger than the annual U.S. flu vaccine distribution effort, and
covers a similar time period of around six months, Moncef Slaoui,
Operation Warp Speed's chief scientific adviser, said
Wednesday.
Although development and manufacturing of the vaccines have been
faster than anticipated, Dr. Slaoui said, the fundamentals for
distributing and administering the Covid-19 shots aren't
significantly different than for flu vaccines, so "using the
existing capabilities and resources is the appropriate and right
thing to do."
Write to Jennifer Smith at jennifer.smith@wsj.com
(END) Dow Jones Newswires
December 18, 2020 06:14 ET (11:14 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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