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 The production of raw materials, vaccine formulation and vial
filling all require "clean rooms" with features like air cleaners,
sterile water and sterilizing steam designed and in some cases built
by specialists.
Moderna Inc on Wednesday announced plans to expand vaccine
manufacturing capacity, but said it will be a year before that can
add to its production.
With vaccines needed for billions of people to end a pandemic that
has claimed more than 2.5 million lives globally, drugmakers have
even had to turn to rivals for help to churn out doses. Space at
third-party contract manufacturers in the United States is largely
allocated, according to one major contract manufacturer and other
smaller companies.
A recent U.S. Government Accountability Office report flagged a
shortage of manufacturing capacity as a challenge in scaling up
vaccine production.
And the emergence of new coronavirus variants is likely to increase
the strain on production capacity.
Public health experts say global vaccination as soon as possible is
critical to curbing the rise of highly contagious additional
variants. Many are counting on authorization of Johnson & Johnson's
vaccine this week.
Longer term, tackling COVID-19 may require annual shots to protect
against new virus mutations, similar to the flu. Vaccine companies
are already designing potential booster shots addressing variants
first identified in South Africa and Brazil.
"What's happening now indicates the importance of markedly
strengthening the capacity of manufacturing capabilities in the
United States," said Larry Corey, a virologist at the Fred
Hutchinson Cancer Research Center who helped design U.S.-backed
vaccine trials. "We should be investing, large scale, in our
abilities to manufacture."
Pfizer and Moderna can increase output some by speeding fill and
finish, said Moncef Slaoui, former chief scientific adviser for the
government's Operation Warp Speed vaccine program. Making much more
vaccine itself is more challenging.
"To change that substantially in terms of drug substance would take
ramping up global manufacturing infrastructure. That takes months,"
he said. "You would have to build, train, validate, and get
regulators to visit and approve a site."
Leading vaccine developers Pfizer and partner BioNTech, Moderna,
AstraZeneca, J&J, Novavax, Russia’s Gamaleya Research Institute, and
CureVac are aiming to make enough vaccine with manufacturing
partners to inoculate some 5.2 billion people in 2021, according to
a Reuters tally of public statements and media reports.
China's Sinovac and Sinopharm will likely deliver significant
supplies as well, though their 2021 targets are unclear. Several
drugmakers have struggled to meet early production targets.
BUILDING FASTER
Building new facilities and even expanding existing manufacturing
sites has typically taken years. During the pandemic, some projects
have been completed in as little as 6-to-10 months, according to
some specialized construction companies involved with Warp Speed.
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 Emergent BioSolutions , which
is making J&J and AstraZeneca vaccines for the
United States, cannot add any more equipment to
facilities dedicated to those vaccines.
The company is not alone. "The contract manufacturing network, like
our facility, is pretty full," said Emergent Executive Vice
President Sean Kirk.
Adding new clean rooms that meet good manufacturing practices
standards is complex and time consuming, said Phil DeSantis, a
consultant and pharmaceutical engineer.
"Building the clean room is probably what we call the critical
path," he said. "That's the part that takes the longest."
Vaccine makers have sidestepped this in part by retrofitting
existing facilities. BioNTech bought a facility in Marburg, Germany,
from Novartis in September, and began producing messenger RNA - the
active ingredient in its vaccine - in early February.
When Emergent joined Warp Speed last year, it stopped everything
else it was working on at its Baltimore facility to make room for
the COVID-19 vaccines.
The U.S. government can use the Defense Production Act to force that
kind of reshuffling. Supply orders with a federal "rating" under the
law must be filled first. But there are limits to what it can do
without threatening supplies of other injectable medicines.
Pfizer last week said it had engaged two U.S. contract manufacturers
and would add capacity to formulate vaccines and make raw materials
at its own sites, but did not specify whether new clean rooms would
be installed.
In adding clean room space to existing sites, drugmakers and their
suppliers have leaned heavily on pre-fabricated wall panels and pods
that speed the process, according to specialist companies that build
those spaces.
G-CON Manufacturing provided pods to some Warp Speed projects. One
contract manufacturer dedicated space to COVID-19 vaccines, and then
used G-CON pods to add clean room space for a different project for
an existing customer, said Chief Executive Maik Jornitz.
"It was sort of the only way," Peter Walters, director of advanced
therapies at CRB, which designs and manages construction of the
facilities, said of the pre-fabricated systems.
CRB has worked on more than 20 coronavirus vaccine-related projects.
The program has "certainly redefined, to a lot of the industry, what
could be possible," Walters said.
Adding more capacity would help the United States tackle COVID-19
variants and future pandemics, said Prashant Yadav, a senior fellow
at the U.S.-based Center for Global Development.
"We can use it for our own needs," he said. "We can use it to serve
the world."
(Additional reporting by Mike Erman in New Jersey, Roxanne Liu in
Beijing and Polina Ivanova in Moscow; Editing by Caroline Humer,
Michele Gershberg and Bill Berkrot)
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