By Allison Martell, Carl O'Donnell and Julie Steenhuysen
Feb 25 (Reuters) - The number of available COVID-19 vaccine
doses is steadily rising, but a shortage of physical space that
meets standards for pharmaceutical manufacturing is a major
bottleneck to further expansion, according to drugmakers,
industry construction experts and officials involved in the U.S.
vaccine program.
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.
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)
Astrazeneca (AZN)
