* Russia has touted Sputnik V vaccine around world
* Vaccine production and exports lower than expected
* Manufacturers face a series of big challenges
* Hurdles serve as a warning to foreign partners
By Polina Nikolskaya and Polina Ivanova
MOSCOW, May 14 (Reuters) - Transforming the site of what
once was a Soviet-era car factory into a state-of-the-art
facility churning out Russia's COVID-19 vaccine Sputnik V was
the easy bit.
Making doses in bulk, finding qualified staff and getting
equipment have been much bigger headaches for Moscow-based
biotech firm R-Pharm and other private Russian companies picked
to make the country's flagship shot to fight the pandemic.
President Vladimir Putin has trumpeted the vaccine around
the world, and said in March that Russia had signed agreements
for the production of 700 million doses of Sputnik V vaccine
abroad.
But Russia had produced just 33 million vaccines as of May
12 and exported fewer than 15 million, according to a Reuters
tally that counted each vaccine as consisting of two doses.
Russia's output is much lower than the hundreds of millions
being made each month by Pfizer and AstraZeneca.
Interviews with four manufacturers and two people involved
in the production process and Russia's supply chain highlight
how difficult it is to make Sputnik V and ramp up production.
The problems are a warning to foreign partners -- including
in India -- that are planning to mass produce the vaccine and
those countries relying on Moscow to supply their inoculation
programmes.
With the United States and European countries focused on
vaccinating domestic populations, Russia has stepped in the
breach, offering shots to more than 50 countries, from Latin
America to Asia.
But delays in getting shots to those countries gives China
and the United States time to fill the gap.
In another blow, Brazil's regulator has denied approval to
import Sputnik V, citing incomplete data on its safety and
efficacy.
The Russian Direct Investment Fund (RDIF), which is
responsible for marketing the vaccine abroad, said the
manufacturing capacity for Sputnik V was increasing globally as
new manufacturers come on board.
RDIF told Reuters it planned to produce enough doses to
vaccinate 800 million people in 2021 and that it had
"demonstrated its strong commitment to honouring supply
contracts".
It said it stood by an offer to provide doses for 50 million
people in the European Union. Russia is hoping the vaccine will
be approved by the European Medicines Agency.
Russia's health ministry did not respond to a request for
comment on production and other problems outlined by
manufacturers.
"BLINDFOLDED"
R-Pharm's new 27,000 square-metre (290,000 square-foot)
factory on the outskirts of Moscow has more than 200 bioreactors
that grow the cells that will form the shots.
R-Pharm was initially learning the process from scratch and
operating the bioreactors was like working "blindfolded", chief
executive Alexei Repik told Reuters.
"Vaccine production takes around 1-1/2 months or more, for
each series," he said. "Then afterwards, you compare the output
to the reference sample. If it matches, you're lucky. If it
doesn't, you pour out the product you made."
The company has also struggled with global shortages of
equipment and raw materials.
R-Pharm was initially gearing up to make 10 million doses a
month but by late March had still not produced 1 million doses.
It began the process of cell growing in November but its new
factory has yet to open officially.
Manufacturers contacted by Reuters said the vaccine was
particularly difficult to make because of its design as an
adenovirus vector vaccine.
The vectors are modified human common cold viruses, used to
carry the genetic information into the body that triggers
immunity-building.
Unlike other adenovirus vaccines, the first and booster
shots of Sputnik V, taken 21 days apart, are made up of two
different vectors and the first shot is easier to produce than
the second, manufacturers said.
"The product is difficult enough and you actually have to
make two different drugs," said Biocad chief executive Dmitry
Morozov, whose company is also making Sputnik V.
To deal with the problems, Russia has teamed up with
AstraZeneca, whose vaccine uses a different adenovirus
shot, two sources familiar with vaccine strategy said. Human
trials of a mix-and-match vaccine are under way in several
countries.
Another option is "Sputnik Light", a single-dose version of
the shot using only the first component.
One private producer, Pharmasyntez, plans to seek permission
to produce only the one-dose vaccine, its chief executive,
Vikram Punia, said. It sent a first batch for quality controls
on May 3.
In response to questions, RDIF said both components of the
Russian vaccine were being produced and delivered on time.
LAND AND PEOPLE
A global rush for equipment has increased Russian producers'
problems, and pharmaceutical plants are in limited supply in
Russia.
Generium, the biggest producer of Sputnik V doses,
re-purposed existing plants to work on the vaccine, as did
Biocad, the only other major producer.
To expand output, new plants will be needed. Generium is
building one to make 200-300 million doses per year, its owner
said in March.
The biggest problem for Pharmasyntez's Punia was a lack of
experienced staff - producing two doses increases strain on
staffing because separate manufacturing spaces and teams are
needed.
"We can buy equipment, we can build plants. But in
biotechnology, competent people is the most important thing. And
there are not very many of them," Punia said.
(Reporting by Polina Nikolskaya and Polina Ivanova; Writing by
Polina Ivanova; Editing by Josephine Mason and Timothy Heritage)
Astrazeneca (AZN)
