Bavarian Nordic vows to boost monkeypox vaccine supply to combat
shortfall
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[August 24, 2022]
By Natalie Grover and Stine Jacobsen
COPENHAGEN/LONDON (Reuters) - Bavarian
Nordic - the maker of the only approved monkeypox vaccine - said it was
exploring the viability of using technically expired doses to help
bridge a growing gap between demand and supply due to the current
outbreak.
In an interview with Reuters, CEO Paul Chaplin said global demand for
the vaccine is "exceeding our ability to deliver."
More than 40,000 confirmed cases of monkeypox, including a handful of
deaths, in over 80 countries where the virus is not endemic have been
reported since early May. About a third of the current global case count
is in the United States.
The World Health Organization has labeled the outbreak a global health
emergency, while scarce supply of the vaccine has incentivised several
countries to stretch out doses, with largely unknown outcomes, to make
the most of existing stocks.
One way to address that problem is evaluating whether millions of doses
delivered to the United States in previous years that have technically
expired are still viable.
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From the testing conducted so far, roughly half a million doses still
have shelf life, Chaplin said, adding that the decision to use such
doses ultimately lies with U.S. regulators.
Meanwhile, U.S., European Union and British regulators have backed
changing the way the vaccine is administered by injecting a smaller
amount of the shot intradermally (between the layers of the skin), which
increases by five-fold the doses that can be used from one vial.
Regulators have justified the approach on the basis of a study involving
more than 500 adults, which compared the performance of the vaccine
given either intradermally or subcutaneously (i.e. injected into a layer
of fat beneath the skin), as two doses given about a month apart.
Those who received the intradermal injection received one-fifth of the
subcutaneous dose, but produced similar levels of antibodies as those
who received the original subcutaneous dose, data showed.
FRACTIONAL DOSING
Chaplin raised doubts about the safety of this so-called fractional
dosing approach, citing evidence from the same study that showed
intradermal administration could result in increased local reactions
compared to the original method, something regulators have also flagged.
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![](../images/082422PIX/health23.jpg)
An employee of the vaccine company
Bavarian Nordic works in a laboratory of the company in Martinsried
near Munich, Germany, May 24, 2022. REUTERS/Lukas Barth
![](http://archives.lincolndailynews.com/2022/Aug/24/images/ads/current/farmandhome_lda_FAIR_2022.png) Chaplin also highlighted that the
study showed that the intradermal administration prevented about a
fifth of participants from getting their second shot.
At the moment, Bavarian is not delivering vaccine doses at the pace
that countries have requested, but the company is expecting to
unveil additional manufacturing partnerships in the coming weeks,
said Chaplin.
"We are gearing up expanding manufacturing capacity to deliver that
demand as soon as we can."
Days ago, the company said it had signed with Michigan-based Grand
River Aseptic to expand its ability to deliver finished doses, and
on Wednesday said its own Danish facility had reopened with expanded
capacity.
Altogether, Bavarian expects to deliver roughly four million vaccine
doses by the end of the year to countries, using doses that have
been newly manufactured since May, Chaplin said.
According to a Reuters tally of government statements, there are 1.5
million vials of vaccine that have either been administered or
currently available in the 10 worst-affected countries, which
account for nearly 90% of all cases. The vast majority of doses are
in the United States.
The WHO estimates 10 million doses will be needed globally to
protect the people at highest risk, with a current focus on certain
men who have sex with men and contacts of people infected.
Bavarian, which has raised its 2022 outlook six times since the
outbreak started in May, said sales of its monkeypox vaccine -
variously called Jynneos, Imvanex and Imvamune depending on
geography - amounted to 117 million Danish crowns ($15.65 million)
in the second quarter. It also reiterated its full-year outlook on
Wednesday.
($1 = 7.4766 Danish crowns)
(Reporting by Stine Jacobsen in Copenhagen and Natalie Grover in
London; editing by Jason Neely, Simon Cameron-Moore and Emelia
Sithole-Matarise)
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