[Ip-health] Endpts: Biden's fight with Moderna over providing vaccines for the poorest countries intensifies

Thiru Balasubramaniam thiru at keionline.org
Thu Oct 14 23:34:36 PDT 2021


October 14, 2021 06:24 AM EDT Updated 06:52 AM Coronavirus
Biden's fight with Moderna over providing vaccines for the poorest
countries intensifies
Zachary Brennan
Senior Editor

With about $10 billion in taxpayer funds invested in Moderna so far, it
would seem that the company would be more understanding of pleas from
President Joe Biden and the federal government to provide more vaccine
doses to low- and middle-income countries.

But the Biden-Moderna feud over supplying the world with doses of mRNA
vaccines is now spilling into the public, with Biden’s chief science
officer of the government’s Covid-19 response David Kessler explaining the
details in an online panel discussion moderated by Yale law professor Amy
Kapczynski on Wednesday.

“We don’t have months to wait,” Kessler said, noting that he’s recently met
with both Moderna’s board of directors and CEO Stéphane Bancel on the
issue, hinting that the Defense Production Act, a way to require a company
to produce more vaccine doses immediately, could be put to use in this case.

Just yesterday, Moderna announced that Gavi exercised its option to
purchase an additional 176.5 million doses of its vaccine for COVAX. But
the majority of those doses won’t be delivered this year. Of these
additional doses, 116.5 million doses are expected to be delivered in the
first quarter of 2022, Moderna said, and 60 million doses are expected to
be delivered in the second quarter of 2022.

According to a recent investigation in the New York Times, only about 1
million doses of Moderna’s vaccine have gone to countries that the World
Bank classifies as low income (vs. 8.4 million Pfizer doses and about 25
million J&J doses).

And of the handful of middle-income countries purchasing Moderna’s vaccine,
most have not yet received any doses, and at least three have had to pay
more than the US or EU, according to government officials in those
countries, the Times reported.

“The government played a very substantial role in making it that company,
and that does up the ante on Moderna,” Kessler said. “They understand what
we expect to happen. This government hasn’t made a decision yet on what it
will do. But we are waiting.”

But overall, he said he didn’t have those same concerns with Pfizer
providing enough doses on schedule.

“I have no doubt, unless something unforeseen happens, that Pfizer will
deliver,” Kessler said. “Moderna can speak for itself. We’ve been in very,
very intense discussions with Moderna. There is very substantial capacity
through 2022 for them to close and even exceed the COVAX gap.”

He also stressed how the companies are protecting their mRNA knowhow as
it’s clearly an asset that “they are reluctant to give up,” he said. But,
having said that, “there is a way to build, with Moderna and Lonza,
significant capacity on continents like Africa and we expect them to do so.”

As far as capacity overall goes, Kessler noted that in addition to billions
of doses in capacity for Moderna and Pfizer, J&J may restart manufacturing
of its vaccine at the previously troubled Emergent facility in Baltimore by
the end of the year.

“There are doses scheduled to come off the line [for J&J] beginning in
April, that should be in the billion plus range. Putting together those
capacities, short term through 2022, there is, if both companies step up as
they need to do, this gap can be closed,” Kessler said.

Several of the other panelists questioned Kessler on other ways that the US
can play a leading role in promoting the manufacture of Covid-19 vaccines.

“Certainly DPA is probably the strongest authority, and that does give the
US president the power to allocate doses,” he said.

But with regard to the government’s ability to unleash the information
around the knowhow of mRNA manufacturing, which Sen. Elizabeth Warren and
other Democrats are calling for, according to a Washington Post report
yesterday, Kessler said that under the government’s R&D contract with
Moderna, that CMC info can be requested but, “they were designated as
limited data rights so they could not be shared.”

“Suffice it to say, and I have asked this question, as I understand it, the
government is not in possession of the knowhow or the recipe for the mRNA
vaccines,” Kessler said. “Do not underestimate the resolve the US
government in addressing this issue. But the best recourse is for them [the
companies] to step up now.”

Moderna CEO Bancel said in a recent statement that the company supports
COVAX’s mission to ensure broad, affordable and equitable access to Covid
vaccines and, “We believe our vaccine can play an important role in
addressing the needs of low income countries given its combination of high
Phase 3 efficacy against COVID-19, strong durability in the real-world
evidence, and superior storage and handling conditions. We recognize that
access to all vaccines, including ours, continues to be a challenge in many
parts of the world which is one of the reasons why we have worked hard to
enable a 50 µg booster dose, which will increase the number of usable
booster doses available to low income countries at no additional cost.”

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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