[Ip-health] HHS Released More Coronavirus Vaccine Contracts As Election Results Unfolded

Claire Cassedy claire.cassedy at keionline.org
Mon Nov 9 10:30:47 PST 2020


HHS Released More Coronavirus Vaccine Contracts As Election Results Unfolded

November 8, 20202:16 PM ET

While the country was focused on the outcome of the election Saturday, the
Department of Health and Human Services released a trove of new Operation
Warp Speed documents.

The newly released contracts include the crash program's $1 billion
agreement with Johnson & Johnson, which was issued through a third-party
firm and lacks some customary protections against potential future

Operation Warp Speed, the Trump administration's expensive push to make a
coronavirus vaccine widely available in record time, has been slow to
reveal details of its deals with vaccine manufacturers worth billions of
dollars. Those that have emerged, reveal weakened taxpayer protections.

"HHS' drip drip release strategy fails to meet the needs of the moment,"
says Zain Rizvi, a law and policy researcher at Public Citizen focused on
pharmaceuticals. "Taxpayers have handed over billions of dollars in the

An HHS spokesman issued the following statement to NPR:

"Operation Warp Speed has long publicly stated its commitment to being as
transparent as possible. These contracts are being posted after the
appropriate review and are proof of that commitment to transparency, as is
the additional review and re-posting of the Moderna contract with fewer
redactions. As we have said before, the government will continue to monitor
what is releasable over time as part of this commitment to transparency."

The newly released contracts were issued through a third party, Advanced
Technology International, a fact NPR brought to light in September. This
arrangement concerned members of Congress and advocacy groups who feared
the nontraditional agreements would omit taxpayer protections that allow
the government to "march in" if the manufacturer receiving federal funding
fails to make its product or sets an unreasonable price.

They also feared the contracts to vaccine manufacturers wouldn't be subject
to public records requests because they were issued by a third party, and
the agency had so far not released them. At least two nonprofits, including
Public Citizen, have sued after their requests for the documents went
unanswered for months.

Johnson & Johnson's Aug. 5 contract for the government's purchase of 100
million doses of its coronavirus vaccine doesn't include the march-in
rights that are typical planks in contracts for federally funded
inventions. Instead, the contract allows a much narrower window for the
government to step in, excluding when COVID-19 stops being a public health
emergency and becomes endemic, as is expected.

"We all want a safe and effective vaccine as quickly as possible," says
attorney Kathryn Ardizzone of Knowledge Ecology International, a nonprofit
public interest group focused on intellectual property. "To get that, the
government doesn't have to compromise access and affordability."

But that's what it seems to be doing, she says. The data rights in the
contract, which typically govern disclosure and sharing of key studies,
cell lines and the know-how for making a product, are especially weak. In
the Johnson & Johnson contract, "data" explicitly excludes
"production/manufacturing know-how, trade secrets, clinical data."

"That is a big issue limiting the government's ability to enable another
qualified company to manufacture the vaccine if there are shortages,"
Ardizzone says.

This is the second contract issued through a third party to be made public.
Regeneron released its contract with Advanced Technology International on
Nov. 5, revealing similar terms. HHS hasn't yet released the Regeneron

Advanced Technology International uses a nontraditional contracting
mechanism known as an "other transaction agreement" to facilitate
government work with several groups of academics and companies. On
Saturday, HHS released the government's base agreement with the consortium
it manages that has been doing work for Operation Warp Speed. It's called
the Medical CBRN Defense Consortium, which is tasked with developing
medical countermeasures to threats against the military.

The base agreement dates back to April 2016, and has been modified for new
projects over the years. To add Operation Warp Speed, the government
modified the agreement, adding more money and contract terms.

HHS also released a new, more transparent version of its $1.5 billion
contract with vaccine frontrunner Moderna.

The agency first posted the Moderna contract on Oct. 25. However, that
version of the document was heavily redacted to protect trade secrets. But
the redactions included information that had previously been made public,
such as the contract's value.

Moderna released its own version of the contract on Oct. 30 in a quarterly
financial filing, revealing much of the information the federal government
concealed. HHS took its redacted document down for about a day before
replacing it with the more transparent version.

"The fact that pharmaceutical corporations continue to provide more details
about the deals to investors than HHS provides to the public is
unacceptable," Rizvi says.

NPR is still working to obtain the remaining contracts

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