[Ip-health] Novavax Releases Federal Contract To Develop COVID-19 Vaccine : Shots - Health News : NPR

James Love james.love at keionline.org
Wed Nov 11 12:30:58 PST 2020


Novavax Posts Coronavirus Vaccine Contract That Government Didn't Disclose
November 11, 20201:10 PM ET

A day after Pfizer's announcement that its COVID-19 vaccine is more than
90% effective, rival Novavax shared its $1.6 billion Operation Warp Speed
contract on Tuesday.

Operation Warp Speed is the Trump administration's crash program to make a
vaccine available in record time. While there's been rapid progress on
vaccines, the government has been slow to release details of its billions
of dollars' worth of deals with manufacturers.

Notably, the Department of Health and Human Services told NPR in late
August that it had "no records" of the Novavax contract in response to a
public records request for it over the summer. The agency announced the
deal July 7 to support development, manufacturing and the purchase of 100
million doses.

Novavax released its federal contract in a quarterly financial filing with
the Securities and Exchange Commission. HHS has yet to release this

"We shouldn't have to be getting the details in these contracts through the
companies and their SEC filings," says Ameet Sarpatwari, assistant director
of Harvard Medical School's Program on Regulation, Therapeutics and Law.
"They should be publicly available, and there should be input even prior to
the execution of the contracts."

The Novavax contract is one of several Operation Warp Speed contracts that
were issued through a third party, Advanced Technology International, a
fact that NPR first revealed in September.

This arrangement concerned members of Congress and advocacy groups who
feared the nontraditional agreements would omit the safeguards that often
come with taxpayer funding, like protections against potential future

Novavax's contract appears to include the kind of "march-in" rights found
in a typical government contract, which allow the government to take over a
drug or vaccine if the manufacturer that received federal funding can't or
won't make its product or sets an unreasonable price.

"The patent rights clauses tend to be more favorable than the other
contracts we're looking at in terms of the public's rights," says James
Love, director of Knowledge Ecology International, a nonprofit public
interest group focused on intellectual property.

The contract's data rights — which typically govern disclosure and sharing
of key studies, cell lines and the know-how for making a product — are also
weaker than they would be under standard federal contracting laws.

Operation Warp Speed's investment is "virtually unheard of" in the
pharmaceutical industry, Sarpatwari says. The government is funding the
manufacturing and purchase of the vaccines before knowing whether those
vaccines are safe and effective, so the taxpayer is also assuming all the
risk. Therefore, he says he'd like to see some kind of explicit price
restrictions in the contract that go beyond the immediate pandemic.

"But we generally know that these contracts don't have that, and that, I
think, it's a big problem in terms of the government's unwillingness to
demand affordable access to products that it has indeed played a primary
role in informing and underwriting," he says.

Even though the Novavax contract has more favorable patent and data rights
for taxpayers than some of the other Operation Warp Speed contracts, Love
says the government should have included something called
exceptional-circumstances authorities, which could potentially allow the
U.S. government to own the vaccine patents. These haven't been included in
any of the contracts that have become public so far. Instead, customary
taxpayer protections have been weakened.

Of the contracts that have been released, many have eliminated the
government's rights to intervene if the vaccine manufacturer sets an
unreasonably high price. Instead, they've rewritten the government's right
to "march in," allowing it to take over a government-funded drug or vaccine
under much narrower circumstances.

In the Johnson & Johnson coronavirus vaccine contract, for example, the
government can only do this during a public health emergency. That's cause
for concern, given that COVID-19 is expected to become endemic, and the
vaccine might require future booster shots to bolster people's immunity.

Novavax's federal coronavirus contract is the third one that went through
Advanced Technology International to have been made public. 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.

The consortium working on Operation Warp Speed is called the Medical CBRN
Defense Consortium, which was created in 2016 to develop medical
countermeasures to threats against the military. The consortium already
included some Operation Warp Speed vaccine manufacturers. Novavax and
Pfizer were recently added to its membership, according to an August notice
in the Federal Register.

A Federal Coronavirus Vaccine Contract Released At Last, But Redactions
Obscure Terms
A Federal Coronavirus Vaccine Contract Released At Last, But Redactions
Obscure Terms
Although members of Congress, advocacy groups and journalists had been
asking for these contracts for months, HHS only began posting the
procurement agreements on Oct. 25, starting with its $1.5 billion contract
with Moderna. It was heavily redacted and excluded even already public

The administration took the document down for about a day following
Moderna's release of the same contract with far fewer redactions. HHS then
reposted a more transparent version on Saturday.

Neither Pfizer nor the federal government has released the nearly $2
billion Operation Warp Speed deal for the purchase of 100 million doses of
Pfizer's coronavirus vaccine. NPR is working to obtain it and the remaining

You can contact NPR pharmaceuticals correspondent Sydney Lupkin at
slupkin at npr.org.

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