Read on Twitter
Some context for today's Pfizer coronavirus vaccine news: Unlike the other Operation Warp Speed companies, Pfizer didn't get $ for R&D, etc. It DID get an Operation Warp Speed purchase agreement in July worth nearly $2B for 100 million doses.
Let's talk about CONTRACTS. 1/
Let's talk about CONTRACTS. 1/
Pfizer is one of four vaccine makers to get its federal purchase agreement through a third party, a fact @NPR brought to light in September. https://www.npr.org/sections/health-shots/2020/09/29/917899357/how-operation-warp-speeds-big-vaccine-contracts-could-stay-secret 2/
The third party uses a non-traditional federal contracting mechanism called an Other Transaction Agreement, which can leave out some taxpayer protections. The arrangement worried advocacy groups & members of Congress, who felt they were in the dark. https://www.npr.org/sections/health-shots/2020/10/10/922617939/call-for-administrations-covid-19-vaccine-contracts-to-be-disclosed 3/
Two other Operation Warp Speed contracts awarded this way came out over the last few days: for Regeneron's antibodies (what Trump got in the hospital) & for Johnson & Johnson's vaccine. Both had weakened customary protections against potential future price-gouging. 4/
Regeneron's contract left out the government's usual right to "march in" and take control of a drug/vaccine if a manufacturer that received federal funding can't or won't make the product or sets an unreasonably high price. Instead, it rewrote them. https://www.npr.org/sections/health-shots/2020/11/06/931795256/federal-supply-deal-for-covid-19-antibody-treatment-lacks-some-customary-protect 5/
According to the contract, the government can only march in during a formal public emergency, not once the coronavirus becomes endemic, as it's expected to. And only if Regeneron is unwilling or unable to make the antibody cocktail — not if it sets an unreasonable price. 6/
"If you take that leverage away, the government just has fewer cards to play," says @jamie_love of Knowledge Ecology International. 7/
With all eyes on the election, HHS released the Johnson & Johnson contract over the weekend. It had similar limitations on its march-in rights. https://www.npr.org/sections/health-shots/2020/11/06/931795256/federal-supply-deal-for-covid-19-antibody-treatment-lacks-some-customary-protect 8/
The government's data rights in that contract, which typically govern disclosure and sharing of key studies, cell lines and the know-how for making a product, explicitly EXCLUDE "production/manufacturing know-how, trade secrets, clinical data." 9/
"That is a big issue limiting the government's ability to enable another qualified company to manufacture the vaccine if there are shortages," says @kei_kathryn.
The Pfizer contract issued through a third party hasn't been made public yet. NPR and others have been pushing. But given the company's not-in-Warp-Speed stance, I wonder what the march-in and data rights will look like - or if they'll be excluded. Stay tuned. 10/
