Source : 'The Pink Sheet'
US lawmakers are raising concerns about the removal of Biomedical Advanced Research and Development Authority scientists from their leadership roles on COVID-19 vaccine contracts with industry, a move that former government employees and industry sources say could be detrimental to the contracts given BARDA’s track record of shepherding products through the Food and Drug Administration.
In a a letter.pdf">letter to Health and Human Services Secretary Alex Azar, the top Democrats on the House and Senate appropriations committees which oversee the health department say that the reassignment of other agency staff to lead BARDA vaccine contracts could delay progress toward COVID-19 vaccine and manufacturing, prolonging the epidemic and putting lives at risk.
Sen. Patty Murray, D-Wash., and Rep. Rosa DeLauro, D-Conn., argue that BARDA is uniquely positioned to lead this work. “It is the only entity at the Department of Health and Human Services with the mission and capability to develop, manufacture and facilitate distribution of medical countermeasures during a public health emergency,” they write.
The two lawmakers also say the Trump administration may be “undermining” Congress’s intent for the $6.5 billion of supplemental appropriations given to BARDA in March 2020. Besides looking for more information on why BARDA scientists were removed from COVID-19 vaccine contracts, including what resources, personnel or other support BARDA may lack that is preventing it from leading the work, the a letter.pdf">letter requests more details on how Operation Warp Speed’s award decisions are made.
HHS said they are working to respond to Murray and DeLauro’s a letter.pdf">letter and declined to provide any details to the Pink Sheet on which specific COVID-19 contracts, if any, have included replacement of BARDA employees with other U.S. government officials or why this was done. A representative for the lawmakers said they also did not have more details on which specific contracts have been impacted.
The a letter.pdf">letter comes as BARDA has been under intense scrutiny after former Director Rick Bright filed a whistleblower complaint alleging widespread politicization of HHS and BARDA contracting practices after his abrupt demotion from his position in late April. ("Beyond COVID19 Ousted BARDA Chiefs Whistleblower Complaint Suggests Widespread Politicization of" "Pink Sheet" )
BARDA was specifically designed to address emergency diseases, said Michael Sinha, a research fellow at Harvard University and Massachusetts Institute of Technology’s Center for Regulatory Science.
“The shift away from BARDA to agencies with less expertise is unfortunate given BARDA’s track record and expertise,” Sinha said in an email. “It strikes me as a political move related to Dr. Bright’s departure/relocation than it does with BARDA’s accomplishments since its inception. In an administration that mistrusts science, this shift (coupled with the unexpected sidelining of the CDC) indicates a willingness to place politics over science and public health.”
BARDA has shepherded 51 products through FDA including multiple vaccines since 2007.
Multiple former government experts and drug industry sources who work on this topic believe that some of the BARDA contracting work has shifted to Department of Defense officials due in part to DOD’s Matthew Hepburn, a project manager at the Defense Advanced Research Projects Agency, stepping in to replace FDA’s Center for Biologics Evaluations and Review Director Peter Mark as the lead of the the vaccine efforts of Operation Warp Speed, the Trump administration's project to speed COVID-19 vaccines to the market. ("COVID19 Staff Shakeup Woodcock Moves to Commissioners Office As Marks Drops Out Of Warp" "Pink Sheet" )
The sources said that BARDA and FDA have a more direct working relationship than the FDA does with DOD, with some suggesting DOD has a worse track record of successfully bringing products to market.
FDA and DOD have also butted heads in recent years after the Defense Department tried to get Congressional authority to approve battlefield-use devices and drugs, skirting FDA’s authority. ("US FDA Creates Expedited Review For MilitaryRelated Products" "Pink Sheet" )
The former government and industry sources also pointed out that BARDA has experience leading government efforts in other infectious disease outbreaks like Ebola and Zika, and that while the COVID emergency may be an even larger challenge for the government, it could be detrimental to restructure roles and responsibilities in the midst of a crisis. Having all hands-on deck in a crisis is important, without undermining the roles of established leaders, they said.
From its inception, the Warp Speed effort has drawn questions about whether its complicated structure and the inclusion of DOD was the right approach in a crisis given its departure from models that have worked successfully in past disease outbreaks. ("Too Many Generals The Potential Downside Of Operation Warp Speed" "Pink Sheet" )
A senior administration official told the Pink Sheet that “everything BARDA is doing to develop vaccines, treatments and diagnostics tests for COVID-19 is in support of Operation Warp Speed and is coordinated across the government through Operation Warp Speed.” The official said that BARDA “plays an integral role in advancing” Operation Warp Speed.
None of the companies mentioned in the Congressional a letter.pdf">letter responded to the Pink Sheet's questions of whether any BARDA staff had been removed from their contracts.
A spokesperson for Moderna Inc. said the company is “working with many people across multiple federal agencies in the United States government.”
An AstraZeneca PLC spokesperson also said that the company is “collaborating with a comprehensive team from BARDA and Operation Warp Speed supporting our efforts.”
Sanofi told the Pink Sheet that their “ongoing relationship with BARDA … continues to remain strong.”
Operation Warp Speed has also drawn questions from Democratic lawmakers in recent weeks over concern that the speed of the project, embedded in its name, might lead to corners being cut.
The House Committee On Oversight and Reform Committee Chair Carolyn Maloney, D-NY, and subcommittee chairs Raja Krishnamoorthi, D-Ill., and James Clyburn, D-SC, released a a letter.pdf">letter that was sent to FDA Commissioner Stephen Hahn arguing that given public concern about the speed of these programs the agency should “bolster public trust,” by laying out in advance how it will decide whether a vaccine is safe and effective enough to approve. ("Speed Of Coronavirus Vaccine Development May Hurt Public Confidence" "Pink Sheet" )
“If we wait until a vaccine candidate is in hand before announcing the rules by which it will be judged, people will not have faith in the process,” the lawmakers wrote.
They want Hahn to say that a COVID-19 vaccine must “prove itself safe and effective in a complete Stage 3 clinical trial with at least 30,000 volunteers,” a population that they say has been endorsed by National Institutes of Heath Director Francis Collins.
The 30,000 figure is also the size of the trial that Moderna has announced it will launch in July for its lead vaccine candidate. ("Moderna Speed Of COVID-19 Vaccine Now Hinges On Enrolling The Right Patients" "Pink Sheet" )
The lawmakers also want FDA to commit to involving the Vaccine and Related Biological Products Advisory Committee in the review of any vaccine along with the inter-agency Public Health Emergency Medical Countermeasures Enterprise.
FDA did not respond to a request for comment on the a letter.pdf">letter. The agency did update its CBER guidance agenda for 2020 in June to add a guidance on the development and licensure of vaccines to prevent COVID-19.
By Sarah Karlin-Smith