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During a hearing on COVID-19 vaccines, Francis Collins, director of the National Institutes of Health, showed off a replica of the virus that causes the disease.

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Operation Warp Speed’s opaque choices of COVID-19 vaccines draw Senate scrutiny

Science’s COVID-19 reporting is supported by the Pulitzer Center.

The leaders of Operation Warp Speed, the Trump administration’s well-funded project to develop COVID-19 vaccines at record speed, have said they are running a transparent project. They have bristled at critics who say they make major decisions behind closed doors. But at a Senate subcommittee hearing today that focused on Warp Speed, scientists at the front of the effort, after repeated questioning, gave limited answers about the vaccine candidates they have chosen as frontrunners in the race and their selection criteria.

At the opening of the hearing—held by the Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies—Senator Patty Murray (D–WA) put the witnesses on notice that she wanted straightforward answers on many issues. “We’re going to need to hold this administration accountable to avoid repeating mistakes and delays,” Murray said. “The administration still has not provided any explanation of how it is selecting vaccine candidates, what the risks are of narrowing down that shortlist or addressed concerns about potential conflicts in contracts that predate this crisis.”

The administration’s three witnesses are the heads of different branches of the Department of Health and Human Services. Senator Tammy Baldwin (D–WI) asked Gary Disbrow, who oversees Warp Speed vaccine investments as the acting director of the Biomedical Advanced Research and Development Authority (BARDA), about the vaccines in the program’s portfolio. “Can you just quickly list for me the vaccine prospects that are being invested in right now?” Baldwin asked. (In May, Warp Speed revealed it had selected 14 candidates and planned to advance  “about eight” to clinical trials;  a New York Times article on 3 June that cited senior administration officials said that list had been whittled down to five.)

“I cannot specifically mention the companies,” Disbrow said. “We’re in active negotiations with many of them.” He named only AstraZeneca, which the administration revealed in May had been awarded a BARDA contract that could total up to $1.2 billion. He did not mention that BARDA had earlier made public two other major contracts with COVID-19 vaccine manufacturers, Johnson & Johnson and Moderna, that could total nearly $500 million each.

“So those company names in terms of the vaccine prospects are not public?” Baldwin asked.

Disbrow replied only that BARDA has made public its other COVID-19 vaccine investments. “I think your specific question may be the composition of the portfolio under Operation Warp Speed,” he said. “That I cannot today talk about, but we are very quickly moving and negotiating contracts.”

When Baldwin asked how many candidates Warp Speed ultimately would select, Disbrow said, “More than one.” He laughed and apologized. “I’m sorry, it really is procurement sensitive,” Disbrow added, stressing that the stock market is affected by these negotiations. “You will see the press releases when we award these contracts.”

Another witness, National Institutes of Health (NIH) Director Francis Collins, said a group of vaccine experts his agency convened to work with Warp Speed did a scientific review of 50 candidate COVID-19 vaccines. This review has not been made public, and NIH did not reply to a request for a copy. Members of that group have also expressed surprise at some of Warp Speed’s choices.

Collins did mention that NIH has collaborated on the development of the Moderna vaccine, noting that, “This month, we plan to launch a Phase 3 clinical trial that will seek to enroll 30,000 volunteers with results expected in a few months.” No date has been announced for the start of the trial, and Moderna says it cannot reveal that information because of regulations about publicly traded companies. (Based on anonymous sources, STAT today reported the trial was “delayed” from a 9 July start date previously suggested by a university working with Moderna, but the company had never confirmed more than that the trial would begin this month.)

At the outset of the hearing, Murray noted she had concerns about why BARDA “has chosen to invest solely in vaccine technologies that have only been studied experimentally and never made it to market, while not pursuing older proven technologies.” Murray was referring BARDA’s funding for vaccines that either synthetically produce the surface protein of SARS-CoV-2, the pathogen that causes COVID-19, or deliver the gene for it into a person’s body. Moderna, for example, injects an RNA form of the gene, a method that has not yet produced an approved vaccine.

Several Chinese companies, in contrast, have developed vaccines that “kill,” or inactivate, the entire, intact virus. Inactivated vaccines have a long track record, and the U.S. Food and Drug Administration has approved them for use against many diseases. But in 1955, an infamous accident—known as the Cutter incident—involving an inactivated poliovirus vaccine made by Jonas Salk harmed some children who received it. Although no inactivated polio vaccine has had that problem again, Senator Dick Durbin (D–IL), who said he was concerned about maintaining the “confidence of the American people of the safety and effectiveness of the vaccine,” asked Collins about the Cutter incident. “I could reassure you and the American people that that strategy of trying to administer a killed vaccine is not currently being pursued for SARS-CoV-2 because of those risks,” Collins said, emphasizing that the vaccines Warp Speed and NIH are considering are not made from intact viruses.

Durbin asked Collins, Disbrow, and the third witness, Centers for Disease Control and Prevention Director Robert Redfield, whether any felt political pressure from the White House or other agency in terms of the selection of vaccine companies or the timing of vaccine development. They each answered no.

Last month, in testimony before the Senate Armed Services Committee, General Gustave Perna, a co-leader of Operation Warp Speed, said that he would not work with China on a vaccine. So far, four of the 18 candidate COVID-19 vaccines that have entered clinical trials are inactivated products made in China. Three of those are slated to start phase III trials soon.