ScienceThe COVID-19 reports are supported by the Pulitzer Center.
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 been angered by critics who say they make important decisions behind closed doors. But today, at a Senate subcommittee hearing that focused on Warp Speed, scientists at the helm of the effort, after repeated questions, gave limited answers about the vaccine candidates they have chosen as race leaders and their selection criteria. .
At the opening of the hearing, conducted by the Subcommittee on Job Assignments, Health and Human Services, Education, and Related Agencies, Senator Patty Murray (D - WA) notified witnesses that she wanted direct answers on many issues. "We are going to need to hold this administration accountable to avoid repeating mistakes and delays," Murray said. "The administration has yet to provide any explanation of how it is selecting vaccine candidates, what the risks are of narrowing that shortlist or addressing concerns about potential conflicts in pre-crisis contracts."
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The three witnesses to the administration are the heads of the different branches of the Department of Health and Human Services. Senator Tammy Baldwin (D - WI) asked Gary Disbrow, who oversees Warp Speed's vaccine investments as interim director of the Advanced Biomedical Research and Development Authority (BARDA), about the vaccines in the program's portfolio. . "Can you quickly list the prospects for the vaccine that are being reversed right now?" Baldwin asked. (In May, Warp Speed revealed that it had selected 14 candidates and planned to advance "about eight" to clinical trials; a New York Times the June 3 article citing senior administration officials said the list had been reduced to five.)
"I can't specifically mention companies," Disbrow said. "We are in active negotiations with many of them." It only named AstraZeneca, which the administration revealed that in May it had been awarded a BARDA contract that could reach a total of $ 1.2 billion. He did not mention that BARDA had released two other major contracts with vaccine makers COVID-19, Johnson & Johnson and Moderna, which could total nearly $ 500 million each.
"So the names of the companies in terms of the vaccine outlook are not public?" Baldwin asked.
Disbrow replied that BARDA has released its other investments in COVID-19 vaccines. "I think your specific question may be the composition of the portfolio under Operation Warp Speed," he said. "I can't talk about that today, but we are moving and negotiating contracts very quickly."
When Baldwin asked how many candidates Warp Speed would eventually select, Disbrow said, "More than one." He laughed and apologized. "Sorry, it really is sensitive to acquisitions," added Disbrow, stressing that the stock market is affected by these negotiations. "You will see the press releases when we award these contracts."
Another witness, the director of the National Institutes of Health (NIH), Francis Collins, said that a group of vaccine experts that his agency convened to work with Warp Speed conducted a scientific review of 50 candidate vaccines for COVID-19. This review has not been made public, and NIH did not respond to a request for a copy. Members of that group have also expressed surprise at some of the Warp Speed elections.
Collins mentioned that the NIH has collaborated in the development of the Modern vaccine, noting that, "This month, we plan to launch a phase 3 clinical trial that will seek to enroll 30,000 volunteers with the expected results in a few months." A date for the start of the trial has not been announced, and Moderna says it cannot disclose that information due to regulations on listed companies. (According to anonymous sources, STAT reported today that the trial was "delayed" from the July 9 start date previously suggested by a university working with Moderna, but the company had never further confirmed that the trial would begin this month. ).
Early in the hearing, Murray said he was concerned why BARDA "has chosen to invest only in vaccine technologies that have only been studied experimentally and never made it to market, without seeking older proven technologies." Murray was referring to BARDA funding for vaccines that synthetically produce the surface protein of SARS-CoV-2, the pathogen that causes COVID-19, or that deliver the gene into a person's body. Moderna, for example, injects a form of RNA from the gene, a method that has not yet produced an approved vaccine.
In contrast, several Chinese companies have developed vaccines that "kill" or inactivate all of the intact virus. Inactivated vaccines have a long history, and have been approved by the US Food and Drug Administration for use against many diseases. But in 1955, an infamous accident, known as the Cutter Incident, which involved 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 is concerned about maintaining "the confidence of the American people in the safety and efficacy of the vaccine," asked Collins about the Cutter incident. . "It could assure you and the American people that that strategy of trying to administer a dead vaccine is not currently being applied for SARS-CoV-2 because of those risks," Collins said, emphasizing that the vaccines that Warp Speed and NIH are considering they are not made of intact viruses.
Durbin asked Francis, Disbrow and the third witness, the Director of the Centers for Disease Control and Prevention, Robert Redfield, if anyone felt political pressure from the White House or another agency in terms of the selection of vaccine companies or the time of vaccine development. Each one answered no.
Last month, in testimony before the Senate Armed Services Committee, Gen. Gustave Perna, co-leader of Operation Warp Speed, said he would not work with China on a vaccine. So far, four of the 18 COVID-19 candidate vaccines that have entered clinical trials are inactivated products made in China. Three of them are scheduled to start Phase III trials soon.
