Trump’s bid for a vaccine could come at a cost


The White House coronavirus task force has dramatically scaled back its meetings, leaving the public awareness effort as a side show rather than the dominant presence it was before in the crisis. Scientists within HHS say they are confused by the rapidly changing organizational structure and the role of outside consultants who now dot the health department.

The search for a vaccine in all federal health agencies has also forced compensation. The Advanced Biomedical Research and Development Authority, for example, has halted the drive for lung treatments to fight coronavirus, which could put a treatment option in the background.

The danger of applying a vaccine may be that President Donald Trump is pinning hopes on a miracle vaccine, while there are reasons to believe the outbreak could last for years.

“There is no guarantee that a vaccine will work,” said Luciana Borio, who served as the FDA’s acting interim scientist and worked on the White House pandemic preparedness efforts previously in the Trump administration. “And even if it does, there is no guarantee that it is the right product for most people, or that people want to take it, or that the virus does not mutate.”

Vaccines are notoriously difficult to make; The fastest mumps vaccine ever developed took four years. Many take much longer, and many still fail animal or human testing and never make it to market. Public health experts say the US government is making a risky bet by focusing much of its pandemic response on the hope that one shot will end the devastating march of the coronavirus.

This story was drawn from interviews with eight officials within the administration, who spoke on condition of anonymity because they were not authorized to speak in public, as well as external scientists and other public health experts.

Inside Operation Warp Speed, officials are full of confidence. Five people involved in the vaccine project insist there are reasons to trust that it will be successful: two vaccines may be just weeks away from starting late-stage clinical trials; There are six other viable candidates being tested and plans to radically accelerate production are underway.

But outside health experts say federal officials must level out with the public, a task complicated by Trump repeatedly reiterating that the vaccine is imminent, perhaps arriving before Election Day.

“The perception of vaccine policy is detrimental,” said a former Trump HHS administration official. “If they pass one quickly, people are going to be skeptical.”

“The White House has always looked for magic solutions (hydroxychloroquine, remdesivir, now vaccines), but that’s not how it works,” added virologist Peter Hotez, dean of the National School of Tropical Medicine at Baylor University. “Our first vaccines from Operation Warp Speed ​​can only be partially protective and reduce the severity of the disease, which is important, but they cannot prevent the disease or interrupt transmission.”

Even if the administration reaches its ambitious vaccine goal, tens of thousands of Americans can die from the coronavirus in the meantime. The United States broke the single-day record of new cases for five consecutive days last week, and states like California and Texas reported record hospitalizations.

The White House is reviewing this new public health guide this week on how states can best mitigate the new increase in cases, three officials said, but it is limited by the administration’s stance that local officials should take the lead, and the President’s repeated votes that the coronavirus crisis will soon subside.

Experts have called on the administration to focus more on this public health guide, especially since vaccine development efforts could easily fall behind on its aggressive schedule. “If you think the vaccine is not going to be a solution for the United States in the next 18 months, there is still time to get it right,” said Rajiv Shah, president of the Rockefeller Foundation and head of USAID during the Obama administration. , calling for a greater focus on public health messages. “There is so much potential to have a positive impact right now, but it is not happening.”

Operation Warp Speed’s first efforts will be closely scrutinized at a Senate hearing Thursday, where health department leaders will provide an update on the vaccine production and development process.

In a statement to POLITICO, HHS touted its Operation Warp Speed ​​efforts and said that the project’s staff for vaccines and treatments were separate from government teams working on their daily response to the virus.

“The January 2021 goal of starting to administer a safe and effective vaccine to Americans is ambitious but achievable,” a spokesman said. “The president has made it clear that this is the team that can do it.”

Operation Warp Speed ​​took shape in early April. HHS Secretary Alex Azar quickly made it clear that the health department, not the White House, should partner with the Pentagon on the project, three officials who spoke to him at the time said. Azar justified the measure as a public health need, but it also had political importance. Weeks earlier, Vice President Mike Pence had abruptly replaced Azar as head of the coronavirus task force, renewing questions about the secretary of health’s future.

“This is a way for him to focus on the definitive arrow on the shuddering pandemic, which is the development of vaccines,” said a senior administration official. “There is a very clear analogy around the Manhattan Project, which is very appealing to the people around the secretary and his legacy.”

The health department disputed characterization of Azar’s role in driving Operation Warp Speed’s leadership. “This is the most ridiculous statement I have heard in the entire week, and it is only Monday,” said Michael Caputo, a department spokesman.

HHS officials have argued that Operation Warp Speed ​​has been based on lessons hard drawn from the previous response. The Trump administration aggressively engaged the private sector and has relied on Army logistics experts, two tactics that helped reverse early government evidence and supply chain failures. Moncef Slaoui, a longtime veteran of the pharmaceutical industry, is the chief scientific advisor to Operation Warp Speed.

“We are in a much better place with this than the supply chain task force,” said an HHS official, referring to the ad hoc effort that began in March to rapidly increase US medical supplies, Supervised. By White House chief adviser Jared Kushner. “There are not the same groups as before, where officials are fighting for influence … there are clear chains of command.”

That opinion is not universally shared, even by the staff of the Advanced Biomedical Research and Development Authority of the health department, who historically has rethought the territory that has been included in Operation Deformation Speed. Some BARDA projects, such as promoting lung treatments to fight coronavirus, have been halted amid fever by a vaccine.

“Operation Warp Speed ​​had a difficult start,” said a BARDA official, adding that staff within the HHS biomedical arm have spent weeks confused about who was “making the decisions” for the new vaccine effort and what it meant for your existing job. The effort was further confounded by HHS’s decision to bring in consultants from the Boston Consulting Group.

Senator Patty Murray (D-Wash.) And Representative Rosa DeLauro (D-Conn.) Last week expressed concern that BARDA officials have been abruptly reassigned as leaders of several vaccine contracts, an issue that according to the Attendees will appear at several HHS supervisory hearings this week. Democrats have also warned that political pressure could interfere with the scientific process, noting how FDA officials were pressured in March and April to accelerate access to the hydroxychloroquine antimalarial drug at the request of the White House, despite the little evidence that it was an effective treatment against coronavirus.

“The ongoing fight for President Trump to take testing seriously should be a warning to Congress that when it comes to vaccines, we cannot leave this Administration to its own devices, we must hold it accountable,” Murray plans. say in comments on Tuesday that they were shared with POLITICO. “We know that this pandemic will not end until we have a vaccine that is safe and effective, that we can widely produce and distribute equitably, and that is free and accessible to all. That is why we need a comprehensive national vaccine plan from the Trump Administration. soon as possible “.