HEALTH CARE BRIEFING: Trump Taps 7 Drugmakers for Vaccine Push

The White House is working with seven pharmaceutical companies as part of its “Warp Speed” coronavirus vaccine program, including a bet on a rapid-but-yet-unproven genetic technology.

The companies include Johnson & Johnson, Merck & Co., Pfizer, Moderna, and the University of Oxford in collaboration with AstraZeneca, as well as two other firms, two people familiar with the matter said. President Donald Trump was briefed on Tuesday on the latest details on the project, one of the people said.

Drugmakers and university researchers are investigating over 130 experimental inoculations, according to the World Health Organization, though fewer than a dozen candidates are currently being assessed in human trials. Moderna, Pfizer and Oxford have already started trials of their vaccines in healthy patients, while J&J and Merck intend to launch studies later in the year.

“Operation Warp Speed” seeks to compress a process that is typically years long into a matter of months, in part by spending as much as $10 billion on research, manufacturing and agreements to guarantee purchase of the vaccines, one of the people said. The effort is being led by Gen. Gustave Perna, who directs U.S. Army Materiel Command, and former GlaxoSmithKline executive Moncef Slaoui.

Moderna and Pfizer’s candidates rely on a new genetics-based technology called messenger RNA that has yet to lead to an approved vaccine. J&J and Oxford are using engineered viruses called adenoviral vectors, another new approach best known for its use in an Ebola vaccine. While it has been more widely tested in people than mRNA vaccines, it has been used in few commercial products.

National Institutes of Health Director Francis Collins told Bloomberg last month that the U.S. believes it’s important to have a mix of vaccine candidates that use promising new technologies such as mRNA, and others that use already-proven platforms. “It’s a horse race,” Collins said. “We want all the horses to win, but we want to be sure there’s plenty in the field.”

Operation Warp Speed’s goal is to have some 300 million doses of a shot ready by the end of the year. Riley Griffin and Jennifer Jacobs have more.

More Headlines:

• Europe May Race the U.S. for Early Vaccine Access With Deals
• The Keys to Speed in Race for Vaccine, and Its Perils: QuickTake

Coronavirus Efforts in Congress

Doctors Said Need Federal Money Faster: Republican congressional leaders joined Democrats in a rare bipartisan rebuke of how the Trump administration is sending out emergency funds meant to bolster hospitals and doctors. HHS is not giving enough money to doctors who rely heavily on Medicaid funds, they said in a letter to Secretary Alex Azar.

Their letter reflects months of frustration by rural hospitals and doctors serving low-income Americans, who say HHS has favored wealthier hospitals and doctors over them in distributing emergency funds.

Signing the letter were Sen. Charles Grassley (R-Iowa), the chairman of the Finance Committee, and Sen. Ron Wyden (D-Ore.), the panel’s ranking member, as well as Rep. Frank Pallone, Jr. (D-N.J.), chairman of the Energy and Commerce Committee, and Rep. Greg Walden (R-Ore.), the panel’s ranking member.

Lawmakers gave the federal government $175 billion in emergency funds as part of two bills this year but largely left it up to the administration to dole out the money. The agency has sent much of the emergency cash out so far based on Medicare spending and to hospitals in hard-hit cities. Read more from Alex Ruoff.

• Meanwhile, the Trump administration is delaying the start of five programs to test new methods for the government to pay doctors and hospitals based on patients’ overall health because of the Covid-19 pandemic. Included in the delay is a payment model to encourage more coordination of care for patients with late-stage chronic kidney disease and kidney failure. Read more from Shira Stein.

Panel Targets Sexual Assaults in Pandemic: The Bipartisan Task Force to End Sexual Violence, led by Reps. Annie Kuster (D-N.H.), Jackie Speier (D-Calif.), David Joyce (R-Ohio), and John Katko (R-N.Y.) will host a virtual discussion later today to address sexual and domestic violence during the pandemic, according to a statement yesterday. Domestic violence is “often exacerbated in times of crisis, and we have evidence of that occurring now,” they said, citing a WHO study that there was a 60% spike in domestic violence emergency calls by women in April 2020.

CDC Chief Testifies on Virus Response: The House Appropriations Labor-HHS-Education Subcommittee will hear testimony from Centers for Disease Control and Prevention Director Robert Redfield on the federal government’s Covid-19 response.

Racial Disparities of Coronavirus: The House Select Subcommittee on the Coronavirus Crisis holds a virtual hearing entitled “An Unequal Burden: Addressing Racial Health Disparities in the Coronavirus Pandemic.

College Health Safety: The Senate Health, Education, Labor and Pensions Committee holds a hearing on Covid-19 and students going back to college safely.

Virus Research & Treatment

Malaria Drug Taken by Trump Provides No Protection: A malaria drug that was touted and then taken by Trump in hopes of preventing Covid-19 failed to offer patients protection in the first scientifically rigorous study of its potential to keep away the novel virus. The study involved 821 health-care workers, first responders and people living with infected patients. Half were given HCQ over five days, and the other half received a placebo. After two weeks, 12% of those taking HCQ had developed an infection, compared with 14% given the placebo, a difference that researchers said could have been due to chance. Read more from Michelle Fay Cortez.

• At the same time, the conservative Association of American Physicians and Surgeons urged the FDA to stop limiting access to hydroxychloroquine. The nonprofit sued the agency in the U.S. District Court for the Western District of Michigan, alleging it’s “irrationally” interfering with doctors’ and patients’ access to the Strategic National Stockpile’s cache of the drug, reports Mary Anne Pazanowski.
• Meanwhile, an international trial using hydroxychloroquine to treat patients will be restarted after questions arose about a study linking it to increased death and heart risks. The WHO said yesterday that it will resume recruiting patients for the hydroxychloroquine arm of a global trial, known as “Solidarity.” Read more.

Painkiller Tested Against Covid-19: Scientists in London are testing whether a variant of the commonly used painkiller ibuprofen can help patients with Covid-19 avoid potentially lethal respiratory failure and the need for ventilators. The study is being conducted by Guy’s and St. Thomas’ NHS Foundation Trust, King’s College London and SEEK, a drug-research company. William Mathis has more.

U.S. Falls Just Short of May Virus Testing Goal With 12 Million: The Trump administration came up shy of meeting its goal of doing about 12.9 million tests in May. Brett Giroir, a top official at the Department of Health and Human Services who has overseen the administration’s efforts to ramp up testing, said yesterday that the country did about 12 million tests last month. Read more from Shira Stein and Emma Court.

• Meanwhile, around 70 U.S. coronavirus testing sites were closed temporarily “due to the threats of violence,” Giroir also said in the briefing with reporters.

More Headlines:

• U.S. Virus Cases Rise 1.2%, in Line With Past Week’s Average
• Giroir Says U.S. Conducting Up to 500,000 Covid-19 Tests a Day
• Telehealth Pay Gaps Loom After Virus When State Orders Expire
• U.S. Army’s Covid-19 Telemedicine Project Can’t Be Protested
• Amazon Warehouse Workers Sue Over Virus They Brought Home
• Roche Test for Severe Covid-19 Gets Emergency FDA Approval
• Hackers Target California University Leading Covid-19 Research

What Else to Know Today

Update to Dietary Guidelines May Stir Dissent: Doctors and academics on a federal nutrition committee could question the scientific integrity of this year’s dietary recommendations designed for the American public, a nutrition policy nonprofit said yesterday. “Without critical reforms, this policy is on track to do virtually nothing to reverse the epidemics of disease that are causing enormous suffering,” Nina Teicholz, director of The Nutrition Coalition, said in a statement.

The nonprofit prompted the government on Tuesday to investigate accusations that the group said one or more anonymous members of the Dietary Guidelines Advisory Committee brought. The independent committee reviews nutrition and health science to create a report on which the dietary guidelines for Americans are based. The coalition said the whistleblower pointed to a “fear of retaliation” as leaving some members to “suffer in silence.” Megan U. Boyanton has more.

More Headlines:

• U.S. Sugar Group Petitions FDA on ‘Accurate’ Food-Package Labels
• California Study Finds Lower Birth Weights Near Oil, Gas Wells

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com