President Donald Trump this morning signed into law an $8.3 billion measure designed in part to fund the development of vaccines, therapies and diagnostic tests for SARS-CoV-2—the virus at the center of the global COVID-19 outbreak.

The emergency supplemental appropriations measure, titled the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074), will also fund construction or upgrades at labs involved in testing, developing vaccines or producing therapies—as well as cover the purchase of vaccines, tests, therapies and necessary medical supplies for the Strategic National Stockpile.

The largest portion of funding under the bill, $3.1 billion available through September 30, 2024, has been set aside for the Public Health and Social Services Emergency Fund. The $3.1 billion is designated for purposes that include the development of “necessary” countermeasures and vaccines, with priority to be given to platform-based technologies “with U.S.-based manufacturing capabilities,” as well as the purchase of vaccines, therapeutics, diagnostics, “necessary” medical supplies, medical surge capacity, and related administrative activities.

To advance the development of treatments, the $3.1 billion portion can be spent as grants for constructing, altering, or renovating non-federally owned facilities for the production of vaccines, therapeutics, and diagnostics, as well as non-Federally owned facilities “to improve preparedness and response capability at the State and local level.” The $3.1 billion portion also includes $100 million to be spent on grants “to prevent, prepare for, and respond to coronavirus” under the federal Health Center Program of HHS’ Health Resources & Services Administration.

Non-federal facilities for improving state and local preparedness and response can also be funded through part of the bill’s $2.2 billion made available through September 30, 2022, for the Centers for Disease Control and Prevention “to prevent, prepare for, and respond to coronavirus, domestically or internationally.”

“Preparedness and Response”

Of that $2.2 billion, at least $950 million is intended to fund grants to States, localities, territories, tribes, tribal organizations, urban Indian health organizations, or health service providers serving tribes, toward “surveillance, epidemiology, laboratory capacity, infection control, mitigation, communications, and other preparedness and response activities.”

The grants shall include reimbursement for expenses dating back to January 20 “to carry out surveillance, epidemiology, laboratory capacity, infection control, mitigation, communications, and other preparedness and response activities to prevent, prepare for, and respond to coronavirus.”

No less than half of that $950 million must be allocated within 30 days of the bill being enacted. And at least $40 million must go to tribes, tribal organizations, urban Indian health organizations, or health service providers to tribes.

A $300 million slice of the $2.1 billion CDC portion will go toward the Infectious Diseases Rapid Response Reserve Fund for global disease detection and emergency response. The Reserve Fund was established within the Treasury by Congress with $50 million in the Fiscal Year 2019 budget, for use by CDC and some entities of the U.S. Department of Health and Human Services, to prevent, prepare for, or respond to “an infectious disease emergency” in the U.S. or overseas.

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) will receive $836 million through September 30, 2024, “to prevent, prepare for, and respond to coronavirus, domestically or internationally.” At least $10 million of that portion will go to the NIH’s National Institute of Environmental Health Sciences’ for training designed to prevent and reduce exposure of hospital employees, emergency first responders, and others at risk of exposure to coronavirus through their duties at work.

In addition, the bill sets aside $61 million for the FDA toward salaries and expenses for professionals “to prevent, prepare for, and respond to coronavirus, domestically or internationally.” Among activities that $61 million is intended to fund are the development of “necessary” medical countermeasures and vaccines, advanced manufacturing for medical products, monitoring of medical product supply chains, and related administrative activities.

The measure also allows healthcare providers to be reimbursed for telemedicine services offered to Medicare beneficiaries.

“I’ll Take It”

The measure is more than three times the $2.5 billion initially proposed by Trump, but less than the $8.5 billion counter-proposed by Senate Minority Leader Sen. Chuck Schumer (D-NY). Trump said February 26 he would sign a measure costlier than his plan if Congressional leaders agreed on such legislation.

“I asked for two and a half and I got 8.3 and I’ll take it,” Trump said today at the signing ceremony for the bill.

The U.S. Senate passed the coronavirus measure 96-1, with Sen. Rand Paul (R-KY) the sole vote against, after he tried but failed to advance an amendment that would have paid for the bill by taking funds from the U.S. State Department and the U.S. Agency for International Development.

The U.S. House of Representatives passed the funding measure 415-2, with Reps. Andy Biggs (R-AZ) and Ken Buck (R-CO) voting against. Afterward, Biggs issued a statement criticizing the $8.3 billion bill as “bloated.”

“By passing this larded-up bill, Congress again fails to wisely appropriate taxpayer dollars,” Biggs asserted. “I would have supported the president’s request for $2.5 billion, knowing that, if we spent all the funds, Congress could have provided additional funding.”

U.S. Sen. Richard Shelby (R-AL)

Sen. Richard Shelby (R-AL) said lawmakers in both chambers succeeded in addressing the COVID-19 outbreak without partisan squabbling.

“We worked together to craft an aggressive and comprehensive response that provides the resources the experts say they need to combat this crisis. I thank my colleagues for their cooperation and appreciate President Trump’s eagerness to sign this legislation and get the funding out the door without delay,” Shelby said in a statement. “This should not be about politics, this is about doing our jobs to protect the American people from a potential pandemic.”

Other Coronavirus Developments

Among news of coronavirus treatments, tests, and trends announced today:

  • More than 100,000 confirmed coronavirus COVID-19 cases were reported for the first time by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.
  • Biogen disclosed that three employees tested positive for SARS-CoV-2 after attending a strategic management meeting in Boston last week that was attended by about 175 people.
  • CVS Health said it will provide COVID-19 diagnostic testing and telemedicine visits with no out-of-pocket costs or cost sharing for Aetna members. CVS acquired Aetna for $69 billion in 2018.
  • Enzo Biochem said its Enzo Clinical Labs subsidiary will begin accepting COVID-19 specimens for testing next week. Enzo will use a molecular test designed to determine viral RNA presence in respiratory specimens collected from patients by their providers.
  • Spherix said it has exercised an exclusive option with the University of Maryland, Baltimore (UMB) for a COVID-19 treatment based on S. Patent No. 10,434,116, “Methods of Treating Coronavirus Infection,” issued October 8, 2019.

The post Trump Signs $8.3B Coronavirus Measure to Fund Treatments, Labs, Supplies appeared first on GEN – Genetic Engineering and Biotechnology News.

Source