COVID-19 Federal Responses: Tuesday, September 8, 2020

Congress

Senate Majority Leader Mitch McConnell (R-KY) introduced a new version of COVID-19 relief legislation. The bill provides less total funding than the previous Republican proposal, the HEALS Act. The new bill provides assistance to small businesses, extends enhanced unemployment benefits and provides legal liability protections.

• The Senate could vote on the bill this week. It is not expected to receive support from any Democrats. If passed by the Senate, the Democrat-controlled House will not consider the legislation. The bill is intended to serve as a new marker for Republicans in negotiations on a bipartisan bill negotiated with Democrats.

House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin reached an informal agreement on a short-term extension of federal funding that reduces the chances of a government shut-down at the end of September. Details of the funding extension are not yet known, but it appears the two parties will exclude controversial policy riders that could jeopardize an extension. Vice President Pence also acknowledged the agreement.

The Congressional Budget Office (CBO) predicts that the federal deficit will reach $3.3 trillion for FY 2020 and will add $13 trillion to the national debt over the next ten years. Additionally, the federal deficit could exceed the U.S. gross domestic product (GDP) in 2021.

• The CBO issued a second report on the Medicare and Social Security trust funds that shows the trust fund for Medicare Part A could become insolvent in four years.

White House and Federal Agencies

The White House said a vaccine could be approved as early as October and is pushing back against critics who say it will exert political pressure to announce a vaccine approval before the November election, potentially with fewer data than it usually uses for approvals.

• Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn said the FDA will consult with outside experts to evaluate COVID-19 data ahead of anticipated approvals.
• Commissioner Hahn also emailed the entire FDA staff to reiterate that the agency will not be influenced by political pressures when making vaccine approval determinations.
• The CEOs of nine companies that are developing COVID-19 vaccines issued a statement that they will not submit Phase III trial result data to the FDA for final vaccine approval until the data set is complete. They will not submit a preliminary partial data set. This will circumvent the FDA approving a vaccine before it has the complete data set.

White House Press Secretary Kayleigh McEnany clarified that the Administration is not considering a controversial strategy to reach “herd immunity” by mass exposure to the virus.

The Federal Reserve has acquired more than  $1 trillion in mortgage bonds since March.

The Federal Reserve published the newest edition of its “Beige Book.” This report summarizes anecdotal economic observations from the agency’s regional branches. According to the report, economic activity increased among most Districts, but gains were generally modest and activity remained well below levels prior to the COVID-19 pandemic.

With many colleges and universities experiencing COVID-19 outbreaks, Dr. Anthony Fauci, Director of the National Institute for Allergy and Infectious Diseases (NIAID), is urging students to remain on campus rather than risk infecting others by traveling home.

National Institutes of Health (NIH) Director Dr. Francis Collins wrote a blog on a study that ties COVID-19 related syndrome in kids to altered immune system.

NIH has launched a study to track the prevalence and impact of SARS-CoV-2 infection among approximately 16,000 pregnant women in seven low- and middle-income countries.

Centers for Disease Control and Prevention (CDC) Updates

CDC updated:

• Information on eCR Now: COVID-19 Electronic Case Reporting, which is the automated generation and transmission of case reports from the electronic health record (EHR) to public health agencies for review and action.
• Information on COVID-19 during pregnancy and is collaborating with state, local, and territorial health departments and external partners to better understand COVID-19 during pregnancy.
• Information for children and teens in combatting COVID-19 and going back to school.
• Its Interim Guidance for Rapid Antigen Testing for SARS-CoV-2. This interim guidance is intended for clinicians who order antigen tests, receive antigen test results, and/or perform point of care testing, as well as for laboratory professionals who perform antigen testing in a laboratory setting or at the point of care and report those results.
• Following an executive order by the Trump Administration, the CDC is using its authority to temporarily halt evictions through the end of 2020, in an effort to slow the spread of COVID-19.

Reopening, Testing, Treatments and Vaccines

The National Academies of Science (National Academies) released a draft framework of a plan to assist the federal government in prioritizing the distribution of COVID-19 vaccines once vaccines are approved.

The White House’s Operation Warp Speed vaccine development initiative says that a vaccine is on track for FDA approval by the end of 2020.

• Dr. Anthony Fauci also predicts a safe and effective vaccine will be available by the end of the year.
• The CDC is hoping to begin distributing COVID-19 vaccines to states by November 1.

The FDA updated its guidance, “Investigational COVID-19 Convalescent Plasma,” to provide additional information related to the recently issued Emergency Use Authorization (EUA) for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. In addition, the agency updated the web page, “Recommendations for Investigational COVID-19 Convalescent Plasma,” which also provides this information.

• The FDA’s EUA for convalescent plasma treatment was controversial because some leaders within the NIH did not agree that the available data supported a EUA.
• The NIH released a statement on the FDA’s EUA for convalescent plasma. The COVID-19 Treatment Guidelines Panel (the Panel) reviewed the available evidence from published and unpublished data on convalescent plasma for the treatment for COVID-19, including the FDA analyses that supported the EUA. As noted, NIH Director Collins says the NIH Panel’s assessment mirror FDA’s conclusions.

AstraZeneca began Phase III clinical trials on its COVID-19 vaccine candidate AZD1222. The trial is funded by the Biomedical Advanced Development Authority (BARDA). However, reports indicate that the study has been halted to analyze a potential adverse reaction.

AstraZeneca is partnering with other companies to increase its vaccine production capacity.

Congressional Hearings

September 9

• 10 am ET – Surgeon General Dr. Jerome Adams and National Institutes of Health Director Dr. Francis Collins will testify before a Senate Health, Education, Labor and Pensions (HELP) Committee hearing on COVID-19 vaccine development.
• 10 am ET – the Senate Banking, Housing and Urban Affairs Committee will hold a hearing on the Federal Reserve’s Emergency Lending Facilities.
• 11:30 am ET – The House Science, Space and Technology Committee’s Subcommittee on Research and Technology will hold a hearing on how COVID-19 impacts university research.
• 1:00 pm ET – The House Small Business Committee will hold a hearing on the challenges and opportunities for small businesses presented by innovations in financial technology (“Fintech”), with a focus on access to capital.

September 10

• 12:00 pm ET – The House Financial Services Committee will hold a hearing on financial aid for states and territories.
• 1:00 pm ET – The Small Business Committee’s Rural Development, Agriculture, Trade, and Entrepreneurship Subcommittee will hold a hearing on small businesses and the economic recovery.