COVID-19 Federal Responses: Thursday, September 17, 2020

Congress

Attempting to break a stalemate on COVID-19 relief legislation, President Trump expressed his support for a relief bill that provides up to $1.5 trillion in spending. Republican and Democratic negotiators have been at an impasse over the total amount for the bill. Negotiations on the finer details of the bill have not occurred pending an agreement on the total amount of funding. Republicans were previously asking for a bill that would spend $1 trillion while Democrats proposed a bill that would spend $2.2 trillion.

Secretary of Health and Human Services (HHS) Alex Azar will testify at a House Select Subcommittee hearing on the coronavirus October 2.

The Centers for Disease Control and Prevention (CDC) Director Dr. Robert Redfield told the Senate Labor-HHS Appropriations Subcommittee that states need at least $6 billion for vaccine distribution.

White House and Federal Agencies

CDC Director Dr. Robert Redfield defended the CDC against a news report that claimed HHS political staff were interfering in the CDC’s Morbidity and Mortality Weekly Reports (MMWR).

The Food and Drug Administration (FDA) issued a temporary guidance document, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations. This guidance provides recommendations to help manufacturers prioritize products and activities as they resume normal operations. It provides more detailed considerations and is specific to the COVID-19 public health emergency.

Data from the CDC shows that children (under age 21) who died from COVID-19 often had at least one underlying condition. It also shows racial disparities in child deaths from the virus.

National Institutes of Health (NIH) Director Dr. Francis Collins released a blog post on COVID-19 and persistent lung problems.

Centers for Disease Control and Prevention Updates

CDC updated:

• The CDC COVID-19 Data Tracker interactive maps, charts, and data on laboratory testing in the U.S. As of 9/15, 247 tests are authorized by FDA under EUAs; these include 197 molecular tests, 46 antibody tests, and 4 antigen tests.
• Guidance for critical workers on how to protect workers who may have been exposed to COVID-19. To ensure continuity of operations of essential functions, CDC advises that critical infrastructure workers may be permitted to continue work following potential exposure to COVID-19, provided they remain asymptomatic and additional precautions are implemented to protect them and the community.
• Its Standard Operating Procedure (SOP) guidance for triage that is intended for use in non-US healthcare settings for healthcare facilities that are receiving or are preparing to receive patients with suspected or confirmed COVID-19.
• Information for people who need extra precautions like pregnant women, people experiencing homelessness, and people with disabilities.
• Information for people who are at increased risk for severe illness from contracting COVID-19.
• Information for older adults. Among adults, the risk for severe illness from COVID-19 increases with age, with older adults at highest risk.
• FAQs for businesses that are looking to reopen and stay safe from COVID-19.
• Information on protecting yourself from COVID-19 when returning to work.
• Information on how to stay safe from COVID-19 while engaging in personal and social activities, running essential errands, and visiting the doctor and getting medicines. CDC also updated information on deciding to go out as communities and businesses are reopening and still trying to protect yourself from COVID-19.
• Information for office building employers, owners and managers, and operations specialists can take the following steps to create a safe and healthy workplace for workers and clients.
• Guidance for people living together in close quarters, such as people who share a small apartment, or for people who live in the same household with large or extended families.
• Information on living in shared housing where residents often gather together closely for social, leisure, and recreational activities, shared dining, laundry facilities, stairwells, and elevators and may have challenges with social distancing to prevent the spread of COVID-19.
• Information for people with moderate to severe asthma who may be at higher risk of getting very sick from COVID-19.
• Information on steps you can take to prevent getting sick, protecting yourself and others, and slowing the spread of COVID-19.
• Information on steps to take if you have or suspect you have COVID-19 .
• Advice on when and how long people should delay their domestic or international travel to avoid spreading COVID-19.
• Public health guidance for potential COVID-19 exposure associated with international or domestic travel.

Economic Recovery, Vaccine, Testing and Treatment

HHS announced its strategy for distributing free COVID-19 vaccines once vaccine candidates are approved by the FDA. In anticipation of a vaccine receiving FDA approval, the federal government is planning to ship vaccines to states within 24 hours of approval.

• Download the Strategy for Distributing a COVID-19 Vaccine – PDF
• Download the COVID-19 Vaccination Program Interim Playbook – PDF
• Download the COVID-19 Vaccine Distribution Process Infographic – PDF

Oxford University, which is partnering with AstraZeneca in its vaccine development work, says it believes the recently reported potential adverse reaction to its vaccine may be unrelated to the vaccine.

• The NIH stated it is “very concerned” about the reported adverse reaction.

German vaccine manufacturer BioNTech purchased a new factory to improve its vaccine production capacity. Pfizer, which is developing its vaccine with BioNTech, reported their vaccine has not produced severe adverse reactions in trials thus far.

The FDA published new comparative data for 55 COVID-19 diagnostic tests.