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COVID-19 Federal Responses: Thursday, October 29, 2020

COVID-19 Federal Responses: Thursday, October 29, 2020
  • The Food and Drug Administration (FDA) consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing. It includes products to diagnose, cure, mitigate, treat or prevent COVID-19; for other critically needed products to treat symptoms of COVID-19; or to provide supportive care to those with COVID-19.
  • CDC launched a new page on its website dedicated to education on the COVID-19 vaccine planning efforts.
  • The Centers for Medicare and Medicaid Services (CMS) published an interim final rule that explains how Medicare and Medicaid will cover COVID-19 vaccines after they are approved by the FDA. Medicare beneficiaries will not have to pay cost sharing for the vaccines.
  • National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci says that the first vaccines will probably be most effective at preventing severe symptoms but will not be effective at stopping infections. This is consistent with what other experts are warning.

Congress

We now know that a COVID relief bill will not be passed before the November 3 election. Whether a bill will be passed before the end of the year likely is dependent on the outcome of the election.

White House and Administration

The Food and Drug Administration (FDA) consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing. It includes products to diagnose, cure, mitigate, treat or prevent COVID-19; for other critically needed products to treat symptoms of COVID-19; or to provide supportive care to those with COVID-19.

The FDA issued an updated FDA COVID-19 Response At-A-Glance Summarywhich provides a quick look at facts, figures and highlights of the agency’s response efforts.

On October 23, the Department of Health and Human Services (HHS) and the Department of Education provided an update on President Trump’s school mask initiative to deliver 125 million cloth masks to states and U.S. territories. To date, 111,637,500 masks have been delivered. These masks – split evenly among adult and youth sizes – support students, teachers, and staff in public and private schools, with an emphasis on low-income or other high-needs students and schools providing in-person instruction.

HHS, through the Health Resources and Service Administration (HRSA), will distribute approximately $333 million in first round performance payments to over 10,000 nursing homes that demonstrated significant reductions in COVID-19 related infections and deaths between August and September.

Centers for Disease Control and Prevention (CDC) Updates

CDC launched a new page on its website dedicated to education on the COVID-19 vaccine planning efforts.

CDC updated its web resources and a toolkit for people ages 15 to 21 designed to keep them healthy as they venture out.

CDC released a Morbidity and Mortality Weekly Report (MMWR) on COVID-19–Associated Hospitalizations Among Health Care Personnel through COVID-NET in 13 states between March 1 and May 31, 2020. Analysis of COVID-19 hospitalization data from 13 sites indicated that 6% of adults hospitalized with COVID-19 were health care personnel. Among health care personnel hospitalized with COVID-19, 36% were in nursing-related occupations.

CDC updated information on when to delay your travel because of COVID-19.

One important way that CDC has supported global efforts to study and learn about SARS-CoV-2 in the laboratory was by growing the virus in cell culture and ensuring that it was widely available. Researchers in the scientific and medical community can use virus obtained from this work in their studies.

CDC updated considerations for returning to work during the COVID-19 pandemic.

In general, reinfection means a person was infected (got sick) once, recovered, and then later became infected again. Based on what we know from similar viruses, some reinfections are expected.CDC is actively working to learn more about reinfection to inform public health action.

Economy, Vaccine, Testing and Treatment

The Centers for Medicare and Medicaid Services (CMS) published an interim final rule that explains how Medicare and Medicaid will cover COVID-19 vaccines after they are approved by the FDA. Medicare beneficiaries will not have to pay cost sharing for the vaccines.

  • CMS also included information on the reimbursement rates for vaccines. The Medicare payment rates will be $28.39 to administer single-dose vaccines. For a COVID-19 vaccine requiring a series of two or more doses, the initial dose(s) administration payment rate will be $16.94, and $28.39 for the administration of the final dose in the series. These rates will be geographically adjusted.

National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci says that the first vaccines will probably be most effective at preventing severe symptoms but will not be effective at stopping infections. This is consistent with what other experts are warning.

Regeneron is reporting that its antibody therapy can reduce recovery time by two-thirds.

The American Academy of Pediatrics states that 800,000 children have been diagnosed with COVID-19.

Eli Lilly & Co. is ending its antibody therapy trial after results indicate no positive health effects. However, other antibody therapy trials are ongoing.

  • Despite the trial results, the government will purchase $375 million worth of Eli Lilly’s antibody therapy.

AstraZeneca is reporting that its vaccine candidate produces a positive immune response in older adults.

NIH Director Dr. Francis Collins released a blog post on a protein mapping study and COVID-19 drug development. With the aim of developing such protein-targeted antiviral drugs, a large, international team of researchers, funded in part by the NIH, has precisely and exhaustively mapped all of the interactions that take place between SARS-CoV-2 proteins and the human proteins found within infected host cells.

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