- The FDA issued a guidance document with 15 pages of recommendations for vaccine sponsors regarding the scientific data and information that it will require to support the issuance of an emergency use authorization for a COVID-19 vaccine.
- The National Institutes of Health (NIH) National Cancer Institute (NCI) created a new Serological Sciences Network to study how the immune system responds to COVID-19.
- HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE), in collaboration with ASPR’s Pediatric Centers of Excellence, are offering a webinar series focused on how the COVID-19 pandemic may affect children. The first webinar was on child health and wellness, and future topics will include child emotional and social effects, the impact of COVID-19 on children with special healthcare needs, and how secondary/other disasters may affect children during the pandemic.
- NIH’s National Institute on Drug Abuse Director Nora Volkow co-authored a study which found that individuals with a recent diagnosis of a mental disorder as being at increased risk for COVID‐19 infection, which is further exacerbated among African Americans and women, and as having a higher frequency of some adverse outcomes of the infection.
- NIH Director Dr. Francis Collins released a blog post titled, “Rogue Antibodies and Gene Mutations Explain Some Cases of Severe COVID-19.” According to the new findings in hundreds of racially diverse people with life-threatening COVID-19, a small percentage of people who suffer the most severe symptoms carry rare mutations in genes that disrupt their antiviral defenses.
Congress
President Trump announced that he is ending negotiations with Democrats over new comprehensive bipartisan COVID-19 relief legislation. However, House Speaker Nancy Pelosi and Treasury Secretary Steven Mnuchin continue to speak about COVID-19 relief legislation.
Both parties are considering advancing some standalone relief bills such as aid for the airline industry, but it is not clear that attempts to move standalone bills will be successful.
White House and Federal Agencies
President Trump reports that he is feeling much better and making great progress in his recovery from COVID-19.
The Food and Drug Administration (FDA) issued a guidance document with 15 pages of recommendations for vaccine sponsors regarding the scientific data and information that it will require to support the issuance of an emergency use authorization (EUA) for a COVID-19 vaccine.
The Centers for Medicare and Medicaid Services (CMS) released new regulatory requirements for all hospitals and critical access hospitals (CAHs) respectively to report information about COVID-19 cases and treatment capacity. The new requirements describe a standardized format for this data. CMS released guidance for hospital reporting and FAQs, as well as a CMS Standards and Quality Memo for the new regulatory requirements
The Trump Administration released an executive order on saving lives through increased support for mental and behavioral health needs. The COVID-19 pandemic has exacerbated mental and behavioral health conditions as a result of stress from prolonged lockdown orders, lost employment, and social isolation.
The National Institutes of Health (NIH) National Cancer Institute (NCI) created a new Serological Sciences Network to study how the immune system responds to COVID-19.
HHS and The Rockefeller Foundation have signed an agreement to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools.
Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE), in collaboration with ASPR’s Pediatric Centers of Excellence, are offering a webinar series focused on how the COVID-19 pandemic may affect children. The first webinar was on child health and wellness, and future topics will include child emotional and social effects, the impact of COVID-19 on children with special healthcare needs, and how secondary/other disasters may affect children during the pandemic.
NIH’s National Institute on Drug Abuse Director Nora Volkow co-authored a study which found that individuals with a recent diagnosis of a mental disorder as being at increased risk for COVID‐19 infection, which is further exacerbated among African Americans and women, and as having a higher frequency of some adverse outcomes of the infection.
NIH Director Dr. Francis Collins released a blog post titled, “Rogue Antibodies and Gene Mutations Explain Some Cases of Severe COVID-19.” According to the new findings in hundreds of racially diverse people with life-threatening COVID-19, a small percentage of people who suffer the most severe symptoms carry rare mutations in genes that disrupt their antiviral defenses.
Centers for Disease Control and Prevention (CDC) Updates
The CDC is adding information about the risks obesity poses as an underlying condition for COVID-19.
CDC updated information on traveling during the COVID-19 pandemic. Travel increases your chance of getting and spreading COVID-19.
CDC released a Morbidity and Mortality Weekly Report (MMWR) on:
- Adolescent with COVID-19 as the Source of an Outbreak at a 3-Week Family Gathering in four states during June and July, 2020. There is increasing evidence that children and adolescents can efficiently transmit SARS-CoV-2.
- Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection in the U.K. and U.S. between March and August, 2020.
Economy, Vaccine, Treatment and Testing
The American Medical Association (AMA) published new CPT codes for a combined flu and COVID-19 test.
Secretary of Health and Human Services (HHS) Alex Azar said that he is optimistic that 100 million vaccine doses will be available by the end of the year. He says these doses should be enough to vaccinate the vulnerable people who will get priority under the government’s vaccine distribution strategy.
Regeneron submitted an Emergency Use Authorization (EUA) request to the FDA for its antibody therapy that President Trump received during his treatment for COVID-19 at Walter Reed Hospital.
Eli Lilly submitted an EUA request to the FDA for its new antibody therapy for COVID-19.
