Coronavirus Disease (COVID-19) Update

HBMA COVID-19 Federal Response Update

IMPORTANT VACCINE NEWS: As noted below, the FDA’s Vaccines and Related Biological Products Advisory Committee recommended that the FDA issues an emergency use authorization (EUA) for Pfizer’s vaccine. This is among the final steps before the FDA issues an EUA. The FDA could issue an EUA for Pfizer’s vaccine as early as Friday. Vaccines will be distributed within 24 hours of FDA authorization. The same Advisory Committee will convene to review Moderna’s vaccine candidate on December 17th.

Congress

• Congress has yet to reach an agreement on COVID-19 relief legislation however negotiations are ongoing.

White House and Federal Agencies

• HHS released new hospital COVID-19 capacity data at the facility level. Previously released data about hospital capacity that had been released was aggregated at the state level. This new, more granular, data release aggregates daily hospital reports into a "week at a time" picture.
  • The public will be able to find more COVID-19 information on HealthData.gov, the home of HHS open data. These COVID-19 datasets are also discoverable and downloadable on Data.gov.
• CMS sent a letter to all Governors on strategies for updating hospital capacity in light of increasing hospitalizations due to COVID-19.
• CMS published new information about how it covers and reimburses monoclonal antibody treatments for COVID-19.
• HHS will distribute $523 million in second round performance payments to over 9,000 nursing homes. These nursing homes are being rewarded for successfully reducing COVID-19 related infections and deaths between September and October.
• FDA issued a guidance, “Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency.” This guidance provides the FDA’s enforcement policy regarding certain requirements for mammography facilities and general considerations in response to common scenarios faced by mammography facilities as a result of the COVID-19 public health emergency. 
• FDA issued a safety communication, Wear Face Masks with No Metal During MRI Exams to inform patients and health care providers that patients may be injured if they wear face masks with metal parts and coatings during an MRI exam.

Centers for Disease Control and Prevention (CDC) Updates

• CDC updated its resource page on vaccinations. The webpage provides information for healthcare professionals on preparing for vaccinations, preparing patients, and the process for vaccine approval.
• CDC updated its webpage with FAQs on Clinical Questions about COVID-19.
• CDC Director Dr. Robert Redfield is expecting high levels of COVID-19 deaths for the next 60 days.
• CDC updated Information for Clinicians on Investigational Therapeutics for Patients with COVID-19. CDC strongly encourages clinicians, patients and their advocates, and health system administrators to regularly consult the COVID-19 Treatment Guidelines published by the National Institutes of Health (NIH). The treatment and management recommendations in these guidelines are based on scientific evidence and expert opinion and are frequently updated.
• CDC updated information on When to Quarantine – Stay at Home When Exposed.
• CDC updated its information on Treatments that your Healthcare Provider Might Recommend if you are Sick. Treatments used for COVID-19 should be prescribed by your healthcare provider. People have been seriously harmed and even died after taking products not approved for COVID-19, even products approved or prescribed for other uses.
• CDC updated its information on protecting yourself during the holiday season.
• CDC updated its FAQs related to Travel and COVID-19.
• CDC updated testing information on who should get tested, how to get tested and how to understand testing results.
• CDC updated its information for Workplaces and Businesses.
• CDC updated its webpage on Things to Know about the COVID-19 Pandemic.
• CDC updated its information on Ventilation. Protective ventilation practices and interventions can reduce the airborne concentration, which reduces the overall viral dose to occupants.
• CDC updated its information on COVID-19 and Animals. Based on the limited information available to date, the risk of animals spreading COVID-19 to people is considered to be low.

Economy, Vaccine, Testing and Treatment

• An FDA staff review of Pfizer’s COVID-19 vaccine confirms the vaccine is successful at preventing COVID-19 symptoms.
  • The FDA’s Vaccines and Related Biological Products Advisory Committee met today to review Pfizer’s vaccine candidate. This is among the final steps before FDA emergency approval.
  • The Advisory Committee recommended that the FDA issues an emergency use authorization (EUA) for Pfizer’s vaccine.
  • The federal government will immediately distribute 2.9 million doses of Pfizer’s COVID-19 vaccine upon FDA approval.
  • The Department of Defense will immediately distribute 44,000 doses.
• Moderna expects to produce 500 million doses of its COVID-19 vaccine in 2021.
• New data released by AstraZeneca and Oxford University about their COVID-19 vaccine candidate suggests it will not be as effective as the candidates from Pfizer and Moderna.
• The U.K., which recently began vaccinating people against COVID-19, reported some allergic reactions to the vaccine.
• The NIH no longer recommends remdesivir for patients on mechanical ventilators.
• The coronavirus that causes COVID-19 has mutated into seven strains.
• NIH released information about an NIH-funded tool that helps organizations plan COVID-19 testing. An innovative online tool funded by the NIH helps organizations choose a COVID-19 testing strategy that will work best for their specific needs. The COVID-19 Testing Impact Calculator is a free resource that shows how different approaches to testing and other mitigation measures, such as mask use, can curb the spread of the virus in any organization. 
• NIH Director Dr. Francis Collins released a blogpost about a study among healthcare workers that shows COVID-19 immunity lasts many months. New findings from a study of thousands of healthcare workers in England show that those who got COVID-19 and produced antibodies against the virus are highly unlikely to become infected again, at least over the several months that the study was conducted.