COVID-19 Situational Report

December 10, 2020

Novel Coronavirus (COVID-19) Pandemic Case Update

• As of December 9, the Centers for Disease Control and Prevention (CDC) officially reports 15,040,175 confirmed cases in the US (including 217,046 reported in the last 24 hours), across all 50 states, the District of Columbia, Puerto Rico, Guam, and the US Virgin Islands, and 285,351 deaths (including 2,566 reported in the last 24 hours). Over the past 7 days, there were over 1,414,240 reported cases in the US, an average of approximately 207,064 cases per day.

• As of December 7, the World Health Organization (WHO) reported over 65.8 million confirmed cases (including just under 4 million new cases over the previous 7 days) and 1.5 million deaths (including 73,000 deaths over the previous 7 days) globally.

Vaccines and Therapeutics

• The first shipments of the Pfizer vaccine candidate were flown to the United States from Belgium on November 28.

• Pfizer released a fact sheet covering the US distribution plan and storage requirements for its vaccine candidate.

• The federal government has purchased 650,000 additional treatment courses of Bamlanivimab for non-hospitalized patients with mild to moderate COVID-19. Bamlanivimab is Eli Lilly and Company’s investigational monoclonal antibody therapeutic.

• On November 23, the Department of Health and Human Services (HHS) announced it would allocate initial doses of Casirivimab and Imdevimab to non-hospitalized patients with mild to moderate COVID-19. Casirivimab and imdevimab are Regeneron’s investigational monoclonal antibody therapeutic.

• The Biotechnology Innovation Organization (BIO) is maintaining a COVID-19 Therapeutic Development Tracker. The tracker includes information on the clinical trials of each candidate and the status of Emergency Use Authorizations (EUAs).

• HHS ASPR is maintaining a portfolio of COVID-19 medical countermeasures. The portfolio provides information on the allocation and distribution processes for therapeutic products made available under EUAs.

• On December 8, Operation Warp Speed held a Vaccine Summit. The full summit can be viewed here.

Medical Countermeasure Development

• Pfizer and BioNTech submitted a formal application to the FDA for authorization of their COVID-19 vaccine candidate. The Vaccines and Related Biological Products Advisory Committee is expected to meet on December 10 to review the data and provide a recommendation to the FDA on approval.

• Moderna has applied to the FDA for an EUA for its vaccine candidate. The Vaccines and Related Biological Products Advisory Committee is expected to meet regarding this vaccine on December 17.

• Further data from the Pfizer and BioNTech COVID-19 vaccine candidate was released by the FDA prior to the Vaccines and Related Biological Products Advisory Committee Meeting on December 10. The data includes confirmation of the vaccine’s high efficacy.

Federal Coordination

• HHS stood up a website for information about clinical trials related to COVID-19. The site answers questions and provides an avenue for those interested in joining appropriate trials.

• The Vaccines and Related Biological Products Advisory Committee (VRBPAC) announced that it will hold open sessions to discuss the Emergency Use Authorizations (EUA) for two COVID-19 vaccine candidates.

• The session for the Pfizer-BioNTech vaccine candidate will take place on December 10.

• The session for the Moderna vaccine candidate will take place on December 17.

• HHS announced that it would create a False Claims Act Working Group to combat fraudulent claims on HHS programs.

• On December 2, HHS made a fourth amendment to the Public Readiness and Emergency Preparedness Act (PREP Act). The amendment covers several areas, including authorizing the provision of certain COVID-19 countermeasures across state lines via telehealth.

Public Health

• A new website, COVID Vaccine Facts, was created by the Biotechnology Innovation Organization (BIO), to answer questions relating to the development, safety, and efficacy of COVID-19 vaccines.

• CDC published updated guidance on delaying travel for those who have been exposed to or tested positive for COVID-19.

• Updated guidance has also been provided on considerations for wearing masks.

• The National Institutes of Health (NIH) is funding the COVID-19 Testing Impact Calculator, a free resource that can help organizations plan specific testing and mitigation measures to stop the spread of COVID-19. The tool is specifically being promoted to help schools and businesses.

• The Association of University Centers on Disabilities released a Frequently Asked Questions document covering COVID-19 vaccine distribution considerations for the disabled community.

• HHS announced on December 1 that all tribal health programs and Urban Indian Organizations have chosen how to access the COVID-19 vaccine. The two options were to receive the vaccine through the Indian Health Service or through their respective states.

Healthcare Resilience

• On December 7, the Health Resources and Services Administration (HRSA) announced it would be distributing $523 million to over 9,000 nursing homes as a reward for reducing COVID-19 related infections and deaths during the fall.

Business Continuity

• CDC continues to update its guidance on testing in high-density critical infrastructure workplaces. This guidance includes recommendations for asymptomatic workers who have had potential exposure to COVID-19.

CHANYS EM Team would like to thank our partners at Healthcare Ready for the information included in this post.

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