COVID-19 Federal Responses: Tuesday, November 24, 2020

Centers for Disease Control (CDC) and Prevention Updates

The CDC updated one-stop shop toolkits on COVID-19 with videos, social media, public service announcements, print resources, checklists, frequently asked questions, and web resources.

The CDC updated guidance and tools to help clinicians make decisions, protect patients and employees, and communicate with their communities.

The CDC released a scientific brief on the community use of cloth masks to control the spread of COVID-19.

The CDC released a Morbidity and Mortality Weekly Report (MMWR) on COVID-19 Incidence by Urban-Rural Classification in the U.S.

The CDC published a series of new resources about the COVID-19 vaccine:

• 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans
• Eight Things to Know about U.S. COVID-19 Vaccination Plans
• Information about COVID-19 Vaccines for the consumer
• How the CDC Is Making COVID-19 Vaccine Recommendations
• Ensuring the Safety of COVID-19 Vaccines
• Ensuring the effectiveness of COVID-19 Vaccines
• Frequently Asked Questions about COVID-19 Vaccination

This CDC Web resource provides guidance on the regulatory requirements for SARS-CoV-2 point of care (POC) testing, using POC tests safely, and information on reporting POC test results.

Testing before and after travel can reduce the risk of spreading COVID-19. Testing does not eliminate all risk, but when paired with a period of staying at home and everyday precautions like wearing masksand social distancing, it can make travel safer by reducing spread on planes, in airports, and at destinations.

People with moderate to severe asthma may be at higher risk of getting very sick from COVID-19.  COVID-19 can affect your nose, throat, lungs (respiratory tract); cause an asthma attack; and possibly lead to pneumonia and acute respiratory disease.

The CDC released an MMWR on Trends in County-Level COVID-19 Incidence in Counties With and Without a Mask Mandate in Kansas between June 1 and August 23, 2020. Countywide mask mandates appear to have contributed to the mitigation of COVID-19 transmission in mandated counties.

Vaccine

The Department of Health and Human Services (HHS) Secretary Alex Azar states the federal government will leave it up to states to distribute their vaccine allocations to patients. The federal government expects to have 40 million vaccines ready for distribution upon the anticipated Food and Drug Administration (FDA) approval in December.

The FDA announced a meeting of its Advisory Committee to discuss Pfizer’s COVID-19 vaccine candidate. The FDA could issue an emergency use authorization (EUA) for the vaccine shortly after the committee’s meeting if the vaccine is favorably reviewed.

The FDA has updated a webpage, Vaccine Development – 101, to provide an overview of the vaccine development process.

In a new webpage, Emergency Use Authorization (EUA) for Vaccines Explained, the FDA offers answers to questions about EUAs, in general, and more specifically, about EUA requests for a vaccine intended to prevent COVID-19.

AstraZeneca, in partnership with Oxford University, is reporting early positive results for its COVID-19 vaccine candidate.

This article explores the similarities and differences between the vaccine candidates from Pfizer and Moderna.

The White House Operation Warp Speed (OWS) states that vaccines could begin reaching those recommended for the nation’s first COVID-19 inoculations in mid-December.

• The Federal Government is beginning to notify federal essential workers that they could begin receiving vaccines in about two months.

The CDC released an MMWR on The Advisory Committee on Immunization Practices’ (ACIP) Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine. During the period when the U.S. supply of COVID-19 vaccines is limited, the ACIP will make vaccine allocation recommendations. In addition to scientific data and implementation feasibility, four ethical principles will assist ACIP in formulating recommendations for the initial allocation of COVID-19 vaccine:

1. Maximizing benefits and minimizing harm.
2. Promoting justice.
3. Mitigating health inequities; and
4. Promoting transparency.

The CMS released an update to the Coverage and Reimbursement of COVID-19 Vaccines, Vaccine Administration and Cost Sharing under Medicaid, the Children’s Health Insurance Program, and Basic Health Program vaccine toolkit that was originally released on October 28.

Testing and Treatment

The FDA issued an emergency use authorization (EUA)for Regeneron’s antibody therapy, casirivimab and imdevimab, which are to be administered together for the treatment of mild to moderate COVID-19.

• HHS announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.

The FDA issued an emergency use authorization (EUA)for Eli Lilly and Company’s arthritis drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19, in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The government has allocated more than 100,000 treatment courses of Eli Lilly and Company’s antibody therapy (bamlanivimab) with about 40,000 courses currently being prepared for distribution. The first allocation began Nov. 10. A jurisdiction-by-jurisdiction dashboard of allocations can be found here, and is updated each Wednesday at 11 a.m. ET.

The World Health Organization (WHO) is now recommending against the use of remdesivir to treat COVID-19.

The National Institutes of Health (NIH) has awarded nearly $45 million to expand the research network of the Rapid Acceleration of Diagnostics – Underserved Populations (RADx-UP)program, adding 20 institutions and seven states and territories. RADx-UP aims to enable and enhance COVID-19 testing of populations disproportionately affected by the disease, including Blacks, American Indians/Alaskan Natives, Latinos/Latinas, Native Hawaiians, older adults, pregnant women and those who are homeless or incarcerated. This second round of awards brings the total investment in the RADx-UP program to more than $283 million at 55 institutions across 33 states and territories and the Cherokee Nation.

A new study shows that hospitalized COVID-19 patients are surviving at higher rates than earlier in the pandemic.