The Food and Drug Administration (FDA) granted an emergency use authorization (EUA) Dec. 18 for the use of the Moderna COVID-19 vaccine in individuals ages 18 and older.
Like the Pfizer vaccine, the vaccine uses a small piece of the SARS-CoV-2 virus’ messenger ribonucleic acid. This triggers human cells to create the virus’ “spike” protein, which in turn triggers the immune system to respond against the virus. The vaccine is administered in two doses, one month apart. CDC has released fact sheets for health care providers and vaccine recipients and their caregivers.
The Department of Health and Human Services (HHS) on Dec. 11 announced the purchase of an additional 100 million doses of the Moderna vaccine, after purchasing an initial 100 million doses in August. Under this agreement, Moderna will fill, finish, and ship vials of the vaccine in the United States, allowing for continued delivery through June 2021. Through Operation Warp Speed, the government has the ability to acquire up to 300 million additional doses of the Moderna vaccine.
CDC Committee Votes on Moderna Recommendation, Vaccine Allocation
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) met Dec. 18 and 19 and issued an interim recommendation for the use of the Moderna vaccine. The recommendation is detailed in CDC’s Dec. 20 Morbidity and Mortality Weekly Report.
ACIP also voted to prioritize adults age 75 and older and front-line essential workers — defined as first responders, teachers and education workers, food and agriculture workers, correctional facility staff, postal workers, public transit workers, and people who work in manufacturing and in grocery stores — in groups 1b and 1c for vaccine allocation. The recommendations now head to CDC Director Robert Redfield for his approval.
As of Dec. 20, 556,208 vaccines have been administered to people in priority group 1a, which includes health care workers and long-term care facility residents.
FDA Authorizes At-Home COVID-19 Test
The FDA on Dec. 16 issued an EUA for the BinaxNOW COVID-19 Ag test, which enables at-home, prescription use of the antigen test for individuals ages 15 years or older within seven days of symptom onset. The test also may be used for individuals ages 4 years or older as long as an adult collects the nasal swab sample.
The test will be offered alongside a telehealth service that will walk users through the sample collection process and explain how to read and understand the results. The telehealth provider will report test results to public health authorities pursuant to local, state, and federal requirements.
FDA in August approved a similar BinaxNOW rapid test for point-of-care use, and HHS in September launched a pilot program to provide the rapid tests to cities and states to aid in reopening efforts.
CMS Adds New COVID-19 Diagnosis Codes
In response to the COVID-19 national emergency, the CDC’s National Center for Health Statistics added six new diagnosis codes to the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), effective Jan. 1, 2021:
- encounter for screening for COVID-19 (Z11.52);
- contact with and (suspected) exposure to COVID-19 (Z20.822);
- personal history of COVID-19 (Z86.16);
- multisystem inflammatory syndrome (M35.81);
- other specified systemic involvement of connective tissue (M35.89); and
- pneumonia due to coronavirus disease 2019 (J12.82).
Interim guidance and the ICD-10-CM browser tool are available on the CDC website.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.