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On December 3, 2020, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic that has disrupted all sectors of society. Less than 1 year after the SARS-CoV-2 genome was first sequenced, an application* for Emergency Use Authorization for a candidate vaccine has been filed with the Food and Drug Administration (FDA). However, even if one or more vaccine candidates receive authorization for emergency use, demand for COVID-19 vaccine is expected to exceed supply during the first months of the national vaccination program. The Advisory Committee on Immunization Practices (ACIP) advises CDC on population groups and circumstances for vaccine use. † ACIP convened on December 1, 2020, in advance of the completion of FDA's review of the Emergency Use Authorization application, to provide interim guidance to federal, state, and local jurisdictions on allocation of initial doses of COVID-19 vaccine. ACIP recommended that, when a COVID-19 vaccine is authorized by FDA and recommended by ACIP, both 1) health care personnel § and 2) residents of long-term care facilities (LTCFs) ¶ be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a**). † † In its deliberations, ACIP considered scientific evidence of SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles. § § The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization. Evidence-based information addressing COVID-19 vaccine topics including early allocation has been explicitly and transparently reviewed during seven public ACIP meetings (1). To inform policy options for ACIP, the COVID-19 Vaccines Work Group, comprising experts in vaccines and ethics, held more than 25 meetings to review data regarding vaccine candidates, COVID-19 surveillance, and modeling, as well as

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On March 2, 2021, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr).On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc, a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey). The Janssen COVID-19 vaccine is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector vaccine, encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19 (1). Vaccination with the Janssen COVID-19 vaccine consists of a single dose (5 × 10 10 virus particles per 0.5-mL dose) administered intramuscularly. On February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Janssen COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. This vaccine is the third COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendations (EtR) framework, † following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. § The ACIP recommendation for the use of the Janssen COVID-19 vaccine under an EUA is interim and will be updated as additional information becomes available.Since June 2020, ACIP has convened 11 public meetings to review data on the epidemiology of COVID-19 and the potential use of COVID-19 vaccines, including the Janssen COVID-19 vaccine (3). The COVID-19 Vaccines Work Group, comprising experts in infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccines. Within the EtR framework for the Janssen COVID-19 vaccine, ACIP considered the importance of COVID-19 as a public health problem, as well as resource use, benefits and * On February 28, 2021, ACIP voted 12-0 in favor of the interim recommendation for use of the Janssen COVID-19 vaccine. One ACIP member recused himself from voting because of recent (<6 months) participation in clinical trials or other studies involving companies producing COVID-19 vaccines. †

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