The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Janssen COVID-19 Vaccine — United States, February 2021

Abstract

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. †

Thrombosis with thrombocytopenia syndrome associated with COVID-19 vaccines

“…The two primary vaccines associated with TTS currently include the ChAdOx1 nCoV-19 (Oxford-AstraZeneca [AZ]; also known as Vaxzevria) and AD26.COV2·S (Johnson & Johnson [JJ]) vaccines [ [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] ]. The ChAdOx1 nCoV-19 and AD26.COV2·S vaccines consist of recombinant adenovirus vectors from a chimpanzee adenovirus or human adenovirus, respectively, which encode a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein [ 11 , 12 , 14 ].…”

“…As of April 4, 2021, 169 cases of cerebral venous thrombosis (CVT) and 53 cases of splanchnic vein thrombosis associated with TTS were found from approximately 34 million ChAdOx1 nCoV-19 vaccine administrations in the European Union [ 11 , 15 ]. On April 13, 2021, the United States Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) recommended pausing administrations of the AD26.COV2·S vaccine due to concern of TTS [ 7 , 11 , [16] , [17] , [18] ]. There were 15 reported cases of thrombosis from over 6.8 million doses of the AD26.COV2·S vaccine administered at that time [ 11 , [16] , [17] , [18] ].…”

“…On April 13, 2021, the United States Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) recommended pausing administrations of the AD26.COV2·S vaccine due to concern of TTS [ 7 , 11 , [16] , [17] , [18] ]. There were 15 reported cases of thrombosis from over 6.8 million doses of the AD26.COV2·S vaccine administered at that time [ 11 , [16] , [17] , [18] ]. In the United Kingdom as of April 14, there were 77 cases of TTS associated with CVT and 91 cases of TTS associated with thrombosis in other veins with 32 deaths, from over 21.2 million doses administered of the ChAdOx1 nCoV-19 vaccine [ 7 , 11 , 15 , 19 ].…”

COVID-19 in Pregnant Women and Their Newborn Infants

“…In the US, there are currently 3 COVID-19 vaccines approved under Emergency Use Authorization (EUA) for use in individuals as young as 16 to 18 years, with more vaccines likely to be approved under EUA during the next 12 months. [9][10][11] These vaccines use a variety of constructs, such as the novel messenger RNA construct, adenovirus vectors, and protein subunit vaccines. Pregnant women were and are excluded from clinical trials of these vaccines, and data are at this time very limited as to pregnancy outcomes and vaccine efficacy in preventing symptomatic disease in pregnant and other vulnerable populations.…”

Challenges and Issues of Anti-SARS-CoV-2 Vaccines

“…Last published was the interim analysis of the phase 3 trial of the Gam-COVID-Vac that showed 91.1% efficacy (95% CI 83.8-95.1) against documented COVID-19 after two doses (27). The firm Johnson and Johnson has already announced its candidate provided 66% efficacy (72% in the US cohort) in preventing symptomatic, laboratory-confirmed COVID-19 from 28 days after injection with even higher efficacy against severe forms of infection and including against the south African variant from the B.1.351 Lineage (33).…”