Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021

Abstract

On April 30, 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 Janssen (Ad.26.COV2.S) COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson) (1). The Janssen COVID-19 vaccine, the third COVID-19 vaccine authorized for use in the United States, uses a replication-incompetent human adenoviral type 26 vector platform* (2) and is administered as a single intramuscular dose, whereas the first two authorized vaccines use an mRNA platform and require 2 doses. On February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for use of Janssen COVID-19 vaccine among persons aged ≥18 years (3). During April 13-23, CDC and FDA recommended a pause in use of Janssen vaccine after reports of six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia (platelet count <150,000/µL of blood) among Janssen vaccine recipients (4). Similar thrombotic events, primarily among women aged <60 years, have been described in Europe after receipt of the AstraZeneca COVID-19 vaccine, which uses a replication-incompetent chimpanzee adenoviral vector (5-7). The U.S. CVST cases that prompted the pause in Janssen vaccination, as well as subsequently detected CVST cases, are described elsewhere (8). This report summarizes adverse events among Janssen vaccine recipients, including non-CVST cases of thrombosis with thrombocytopenia syndrome (TTS), reported to the Vaccine Adverse Events Reporting System (VAERS), a passive surveillance system, and through v-safe, an active monitoring system. As of April 21, 2021, 7.98 million doses of the Janssen COVID-19 vaccine had been administered. Among 13,725 VAERS reports reviewed, 97% were classified as nonserious and 3% as serious, † including three reports among women of cases of thrombosis in large arteries or veins accompanied by thrombocytopenia during the second week after vaccination. These three cases and the previously detected CVST cases are * The Janssen COVID-19 vaccine contains double-stranded DNA encoding a variant of the SARS-CoV-2 spike glycoprotein inserted into a replicationincompetent human adenovirus type 26 virus. † VAERS reports are classified as serious if any of the following are reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly, or birth defect.

The role of trust in the likelihood of receiving a COVID-19 vaccine: Results from a national survey

“…In addition, transparency in the approval process and effective communication to the public from ACIP ( McClung et al, 2020 ), the National Academy of Sciences ( National Academies of Sciences et al, 2020 ) and other groups regarding ethical vaccine allocation should help build trust in the vaccines. This is particularly important as rare side effects of the vaccines occur and federal agencies continue to review the safety profile of the vaccines ( Shay et al, 2021 ).…”

US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021

“…12 Six cases of CVST with thrombocytopenia after Ad26.COV2.S vaccination were reported through the Vaccine Adverse Event Reporting System (VAERS) to the Centers for Disease Control and Prevention (CDC) and FDA as of April 12, 2021; information about 1 case was published. 13 On April 13, the CDC and FDA recommended a pause in the use of the Ad26.COV2.S vaccine. 2,14 By April 21, 6 additional cases of CVST with thrombocytopenia and 3 cases of non-CVST TTS following administration of Ad26.COV2.S vaccine were reported to VAERS.…”

Thrombotic thrombocytopenic purpura: a new menace after COVID bnt162b2 vaccine

“…Reports on Ad26.COV2.S vaccine reported symptoms like bilateral lower leg edema and shortness of breath, along with thrombotic thrombocytopenic events in women aged less than 60 years [ 8 ].…”