¶¶ Enrollees who report seeking medical care are contacted by CDC’s v-safe call center and encouraged to complete a VAERS report, if indicated. §§ Vaccine recipients who enroll in v-safe receive regularly scheduled text message reminders to complete short online health surveys that include questions about local injection site and systemic reactions and health impacts (i.e., whether the enrollee was unable to perform normal daily activities, missed work, or received care from a medical professional because of new symptoms or conditions). V-safe is a new, voluntary text-based surveillance system designed to collect additional information about COVID-19 vaccine adverse events, particularly for common side effects. †† VAERS staff members attempt to obtain medical records and supporting information from health care providers for all reported serious events, as well as death certificates and autopsy reports for all deaths. Under EUAs for each COVID-19 vaccine, health care providers are required to report several types of adverse events to VAERS, including all deaths.** Signs and symptoms in VAERS reports are coded using the Medical Dictionary for Regulatory Activities (MedDRA). VAERS reports are accepted from health care providers, vaccine manufacturers, and the public. VAERS is a national passive surveillance program managed by CDC and FDA that monitors adverse events after all vaccinations ( 9). Ongoing monitoring of adverse events after COVID-19 vaccination, including vaccination with the Janssen single-dose vaccine, is essential for evaluating the risks and benefits of each vaccine. vaccine safety data detected three additional cases of non-CVST TTS, in addition to the previously recognized CVST cases that initiated the pause in use of the Janssen COVID-19 vaccine. The overall safety profile is consistent with preauthorization clinical trials data. ¶ Fatigue and pain were commonly reported symptoms in both VAERS and v-safe. Approximately 338,700 Janssen COVID-19 vaccine recipients completed at least one v-safe survey during the week after vaccination 76% reported a systemic reaction, 61% reported a local reaction, and 34% reported a health impact. These three cases and the previously detected CVST cases are consistent with 17 cases of TTS, § a newly defined condition. 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. As of April 21, 2021, 7.98 million doses of the Janssen COVID-19 vaccine had been administered. 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. CVST cases that prompted the pause in Janssen vaccination, as well as subsequently detected CVST cases, are described elsewhere ( 8). 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). 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). 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). 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 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).
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