Publications by authors named "R F Helfand"
Safety and efficacy of vaccines against the SARS-CoV-2 coronavirus has been demonstrated in clinical trials and next by their real world use through the course of the ongoing COVID-19 pandemic. However, very rare adverse events have been detected post-authorization in certain parts of the world. This meeting report summarizes an EMA workshop’s discussion on the epidemiology, clinical presentation and biology of thrombosis with thrombocytopenia syndrome after adenovirus vector COVID-19 vaccination.
View Article and Find Full Text PDFOn December 19, 2019, the Food and Drug Administration (FDA) approved rVSVΔG-ZEBOV-GP Ebola vaccine (ERVEBO, Merck) for the prevention of Ebola virus disease (EVD) caused by infection with Ebola virus, species Zaire ebolavirus, in adults aged ≥18 years. In February 2020, the Advisory Committee on Immunization Practices (ACIP) recommended preexposure vaccination with ERVEBO for adults aged ≥18 years in the United States who are at highest risk for potential occupational exposure to Ebola virus because they are responding to an outbreak of EVD, work as health care personnel at federally designated Ebola treatment centers in the United States, or work as laboratorians or other staff members at biosafety level 4 facilities in the United States (1).
View Article and Find Full Text PDFArticle Synopsis
- - The Advisory Committee on Immunization Practices (ACIP) recommends the rVSVΔG-ZEBOV-GP Ebola vaccine (Ervebo) for use in the U.S., specifically for adults aged 18 and older who are at high risk of exposure to the Ebola virus.
- - Ervebo is the first and only FDA-approved vaccine for preventing Ebola virus disease (EVD), but individuals with a severe allergic reaction to rice protein should not receive it.
- - Future guidelines will adapt as new data emerges or as new vaccines are approved, with ACIP planning to discuss Ervebo's use for other at-risk populations.
Background: Colombia began official surveillance for Zika virus disease (ZVD) in August 2015. In October 2015, an outbreak of ZVD was declared after laboratory-confirmed disease was identified in nine patients.
Methods: Using the national population-based surveillance system, we assessed patients with clinical symptoms of ZVD from August 9, 2015, to April 2, 2016.