Killian Meara

The Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation to the Janssen COVID-19 vaccine for use in individuals aged ≥18 years for the prevention of COVID-19 this past Sunday. The committee is composed of both medical and public health experts that develop recommendations for the use of vaccines in the civilian population. The recommendation is a respected guidance in public health for the safe use of vaccines and related biological products.

During the assessment prior to the recommendation, the committee employs the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, followed by the Evidence to Recommendations (EtR) framework to guide their deliberations. The GRADE approach rates the vaccine on a scale of 1 to 4, with 1 being a high certainty of evidence for outcomes related to the vaccine, and 4 being a very low certainty.

Within the EtR framework, the committee reviewed the importance of COVID-19 as a public health problem, as well as resource use, benefits and harms, patients’ values and preferences, acceptability, feasibility, and equity. The committee graded the Janssen vaccine a type 2 (moderate certainty), for the prevention of symptomatic disease and for the estimate of prevention of COVID-19—associated hospitalization and death. Evidence for possible harms after vaccination was given a type 1 (high certainty) for reactogenicity and type 2 for serious adverse events.

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ACIP issued an interim recommendation to the Janssen COVID-19 vaccine for use in individuals aged ≥18 years for the prevention of COVID-19.

Advisory Committee on Immunization Practices Issues Interim Recommendation for Janssen's COVID-19 Vaccine

The FDA has granted an Emergency Use Authorization (EUA) to a novel coronavirus disease 2019 (COVID-19) antibody test that is able to determine the severity of an individual’s symptoms. The test was developed by Vibrant American Clinical Labs, a leading science and technology company, and tested by investigators from the University of Denver’s Knoebel Institute for Healthy Aging and Resilience Code, a functional medicine and human performance clinic.

“This antibody test has more test points than others that have been approved by the FDA,” Lotta Granholm-Bentley, the founding executive director of the Knoebel Institute and one of the project’s lead researchers said. “Other tests check for only a few viral antigens, whereas this one could test for as many as a dozen.”

Investigators discovered different profiles of antibodies between people who were positive with the virus and had mild or severe symptoms. Using this information from the test, they were able to predict the severity of their outcome.

COVID-19 antibody test may also be able to identify those who have been exposed to the disease but have so far been asymptomatic.