Elnahal: COVID-19 vaccine trial at University Hospital will follow ethical guidelines, says participation is voluntary

    University Hospital CEO Shereef Elnahal attempted to quell fears of the Black community in Newark regarding the Moderna COVID-19 vaccine trial that will take place at the hospital in the city. He made it clear: The trial is voluntary. No one can be forced to participate.

    Elnahal, in fact, has signed up to participate himself.

    University Hospital is one of 90 hospitals in the country that will be participating in the study. The Newark trial is being run by the hospital and Rutgers New Jersey Medical School. Hackensack University Medical Center also will be a host for the study.

    Shereef Elnahal.

    Elnahal, in a statement Monday, said he understood the concerns of citizens — and stressed University Hospital is following all ethical guidelines in the study.

    “As an academic medical center, University Hospital plays an important role in ensuring that all clinical research, including this vaccine study, is conducted using the tenets we all must demand from modern medicine,” he said.

    Elnahal said the COVID-19 vaccine trial upholds these bioethical standards because:

    • All enrolled participants must provide informed consent;
    • This informed consent can be revoked at any time, without repercussion and even if against the advice of the patient’s physician;
    • At all times, participants will be provided with a detailed account of any possible side effects and potential benefits as they become known; and
    • This trial went through a full ethics review and meets international research standards for ethical research.

    Elnahal noted that the trial is not exclusive to Newark or Black or Latino communities. Recent reports, in fact, have stated a concern that there are not enough members of those communities in the study, casting uncertainty on whether an eventually approved vaccine would work in diverse populations.

    Elnahal also said that, regardless of whether University Hospital, or any residents in Newark and the surrounding communities, participate in this vaccine study or any other vaccine study, it appears likely that a vaccine will be approved by January 2021.

    The specific goal of enrolling residents in Newark and our surrounding communities is to ensure that the community is represented in these trials, in order to understand whether vaccine candidates will work in minority communities.

    ‍Here are details of the Moderna COVID-19 Trial (also known as the COVE Study), as provided by University Hospital:

    • The Moderna COVE study will enroll 30,000 participants at over 90 different testing sites across the country, who will receive either a vaccine or a placebo dose. This study is not exclusive to the Newark community or the minority community.
    • Enrollment in the Moderna COVE study is purely voluntary and requires informed consent about the potential risks and benefits. Participants will be fully informed of any data that becomes available along the way and may withdraw from the study at any time without repercussion.
    • It is anticipated that the demographic of the enrollees in this study will be representative of the racial demographics of the country, including a majority of the participants being white Americans.
    • Since March 2020, several hundred people have received the vaccine so far with no serious side effects.
    • Both the Phase 1 and Phase 2 trials have been conducted elsewhere in the U.S.; Rutgers NJMS and University Hospital did not participate in these phases.
    • Phase 1 trial data has been published and it was shown that the vaccine induced an appropriate immune response in all 45 participants and no trial-limiting safety concerns were identified.
    • Phase 2 is ongoing and has completed enrollment of up to 600 participants.