A clinical trial at the National Institutes of Health will evaluate if a dose-sparing strategy to stretch the limited quantities of the monkeypox vaccine is as effective at protecting against the virus as the typical dose.
The trial, which will enroll over 200 adults between 18 and 50 years old, will assess if the immune responses induced by using one-fifth of the dose in the top layer of the skin are as good as administering the full dose to the fat underneath the skin.
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“NIAID’s trial of JYNNEOS will provide important information on the immunogenicity, safety, and tolerability of alternative dosing approaches that would expand the current supply of vaccine,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the president.
The Department of Health and Human Services announced last month that healthcare providers could begin administering the vaccine intradermally versus subcutaneously, relying on results from a 2015 study. Over 70% of all monkeypox vaccine doses being administered in the United States are now using the new approach, Bob Fenton, the White House’s monkeypox response coordinator, told reporters Wednesday.
Fenton said the new dose-sparing strategy does not sacrifice safety, as the administration remains eager to get more shots in arms to control the current outbreak.
Little is known about how well the only vaccine the FDA approved to prevent monkeypox, Jynneos, will perform against the virus. Officials were forced to rely on sparse data stemming mainly from animal studies for the vaccine’s approval.
The clinical trial is anticipated to stretch over 15 months, and initial results may be available as soon as the beginning of next year.
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As of Wednesday, over 21,000 cases of monkeypox have been identified in the U.S., according to the Centers for Disease Control and Prevention.
