NIH Will Study New ‘Dose Sparing’ Monkeypox Vaccination Method

Topline

The National Institutes of Health plans to launch a clinical trial evaluating a new method of administering the monkeypox vaccine, the agency confirmed to Forbes, two weeks after the Food and Drug Administration approved the method, which allows healthcare workers to stretch limited vaccine supplies by injecting one-fifth of a standard dose.

A man waits in line to receive the Monkeypox vaccine.

AFP via Getty Images

Key Facts

The agency will use the clinical trial to “gather more data” about the method—which involves injecting one-fifth of the vaccine intradermally, or into the skin, instead of injecting a full dose subcutaneously, or underneath the skin into the fat—and look into potential side effects, the National Institute of Allergy and Infectious Diseases said.

The news comes after some experts raised concerns about limited data on the new “dose sparing” strategy, which is based largely on a single study sponsored by the NIH in 2015 that found intradermal administration of the monkeypox vaccine elicited a similar antibody response compared to standard injections.

The agency did not specify how long the trial will take, but plans to share more information on the trial in a “forthcoming” announcement, NIAID told Forbes.

Tangent

Health officials have used intradermal vaccination to stretch out a short supply of shots in other instances, including for polio. The method is also used for tuberculosis tests, which involve injecting a small amount of fluid into the skin to measure the immune system’s response.

Key Background

Monkeypox cases have surged in the U.S. over the past three months, with a total of 14,115 cases of monkeypox and orthopoxvirus—the class of viruses that monkeypox belongs to—confirmed as of August 18, according to the Centers for Disease Control and Prevention. The federal government has faced backlash for its slow rollout of the Jynneos vaccine, which is produced exclusively by the Danish company Bavarian Nordic and is the only shot specifically approved by the FDA for monkeypox. In response, after declaring monkeypox a public health emergency, the White House said it would adopt the new intradermal vaccination strategy to expand supplies of Jynneos. White House officials have said the method is safe, and that evidence suggests it produces the same immune response as the standard dosage and method. But the new strategy also comes with another challenge: Most health care workers are not trained on how to give intradermal injections. The CDC said last week it is providing training to help workers learn how to do so.

Contra

In a letter to Secretary of Health and Human Services Xavier Becerra and FDA Commissioner Robert Califf earlier in August, Bavarian Nordic CEO Pal Chaplin said the company had some “reservations” about the intradermal approach because of “very limited safety data,” as well as concerns people may not receive the necessary second vaccine dose, the New York Times reported. Chaplin also faulted the White House for not effectively communicating with the company before making the announcement so Bavarian Nordic could discuss best practices for administration with the federal government.

What To Watch For

More local jurisdictions could transition to intradermal vaccination. New York Health Commissioner Mary Bassett said Monday the state—which is the epicenter of the U.S. outbreak—has started to adopt the dose sparing strategy. Health officials in Los Angeles and Fulton County, which includes Atlanta, have also switched to the new method, the White House said last week.