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Thursday, September 8, 2022
NIH Trial is Evaluating Intradermal Delivery to Expand the Vaccine Supply.
Interested volunteers can visit clinicaltrials.gov and search identifier NCT05512949 for more information about the trial, including a list of sites. Please do not call or email the NIAID News and Science Writing Branch to inquire about enrolling in this trial.
A clinical trial evaluating alternative strategies for administering the JYNNEOS monkeypox vaccine to increase the number of available doses has begun enrolling adult volunteers. The trial, which will enroll more than 200 adults across eight U.S. research sites, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. JYNNEOS is manufactured by Bavarian Nordic, based in Copenhagen. It is approved by the U.S. Food and Drug Administration for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
JYNNEOS contains an attenuated orthopoxvirus called modified vaccinia Ankara (MVA), which does not replicate in human cells. It is approved for administration by two subcutaneous (in the tissue beneath the skin) injections 28 days apart; however, the FDA recently authorized intradermal (between layers of the skin) administration of the vaccine for adults, which expands the number of people who can be vaccinated with the currently limited supply. This alternative intradermal dosing regimen uses one-fifth of the standard dose used for subcutaneous administration, allowing health care providers to administer up to five times the number of vaccine doses per vial of JYNNEOS vaccine.
“To halt the global outbreak of monkeypox and to help protect those at risk of infection, we need to ensure we have an adequate supply of monkeypox vaccine,” said NIAID Director Anthony S. Fauci, M.D.
NIH Trial is Evaluating Intradermal Delivery to Expand the Vaccine Supply.
Interested volunteers can visit clinicaltrials.gov and search identifier NCT05512949 for more information about the trial, including a list of sites. Please do not call or email the NIAID News and Science Writing Branch to inquire about enrolling in this trial.
A clinical trial evaluating alternative strategies for administering the JYNNEOS monkeypox vaccine to increase the number of available doses has begun enrolling adult volunteers. The trial, which will enroll more than 200 adults across eight U.S. research sites, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. JYNNEOS is manufactured by Bavarian Nordic, based in Copenhagen. It is approved by the U.S. Food and Drug Administration for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
JYNNEOS contains an attenuated orthopoxvirus called modified vaccinia Ankara (MVA), which does not replicate in human cells. It is approved for administration by two subcutaneous (in the tissue beneath the skin) injections 28 days apart; however, the FDA recently authorized intradermal (between layers of the skin) administration of the vaccine for adults, which expands the number of people who can be vaccinated with the currently limited supply. This alternative intradermal dosing regimen uses one-fifth of the standard dose used for subcutaneous administration, allowing health care providers to administer up to five times the number of vaccine doses per vial of JYNNEOS vaccine.
“To halt the global outbreak of monkeypox and to help protect those at risk of infection, we need to ensure we have an adequate supply of monkeypox vaccine,” said NIAID Director Anthony S. Fauci, M.D.