A clinical trial by the National Institutes of Health (NIH) showed that Bavarian Nordic’s MPOX vaccine elicited antibody responses in adolescents comparable to those in adults.
The interim results, presented at the Infectious Diseases Society of America’s IDWeek 2024 conference in Los Angeles, support the long-term use of the vaccine in people under 18 in the United States and other regions where mpox cases are occurring. There is a possibility.
Bavarian Nordic received European Medicines Agency (EMA) approval for the use of MVA-BN in adolescents in September, but it is still only approved for adults in the United States under the brand name Jynneos. However, during the 2022-2023 mpox outbreak, the FDA granted emergency use authorization for the vaccine in both pre- and post-exposure settings in adolescents.
The NIH said in an Oct. 16 press release that while several countries have approved vaccines for the prevention of Mupox and smallpox in adults, “there are no available data to support authorization for people under 18 years of age.” “It’s not enough,” he said.
The Phase II study (NCT05512949), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), was conducted in the United States in individuals aged 12 to 17 years. After two doses, antibody levels at day 43 were found to be similar to those in adults aged 18 to 50. The overall frequency of adverse events was comparable between study groups, and the vaccine was well tolerated through day 210 of the study. Although dizziness has been reported more frequently in adolescents, the NIH said it is also seen with many other vaccines given to younger age groups.
This randomized, mid-term study enrolled 229 healthy adolescents, some of whom had human immunodeficiency virus (HIV) infection. People with compromised immune systems and those who are pregnant have been adversely affected by the outbreak of clade II mpox in Africa, and the majority of people testing positive on the continent are under 18 years of age.
Although mpox cases have been steadily increasing in the African region over the past decade, the number of cases reported so far this year has already exceeded last year’s total, with clade I and clade II accounting for over 24,000 mpox cases. Confirmed or suspected deaths, including more than 600.
The NIH research team says the data supports the safety and quality of the immune response in adolescents, but the authors reiterated that further evaluation is needed in younger children.
Bavarian Nordic is preparing its own Phase II clinical trial (NCT06549530) to evaluate the immunogenicity and safety of MVA-BN in children aged 2 to 12 years. The company previously said it aimed to “further expand the vaccine’s indications to younger populations.” The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is scheduled to begin this month.
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In September, the Bavarian Nordic government announced it would prioritize the production of 2 million mpox vaccines by the end of this year to help fight the disease in Africa. The Swiss biotech company has already shipped 250,000 doses of its vaccine to the Democratic Republic of Congo, the epicenter of the outbreak.
“Bavarian Nordic’s mpox vaccine is equally effective in teenagers and adults” was originally created and published by Pharmaceutical Technology, a brand owned by GlobalData.
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