Mpox vaccine maker Bavarian Nordic seeks ‘pivotal’ approval for teens

LONDON — Danish biotech company Bavaria Northern Europe The company said on Friday it had submitted data to the European Union’s medicines regulator to extend the use of its MPox vaccine in adolescents.

CEO Paul Chaplin told CNBC that expanding approval to 12- to 17-year-olds was critical to responding to the outbreak of the latest strain of the virus, Type 1b, which particularly affects teens and children.

Earlier, the World Health Organization announced on Wednesday that the MPox outbreak in Africa was escalating. Public Health EmergenciesOn Thursday, Sweden confirmed the first case of coronavirus infection outside continental Europe.

“The latest data that we’ve submitted is very, very important because hopefully it will expand the use of our vaccine to adolescents,” Chaplin told “Squawk Box Europe.”

“More than 70% of cases in Africa are currently occurring in people under the age of 18, so it is vital that our vaccine is available to this younger age group,” he said.

Bavarian Nordic’s JYNNEOS vaccine, also known as IMVANEX, is currently licensed only for use in adults aged 18 and over and is the only mpox vaccine approved by the U.S. Food and Drug Administration and the European Medicines Agency.

The company said that if the European Medicines Agency approves the vaccine for use in adolescents, it would pave the way for approval for adolescents in Africa. The company is also currently studying the vaccine’s efficacy in children aged two and above, with results expected next year.

Shares in Bavaria Nordic rose 17 percent on Thursday after the World Health Organization declared a state of emergency. Other Healthcare Stocksas people believe that demand for vaccines is increasing. As of noon on Friday, the Copenhagen stock market in Denmark rose another 17.5%.

Chaplin said the company had large stocks of the vaccine “ready to ship” to countries in need, but noted that bottlenecks in Africa had so far hampered distribution.

The vaccine is currently only approved in the Democratic Republic of Congo and Nigeria, the epicenter of the outbreak, but Chaplin said the company is continuing to work with authorities in neighboring affected countries to ensure supply of the vaccine.

“Now that the Democratic Republic of Congo and Nigeria have also approved the vaccine, it opens the door for governments to buy it and for Bavaria Nordic to donate it and deliver it, and hopefully we can start vaccinating people soon,” he said.

The outbreak has led to more than 15,000 cases and at least 537 deaths so far this year. World Health Organization. In 2022, another strain of the MPOX virus also broke out and was declared a public health emergency.

Chaplin said authorities were better able to respond now because vaccines were in place, particularly in wealthy countries that stockpiled them during the last pandemic, but he urged greater international cooperation to ensure vaccines reached those who needed them most.

“Bavarian Nordic is part of the solution, but we are not the only solution,” he said. “The international community needs to work hand in hand with Bavarian Nordic to really find a way to distribute the vaccine and control the epidemic.”