据了解，Imvanex（MVA-BN，在美国的商品名为Jynneos，在加拿大为Imvamune）是一种用于保护成年人的天花疫苗，但数据显示其在预防猴痘方面有效。Bavarian Nordic announced that it has submitted clinical data to the European Medicines Agency to seek expansion of the indications for the Imvanex vaccine to include adolescents aged 12 to 17. Yesterday, Sweden, a neighbor of Denmark, reported the first confirmed case of monkeypox, the first confirmed case outside of the African continent since the outbreak of the epidemic.
On August 16th, Caixin reported (Editor Zhao Hao) that Bavarian Nordic, a Danish pharmaceutical company, announced on its official website that it has submitted clinical data to the European Medicines Agency (EMA) to seek expansion of the indications for the Imvanex vaccine to include adolescents aged 12 to 17.
Source: Bavarian Nordic official website
It is understood that Imvanex (MVA-BN, known as Jynneos in the US and Imvamune in Canada) is a smallpox vaccine used to protect adults, but data shows that it is effective in preventing monkeypox.
In 2022, it was approved for use in response to monkeypox outbreaks by both the European Union and the United States, and is suitable for adults 18 years of age and older. At that time, the U.S. Food and Drug Administration (FDA) also granted the vaccine emergency use authorization for adolescents.
Currently, the vaccine is still the only monkeypox vaccine approved by the FDA and EMA, but it is not yet applicable to adolescents in Europe.
Bavarian Nordic wrote that the mid-term results of a clinical study showed that 315 adolescents aged 12-17 and 211 adults aged 18 and above received two standard doses of the vaccine, with similar immune responses and safety profiles in both age groups.
The press release also stated that the company is preparing for another clinical trial, which is scheduled to be launched later this year in the Democratic Republic of Congo and Uganda to evaluate the vaccine's immunogenicity and safety in children aged 2-12 years, providing evidence for further expansion of its applicability.
Bavarian Nordic's CEO Paul Chaplin said in a statement, "In the ongoing epidemic in Africa, children and adolescents are particularly affected by monkeypox, highlighting the importance and urgency of expanding access to vaccines and treatments for this vulnerable population."
Earlier this week, the Director of the Africa Centers for Disease Control and Prevention, Jean Kasai, announced that the monkeypox epidemic is a public health emergency in Africa. The next day, the World Health Organization Director-General Tedros Adnom Ghebreyesus declared the monkeypox epidemic a "public health emergency of international concern."
This is the second time in more than two years that the WHO has declared the monkeypox epidemic a "public health emergency of international concern." The organization's data shows that the number of reported monkeypox cases exceeds 0.0156 million so far this year, surpassing the total number of cases last year, with 537 deaths.
Yesterday, Sweden, a neighbor of Denmark, reported the first confirmed case of monkeypox, the first confirmed case outside of the African continent since the outbreak of the epidemic. Shortly before the deadline, the Pakistani Ministry of Health also reported the first confirmed case of monkeypox since 2024.
As of the deadline, Bavarian Nordic, which is traded in Denmark, has risen more than 17%, reaching its highest level since September 2022. Monkeypox-related concepts in A-shares have also shown obvious strength, with Tellgen Corporation, Hainan Poly Pharm, Nanjing Hicin Pharmaceutical, and Lanwei Medical all reaching the limit.
In pre-market trading, vaccine developer Emergent BioSolutions rose more than 10%, while GeoVax Labs rose more than 9%.