Mpox vaccine maker seeks approval for use in teens

A Danish biotechnology firm that develops pharmaceuticals, Bavarian Nordic, announced, on August 16, 2024, that it is seeking European approval to administer its Mpox vaccine to children aged 12 to 17, following the WHO’s declaration of the current virus surge as a global public health emergency.

This week, the World Health Organization (WHO) declared the rapid spread of the new, more dangerous Mpox strain, Clade 1b, a public health emergency of international concern.

This is the highest level of alert the UN agency can issue.

Currently, Bavarian Nordic’s vaccine is only approved for people 18 years and older.

Bavarian Nordic in a statement said:

“Children and adolescents are disproportionately affected by Mpox in the ongoing outbreak in Africa…

“Highlighting the importance and urgency to broaden the access to vaccines and therapies for this vulnerable population.”

The company stated that it had provided the European Medicines Agency with clinical data from a study demonstrating:

“Non-inferiority of immune responses from Mpox/Smallpox vaccination in adolescents and (a) similar safety profile compared to adults.”

During the 2022 global Mpox outbreak, the US Food and Drug Administration (FDA) issued an “emergency use authorization” for the vaccine for adolescents.

Bavarian Nordic, yesterday, said it was ready to produce 10 million vaccine doses by 2025 but was waiting for countries to place orders.

Mpox origin and transmission

Mpox, formerly monkeypox, is a viral zoonotic disease caused by the Mpox virus, related to the smallpox-causing variola virus.

Here’s a detailed overview

Zoonotic Disease: Mpox primarily spreads from animals to humans.

It was first discovered in 1958 when two outbreaks of a pox-like disease occurred in colonies of monkeys kept for research, leading to the name “monkeypox.”

However, the primary carriers in the wild are believed to be rodents and other small mammals, not monkeys.

Human Transmission: The virus can also spread from person to person through direct contact with infectious sores, scabs, or body fluids.

Respiratory secretions during prolonged face-to-face contact or during intimate physical contact, such as kissing, hugging, or sex, can also lead to transmission.

It can also spread through contaminated materials like bedding.

Symptoms

Incubation Period: The incubation period (time from infection to symptoms) is typically 6 to 13 days but can range from 5 to 21 days.

Initial Symptoms: Early symptoms include fever, headache, muscle aches, backache, swollen lymph nodes, chills, and exhaustion.

Rash Development: After the initial symptoms, a rash typically appears, beginning on the face and then spreading to other parts of the body, including the palms and soles.

The rash goes through several stages before forming a scab, which eventually falls off. The rash can resemble chickenpox, syphilis, or herpes.

Treatment and prevention

No Specific Treatment: There is no specific treatment for Mpox.

However, smallpox vaccines, antivirals, and Vaccinia Immune Globulin (VIG) can be used to control outbreaks of Mpox.

Vaccination: Smallpox vaccination has been shown to provide protection against Mpox.

In 2019, a newer vaccine based on a modified vaccinia Ankara strain was approved for prevention of smallpox and Mpox.

This vaccine is known as JYNNEOS, Imvanex, or Imvamune depending on the region.

Preventive Measures: Preventing Mpox involves reducing the risk of human-to-human transmission.

This includes avoiding close contact with infected people, practicing good hygiene, and isolating infected individuals.

It also involves avoiding contact with sick or dead wild animals and practicing safe food preparation to reduce zoonotic transmission risk.

Mpox remains a public health concern, particularly in regions where it is endemic, and during outbreaks that spread to non-endemic areas.

Continued vigilance, research, and public health efforts are necessary to manage and prevent the disease.

About Bavarian Nordic

Bavarian Nordic is a biotechnology company based in Denmark, known for developing and manufacturing innovative vaccines. Here’s an overview of the company:

Company background

Founded: 1994

Headquarters: Kvistgaard, Denmark

Specialization: Bavarian Nordic specializes in vaccines for infectious diseases and cancer immunotherapies.

The company focuses on diseases with unmet needs, including smallpox, monkeypox, Ebola, and respiratory syncytial virus (RSV).

Key products and technologies

MVA-BN® Technology: One of the company’s core platforms is the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN®) technology.

This is a versatile vaccine platform used to develop vaccines for various diseases.

MVA-BN® is a non-replicating viral vector, which makes it a safe option for people with weakened immune systems.

Imvamune®/Jynneos®: This is a non-replicating smallpox vaccine that is also approved for use against monkeypox.

It’s particularly important for people with compromised immune systems, as it provides protection without the risks associated with traditional smallpox vaccines.

Ebola Vaccine: Bavarian Nordic has developed an Ebola vaccine candidate in collaboration with Janssen Pharmaceuticals.

This vaccine is part of a broader two-dose regimen for Ebola virus disease.

RSV Vaccine: The company is also working on a vaccine for respiratory syncytial virus (RSV), which is a leading cause of respiratory infections in infants and older adults.

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