Bavarian Nordic's Mpox Vaccine Gains WHO Prequalification Status

Bavarian Nordic Achieves Milestone with WHO Prequalification

Bavarian Nordic A/S (OMX: BAVA) has reached a significant achievement as its IMVANEX vaccine becomes the first mpox vaccine to obtain prequalification from the World Health Organization (WHO). This major development is expected to enhance vaccine access across various countries, particularly in Africa.

Significance of WHO Prequalification

The WHO's prequalification status serves as an important stepping stone for vaccines, enabling governmental and non-governmental organizations to procure and distribute them effectively. With the need for a reliable vaccine in the wake of mpox outbreaks, this approval is a timely boon for public health. Bavarian Nordic's vaccine, MVA-BN, is critical not just for controlling mpox but also for protecting against smallpox and other orthopoxvirus infections.

Understanding MVA-BN

The MVA-BN vaccine is targeted for adults aged 18 and older for active immunization against smallpox and mpox. Interestingly, while it is primarily recommended for adults, the WHO has also noted that its use may extend to infants, children, and other vulnerable groups during outbreak situations.

Background on Bavarian Nordic

Bavarian Nordic has established itself as a leader in vaccine innovation. The company originally developed MVA-BN in collaboration with the U.S. government to ensure a robust smallpox vaccine supply, while also addressing the needs of immunocompromised individuals unable to receive traditional smallpox vaccines. MVA-BN is unique as a non-replicating vaccine, providing a safe option for diverse populations.

Recent Approvals and Support

In addition to the WHO prequalification, the MVA-BN vaccine recently received provisional consent from New Zealand's regulatory authority and full approval from Mexico's health committee. These developments not only highlight the vaccine's global acceptance but also its effectiveness in addressing mpox and potential smallpox threats.

CEO's Perspective

Paul Chaplin, President and CEO of Bavarian Nordic, expressed optimism regarding the prequalification, emphasizing the rigorous studies that reaffirm the vaccine's safety and efficacy. This progress aims to accelerate vaccine availability for communities that need it most, particularly in regions severely affected by mpox.

Continued Commitment to Public Health

Bavarian Nordic is dedicated to enhancing public health through its ongoing efforts to supply vaccines to national stockpiles and extend its reach during health emergencies. The company played a vital role during the recent mpox outbreak, providing vaccines to over 70 countries worldwide.

Future Directions

The company remains focused on expanding the MVA-BN vaccine's approval to younger demographics. Bavarian Nordic has filed to extend eligibility to adolescents aged 12-17 and is collaborating with partners to study its safety and efficacy in children aged 2-12.

Conclusion

As Bavarian Nordic continues its mission to protect lives with innovative vaccines, the WHO prequalification of the MVA-BN vaccine marks a transformative milestone for public health. This achievement not only facilitates rapid access to essential vaccines in Africa but also reinforces the global commitment toward combatting mpox and similar outbreaks.

Frequently Asked Questions

What is the significance of WHO prequalification for MVA-BN?

The WHO prequalification ensures that the vaccine meets global standards for safety, efficacy, and quality, facilitating its procurement and distribution, particularly in resource-limited settings.

Who can receive the MVA-BN vaccine?

The vaccine is primarily indicated for adults aged 18 and older but may also be used in infants, children, and other vulnerable populations in specific outbreak situations as recommended by the WHO.

What other approvals has Bavarian Nordic received for MVA-BN?

Besides WHO prequalification, the MVA-BN vaccine has received provisional consent from New Zealand and full approval in Mexico, indicating its global acceptance and trust.

How does Bavarian Nordic support public health initiatives?

The company has provided significant doses of its vaccines to over 70 countries during the mpox outbreak and maintains commitments to supplying vaccines for various public health needs.

What future plans does Bavarian Nordic have for MVA-BN?

Bavarian Nordic aims to extend the vaccine's use to adolescents and younger children and is conducting studies to ensure its safety and efficacy in these age groups.

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