Mpox Vaccine to Manufacture by Serum Institute of India and Bavarian Nordic Collaborate
Danish vaccine company Bavarian Nordic and the Serum Institute of India (SII), the world’s largest vaccine producer by volume, have entered into a licensing and manufacturing agreement to produce Bavarian Nordic’s Mpox vaccine, MVA-BN, for the Indian market.
Under this agreement, Bavarian Nordic will transfer its current manufacturing technology to SII, enabling vaccine production and supply within India. Additionally, SII will distribute and market the vaccine in India. Upon securing the necessary regulatory approvals, the partnership also allows SII to contract-manufacture the vaccine for Bavarian Nordic, significantly boosting production capacity and ensuring global access, especially during Mpox outbreaks.
The agreement follows a profit-sharing model with no upfront or milestone payments. SII will oversee and maintain regulatory approvals for the vaccine in India, and both companies will bear the costs associated with the technology transfer independently.
Adar Poonawalla, CEO, Serum Institute of India, said “Our mission has always been to deliver high-quality, affordable vaccines worldwide. The recent mpox outbreak underscores the critical need for a swift and coordinated response. Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox.“
Paul Chaplin, President & CEO of Bavarian Nordic, said “We are pleased to enter this license and manufacturing agreement for MVA-BN as an mpox vaccine, which represents significant progress in our endeavors to expand access to the vaccine for all populations. While there are currently no capacity constraints, scaling of global manufacturing is an important step to ensure the continued equitable access to the vaccine for all countries, and we are pleased to establish this collaboration with SII, the world’s largest vaccine manufacturer by volume. We continue to work with partners globally to explore additional opportunities for local manufacturing to further support vaccine supply.“
In response to the 2022 global Mpox outbreak, UNICEF, Africa CDC, Gavi, and WHO have urged manufacturers to scale production and secure vaccines for the hardest-hit countries. Earlier this year, Mpox cases were reported in 122 countries, with over 65,700 cases and 1,200 deaths recorded. The Democratic Republic of Congo remains one of the most severely affected regions.
In India, two Mpox cases were confirmed in September, including a Clade 1b strain, which had previously prompted WHO to issue a public health emergency alert. While Clade Ib and II strains were primarily responsible for the 2022 outbreak, the partnership between Bavarian Nordic and SII is poised to play a crucial role in ensuring epidemic preparedness and expanding equitable access to vaccines globally.
This collaboration further aligns with Bavarian Nordic’s ongoing efforts to establish partnerships, including exploring opportunities with manufacturers in Africa, to ensure widespread vaccine availability during health emergencies.
Current Mpox Vaccine
There are currently Three primary vaccines used to protect against Mpox (monkeypox), both initially developed for smallpox due to the genetic similarity between the two viruses.
1. LC16m8 (LC16)
- Manufacturer: KM Biologics (Japan)
- Type: Live attenuated vaccine
- Use: Originally developed for smallpox, now used for Mpox prevention.
- Administration: Subcutaneous injection.
Benefits:
- Demonstrates strong immune response and safety profile.
- Suitable for individuals with no immune deficiencies.
Global Availability:
- Primarily available in Japan, with limited global distribution.
- Access outside Japan is constrained, raising concerns about equitable availability.
Side Effects and Risks
Mild to moderate local and systemic adverse events are common with this vaccine. However, serious adverse events, such as encephalitis and symptomatic myocarditis, were not observed in clinical trials or cohort studies. While preclinical evidence suggests the LC16m8 vaccine may be safe for immune compromised individuals and those with atopic dermatitis, it is not currently recommended for widespread use in these populations.
2. ACAM2000
- Manufacturer: Emergent Bio Solutions (U.S.)
- Type: Live, replicating vaccinia virus vaccine
- Use: Approved for smallpox; used under emergency protocols for Mpox.
- Administration: Single dose via bifurcated needle (scarification technique).
Benefits:
- Single-dose vaccine providing rapid protection.
- Large stockpiles exist, particularly in the United States.
Limitations:
- Not suitable for immunocompromised individuals, pregnant women, or those with certain skin conditions (e.g., eczema).
- Higher risk of side effects due to live virus replication.
Global Availability:
- Mainly available in the US and used under specific emergency guidelines.
Side Effects and Risks
The ACAM2000 vaccine, a live, replicating vaccinia virus vaccine, can cause common side effects such as injection site pain, lymph node swelling, itching, headache, fever, rash, fatigue, and flu-like symptoms. It requires 15 small skin pokes with a bifurcated needle, and the vaccination site must be carefully managed until the scab falls off (2–4 weeks) to prevent spreading the live virus to other parts of the body or individuals, especially immunocompromised persons.
Severe side effects include myopericarditis (1 in 175 recipients), neurological events (2 in 100,000), encephalitis, progressive vaccinia, and even rare fatal outcomes. Risk factors for serious complications include:
- Skin diseases (e.g., eczema), cardiac issues, immunocompromised status, pregnancy, lactation, and steroid eye drop use.
- Allergies to neomycin or polymyxin B increase the risk of adverse reactions.
Pregnant women face risks of stillbirth or fetal harm, and lactating mothers risk transmitting the live virus to infants. Overall, ACAM2000 requires strict precautions due to its potential for significant side effects.
3. MVA-BN (Modified Vaccinia Ankara-Bavarian Nordic)
- Brand Names: Jynneos (US), Imvanex (Europe), Imvamune (Canada)
- Manufacturer: Bavarian Nordic (Denmark)
- Type: Live, non-replicating vaccine
- Use: Approved for prevention of both smallpox and Mpox in adults.
Benefits:
- Safe for immunocompromised individuals and those with skin conditions like eczema.
- Does not cause replication of the virus in the body, reducing side effects.
- Suitable for pre-exposure and post-exposure prophylaxis (PEP).
Global Availability:
- Widely used in high-income countries like the US, Canada, and European nations.
- Currently being scaled up for manufacturing in India through a partnership with Serum Institute of India (SII) to expand access globally.
Side Effects and Risks
JYNNEOS, approved for Mpox vaccination, is considered a safer alternative to ACAM2000, particularly for immunocompromised patients (e.g., HIV, transplant recipients, and atopic dermatitis cases). Clinical trials have reported mild and manageable side effects, such as injection site reactions (redness, pain, itching, induration), sore throat, myalgia, headache, chills, and nausea.
According to the Advisory Committee on Immunization Practices (ACIP), JYNNEOS shows fewer serious adverse events than ACAM2000, based on 3 randomized trials and 15 studies involving 5,775 subjects. A retrospective study (Sharff et al., 2022) noted 10 cardiac events post-vaccination, though no direct link to JYNNEOS was confirmed. WHO reports local adverse events (up to 99%) but no serious issues like myopericarditis in 9,713 participants across 19 studies.
Due to its lower risk profile, ACIP recommended JYNNEOS over ACAM2000 for Orthopoxvirus immunization on November 3, 2021.
View Ahead:
Efforts are underway to ensure equitable access to Mpox vaccines globally:
- Bavarian Nordic’s partnership with Serum Institute of India (SII) aims to increase production and distribution of the MVA-BN vaccine.
- UNICEF, WHO, and Gavi are collaborating to secure vaccines for low- and middle-income countries, especially in Africa, which remains disproportionately affected.
- Local partnerships and manufacturing agreements are being explored to expand access further.
This collective approach highlights the need for global preparedness and vaccine equity in managing Mpox outbreaks.
Source of Information:- https://www.business-standard.com/health/serum-institute-ties-up-with-bavarian-nordic-to-manufacture-mpox-vaccine-124121601219_1.html
