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Excited to be part of  ! BioNet will be heading to Bologna, Italy (June 1–5) for the 44th Annual Meeting of the European...
27/05/2026

Excited to be part of ! BioNet will be heading to Bologna, Italy (June 1–5) for the 44th Annual Meeting of the European Society for Paediatric Infectious Diseases.

We’ll be sharing our latest research on pertussis prevention:

E-Poster #2837
Addressing waning immunity: Immunogenicity and pooled safety of a PTGen-containing recombinant pertussis vaccine across populations

Presented by Dr. Giuseppe Del Giudice
Catch it on the ESPID e-poster platform or onsite in the afternoons of June 3–4.

Reach out to Dr. Giuseppe Del Giudice at [email protected]
Looking forward to collaborating and exchanging expertise.

BioNet‑Asia กับภารกิจพาวัคซีนสัญชาติไทยสู่การยอมรับระดับสากลเคยมีช่วงเวลาที่การพัฒนา “วัคซีน” ในประเทศไทยถูกมองว่าเป็นเร...
23/03/2026

BioNet‑Asia กับภารกิจพาวัคซีนสัญชาติไทยสู่การยอมรับระดับสากล

เคยมีช่วงเวลาที่การพัฒนา “วัคซีน” ในประเทศไทยถูกมองว่าเป็นเรื่องไกลเกินเอื้อม ไม่ใช่เพราะคนไทยไม่เก่ง แต่เพราะระบบและทรัพยากรไม่เอื้ออำนวย แต่ BioNet‑Asia คือหนึ่งในองค์กรที่พิสูจน์ว่า ความเชื่อ + ความมุ่งมั่น + วิทยาศาสตร์ สามารถเปลี่ยนข้อจำกัดให้กลายเป็นโอกาสได้จริง

จุดเปลี่ยนสำคัญของอุตสาหกรรมวัคซีนไทย BioNet‑Asia เป็นผู้พัฒนาและผลิตวัคซีนด้วยเทคโนโลยีขั้นสูง ตั้งแต่ต้นน้ำถึงปลายน้ำในประเทศไทย ประสบความสำเร็จในการสร้างวัคซีนสัญชาติไทยที่ได้รับการยอมรับในระดับโลก ลดการพึ่งพาการนำเข้า และยกระดับความมั่นคงทางสุขภาพของประเทศ

จาก Local Solution สู่ Global Impact สิ่งที่ BioNet‑Asia ทำ ไม่ได้หยุดแค่ “การผลิตวัคซีน” แต่คือการสร้างระบบนิเวศนวัตกรรมที่เชื่อมโยงนักวิทยาศาสตร์ภาคการแพทย์ และมาตรฐานสากลเข้าด้วยกัน นี่คือบทเรียนสำคัญว่านวัตกรรมระดับโลก สามารถเริ่มต้นได้จากประเทศไทย หากมีวิสัยทัศน์และความเชื่อที่ชัดเจน

เรื่องราวของ BioNet‑Asia จึงไม่ใช่แค่ความสำเร็จของบริษัทหนึ่ง แต่คือแรงบันดาลใจของนวัตกรรมไทยบนเวทีโลก

อ่านเรื่องเต็มได้ที่ THE STANDARD

ถอดกลยุทธ์ความสำเร็จของ BioNet-Asia ในงาน National Thai FDA Forum 2026 โดย วิฑูรย์ วงศ์หาญกุล กับการพัฒนาวัคซีนไอกรนชนิดไร้เซลล์

New Pertussis Vaccine Set for ImplementationThe Committee for Medicinal Products for Human Use (CHMP), a part of the Eur...
20/12/2025

New Pertussis Vaccine Set for Implementation

The Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), recently recommended approval of a pertussis vaccine for teenagers, adults and newborns.

According to the agency, VacPertagen could serve as an effective pertussis booster vaccine for kids aged 12 and above, helping prevent diagnoses of whooping cough. It could also offer passive protection to infants when administered to pregnant women in their 2nd or 3rd trimesters.

This is because the vaccine uses a blend of two refined pertussis antigens - recombinant pertussis toxin (PTgen) and filamentous haemagglutinin (FHA).

Currently available as prefilled syringes, this vaccine can trigger pertussis antibody responses in individuals with a single intramuscular injection.

The EMA has greenlighted the use of this vaccine following the success of its clinical trials.

The studies showed that VacPertagen could trigger an antibody response within 28 days of administration. This period remained the same even when the vaccine was administered to pregnant women in their second and third trimesters, after which they were transferred through the placenta to the newborns.

They also highlighted that the vaccine provided antibody persistence for up to 3 years in adults and 5 years in adolescents.

No serious safety concerns were identified in the trials. Reported side effects were mild and consistent with common vaccine reactions, such as injection-site pain, headache, nausea and fatigue.

With the CHMP’s positive opinion, the vaccine now awaits formal marketing authorisation. Rollout decisions will follow regional regulatory approvals and vaccination guidelines.

Source: https://www.hdfcergo.com/news/health-insurance/new-pertussis-vaccine-set-for-implementation

VacPertagen วัคซีนไอกรนชนิดวัคซีนเดี่ยวจากไบโอเนทได้รับความเห็นเชิงบวกจากคณะกรรมการผลิตภัณฑ์ทางการแพทย์สำหรับมนุษย์ (CHM...
24/11/2025

VacPertagen วัคซีนไอกรนชนิดวัคซีนเดี่ยวจากไบโอเนทได้รับความเห็นเชิงบวกจากคณะกรรมการผลิตภัณฑ์ทางการแพทย์สำหรับมนุษย์ (CHMP) ขององค์การยาแห่งสหภาพยุโรป (EMA) เพื่ออนุมัติใช้ในสหภาพยุโรป

Latest Update! On 13 November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion...
18/11/2025

Latest Update!

On 13 November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product VacPertagen, a vaccine intended for prophylaxis against pertussis.

The applicant for this medicinal product is BioNet Europe.

VacPertagen will be available as a suspension for injection in pre-filled syringes. The active substances in VacPertagen are two purified pertussis antigens: recombinant pertussis toxin (PTgen) and filamentous haemagglutinin (FHA). Following intramuscular administration of a single dose, VacPertagen induces a boost in PT-specific and FHA-specific antibody responses. Maternal antibodies are transferred to infants born to women vaccinated during the second or third trimester of pregnancy.

The benefits of VacPertagen were shown in 3 clinical studies, which found that VacPertagen triggered the production of antibodies at 28 days after vaccination in adults and adolescents, with antibodies persisting for up to 3 years in adults and 5 years in adolescents. It also induced an immune response in pregnant women 28 days after vaccination during the second or third trimester of pregnancy. In addition, the pertussis antibodies were transferred from mothers to infants at birth and persisted for up to 2 months of age. The most common side effects with VacPertagen include pain at the injection site, headache, fatigue, myalgia, arthralgia, malaise and nausea.

The full indication is:
VacPertagen is indicated for:
- booster immunisation against pertussis of individuals 12 years of age and older,
- passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see sections 4.4, 4.6 and 5.1).

The use of this vaccine should be in accordance with official recommendations.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Read the full report:https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vacpertagen_en.pdf

BioNet Achieves EU-GMP Certification for its Pertussis Vaccine ManufacturingLyon, France – October 29, 2025, BioNet toda...
29/10/2025

BioNet Achieves EU-GMP Certification for its Pertussis Vaccine Manufacturing

Lyon, France – October 29, 2025, BioNet today announced it has received European Union Good Manufacturing Practice (EU-GMP) certification, an internationally recognized benchmark of pharmaceutical quality and compliance, to produce its acellular pertussis vaccine.

“This milestone underscores BioNet’s resolute dedication to world-class manufacturing standards and marks a key step in the ongoing centralized regulatory review of its recombinant acellular pertussis vaccine candidate, VacPertagen, by the European Medicines Agency (EMA).” said Philippe Guillot-Chêne, CEO, BioNet in Europe.

The EU-GMP certification confirms that BioNet’s facilities, quality systems and quality controls meet the highest international criteria.

“The certificate was received following the inspection of BioNet production site by the Ireland Health Products Regulatory Authority (HPRA).” added Dario Cresci, Director Quality. “This achievement reflects BioNet’s long-standing culture of excellence and commitment to provide public health authorities with innovative solutions to the global pertussis resurgence.”

About BioNet
BioNet is a pioneering biotechnology group that specialises in the development of next-generation vaccines. Leveraging its expertise in translational research and its GMP production facilities, BioNet is today the leading global manufacturer of recombinant pertussis vaccines. For 25 years, BioNet has fostered multiple partnerships to accelerate access to technology and to increase and expand global vaccine capability.

BioNet’s pertussis vaccine is licensed under Pertagen® tradename in Asia and has been submitted under VacPertagen name to EMA centralized procedure by BioNet in France.

Contact
Mr Philippe Guillot-Chêne, BioNet, France.
Tel: +33 4 81 49 46 00
[email protected]
www.bionet.one

Avidity of pertussis toxin antibodies following vaccination with genetically versus chemically detoxified pertussis toxi...
20/06/2025

Avidity of pertussis toxin antibodies following vaccination with genetically versus chemically detoxified pertussis toxin-containing vaccines during pregnancy

Both the quantity and quality of circulating anti-pertussis toxin antibodies are important for protection against severe pertussis. We compared the avidity of PT-IgG antibodies in pregnant women and their infants following vaccination during pregnancy with pertussis vaccines containing genetically-detoxified pertussis toxin (PTgen) or chemically-detoxified PT (PTchem).

Methods: We analyzed serum samples collected earlier from pregnant women (at delivery) and their infants (at birth and 2 months of age) participating in a clinical trial where pregnant women had been vaccinated during pregnancy with recombinant acellular pertussis vaccine containing 1 µg PTgen (standalone, ap1gen, [n=37], or combined to tetanus and diphtheria, Tdap1gen [n=34]), 2 µg PTgen (Tdap2gen, n=35), or 5 µg PTgen (TdaP5gen, n=34), or acellular pertussis vaccine containing 8 µg PTchem (Tdap8chem, n=35). Avidity was assessed by adding increasing concentrations (0.25, 0.5, 1, 1.5, 2, and 3 M) of NH4SCN as a bond-breaking agent and measuring PT-IgG levels by ELISA.

Findings: Compared with Tdap8chem, TdaP5gen vaccination was associated with significantly higher total absolute avidity (p

Press Release: BioNet and Bio Farma Sign Strategic MoU to Expand TdaP Vaccine Access in ASEANJakarta, May 28, 2025 — Bio...
30/05/2025

Press Release: BioNet and Bio Farma Sign Strategic MoU to Expand TdaP Vaccine Access in ASEAN

Jakarta, May 28, 2025 — BioNet, a Franco-Thai vaccine biotech group, and PT Bio Farma (Persero), Indonesia’s state-owned vaccine manufacturer, have signed a Memorandum of Understanding (MoU) to collaborate on the development and regional distribution of a combined TdaP vaccine (tetanus, diphtheria, and acellular recombinant pertussis).

Signed during the State Visit of French President Emmanuel Macron to Indonesia, the agreement underscores a shared commitment to accelerating access to innovative vaccines across Southeast Asia. The partnership combines BioNet’s proprietary recombinant pertussis technology and global clinical development experience with Bio Farma’s large-scale manufacturing capabilities and public health reach to address critical immunization needs in ASEAN.

“This agreement reflects our shared vision to make next-generation vaccines more accessible where they are most needed,” said Philippe Guillot-Chêne, CEO of BioNet Europe. “By aligning our strengths, BioNet and Bio Farma are helping to build a stronger regional health ecosystem and reinforce ASEAN’s capacity to respond to both current and emerging infectious disease threats.”

The MoU outlines cooperation in clinical development, regulatory alignment, and market access strategies. Bio Farma will conduct clinical trials and manage regulatory submissions in Indonesia, while BioNet will do so in other ASEAN countries.

The collaboration aims to accelerate vaccine availability by reducing the time gap in introducing innovative vaccines to the region—from 10–15 years down to less than five.

“Through this collaboration, we are reinforcing Indonesia’s commitment to regional vaccine self-sufficiency and innovation,” said Yuliana Indriati, Director of Business Development at Bio Farma. “With BioNet’s advanced recombinant pertussis technology and our production capacity, we aim to ensure timely access to TdaP vaccines for Indonesian adolescents, pregnant women, and the elderly. We hope this product will soon be part of our national immunization program.”

The TdaP vaccine developed under this partnership will leverage antigens contributed by both parties—Td from Bio Farma and aP from BioNet. The combined product is targeted for use across ASEAN, with a potential market of 10–15 million doses annually, valued at around USD 200 million.

This collaboration is expected to help strengthen regional pandemic preparedness, build resilient vaccine supply chains, and promote equitable health access across Southeast Asia.
This step is in line with President Prabowo Subianto’s Asta Cita, particularly the goals of realizing national self-reliance in the fields of economy, food, and energy, as well as improving the quality of life of the people and expanding access to affordable and high-quality healthcare services.

About BioNet
BioNet is a French-Thai vaccine organization developing and manufacturing genetically designed vaccines with a global footprint. The group includes:
• BioNet Europe, a fast-growing French biotech company which has recently submitted an EU-GMP certified recombinant pertussis vaccine application to the European Medicines Agency (EMA) for centralized approval.
• BioNet Asia, a leading vaccine company based in Thailand, producing and marketing a range of vaccines that include the world’s only recombinant pertussis standalone vaccine.
BioNet has also developed a clinically-proven, end-to-end mRNA production process, enabling multiple collaborations with leading organizations and academic institutions worldwide to promote technology transfer, regional manufacturing, and pandemic preparedness.

About Bio Farma
PT Bio Farma (Persero) is Indonesia’s largest state-owned pharmaceutical holding company, operating in the healthcare sector with integrated end-to-end services — ranging from pharmaceutical research and development, manufacturing, and distribution to retail pharmacy operations, clinics, and clinical laboratories.To support its business operations, Bio Farma operates a head office and manufacturing facility in Bandung, West Java, which includes office buildings and production facilities. The company also maintains a representative office in Jakarta. With an annual production capacity of over 3.2 billion doses of vaccine, Bio Farma exports its products to more than 150 countries worldwide. It serves as the parent company of two publicly listed pharmaceutical companies on the Indonesia Stock Exchange (IDX): PT Kimia Farma Tbk (KAEF) and PT Indofarma Tbk (INAF). For more information, please visit: www.biofarma.co.id.

https://bionet.one/bionet-and-bio-farma-sign-strategic-mou-to-expand-tdap-vaccine-access-in-asean/

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