Pfizer’s 20-valent Pneumococcal Conjugate Vaccine Now Approved in Malaysia, Protecting Against 20 Pneumococcal Strains

Now approved for use in individuals from 6 weeks to less than 18 years of age, and in adults aged 18 years and above across Malaysia¹. Covers 20 disease-causing pneumococcal serotypes, including 7 additional strains linked to antibiotic resistance and high mortality². Designed to address shifting serotype patterns and increasing disease burden among the elderly and those with chronic illnesses³.

Pfizer Malaysia announced that its 20-valent pneumococcal conjugate vaccine (PCV20) has been approved by the Ministry of Health (MOH) for use in individuals from 6 weeks to less than 18 years of age, and in adults aged 18 years and above across Malaysia¹. PCV20 offers a broader pneumococcal conjugate vaccine option in Malaysia, providing coverage against 20 serotypes of Streptococcus pneumoniae, the bacteria responsible for a significant burden of pneumonia, meningitis, sepsis, and ear infections^1,4.

The announcement is timely, as Malaysia continues to address a high burden of pneumococcal disease, particularly among two key population groups: young children and older adults⁵. Additionally, pneumococcus is a leading cause of various invasive infections across all age groups, including invasive pneumonia⁴. According to the Ministry of Health Malaysia, pneumonia is the principal cause of death nationwide, accounting for over 18,000 deaths in 2023⁶. Risk increases significantly among older adults and individuals with non-communicable diseases (NCDs) such as diabetes, heart disease, and chronic lung conditions⁷.

“This approval represents a major milestone for pneumococcal disease prevention in Malaysia,” said Ms. Deborah Seifert, Cluster Lead for Malaysia, Indonesia, Singapore, and the Philippines at Pfizer. “PCV20 strengthens our commitment to supporting healthier communities by helping protect more people, across more life stages, from potentially serious pneumococcal infections¹. We’re proud to make available a vaccine that reflects over two decades of legacy in pneumococcal protection⁸.”

A Local Health Imperative: Broader Coverage Needed in the Face of Changing Threats
Malaysia’s demographic profile is rapidly shifting. By 2030, one in five Malaysians will be aged 60 or older⁹. At the same time, non-communicable diseases (NCDs) continue to rise, with one in six Malaysian adults living with diabetes and one in three with hypertension or high cholesterol¹⁰. Chronic conditions such as heart failure and chronic kidney disease are also becoming more prevalent. These conditions may lower immunity and contribute to higher susceptibility to respiratory infections like pneumococcal pneumonia^4,11,12.

“Pneumococcal disease is often under-recognised until it’s too late. In my practice, I’ve seen many elderly Malaysians hospitalised with pneumonia complications; some requiring intensive care, others with prolonged recovery¹³. In fact, pneumonia accounts for most respiratory-related hospital admissions, and its severity tends to increase with age, often resulting in intensive care unit (ICU) admission in critical cases^13,14. These are not rare cases, they point to a preventable trend. Pneumococcal pneumonia, in particular, is a vaccine preventable disease⁴,” said Associate Professor Dr Pang Yong Kek, Senior Consultant Respiratory Physician.

PCV20 builds on the foundation established by PCV13, adding coverage for 7 additional serotypes – 8, 10A, 11A, 12F, 15B, 22F, and 33F – which have been associated with antibiotic resistance and invasive disease².

Broader Protection for Malaysian Children
Challenges remain due to the dynamic nature of circulating pneumococcal serotypes¹⁶. PCV20 was developed to address this gap, with broader serotype coverage in response to emerging disease patterns^1,15.

“Every parent wants to give their child the best start in life, and as paediatricians, we see just how important the early years are in shaping lifelong health,” said Prof Datuk Dr Zulkifli Ismail, Consultant Paediatrician and Paediatric Cardiologist.

“A child’s immune system is still developing in those first few years, and this is when they are most vulnerable to serious infections like pneumococcal meningitis or sepsis, which can have lasting consequences^17,18.”

Built on Pfizer’s Legacy: PCV7 → PCV13 → PCV20
Pfizer introduced its first pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine (PCV7) over two decades ago, followed by 13-valent pneumococcal conjugate vaccine, PCV13¹⁹. These vaccines have been adopted globally and used widely in public immunization programmes^20,21. PCV20 is the next evolution, designed to reflect current disease patterns and population needs^1,15.

“In recent years, we have observed the rise of non-PCV13 serotypes globally. Serotype 8 has emerged as a leading cause of invasive pneumococcal disease in both children and adults, a trend that has persisted in recent years²²,” said Prof. Dr. Mark van der Linden, Director, National Reference Center for Streptococci, Germany. “The shift in epidemiology reinforces the importance of higher-valent vaccines like PCV20, which close critical gaps in protection and reflect the latest scientific understanding^1,15,22.”

“As we work to strengthen Malaysia’s adult immunisation landscape, public education and consistent disease awareness campaigns will be key,” said Prof. Dr. Zamberi Sekawi, President  of  the  Malaysian  Society  of  Infectious  Diseases  and  Chemotherapy. “Now that PCV20 is available, we must mobilise to strengthen adult immunisation in Malaysia. Healthcare professionals are key messengers in encouraging more adults to get immunised²³. With support from medical societies, policymakers, and the media, we can build a healthier, better- protected nation.”

PCV20 has been approved in over 40 countries, including the United States, United Kingdom, Hong Kong, and Singapore^8,24,25,26. Its approval in Malaysia is supported by comprehensive data from adult and paediatric clinical studies, demonstrating comparable immune responses to PCV13 for the original 13 serotypes and additional immunogenicity for the 7 newly included strains. The vaccine has also shown consistent tolerability across different age groups, including when administered alongside other routine vaccinations¹.

KKLIU 2376 / EXP 21012026

References

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2. Advisory Committee on Immunization Practices Recommends PREVNAR 20® (20-Valent Pneumococcal Conjugate Vaccine) for Adults Aged 50 and Available at: https://www.pfizer.com/news/press-release/press-release-detail/advisory-committee- immunization-practices-recommends. Accessed on 3 July 2025.
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