Singapore’s Health Sciences Authority Approves Pfizer’s Pneumococcal 20-Valent Conjugate Vaccine For Adults 18 Years Or Older

Saturday, Mar 18, 2023 13:00

  • First pneumococcal conjugate vaccine that protects against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia[1],[2],[3],[4],[5],[6],[7]. In Singapore, pneumonia is the third leading cause of death[8] and fourth most common cause of hospitalisations[9]
  • Offers the broadest serotype coverage of any pneumococcal conjugate vaccine currently available, building on Pfizer's more than 20-year legacy and innovation in developing pneumococcal conjugate vaccines
  • Approval of APEXXNAR in Singapore, the first in Southeast Asia, aligns with Singapore's Healthier SG Strategy to place a sustained focus on preventive care in achieving overall healthier living

SINGAPORE - Media OutReach - 18 March 2023 - Pfizer announced today that the Singapore Health Sciences Authority (HSA) has approved its 20-valent pneumococcal conjugate vaccine (PCV20) that protects against invasive pneumococcal disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. Marketed under the brand name APEXXNAR, this vaccine is approved for active immunisation for individuals aged 18 years and older, advancing the company's ongoing commitment to help prevent certain potentially-serious infectious respiratory diseases.

The approval of APEXXNAR in Singapore, being the first in Southeast Asia, underscores Pfizer's 20 years of growing legacy and experience in developing and supplying innovative pneumococcal conjugate vaccines that have had a pivotal impact on the global disease burden. This approval also supports Singapore's Healthier SG initiative that focuses on improving population health and quality of life through proactive preventive care, regular screening and recommended vaccinations.

"Singapore's approval of APEXXNAR today signals the importance of continually addressing the ever-evolving burden of pneumococcal disease. This is especially critical against the rapidly ageing landscape to ensure comprehensive coverage for the population," said Erika Pagani, Country Manager, Pfizer Singapore. "As the country progresses towards a Healthier SG, Pfizer looks forward to continue playing a key role to protect adults from this widespread life-threatening disease."

According to the Singapore Ministry of Health, pneumonia is the fourth most common cause for hospitalisation[9] and third leading cause of death[8], responsible for more than 4000 deaths annually[10]. Singapore continues to face a rising burden of the disease in light of the increasing prevalence of new infectious variants and a rapidly ageing population.

"Despite its severity and burden on the population, the awareness surrounding pneumococcal disease and the uptake of the vaccine in Singapore remains relatively low," said Dr Leong Hoe Nam, Infectious Disease expert at Mount Elizabeth Novena Hospital. "With the approval of APEXXNAR, and in line with the Healthier SG initiative, we encourage all adults to take proactive steps towards preventive care and vaccinate against this disease."



[1] Centers for Disease Control and Prevention. Active Bacterial Core (ABCs) surveillance. National Center for
Immunization and Respiratory Diseases. Atlanta, GA.
[2] Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal
disease in England and Wales, 2000–17: a prospective national observational cohort study. Lancet Infect Dis.
2018;18(4):441-451.
[3] Menéndez R, España PP, Pérez-Trallero E, et al. The burden of PCV13 serotypes in hospitalized pneumococcal
pneumonia in Spain using a novel urinary antigen detection test. CAPA study. Vaccine. 2017;35(39):5264-5270.
[4] Azzari C, Cortimiglia M, Nieddu F, et al. Pneumococcal serotype distribution in adults with invasive disease and in
carrier children in Italy: Should we expect herd protection of adults through infants' vaccination? Hum Vaccin
Immunother. 2016;12(2):344-350.
[5] Pivlishi T. Impact of PCV13 on invasive pneumococcal disease (IPD) burden and the serotype distribution in the
U.S. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. October 24th,
2018.
[6] European Centre for Disease Prevention and Control. Invasive pneumococcal disease. In: ECDC. Annual
epidemiological report for 2016. Stockholm: ECDC; 2018.
[7] Beall B, Chochua S, Gertz RE Jr, et al. A population-based descriptive atlas of invasive pneumococcal strains
recovered within the U.S. during 2015-2016. Front Microbiol. 2018;19(9).
[8] Singapore Ministry of Health. Principal Causes of Death https://www.moh.gov.sg/resources-statistics/singapore-health-facts/principal-causes-of-death
[9] Singapore Ministry of Health. Top 10 Conditions of Hospitalisation https://www.moh.gov.sg/resources-statistics/singapore-health-facts/top-10-conditions-of-hospitalisation
[10] The Straits Times. What's behind the recent rise in Covid-19 deaths in S'pore? Here are some facts you may not know https://www.straitstimes.com/opinion/deaths-in-a-world-where-the-coronavirus-is-endemic

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The issuer is solely responsible for the content of this announcement.

About PCV20

PCV20—known as APEXXNAR in Singapore and the EU, and PREVNAR 20TM in the US—is Pfizer's next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Singapore-registered PREVENAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. APEXXNAR contains the broadest serotype coverage of any available conjugate vaccine and helps protect against the 20 Streptococcus pneumoniae serotypes in the vaccine.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. In addition, to learn more, please visit us on and like us on Facebook at Facebook.com/PfizerSG.

DISCLOSURE NOTICE:
The information contained in this release is as of March 18, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward‐looking information about APEXXNAR® [pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)] (PCV20), including its potential benefits, an approval in the European Union for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age or older, a potential pediatric indication and a supplemental Biologics License Application (sBLA) to include data in the U.S. prescribing information for adults age 18 years or older regarding coadministration of PREVNAR 20 with a seasonal inactivated influenza vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of PCV20; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any biologics license applications may be filed in particular jurisdictions for PCV20 for the prevention of invasive disease and pneumonia in adults age 18 years or older or for any other potential indications; whether and when the sBLA pending in the U.S. may be approved and whether and when any such other applications that may be pending or filed for PCV20 may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether PCV20 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PCV20; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding PCV20 and uncertainties regarding the commercial impact of any such recommendations; the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and .




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