Pfizer's First Dual Indication Vaccine for Respiratory Syncytial Virus (RSV) is Available This Month in Hong Kong

• The first and only bivalent, single-dose vaccine that fights against both RSV A and RSV B has been approved by health authorities in Hong Kong and Macau earlier, and is available in Hong Kong this month (July 2024)
• Helps fight against RSV in older adults aged 60 and above and infants (through maternal immunization*)^[1],[2]
• Availability of bivalent RSV prefusion F vaccine provides a viable option in the strategy to fight against RSV
• RSV is a common respiratory virus associated with hospitalization in children under 1-year-old, contributes to a higher mortality rate than influenza, and is a common cause of death among hospitalized elderly in Hong Kong

HONG KONG and MACAU, July 18, 2024 /PRNewswire/ -- Today, Pfizer Inc. announced in Hong Kong the availability of the company's bivalent RSV prefusion F (RSVpreF) vaccine. The vaccine helps fight against lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older, as well as LRTD and severe LRTD caused by RSV in infants from birth up to six months of age through active immunization of pregnant individuals^*.^[1] Pfizer Inc. is currently the only company with an RSV vaccine suitable for use in both older adults and pregnant individuals.

RSV is a contagious virus and a common cause of respiratory illness worldwide.^[3],[4] The virus can affect the lungs and breathing passages of an infected individual, potentially causing serious complication or death in babies, especially pre-term infants or infants under 6 months, as well as high-risk older adults.^[4-6] In 2019, 33 million cases of RSV-associated acute lower respiratory infection were recorded globally, with 101,400 RSV-attributable deaths in children aged 5 years and younger.^[7] In adults aged 65 years and above, the estimated global burden of disease in 2015 was 336,000 hospitalizations and 14,100 in-hospital deaths.^[8] In Hong Kong, RSV is the leading viral cause of hospitalization due to common respiratory viruses (more than 50% of all cases) in children under the age of one,^[9] and a common cause of death among hospitalized elderly.^[10]

"The availability of this bivalent RSVpreF vaccine in the market reinforces our commitment to address critical public health needs. With this, we can help protect two vulnerable groups against RSV: babies and older adults,"^[11] said Krishnamoorthy Sundaresan, General Manager of Pfizer Hong Kong and Macau Market.

RSV disease is caused by two major virus subgroups: RSV A and RSV B. Both subgroups can co-circulate or alternate in predominance from season to season.^[12] The bivalent vaccine is unadjuvanted and composed of two preF proteins selected to optimize defense against RSV A and B strains and has been observed to be safe and effective.^[11] 

"Having the vaccine available to the market also supports the Hong Kong Health Bureau's Primary Healthcare Blueprint that endorses population health improvement through a more prevention-focused mindset rather than treatment-focused," said Eugenia Ng, Medical Director of Pfizer Hong Kong and Macau. "Aside from older adults, infants from birth up to 6 months can be protected against severe RSV, in which these infants experience the highest burden of RSV illness." In Hong Kong, the annual hospitalization rate for RSV in infants 6 months of age or less was 233.4 to 311.2 per 10,000.^[13]

For more information about the new bivalent RSV vaccine, please go to your local healthcare providers.

^* For details about the suggested gestation age for maternal immunization, please refer to the prescribing information in respective markets.

About RSVpreF Vaccine

Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as infants through maternal immunization. This bivalent vaccine was designed to provide broad protection against all RSV-LRTD, regardless of the virus subgroup. The RSV fusion protein (F) in the prefusion conformation is a major target of virus infection blocking antibodies and is the basis of Pfizer's RSV vaccine. Sequence variability in F between RSV subgroup A and B strains clusters in potent neutralizing antibody binding sites on prefusion F.

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 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.hk. In addition, to learn more, please visit us on www.Pfizer.com.hk. 

References:

1. Respiratory syncytial virus vaccine Prescribing Information. Pfizer Corporation Hong Kong Limited: Version MAR 2024.
2. Respiratory syncytial virus vaccine (bivalent, recombinant) Package Leaflet. Pfizer Europe. Version: 08/2023.
3. World Health Organization. Respiratory Syncytial Virus (RSV) disease. Available at: www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/respiratory-syncytial-virus-disease. Accessed May 2024.
4. Centers for Disease Control and Prevention. RSV transmission. Available at: www.cdc.gov/rsv/about/transmission.html. Accessed May 2024.
5. Centers for Disease Control and Prevention. Respiratory syncytial virus infection (RSV) – Older adults are at high risk for severe RSV infection fact sheet. Available at: www.cdc.gov/rsv/factsheet-older-adults.pdf. Accessed May 2024.
6. Centers for Disease Control and Prevention. RSV in Infants and Young Children. Available at: www.cdc.gov/rsv/high-risk/infants-young-children.html. Accessed May 2024.
7. Li Y, Wang X, Blau DM, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022;399:2047-2064.
8. Shi T, Denouel A, Tietjen AK, et al. Global disease burden estimates of respiratory syncytial virus-associated acute respiratory infection in older adults in 2015: A systematic review and meta-analysis. J Infect Dis 2020;222:S577-S583.
9. Chan PKS, Tam WWS, Lee TC, et al. Hospitalization incidence, mortality and seasonality of common respiratory viruses over a period of 15 years in a developed subtropical city. Medicine (Baltimore) 2015;94:e2024.
10. Wang Y, Fekadu G, You JHS. Comparative Cost-Effectiveness Analysis of Respiratory Syncytial Virus Vaccines for Older Adults in Hong Kong. Vaccines 2023;11(10):1605. https://doi.org/10.3390/vaccines11101605
11. Awosika AO, Patel P. Respiratory Syncytial Virus Prefusion F (RSVPreF3) Vaccine. [Updated 2024 Mar 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK594261/
12. Ciarlitto, C., Vittucci, A.C., Antilici, L. et al. Respiratory Syncityal Virus A and B: three bronchiolitis seasons in a third level hospital in Italy. Ital J Pediatr 2019;45(115). https://doi.org/10.1186/s13052-019-0704-0
13. Chiu SS, Chan KH, Chen H, et al. Virologically Confirmed Population-based Burden of Hospitalization Caused by Respiratory Syncytial Virus, Adenovirus, and Parainfluenza Viruses in Children in Hong Kong. Pediatr Infect Dis J 2010;29(12):1088-1092. 

PP-A1G-HKG-0058 JUL 2024

SOURCE Pfizer