Pfizer Receives Authorization from Health Authority for the First Dual Indication Vaccine Approved in Hong Kong

A Vaccine to Fight Against Respiratory Syncytial Virus (RSV) in Older Adults Aged 60 and Above and Infants (Through Maternal Immunization)

• The first and only bivalent, single-dose vaccine that fights against both RSV A and RSV B disease through two seasons has been approved by Hong Kong Department of Health in April 2024; it has also been approved by Instituto para a Supervisão e Administração Farmacêutica in Macau in January 2024
• The bivalent vaccine is expected to be available in Macau by June 2024, followed by Hong Kong by August 2024

HONG KONG and MACAU, May 8, 2024 /PRNewswire/ -- Pfizer Inc. announced today that the Hong Kong Department of Health (DH) has granted marketing authorization for the company's bivalent RSV prefusion F (RSVpreF) vaccine to fight against lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in individuals aged 60 years and older, and infants from birth up to six months of age through the active immunization of pregnant individuals^*.

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.^1,2 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.^2-4 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.⁵ 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.⁶ 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.⁷

"With our commitment to improving lives, Pfizer is introducing a new RSV vaccine that is especially designed to help protect two vulnerable groups,^3,4" said Krishnamoorthy Sundaresan, Pfizer Hong Kong and Macau Market Lead. "This vaccine can help babies and older adults in Hong Kong fight against RSV-associated LRTD, and we are working towards making it available to the market as soon as possible."

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. 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.

The Department of Health's decision is based on the data from two clinical trials: RENOIR for older adults, and MATISSE for newborns and young infants.

RENOIR is a global, randomized, double-blinded, placebo-controlled, pivotal Phase 3 clinical trial (NCT05035212) designed to assess a single dose of the vaccine in adults 60 years of age and older. The study has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 μg or placebo in a 1:1 ratio.

Meanwhile, MATISSE is a randomized, double-blinded, placebo-controlled, pivotal Phase 3 clinical trial (NCT04424316) designed to evaluate the vaccine against LRTD and severe LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy.

"We are encouraged by the results that we observed after two full RSV seasons of studying the vaccine. This new data indicates that broad and durable protection against both types of RSV that cause disease, RSV A and RSV B, is the potential benefit to having a bivalent vaccine," said Eugenia Ng, Medical Director of Pfizer Hong Kong and Macau.

The bivalent vaccine is expected to be available in Macau by June 2024, followed by in Hong Kong by August 2024. 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 more than 170 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. 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.
2. Centers for Disease Control and Prevention. RSV transmission. Available at: www.cdc.gov/rsv/about/transmission.html. Accessed May 2024.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

PP-RES-HKG-0066 MAY 2024