• 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

Pfizer Inc. announced 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.