ABRYSVO® Demonstrates Sustained Efficacy Against RSV in Seniors Through Second Season

ABRYSVO, Pfizer's innovative bivalent vaccine, has demonstrated its ability to provide robust protection against respiratory syncytial virus (RSV) in adults aged 60 and above. The vaccine's efficacy was notably high at 77.8% against RSV lower respiratory tract disease (LRTD) characterized by three or more symptoms during the second RSV season, following an 88.9% efficacy in the first season. This sustained efficacy showcases the vaccine's potential to offer long-lasting defense against both RSV A and RSV B subtypes, which are known to cause significant respiratory illness.

The pivotal Phase 3 clinical trial, known as RENOIR, has been instrumental in establishing the vaccine's effectiveness. After two seasons, the vaccine maintained an efficacy of over 80% against LRTD for both subtypes when defined by three or more symptoms. Furthermore, it showed sustained efficacy against less severe LRTD, defined by two or more symptoms, reinforcing the vaccine's broad protective capabilities.

Safety has been a paramount consideration in the development of ABRYSVO. Encouragingly, no new adverse events were reported beyond the first clinical trial season. Pfizer remains dedicated to monitoring the vaccine's safety through post-marketing studies and surveillance programs.

Annaliesa Anderson, Ph.D., a leading figure in Pfizer's Vaccine Research and Development, expressed optimism regarding ABRYSVO's protective efficacy after two full RSV seasons. The data suggest that the bivalent nature of the vaccine contributes to its broad and durable protection against the disease-causing subtypes of RSV.

Pfizer is committed to sharing the results of this breakthrough vaccine. The company plans to submit the data to regulatory authorities and vaccine technical committees and intends to publish the findings in a peer-reviewed scientific journal. Additionally, Pfizer will present the data at an upcoming scientific congress, further highlighting the significance of these results.

RSV is a highly contagious virus that poses a significant health risk, particularly to older adults, young infants, and those with chronic medical conditions. In the United States, RSV is responsible for a considerable number of hospitalizations and deaths among the elderly population each year. With two major subgroups, RSV A and RSV B, causing disease and potentially co-circulating, the development of a vaccine like ABRYSVO is a crucial advancement in public health.

ABRYSVO's unique design targets the RSV fusion protein (F) in its prefusion conformation, a key area for virus infection-blocking antibodies. This approach underpins the vaccine's effectiveness against all RSV-LRTD, irrespective of the virus subgroup. The FDA's approval of ABRYSVO in May 2023 marked a significant milestone, with further recommendations for its use in older adults and pregnant individuals to protect infants through maternal immunization.

Internationally, ABRYSVO has received marketing authorization from the European Medicines Agency and regulatory bodies in Argentina, the United Kingdom, Canada, Macau, and Japan. Pfizer has also initiated additional clinical trials to evaluate the vaccine's efficacy in children and adults at higher risk for RSV disease due to various medical conditions.

The indications for ABRYSVO in the US include its use in preventing LRTD in individuals aged 60 and older and in pregnant individuals between 32 to 36 weeks gestational age to prevent LRTD in infants up to six months old.

Safety information for ABRYSVO highlights precautions for individuals with a history of severe allergic reactions, guidelines for administering the vaccine to pregnant individuals to avoid preterm birth risks, and warnings about potential fainting after vaccination. It also notes that individuals with weakened immune systems may have a reduced response to the vaccine and that vaccination may not protect everyone. The most common side effects in the elderly include fatigue, headache, injection site pain, and muscle pain, while in pregnant individuals, side effects include injection site pain, headache, muscle pain, and nausea. Clinical trials have also observed low birth weight and jaundice in infants born to vaccinated pregnant women.

Pfizer's commitment to improving patient lives through breakthroughs is exemplified by ABRYSVO. The company's dedication to quality, safety, and value is evident in its extensive work across global markets. Pfizer's mission is to advance wellness, prevention, treatments, and cures for significant diseases, collaborating with healthcare providers, governments, and communities to expand access to reliable and affordable healthcare worldwide.

ABRYSVO's development and approval历程 reflect Pfizer's ongoing efforts to address unmet needs in healthcare. The vaccine's success in clinical trials and its potential to provide durable protection against RSV highlight the importance of continued research and innovation in vaccine development. As Pfizer moves forward with additional trials and seeks to share these results with the broader scientific community, the hope is that ABRYSVO will make a meaningful difference in the lives of those most vulnerable to RSV infection.