September 23, 2023
CDC's ACIP endorsed Pfizer's RSV vaccine
Pfizer is expanding its roster of recommended respiratory vaccines, endorsed by the CDC's Advisory Committee on Immunization Practices (ACIP). The latest addition to the list is Abrysvo [Respiratory Syncytial Virus Vaccine], Pfizer's bivalent RSV prefusion F (RSVpreF) vaccine, which has been recommended as a maternal immunisation for pregnant individuals between 32 and 36 weeks of gestation. This recommendation is intended to protect infants from respiratory syncytial virus (RSV) infections starting from birth through their first six months of life. This expansion strengthens Pfizer's existing portfolio of respiratory vaccines designed to combat RSV in older adults, COVID-19, and pneumococcal pneumonia in adults.
The ACIP has issued the following recommendations: Pregnant individuals between 32 and 36 weeks of gestation should receive the maternal RSV vaccine, with seasonal administration, to prevent RSV lower respiratory tract infections in infants.
It's important to note that this recommendation will become official once it is reviewed and approved by the CDC's director. This decision follows the FDA's approval of Abrysvo in August, marking it as the first and only maternal vaccine for preventing lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants up to six months of age through active immunisation of pregnant individuals at 32 through 36 weeks of gestational age.
This ACIP action is in line with recent recommendations from the CDC, including the authorisation and approval of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula for individuals aged six months and older, aimed at safeguarding against COVID-19 during the forthcoming fall and winter.
Abrysvo is presently available and recommended for adults aged 60 and older through shared clinical decision-making to protect against RSV disease. Given the significant number of individuals aged 60 and older in the U.S., the recommended use of this vaccine can significantly mitigate the severe consequences associated with RSV, which results in the hospitalisation of more than 60,000 adults in this age group each year.
Also, Prevnar 20 has been recommended by the CDC since October 2021 to prevent pneumococcal disease among adults aged 65 years plus and adults aged 19-64 years with specific medical conditions, such as asthma or diabetes, which put them at higher risk. Pneumococcal pneumonia leads to more than 180,000 adult hospitalisations and over 150,000 adult outpatient visits in the U.S. annually.
The CDC is introducing a new measure to safeguard infants from the primary cause of hospitalization, marking a significant milestone. This novel immunization, the first in the U.S., is designed to thwart severe respiratory syncytial virus (RSV) disease among all infants. Scheduled to commence this fall, the CDC is advocating for this new immunization to protect infants below eight months of age and certain older babies who face heightened risks of severe respiratory illnesses triggered by RSV.
RSV is one of the most prevalent culprits behind childhood respiratory ailments, triggering annual waves of respiratory infections spanning all age groups. Each year witnesses the hospitalization of an estimated 58,000 to 80,000 children under the age of 5 due to RSV infection, most of whom are infants. Some cases necessitate interventions like oxygen therapy, intravenous (IV) fluids, and mechanical ventilation. Tragically, RSV claims the lives of approximately 100 to 300 children below five each year.
To combat this health threat, the CDC advocates administering one dose of Beyfortus, an injectable solution, to all infants under eight months of age entering or experiencing their first RSV season (typically from fall through spring). Moreover, a dose during their second season is recommended for a subset of children aged 8 to 19 months at elevated risk of severe RSV disease, such as those who are significantly immunocompromised. In tandem with this recommendation, the Committee has also supported the routine use of Beyfortus for children aged 8 to 19 months who are confronting their second RSV season and facing elevated risks.
Additionally, the ACIP, unanimously decided to include Beyfortus in the Vaccines for Children (VFC) program. This pivotal decision ensures the accessibility of Beyfortus in the U.S. before the impending 2023-2024 RSV season.
Beyfortus, which recently secured approval from the U.S. Food and Drug Administration (FDA), is administered through injections, offering infants and toddlers crucial antibodies for protection against severe RSV illness. This intervention is pivotal during a baby's inaugural RSV season, marked by elevated vulnerability to severe diseases.
Anticipated for release this fall, expectant parents and guardians of infants below eight months and those with slightly older infants are encouraged to engage in discussions with their healthcare providers.
In an equally important decision, ACIP has embraced Beyfortus in the Vaccines for Children program, a comprehensive initiative delivering recommended immunizations to nearly half of the nation's children at no cost.