FDA expands age indication for Prevnar 13 use in younger adults
The US Food and Drug Administration (FDA) has expanded the age indication for Pfizer's Prevnar 13, the pneumococcal 13-valent conjugate vaccine, allowing its use in adults ages 18 through 49 years old, the company said yesterday in a press release.
The vaccine is already approved for use in children as young as 6 weeks old and adults age 50 and older, making Prevnar 13 the only pneumococcal vaccine approved across the lifespan, Pfizer said.
FDA's decision was based on a phase 3 trial of Prevnar 13 in adults who had not been previously vaccinated with the 23-valent pneumoccal polysaccharide vaccine. The study, published in 2015, compared the immunogenicity, safety, and tolerability of Prevnar 13 in younger adults and those ages 60 to 64.
Expansion of the age indication aligns the vaccine more closely with a 2012 recommendation from the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) that adults 19 and older with immunocompromising conditions such as HIV, chronic renal failure, and cancer be vaccinated against pneumococcal disease, similar to a 2014 ACIP recommendation for adults 65 and older.
Prevnar 13 is designed to protect against pneumonia and invasive disease caused by 13 strains of Streptococcus pneumoniae, the most common cause of community-acquired pneumonia.
Jul 12 Pfizer press release
Promising findings for a Rift Valley fever outbreak prediction tool
An analysis of Rift Valley fever epidemics in South African livestock identified a weather pattern that seems to trigger outbreaks, and researchers incorporated the data into a model that can help predict the events, which may be useful to farmers to protect their herds with vaccines. The findings appeared yesterday in Emerging Infectious Diseases.
Livestock vaccination is the best way to prevent the mosquito-borne disease, which takes a toll on livestock and can result in infections in humans. Researchers said, however, that between Rift Valley fever epidemics, farmers sometimes discontinue vaccination, and when another outbreak strikes, it's usually too late to immunize the animals. Hence, an early warning strategy would be useful to support vaccination, they wrote.
Data from South African epidemics from 2008 through 2011 revealed that the weather pattern that triggered outbreaks entailed continuous, widespread seasonal rainfall that saturated the soil and was followed by rainfall events that flooded dambos (seasonally flooded depressions).
When the investigators tested their prediction model designed to forecast the outbreaks, they found that it correctly identified the risk in 90% of instances at least 1 month before outbreaks occurred. In the other 10% of outbreaks, the said irrigation played an important role.
The researchers said the model needs to be validated in future Rift Valley fever epidemics and that a reliable early warning system to identify high-risk areas for livestock can be a key part of the management strategy, which also includes regular serologic surveys to assess livestock immune status and an immunization program supported by vaccine stockpiling.
Jul 12 Emerg Infect Dis report