Pfizer seeks to expand RSV shot eligibility

Shot of a young doctor applying a band-aid after injecting her patient during a consultation in the clinic.

On April 9, Pfizer posted promising new data from its phase 3 clinical trial of Abrysvo. The ongoing study (MONeT) is evaluating the efficacy and safety of Abrysvo versus placebo in adults 18 to 59 years old who are at increased risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). This includes people with chronic conditions, such as asthma, COPD and diabetes.

Pfizer’s latest results have achieved the study’s primary endpoints.

·      Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses similar to the responses seen in the phase 3 RENOIR study of Abrysvo in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated. 

·      Participants attained at least a four-fold increase in serum neutralizing titers for RSV-A and RSV-B one month following administration of Abrysvo compared to pre-vaccination.

·      Participants tolerated Abyrsvo, and safety findings were consistent with those from previous investigations of Abyrsvo in other populations. 

Additionally, Pfizer met its diversity recruitment goals for the study, providing data from participants that reflect the diverse U.S. population and had a balanced representation across underlying medical conditions.

Next, Pfizer intends to submit these data to regulatory agencies and request expansion of the age group from the current indication to 18 years and older. It will also publish and present the full data later this year.

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