The FDA has granted fast track designation to two combination vaccine candidates that aim to protect adults 50 and older from both influenza and COVID-19, according to a Dec. 16 AJMC report.
These vaccine candidates combine the flu vaccine with the Novavax COVID-19 vaccine, offering a potential single shot to address both diseases.
The designation was granted to expedite the development of vaccines that could help reduce the health burdens of flu and COVID-19, especially for groups that are at higher risk of severe outcomes such as prolonged hospital stays and long-term complications.
The first combination candidate combines Fluzone High-Dose, a high-dose flu vaccine, with Novavax's COVID-19 vaccine. The second candidate uses Flublok, a recombinant flu vaccine paired with the same Novavax COVID-19 vaccine.
Both flu vaccines have been shown to be more effective than standard-dose flu vaccines in preventing infections and reducing hospitalizations in older adults. The Novavax COVID-19 vaccine has also demonstrated good safety and efficacy profiles in previous clinical trials, according to the release.
Sanofi, which is developing the vaccines, has launched phase ½ clinical trials to evaluate the safety and immune responses to the combination shots. The trials aim to assess whether combining these vaccines can maintain their efficacy while simplifying vaccination schedules, potentially improving uptake among older adults.