Older adults begin to drop out of Novavax vaccine trial to get Pfizer and Moderna vaccines

As it tests its candidate COVID-19 vaccine, Novavax is seeing older adult volunteers leave the study to get immunized with the Pfizer or Moderna products already known to be effective against coronavirus. The exodus has been motivated in part by state efforts to open up vaccination to broad swaths of Americans aged 65 years and older—not just residents of long-term care facilities. While good news for people in that demographic, the expansion is contributing to a shortage of participants in vaccine trials that are still underway. Maryland-based Novavax, for instance, needs 30,000 people for its placebo-controlled study, a quarter of whom would fall into the critical age 65-plus category. Without a robust cohort of older adult participants through followup, however, the trial data would carry less weight. Only about 9,000 people were enrolled as of last week. If it fails to recruit enough older adults, company officials plan to ask FDA to consider data from a U.K. trial that is fully populated. FDA is open to that possibility. “We’re not going to cut corners, but we’re not going to stand on ceremony,” explains one senior agency official. The official added, “It’s not like we’re going to sit there and make rules to make it difficult to use foreign data.”