The European Medicines Agency (EMA) has published a draft addendum to a guideline on vaccine development that encourages collecting clinical trial data on immunocompromised people in certain situations. The agency advised that when testing live vaccines, sponsors should wait to collect more safety and efficacy data on immunocompetent patients before evaluating immunocompromised patients.
EMA noted that while the vast majority of vaccines won’t be studied in immunocompromised patients, there may be situations when trials to evaluate the product in such people are necessary…
