The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizing heterologous booster doses for all populations eligible for boosters under today's expansion of the emergency use authorizations for COVID-19 vaccines.   A booster is recommended for all recipients of the one-dose Janssen vaccine, an...

API mixes, which are mixtures of one or more excipients and an active pharmaceutical ingredient, are used to improve the safety, stability or workability of an active ingredient. Some examples of commonly used excipients for these purposes include antioxidants, preservatives and diluents. EMA says it considers the mixing process "to be the first step of the manufacture of a finished product." As such, sponsors are required to submit information about the mixture just as ...