EMA approves first adapted COVID-19 booster vaccines
The CHMP has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron BA.1 are for use in people aged 12 years and above who have received at least primary vaccination against COVID-19.
These vaccines are adapted to better fight the circulating variants of SARS-CoV-2. Adapted vaccines can broaden protection against different variants, and are therefore expected to help maintain optimal protection against COVID-19, as the virus continues to evolve.
The ECDC and EMA have issued a joint statement, stating that: “Exposing the immune system to contemporary versions of the virus so that it learns and recognises subsequent variants is key for building up a broader immune response.”
EMA issues positive feedback to Destiny Pharma on antibiotic treatment
Destiny Pharma has received positive feedback from the EMA regarding the proposed Phase III development programme of its new antibiotic treatment.
The EMA has declared that a single, final-stage study of NTCD-M3, the group’s lead clinical candidate for the prevention of the recurrence of infections caused by toxic strains of the gut bacteria, would be sufficient for it to file a marketing authorisation application.
The group added that the EMA has also endorsed a new capsule formulation of the drug, currently in development with an aim to treat the recurrence of Clostridioides difficile (CDI).