Moderna has submitted Covid-19 booster shot data to the European Medicines Agency (EMA) for a conditional marketing approval (CMA). The company seeks conditional approval for a booster dose of its mRNA-1273 vaccine at the 50 µg dose level. The move comes after an analysis of an amended study showed that the booster dose induced robust antibody responses for all variants of concern.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has issued updated advice recommending against universal Covid-19 vaccination for young people within the age group of 12-15 years. The committee made the recommendation after an assessment concluded that the health benefits from vaccination are only “marginally greater than the potential known harms”. However, JCVI said that children with existing health conditions are at a higher risk and should be offered Covid-19 vaccination.
Swedish Orphan Biovitrum (Sobi) has reported positive data from the Phase III SAVE-MORE study assessing the efficacy of anakinra plus standard of care in patients with moderate-to-severe Covid-19 pneumonia. The study was published by Nature Medicine. Based on day 28 results, anakinra reduced risk of disease progression and death by 64%. It also found that the percentage of patients who fully recovered was over 50%, while the number of patients remaining with severe disease dropped by 54%.