US FDA s decision to expand the emergency use of both the Pfizer-BioNTech and Moderna vaccines is meant to help those patients with immune deficiencies
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) used for arthritis for the treatment of hospitalised patients with Covid-19. Under the EUA, the drug can be administered only ot hospitalised adults and pediatric patients (2 years of age and older), receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). However, Actemra is not authorised for use in outpatients with Covid-19, the FDA said in a statement. Clinical trials showed that administering Actemra to hospitalised Covid-19, in addition to routine care which included corticosteroid therapy, reduced the risk of death as well as decreased the amount of time patients remained hospitalised.
"Sahpra reviewed the data provided by the FDA and has made a decision not to release vaccines produced using the drug substance batches that were not suitable."
Ocugen in a statement on Thursday announced that as recommended by theFDA,it will pursue submission of a biologics licence application (BLA) for Covaxin.