Covid vaccine, Johnson & Johnson requests authorization from FDA for recall

Recall coming for Johnson & Johnson single-dose Covid vaccine. The company announced that it had sent the data to the US FDA to obtain the okay for the administration of a booster in people aged 18 and over. The request to supplement the emergency use authorization to support the single injection vaccine upgrade includes the results of the recently submitted Phase 3 Ensemble 2 study, according to which a second dose of J&J vaccine administered 56 days post dose primary increased protection to 94% against symptomatic disease in the United States and to 100% against severe or critical Covid, starting 14 days after the recall. In the dossier submitted to the US regulatory body there are also phase 1 / 2a data showing that, when the booster is given 6 months after the primary dose, the antibody levels increase 9 times a week after the booster dose and continue. to rise to become 12x taller 4 weeks later. The company plans to present the data to other regulatory bodies, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (Nitag) worldwide to inform decision-making on local vaccine delivery strategies. if necessary. In the US, the vaccine received the authorization for emergency use on February 27, 2021, and on March 11 it received the green light in the EU as well.