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 Emergency Use Authorization Supplement Request to support single injection vaccine enhancement 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 after the primary dose 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.

Ema: decision in the coming weeks

“We are in contact with Johnson & Johnson,” to understand when there will be a clinical data package that could support a potential second-dose authorization “of its single-dose Covid vaccine. “Data from a large study on the safety and efficacy of the two doses, but with an interval of 2 months” from each other, have recently been released by J&J. “What we will also discuss is what is the useful interval for the second dose. And we may decide in the next few weeks what to do about that.” This is how Marco Cavaleri, head of Vaccines and Therapeutic Products for Covid-19 of the European Medicines Agency Ema, explains during a press briefing the next steps in view for the J&J anti-Covid vaccine (developed by Janssen).

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