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US FDA advisers unanimously endorse second dose of J&J vaccine

Por Julie Steenhuysen y Michael Erman

Reuters) – Outside advisers to the U.S. Food and Drug Administration voted unanimously on Friday to recommend that regulators authorize a second injection of Johnson & Johnson’s COVID-19 vaccine, to better protect those who received it. a single dose.

The FDA Vaccines and Related Biologics Advisory Committee endorsed injections for all J&J vaccine recipients age 18 and older at least two months after their first dose.

The FDA is not required to follow the recommendations of the advisory committee, but usually does.

After hearing presentations from the scientists at J&J and the FDA, many members of the advisory panel asked whether the J&J single-dose vaccine should really be considered a two-dose injection for everyone.

Advisors mentioned the lower levels of neutralizing antibodies to the virus it elicits compared to vaccines using messenger RNA (mRNA) technology from Moderna Inc and Pfizer Inc / BioNTech SE.

“There is a public health imperative. What we are seeing is that this is a group with an overall efficacy lower than what we have seen with the mRNA vaccine, so it is urgent to do something,” said Dr. Arnold Monto, epidemiologist at the University of Michigan School of Public Health, who chaired the meeting.

The J&J scientists said their vaccine was more durable than mRNA vaccines.

(Report by Manojna Maddipatla in Bengaluru; Edited in Spanish by Javier López de Lérida)

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