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FDA Panel Recommends Second Johnson & Johnson Vaccine Dose

Oct. 15, 2021 — A FDA advisory committee on Friday voted unanimously to advocate second doses of the Johnson & Johnson COVID-19 vaccine to anybody over 18, the second vote in as many days to again a change to a COVID vaccine timeline.

The panel recommends that the second J&J dose come at the least 2 months after the primary shot. It’s not technically a booster, nevertheless it’s shifting Johnson & Johnson from a one-dose vaccine to a two-dose one, just like Moderna’s and Pfizer’s vaccines.

The identical panel voted Thursday to advocate booster photographs for Moderna vaccine, however for a narrower group of individuals.

Studies of the effectiveness of the J&J vaccine in the real world present that its safety — whereas good — has not been as robust because the mRNA vaccines made by Pfizer and Moderna, that are given as a part of a two-dose collection.

This is an particularly necessary problem for adults over the age of fifty. A latest study in TheNew England Journal of Medicine discovered that older adults who acquired the Johnson & Johnson vaccine had been much less protected towards an infection and hospitalization than those that acquired mRNA vaccines.

Limited Data

The firm’s information offered to the FDA panel in help of booster doses was restricted however did present {that a} second dose considerably elevated ranges of neutralizing antibodies, that are the physique’s first line of safety towards COVID-19 an infection.

But the corporate turned this information over to the FDA so lately that company scientists repeatedly careworn that they’d not had time to observe their regular technique of independently verifying the information and following up with their very own evaluation of the research outcomes.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, stated it will have taken months to finish that rigorous stage of evaluation.

Instead, within the curiosity of urgency, the FDA stated it had tried to deliver some readability to the tangle of research outcomes offered that included three dosing schedules and totally different measures of effectiveness.

Still Call It a Booster?

In the tip, the 19 members of the Vaccines and Related Biological Products Advisory Committee stated they felt that the corporate hadn’t made a case for calling it second shot a booster, however had proven sufficient information to recommend that everybody over the age of 18 ought to think about getting two photographs of the Johnson & Johnson vaccine as a matter after all.

“Here’s how this strikes me,” stated committee member Paul Offit, MD, a professor of pediatrics and infectious illness at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”

“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” stated James Hildreth, MD, PhD, a professor of inner drugs at Meharry Medical College in Nashville.

The committee’s assembly is ongoing. This story might be up to date.

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