FDA Panel Recommends Second Johnson & Johnson Vaccine Dose

Oct. 15, 2021 — A FDA advisory committee on Friday voted unanimously to suggest 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 no less than 2 months after the primary shot. It’s not technically a booster, however it’s shifting Johnson & Johnson from a one-dose vaccine to a two-dose one, much like Moderna’s and Pfizer’s vaccines.

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

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

That is an particularly vital difficulty for adults over the age of fifty. A latest study in TheNew England Journal of Drugs discovered that older adults who acquired the Johnson & Johnson vaccine have been much less protected towards an infection and hospitalization than those that acquired mRNA vaccines.

Restricted Knowledge

The corporate’s information introduced to the FDA panel in assist 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.

However the firm turned this information over to the FDA so not too long ago that company scientists repeatedly pressured that they’d not had time to observe their regular strategy of independently verifying the information and following up with their very own evaluation of the examine outcomes.

Peter Marks, MD, director of the FDA’s Middle for Biologics Analysis and Analysis, stated it might have taken months to finish that rigorous degree of overview.

As a substitute, within the curiosity of urgency, the FDA stated it had tried to convey some readability to the tangle of examine outcomes introduced that included three dosing schedules and totally different measures of effectiveness.

Nonetheless Name It a Booster?

Ultimately, the 19 members of the Vaccines and Associated Organic Merchandise 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 contemplate getting two photographs of the Johnson & Johnson vaccine as a matter after all.

“Right here’s how this strikes me,” stated committee member Paul Offit, MD, a professor of pediatrics and infectious illness at Kids’s Hospital of Philadelphia. “I feel this vaccine was at all times a two-dose vaccine. I feel it’s higher as a two-dose vaccine. I feel it might be exhausting to suggest this as a single-dose vaccine at this level.”

“So far as I’m involved, it was at all times going to be crucial for J&J recipients to get a second shot,” stated James Hildreth, MD, PhD, a professor of inside drugs at Meharry Medical School in Nashville.

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

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