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 a minimum of 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 suggest booster photographs for Moderna vaccine, however for a narrower group of individuals.

Research of the effectiveness of the J&J vaccine in the actual 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.

That is an particularly essential concern for adults over the age of fifty. A latest examine in TheNew England Journal of Medication discovered that older adults who received the Johnson & Johnson vaccine have been much less protected in opposition to an infection and hospitalization than those that received mRNA vaccines.

Restricted Information

The corporate’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 in opposition to COVID-19 an infection.

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

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

As a substitute, within the curiosity of urgency, the FDA mentioned it had tried to deliver some readability to the tangle of examine outcomes offered that included three dosing schedules and completely different measures of effectiveness.

Nonetheless Name It a Booster?

Ultimately, the 19 members of the Vaccines and Associated Organic Merchandise Advisory Committee mentioned they felt that the corporate hadn’t made a case for calling it second shot a booster, however had proven sufficient information to counsel that everybody over the age of 18 ought to contemplate getting two photographs of the Johnson & Johnson vaccine as a matter in fact.

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

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

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

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