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 at the very least 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 pictures 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 robust because the mRNA vaccines made by Pfizer and Moderna, that are given as a part of a two-dose sequence.
That is an particularly necessary concern for adults over the age of fifty. A latest study in TheNew England Journal of Drugs discovered that older adults who obtained the Johnson & Johnson vaccine had been much less protected in opposition to an infection and hospitalization than those that obtained mRNA vaccines.
Restricted Knowledge
The corporate’s information offered 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 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 that they had not had time to comply with their regular technique 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 Heart for Biologics Analysis and Analysis, mentioned it might have taken months to finish that rigorous stage of assessment.
As a substitute, within the curiosity of urgency, the FDA mentioned it had tried to carry 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 recommend that everybody over the age of 18 ought to think about getting two pictures 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 Youngsters’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 arduous 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 vital for J&J recipients to get a second shot,” mentioned James Hildreth, MD, PhD, a professor of inside drugs at Meharry Medical School in Nashville.
The committee’s assembly is ongoing. This story might be up to date.
