FDA Panel Recommends Second Johnson & Johnson Vaccine Dose



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

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

The same panel voted Thursday to recommend booster shots for Moderna vaccine, but for a narrower group of people.

Studies of the effectiveness of the J&J vaccine in the real world show that its protection — while good — has not been as strong as the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

This is an especially important issue for adults over the age of 50. A recent study in TheNew England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.

Limited Data

The company’s data presented to the FDA panel in support of booster doses was limited but did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.

But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed that they had not had time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.

Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.

Still Call It a Booster?

In the end, the 19 members of the Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling it second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.

“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease 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,” said James Hildreth, MD, PhD, a professor of internal medicine at Meharry Medical College in Nashville.

The committee’s meeting is ongoing. This story will be updated.


Source link


Please enter your comment!
Please enter your name here