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FDA panel recommends second dose of Johnson & Johnson vaccine

October 15, 2021 – An FDA advisory committee voted unanimously on Friday to recommend second doses of the Johnson & Johnson COVID-19 vaccine to anyone over 18, the second vote in as many days to support a modification of the COVID vaccine schedule.

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

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

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

This is a particularly important problem for adults over 50. A recent study in TheNew England Journal of Medicine found that older people who received the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who received mRNA vaccines.

Limited data

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

But the company turned this data over to the FDA so recently that the agency’s scientists have repeatedly pointed out that they haven’t had time to go through their normal process of independent data verification and follow-up on their own. analysis of study results.

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

Instead, in the interest of the emergency, the FDA said it had tried to clarify the tangle of study results presented which included three dosing regimens and different measures of effectiveness.

Still call it a booster?

Ultimately, the 19 members of the Vaccines and Related Biologics Advisory Committee said they felt the company had not argued to call it a second shot a booster, but had shown enough data to suggest. that anyone over the age of 18 should consider receiving two injections of the Johnson & Johnson vaccine routinely.

“Here’s how it hits me,” said committee member Paul Offit, MD, professor of pediatrics and infectious diseases at Children’s Hospital of Philadelphia. “I think this vaccine has always been a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be difficult to recommend it as a single dose vaccine at this point. “

“As far as I was concerned, it was always going to be necessary for J&J recipients to get a second injection,” said James Hildreth, MD, PhD, professor of internal medicine at Meharry Medical College in Nashville.

The committee meeting is in progress. This story will be updated.


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