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The FDA panel recommends Johnson & Johnson’s second dose of vaccine

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

The panel recommends that the second J&J dose be given at least 2 months after the first injection. It’s not technically a boost, but it’s moving Johnson & Johnson from an overdose vaccine to a two – dose vaccine, similar to that of Moderna and Pfizer. vaccines.

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

Studies on the efficacy of the J&J vaccine in the real world shows that its protection, although good, was not as strong as the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.

This is a particularly important issue for adults over 50. A recent study in TheNew England Journal of Medicine found that older adults 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 submitted to the FDA panel in support of booster doses was limited, but showed that a second dose significantly increased the level of neutralizing antibodies, giving the body its first protection against COVID-19 infection. is.

But the company handed over this data to the FDA so recently that agency scientists have repeatedly stressed that they did not have time for their normal process of independently verifying the data and following up on their own analysis of the study results.

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

Instead of urgency, the FDA said it was trying to provide some clarity on the confusion of study results that include three dosing schedules and different efficacy measures.

Still calling it a booster?

Finally, the 19 members of the Advisory Committee on Vaccines and Related Biological Products said that they believe that the company did not make a case to give it a second shot, but that they showed enough data to indicate that all older than 18 years, of course, should consider getting two shots of the Johnson & Johnson vaccine.

‘This is how it strikes me,’ says committee member Paul Offit, MD, professor of pediatrics and infectious diseases at Philadelphia Children’s Hospital. ‘I think this vaccine has always been a two-dose vaccine. I think it’s better than a two – dose vaccine. I think it will be difficult at this stage to recommend it as a vaccine for one dose. ”

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

The committee meeting continues. This story will be updated.

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