The FDA panel recommends a second dose of Johnson & Johnson vaccine


October 15, 2021 – The FDA Advisory Committee on Friday voted unanimously to recommend second doses of the Johnson & Johnson COVID-19 vaccine to anyone over the age of 18, with a second vote after so many days supporting a change in the COVID vaccine schedule.

The panel recommended that the second dose of J&J come at least 2 months after the first shot. Technically, this is not a booster, but it moves Johnson & Johnson from a single-dose vaccine to a two-dose vaccine, similar to Moderna and Pfizer vaccines.

The same panel voted on Thursday to recommend booster injections for the 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 – although good – was not as strong as the mRNA vaccines made by Pfizer and Moderna, which were 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 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 booster doses were limited, but showed that a second dose significantly increased levels of neutralizing antibodies, which are the body’s first line of defense against COVID-19 infection.

But the company passed the data to the FDA so recently that the agency’s scientists have repeatedly stressed that they did not have time to follow their normal process of independent verification of the data and subsequent own analysis of the results of the study.

Dr. Peter Marx, director of the FDA’s Center for Evaluation and Research of Organic Products, said it would take months to complete this rigorous level of review.

Instead, in the interests of urgency, the FDA said it had tried to bring some clarity to the entanglement of the results of the study, which included three dosing regimens and different effectiveness measures.

Do you still call it a booster?

In the end, the 19 members of the Advisory Committee on Vaccines and Related Organic Products said they believed the company did not claim to call it a second shot booster, but showed enough data to suggest that everyone over the age of An 18-year-old should consider getting two injections of the Johnson & Johnson vaccine as a matter of course.

“That’s how it sounds to me,” said committee member Dr. Paul Ofit, a 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 at this point it would be difficult to recommend this as a single-dose vaccine. “

“As far as I’m concerned, it would always be necessary for J&J recipients to get a second shot,” said Dr. James Hildret, a professor of internal medicine at Mehari Medical College in Nashville.

The committee meeting continues. This story will be updated.



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