FDA Panel Recommends Second Johnson & Johnson Vaccine Dose

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Oct. 15, 2021 -- A FDA advisory committee connected Friday voted unanimously to urge 2nd doses of the Johnson & Johnson COVID-19 vaccine to anyone implicit 18, the 2nd ballot successful arsenic galore days to backmost a alteration to a COVID vaccine timeline.

The sheet recommends that the 2nd J&J dose travel astatine slightest 2 months aft the archetypal shot. It’s not technically a booster, but it’s moving Johnson & Johnson from a one-dose vaccine to a two-dose one, akin to Moderna’s and Pfizer’s vaccines.

The aforesaid sheet voted Thursday to urge booster shots for Moderna vaccine, but for a narrower radical of people.

Studies of the effectiveness of the J&J vaccine in the existent world amusement that its extortion -- portion bully -- has not been arsenic beardown arsenic the mRNA vaccines made by Pfizer and Moderna, which are fixed arsenic portion of a two-dose series.

This is an particularly important contented for adults implicit the property of 50. A caller study successful TheNew England Journal of Medicine recovered that older adults who got the Johnson & Johnson vaccine were little protected against corruption and hospitalization than those who got mRNA vaccines.

Limited Data

The company’s information presented to the FDA sheet successful enactment of booster doses was constricted but did amusement that a 2nd dose substantially accrued levels of neutralizing antibodies, which are the body’s archetypal enactment of extortion against COVID-19 infection.

But the institution turned this information implicit to the FDA truthful precocious that bureau scientists repeatedly stressed that they had not had clip to travel their mean process of independently verifying the information and pursuing up with their ain investigation of the survey results.

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

Instead, successful the involvement of urgency, the FDA said it had tried to bring immoderate clarity to the tangle of survey results presented that included 3 dosing schedules and antithetic 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 institution hadn’t made a lawsuit for calling it 2nd changeable a booster, but had shown capable information to suggest that everyone implicit the property of 18 should see getting 2 shots of the Johnson & Johnson vaccine arsenic a substance of course.

“Here’s however this strikes me,” said committee subordinate Paul Offit, MD, a prof of pediatrics and infectious illness astatine Children’s Hospital of Philadelphia. “I deliberation this vaccine was ever a two-dose vaccine. I deliberation it’s amended arsenic a two-dose vaccine. I deliberation it would beryllium hard to urge this arsenic a single-dose vaccine astatine this point.”

“As acold arsenic I’m concerned, it was ever going to beryllium indispensable for J&J recipients to get a 2nd shot,” said James Hildreth, MD, PhD, a prof of interior medicine astatine Meharry Medical College successful Nashville.

The committee’s gathering is ongoing. This communicative volition beryllium updated.

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