J&J to Ask FDA to Approve Its COVID Booster Shot

MONDAY, Oct. 4, 2021 (Healthday Information)

Johnson & Johnson ideas to ask the U.S. Food stuff and Drug Administration to approve emergency use of a booster shot of its solitary-dose COVID-19 vaccine early this week.

While the ask for has however to be submitted, the Food and drug administration on Friday scheduled an Oct. 15 meeting of its expert advisory panel to examine no matter if a booster shot of the vaccine must acquire emergency use authorization, The New York Occasions documented.

The scheduling of that meeting right before Johnson & Johnson has even submitted its application with the Food and drug administration highlights the Biden administration’s worries that the 15 million Individuals who obtained the firm’s vaccine involve far more security, the Occasions claimed.

Johnson & Johnson is the last of the 3 Food and drug administration-licensed vaccine vendors to look for acceptance of booster shots, as escalating proof implies that older adults and other superior-risk individuals might will need them.

Last thirty day period, the Food and drug administration licensed a booster shot for numerous individuals who obtained Pfizer’s vaccine and is thinking of undertaking the exact this thirty day period for Individuals who obtained Moderna’s vaccine, the Occasions documented.

A current U.S. Facilities for Condition Handle and Prevention review located that Johnson & Johnson’s vaccine was only seventy one% helpful against hospitalization from COVID-19, when compared with 88% for Pfizer’s vaccine and ninety three% for Moderna’s vaccine. Both equally are two-dose vaccines.

Johnson & Johnson recipients ended up also far more very likely to have breakthrough bacterial infections or symptomatic COVID-19 than recipients of the other two vaccines, other study has proven, the Occasions documented.

But a enterprise-funded review of almost two million individuals located the vaccine was eighty one p.c helpful against hospitalization. And other reports counsel that security from Johnson & Johnson’s vaccine does not wane about time like Pfizer’s vaccine does, the Occasions claimed.

Regardless, the enterprise declared last thirty day period that a second dose, provided two months just after the initial, amplified the vaccine’s efficiency against symptomatic COVID-19 by about 22 percentage details, to ninety four p.c. Johnson & Johnson also claimed two shots ended up one hundred p.c helpful against serious ailment, despite the fact that that estimate was a lot less conclusive, the Occasions documented.

Extra facts

Go to the U.S. Facilities for Condition Handle and Prevention for far more on booster shots.

Resource: The New York Occasions

Robert Preidt and Robin Foster

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