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

News Picture: J&J to Ask FDA to Approve Its COVID Booster Shot

MONDAY, Oct. four, 2021 (Healthday Information)

Johnson & Johnson plans to talk to the U.S. Food stuff and Drug Administration to approve unexpected emergency use of a booster shot of its one-dose COVID-19 vaccine early this 7 days.

Even though the ask for has but to be submitted, the Food and drug administration on Friday scheduled an Oct. 15 meeting of its qualified advisory panel to explore no matter if a booster shot of the vaccine should obtain unexpected emergency use authorization, The New York Occasions claimed.

The scheduling of that meeting in advance of Johnson & Johnson has even submitted its software with the Food and drug administration highlights the Biden administration’s issues that the 15 million People in america who received the firm’s vaccine involve additional protection, the Occasions mentioned.

Johnson & Johnson is the last of the 3 Food and drug administration-approved vaccine providers to look for acceptance of booster photographs, as expanding evidence indicates that older grownups and other higher-danger persons may possibly will need them.

Past month, the Food and drug administration approved a booster shot for several persons who received Pfizer’s vaccine and is thinking of performing the identical this month for People in america who received Moderna’s vaccine, the Occasions claimed.

A latest U.S. Centers for Ailment Control and Avoidance analyze discovered that Johnson & Johnson’s vaccine was only 71% helpful in opposition to hospitalization from COVID-19, when compared with 88% for Pfizer’s vaccine and ninety three% for Moderna’s vaccine. Each are two-dose vaccines.

Johnson & Johnson recipients were being also additional very likely to have breakthrough bacterial infections or symptomatic COVID-19 than recipients of the other two vaccines, other investigate has shown, the Occasions claimed.

But a firm-funded analyze of almost two million persons discovered the vaccine was 81 per cent helpful in opposition to hospitalization. And other scientific tests counsel that protection from Johnson & Johnson’s vaccine does not wane in excess of time like Pfizer’s vaccine does, the Occasions mentioned.

Irrespective, the firm announced last month that a second dose, given two months following the to start with, amplified the vaccine’s effectiveness in opposition to symptomatic COVID-19 by about 22 share points, to 94 per cent. Johnson & Johnson also mentioned two photographs were being one hundred per cent helpful in opposition to extreme sickness, while that estimate was much less conclusive, the Occasions claimed.

A lot more facts

Pay a visit to the U.S. Centers for Ailment Control and Avoidance for additional on booster photographs.

Source: The New York Occasions

Robert Preidt and Robin Foster

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