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Johnson & Johnson Reportedly Set to Seek FDA OK for Covid Booster

Johnson & Johnson says that six months after original shots, its Covid booster shot lifts antibody counts 12-fold.
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Health-care giant Johnson & Johnson  (JNJ) - Get Johnson & Johnson (JNJ) Report is set to request Food and Drug Administration authorization for its Covid-19 vaccine booster shot later this week, according to a report. 

The company declined to comment on the New York Times report, but did point to a Sept 21 news release saying that it had submitted available data to U.S. health regulators with the intent to also submit the data to other regulators. 

Johnson & Johnson showed that four weeks after the first dose of its single-shot vaccine, efficacy was 66.3% at preventing infection and 85% effective at preventing severe or critical disease.

The company recently released data from a trial of patients receiving their booster dose two or six months after the first dose.

Patients receiving the boost after two months saw Covid-19 antibodies increase to 94% from 85%.

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The booster administered six months after the first shot saw antibody levels increase 12-fold. 

"With these new data, we also see that a booster dose of the Johnson & Johnson Covid-19 vaccine further increases antibody responses among study participants who had previously received our vaccine," said Mathai Mammen, global head of Janssen Research and Development at Johnson & Johnson.

The FDA has already greenlighted the booster dose from Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech  (BNTX) - Get BioNTech SE Sponsored ADR Report for vaccinated people 65 and older, people at high risk of severe disease and those who are regularly exposed to the virus like healthcare workers. 

Moderna  (MRNA) - Get Moderna, Inc. Report in September submitted its application, seeking authorization for its booster shot.

Johnson & Johnson shares at last check were little changed at $160.61.