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J&J (JNJ) Seeks FDA Authorization for COVID-19 Booster Jab
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Johnson & Johnson (JNJ - Free Report) announced that it has submitted an emergency use authorization (“EUA”) amendment request to the FDA for its COVID-19 vaccine. The company has submitted the clinical data to the FDA to support the EUA amendment to include a booster dose of its single-shot vaccine for use in adults.
The company’s request is backed by data from several clinical studies including the phase III ENSEMBLE 2 study. Data from the ENSEMBLE 2 study showed that a booster dose given 56 days after the first jab led to 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the United States and 75% protection globally. Meanwhile, the “second” or booster shot provided 100% protection against severe/critical COVID-19 — at least 14 days post-final vaccination.
The data demonstrated that when the booster jab was given two months after the first shot, antibody levels were four to six times higher than the levels observed after the first vaccination.
Data from the phase I/II study demonstrated that J&J’s COVID-19 vaccine booster, after the single dose primary regimen, led to a rapid and robust increase in spike-binding antibodies. These antibody levels were nine-fold higher than 28 days after the primary single-dose vaccination, following one week of booster dose administration. The antibody levels continued to climb and were 12-fold higher after four weeks of the booster dose.
J&J also said that the phase III data together with real-world evidence confirmed its vaccine’s strong and long-lasting protection against COVID-related hospitalizations and death even after a single shot.
This year so far, J&J’s shares have risen 1.3% compared with an increase of 8.1% for the industry.
Image Source: Zacks Investment Research
Last month, the FDA granted EUA to a booster or “third” dose of Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) Comirnaty for all individuals 65 years and older and also those in high-risk groups.
Moderna (MRNA - Free Report) has already submitted an application for authorization/approval for a booster dose of its COVID-19 vaccine and provided clinical data to support the efficacy of a booster dose to the FDA. A decision from the FDA is expected in the coming weeks.
Image: Bigstock
J&J (JNJ) Seeks FDA Authorization for COVID-19 Booster Jab
Johnson & Johnson (JNJ - Free Report) announced that it has submitted an emergency use authorization (“EUA”) amendment request to the FDA for its COVID-19 vaccine. The company has submitted the clinical data to the FDA to support the EUA amendment to include a booster dose of its single-shot vaccine for use in adults.
The company’s request is backed by data from several clinical studies including the phase III ENSEMBLE 2 study. Data from the ENSEMBLE 2 study showed that a booster dose given 56 days after the first jab led to 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the United States and 75% protection globally. Meanwhile, the “second” or booster shot provided 100% protection against severe/critical COVID-19 — at least 14 days post-final vaccination.
The data demonstrated that when the booster jab was given two months after the first shot, antibody levels were four to six times higher than the levels observed after the first vaccination.
Data from the phase I/II study demonstrated that J&J’s COVID-19 vaccine booster, after the single dose primary regimen, led to a rapid and robust increase in spike-binding antibodies. These antibody levels were nine-fold higher than 28 days after the primary single-dose vaccination, following one week of booster dose administration. The antibody levels continued to climb and were 12-fold higher after four weeks of the booster dose.
J&J also said that the phase III data together with real-world evidence confirmed its vaccine’s strong and long-lasting protection against COVID-related hospitalizations and death even after a single shot.
This year so far, J&J’s shares have risen 1.3% compared with an increase of 8.1% for the industry.
Last month, the FDA granted EUA to a booster or “third” dose of Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) Comirnaty for all individuals 65 years and older and also those in high-risk groups.
Moderna (MRNA - Free Report) has already submitted an application for authorization/approval for a booster dose of its COVID-19 vaccine and provided clinical data to support the efficacy of a booster dose to the FDA. A decision from the FDA is expected in the coming weeks.
Johnson & Johnson Price
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J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.