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J&J (JNJ) COVID-19 Jab Linked to New Rare Neurological Disorder
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J&J (JNJ - Free Report) , on Monday, issued a statement mentioning that a rare neurological disorder called Guillain-Barré syndrome has been reported in some people who have taken its single-shot COVID-19 vaccine.
Guillain-Barré syndrome causes the body's immune system to attack nerve cells, resulting in muscle weakness and occasionally paralysis. There have been about 100 cases of this disorder reported in around 12.6 million people who have already received the J&J shot.
J&J, in its statement, said the chance of having this disorder, which occurs within 42 days of receiving the shot, is very low. J&J has updated its Emergency Use Authorization Fact Sheets to notify about these rare cases and symptoms of Guillain-Barré syndrome. The FDA has updated its warning labels for J&J’s vaccine to include information about increased risk of this disorder.
This year so far, J&J’s shares have risen 7.6% compared with an increase of 10.2% for the industry.
Image Source: Zacks Investment Research
J&J’s vaccine was investigated for a rare blood clot event in April. Back then, the FDA and U.S. Centers for Disease Control and Prevention (“CDC”) had jointly issued a statement to recommend a temporary pause in the use of J&J’s vaccine in the United States as they reviewed six reports of “rare and severe” blood clots in a few individuals who had taken the J&J vaccine. Vaccinations resumed in late April, following a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP). J&J updated the Fact Sheets to include important information about diagnosis and management of the blood clot issues.
Among other vaccine makers, AstraZeneca (AZN - Free Report) has also been investigated for a “possible link” between its COVID-19 vaccine and extremely rare blood clot events. Please note that J&J and AstraZeneca’s vaccines have been developed using adenovirus technologies while the other two vaccines, which have been launched, Pfizer (PFE - Free Report) -BioNTech’s BNT162b2 and Moderna’s (MRNA - Free Report) mRNA-1273 vaccines are mRNA-based vaccines.
In a separate press release, J&J announced FDA approval of Darzalex Faspro in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The approval is for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Darzalex Faspro is the subcutaneous (SC) formulation of J&J’s blockbuster multiple myeloma drug, Darzalex (IV formulation). The regulatory applications were based on positive data from the phase III APOLLO study. This is the sixth indication in multiple myeloma for Darzalex Faspro. The Darzalex plus pomalidomide and dexamethasone combination regimen is already approved as the IV formulation in the United States. The approval for the SC formulation will reduce administration time from hours to minutes compared with the IV formulation
Image: Bigstock
J&J (JNJ) COVID-19 Jab Linked to New Rare Neurological Disorder
J&J (JNJ - Free Report) , on Monday, issued a statement mentioning that a rare neurological disorder called Guillain-Barré syndrome has been reported in some people who have taken its single-shot COVID-19 vaccine.
Guillain-Barré syndrome causes the body's immune system to attack nerve cells, resulting in muscle weakness and occasionally paralysis. There have been about 100 cases of this disorder reported in around 12.6 million people who have already received the J&J shot.
J&J, in its statement, said the chance of having this disorder, which occurs within 42 days of receiving the shot, is very low. J&J has updated its Emergency Use Authorization Fact Sheets to notify about these rare cases and symptoms of Guillain-Barré syndrome. The FDA has updated its warning labels for J&J’s vaccine to include information about increased risk of this disorder.
This year so far, J&J’s shares have risen 7.6% compared with an increase of 10.2% for the industry.
Image Source: Zacks Investment Research
J&J’s vaccine was investigated for a rare blood clot event in April. Back then, the FDA and U.S. Centers for Disease Control and Prevention (“CDC”) had jointly issued a statement to recommend a temporary pause in the use of J&J’s vaccine in the United States as they reviewed six reports of “rare and severe” blood clots in a few individuals who had taken the J&J vaccine. Vaccinations resumed in late April, following a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP). J&J updated the Fact Sheets to include important information about diagnosis and management of the blood clot issues.
Among other vaccine makers, AstraZeneca (AZN - Free Report) has also been investigated for a “possible link” between its COVID-19 vaccine and extremely rare blood clot events. Please note that J&J and AstraZeneca’s vaccines have been developed using adenovirus technologies while the other two vaccines, which have been launched, Pfizer (PFE - Free Report) -BioNTech’s BNT162b2 and Moderna’s (MRNA - Free Report) mRNA-1273 vaccines are mRNA-based vaccines.
In a separate press release, J&J announced FDA approval of Darzalex Faspro in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The approval is for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Darzalex Faspro is the subcutaneous (SC) formulation of J&J’s blockbuster multiple myeloma drug, Darzalex (IV formulation). The regulatory applications were based on positive data from the phase III APOLLO study. This is the sixth indication in multiple myeloma for Darzalex Faspro. The Darzalex plus pomalidomide and dexamethasone combination regimen is already approved as the IV formulation in the United States. The approval for the SC formulation will reduce administration time from hours to minutes compared with the IV formulation
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.