Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) ReviewEMA Confirms Overall Benefit-Risk Profile Remains Positive
NEW BRUNSWICK, N.J., April 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine. As a result, Johnson &...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Management of patients presenting to the Emergency Department/ Acute Medicine with symptoms: Covid-19 Vaccine induced Thrombosis and Thrombocytopenia (VITT), RCEM/RCP/SAM
Guidance document on how to deal with a patient presenting to ED or acute medicine with COVID-19 vaccine-induced thrombosis and thrombocytopenia (VITT). (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 19, 2021 Category: Consumer Health News Source Type: news
Management of patients presenting to the Emergency Department/ Acute Medicine with symptoms, RCEM
The condition of concern is Covid-19 Vaccine induced Thrombosis and Thrombocytopenia (VITT). (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 16, 2021 Category: Consumer Health News Source Type: news
Guidance produced from the Expert Haematology Panel (EHP) focussed on Covid-19 Vaccine induced Thrombosis and Thrombocytopenia (VITT), British Society of Haematology
There are currently no robust data to inform management of this condition. In the absence of evidence, these are pragmatic guidelines based on experience of managing alternative similar conditions and the theoretical risks and benefits of interventions. As evidence emerges, recommendations are expected to change. Patient management should be individualised according to specific circumstances. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 16, 2021 Category: Consumer Health News Source Type: news
FDA and CDC Recommend Pausing COVID-19 Vaccination With J & J-Janssen Shot While They Investigate Blood Clot Risks
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are recommending that vaccinations with the Johnson & Johnson/Janssen COVID-19 vaccine be temporarily halted while the agencies review reports of blood clots among vaccinated people.
On April 13, the two government agencies issued a joint statement announcing a recommended pause as federal regulators review six cases of blood clots reported six to 13 days after the people received the single-dose vaccine. “Until that [review] process is complete, we are recommending a pause in the use of this vaccine out of an abundance of cautio...
Source: TIME: Health - April 13, 2021 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news
Rare Thrombosis, Thrombocytopenia Seen After AstraZeneca COVID-19 Vaccine
TUESDAY, April 13, 2021 -- While rare, thrombosis and thrombocytopenia can occur after the ChAdOx1 nCoV-19 adenoviral vector vaccine against COVID-19 (AstraZeneca), according to two reports published online April 9 in the New England Journal of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 13, 2021 Category: Pharmaceuticals Source Type: news
Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). (Source: World Pharma News)
Source: World Pharma News - April 13, 2021 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
How worried should we be about blood clots linked to AstraZeneca and J & J vaccines?
With both the AstraZeneca and Johnson& Johnson (J&J)vaccines, the reports involve extremely rare clotting, including a type of blood clot called cerebral venous sinus thrombosis (CVST), that were seen in combination with low levels of blood platelets, called thrombocytopenia. (Source: The Economic Times)
Source: The Economic Times - April 13, 2021 Category: Consumer Health News Source Type: news
Two New Studies Point to How AstraZeneca ’s COVID-19 Vaccine Is Linked to Blood Clots
In two papers published in the New England Journal of Medicine (NEJM), researchers in Europe provide the most detailed explanation yet for what is behind the clotting side effects reported among people getting vaccinated with the AstraZeneca COVID-19 shot.
In both papers, researchers found that people getting the vaccine had higher levels of antibodies directed against a cluster of immune-related cells that the body might form in response to the vaccine. These clusters include platelets, which help blood to clot when you get cut or injured, and the antibodies stick to the platelet-complex and form dangerous clots that can ...
Source: TIME: Health - April 9, 2021 Category: Consumer Health News Tags: Uncategorized COVID-19 Source Type: news
Parallels in Sepsis and COVID-19 Conditions: Implications for Managing Severe COVID-19, Frontiers in immunology
Sepsis is a life-threatening systemic illness attributed to a dysregulated host response to infection. Sepsis is a global burden killing ~11 million persons annually. In December 2019, a novel pneumonia condition termed coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged and has resulted in more than 1,535,982 deaths globally as of 8 th December 2020. These two conditions share many pathophysiological and clinical features. Notably, both sepsis and COVID-19 patients experience consumptive thrombocytopenia, haemolytic anaemia, vascular microthrombosis, multi-o...
Source: Current Awareness Service for Health (CASH) - April 9, 2021 Category: Consumer Health News Source Type: news
EMA Again Reassures on AstraZeneca COVID Vaccine EMA Again Reassures on AstraZeneca COVID Vaccine
But the agency says it cannot rule out a link between rare and serious cases of thrombosis with thrombocytopenia with the vaccine.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - April 7, 2021 Category: Neurology Tags: Infectious Diseases News Source Type: news
AstraZeneca COVID Vaccine: Clotting Disorder Mechanism Revealed? AstraZeneca COVID Vaccine: Clotting Disorder Mechanism Revealed?
More information has become available indicating that the vaccine may be linked to a condition that clinically resembles heparin-induced thrombocytopenia and seems to occur mainly in younger women.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - April 1, 2021 Category: Cardiology Tags: Public Health & Prevention News Source Type: news
CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
SEATTLE, March 31, 2021 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application ( " NDA " ) submission to the U.S. Food and Drug Administration ( " FDA " ) seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 31, 2021 Category: Drugs & Pharmacology Source Type: news
CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Commercial Preparations Underway to Support Potential Approval and Launch of Pacritinib in the United States in 2021
SEATTLE, March 31, 2021 -- (Healthcare Sales & Marketing Network) -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has com... Biopharmaceuticals, FDA CTI BioPharma, pacritinib, myelofibrosis, thrombocytopenia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 31, 2021 Category: Pharmaceuticals Source Type: news
Why Countries Around the World Are Suspending Use of AstraZeneca ’s COVID-19 Vaccine
It’s the last thing public health officials want to see in the midst of a pandemic: more than two months after pharmaceutical giant AstraZeneca and Oxford University scientists released their COVID-19 vaccine, countries in Europe and elsewhere are pausing its use amid disconcerting reports that a small number of recipients have experienced blood clots, some of them fatal.
The European Medicines Agency, which oversees drugs and vaccines in Europe, is expected to issue a guidance on March 18 about whether the side effects were related to the vaccine after reviewing the reports; in the meantime, it says the benefits of ...
Source: TIME: Health - March 16, 2021 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news
