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NEW BRUNSWICK, N.J., April 20, 2021 /PRNewswire/ 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 & Johnson will update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet to include important information on the diagnosis and management of this very rare adverse event. Healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as well as the appropri
Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review biospace.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biospace.com Daily Mail and Mail on Sunday newspapers.
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DGAP-News: Immunic, Inc. / Key word(s): Study results
Immunic, Inc. Announces EMPhASIS Interim Analysis of 10 mg Cohort Confirms IMU-838 s Dose Response in Relapsing-Remitting Multiple Sclerosis and Supports Phase 3 Dose Selection
15.04.2021 / 12:30
The issuer is solely responsible for the content of this announcement.
Immunic, Inc. Announces EMPhASIS Interim Analysis of 10 mg Cohort Confirms IMU-838 s Dose Response in Relapsing-Remitting Multiple Sclerosis and Supports Phase 3 Dose Selection
- Preplanned Interim Analysis of 12-Week MRI Data from 10 mg IMU-838 Dose and Placebo, in Combination with Existing 30 and 45 mg Dose Data, Establishes Clear Dose-Response Relationship for IMU-838 -
- Totality of Data Clearly Supports Decision that 30 mg Once Daily Dose of IMU-838 Will Now Be Targeted for Phase 3 Development in Relapsing-Remitting Multiple Sclerosis -
Press release content from PR Newswire. The AP news staff was not involved in its creation.
Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
March 12, 2021 GMT
(PRNewsfoto/Johnson & Johnson)
NEW BRUNSWICK, N.J., March 12, 2021 /PRNewswire/ Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.
Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.
Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.