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Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review | More News

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EMA Confirms Overall Benefit-Risk Profile Remains Positive
Company to update the COVID-19 Vaccine Janssen Summary of Product Characteristics and Package Leaflet to include important information on very rare adverse event
Johnson & Johnson remains committed to supplying 200 million doses of its COVID-19 vaccine to the European Union, Norway and Iceland
NEW BRUNSWICK, NJ, USA I April 20, 2021 I 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. ....

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Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review

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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 ....

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Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review

Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review
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Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization

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- ....

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Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization

Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
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