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TOP NEWS: J&J to restart rollout of Covid-19 jab on EMA guidance

TOP NEWS: J&J to restart rollout of Covid-19 jab on EMA guidance
Tue, 20th Apr 2021 17:36
(Alliance News) - Johnson & Johnson on Tuesday announced that it will resume the rollout of its Covid-19 vaccine in Europe following the European Medicines Agency s updated guidance for the jab.
The EU s drug watchdog announced earlier Tuesday that blood clots should be listed as a very rare side effect of the J&J coronavirus vaccine but its benefits still outweigh the risks.
The guidance follows a review of a small number of cases of a 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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Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
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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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Paul Stoffels , None Of The Janssen Pharmaceutical Companies , Pharmacovigilance Risk Assessment Committee , Us Centers For Disease , European Commission , Drug Administration , Advisory Committee On Immunization Practices , Janssen Pharmaceutical Companies , Janssen Pharmaceutical Companies Of Johnson , Exchange Commission , Companies Of Johnson , European Union , European Medicines Agency , European Commission On , Product Characteristics , Package Leaflet , Healthcare Professionals , Vice Chairman , Executive Committee , Chief Scientific Officer , Disease Control , Advisory Committee , Immunization Practices , Conditional Marketing Authorization , Pharmaceutical Companies , Infectious Diseases ,

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®
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®, bringing total doses to 600 million for 27 EU member states
All doses expected to be delivered in 2021
BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY
®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on
1. This brings the total number of doses to be delivered to the EU to 600 million. ....

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