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BioNTech SE Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY® Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY® New agreement to supply 900 million doses to the European Commission (EC), with option to request up to an additional 900 million doses Additional dose deliveries beginning December 2021 through 2023 Pfizer and BioNTech have now committed a total of up to 2.4 billion doses of COMIRNATY® to the EC since the beginning of the pandemic NEW YORK AND MAINZ, GERMANY, May 20, 2021 ...

BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents 1 (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar re...

Search jobs Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all pri...

Hits: 143 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 u...

EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the overall benefit-risk profile of Johnson & Johnson’s (J&J) COVID-19 vaccine is positive. The PRAC concluded in a meeting yesterday, however, that a warning regarding unusual blood clots with low blood platelets should be added to the product information for the vaccine, after finding a possib...