BRIEF-EMA Aware Of Contamination In Batch Of Active Substance For COVID-19 Vaccine Janssen
European Medicines Agency: * EMA SAYS COVID-19 VACCINE JANSSEN: AUTHORITIES IN EU TAKE STEPS TO SAFEGUARD VACCINE QUALITY
* EMA PRESS RELEASE: AUTHORITIES IN THE EU ARE AWARE THAT A BATCH OF THE ACTIVE SUBSTANCE FOR COVID-19 VACCINE JANSSEN HAD BEEN CONTAMINATED WITH MATERIALS FOR ANOTHER VACCINE MANUFACTURED AT THE SAME SITE * EMA SAYS CONTAMINATION OCCURRED AT A MANUFACTURING SITE FOR ACTIVE SUBSTANCE IN MARYLAND, UNITED STATES, OWNED BY EMERGENT BIOSOLUTIONS
* EMA SAYS AUTHORITIES IN THE EU ARE DOING EVERYTHING POSSIBLE TO SAFEGUARD SUPPLIES AND MITIGATE THE EFFECTS OF ANY DELAY IN THE DELIVERY OF VACCINE JANSSEN * EMA: MANUFACTURING ISSUES AT EMERGENT BIOSOLUTIONS ARE NOT RELATED TO EMA'S RECENT REVIEW OF VERY RARE CASES OF BLOOD CLOTS AND LOW BLOOD PLATELETS
* EMA SAYS CONTAMINATED JANSSEN VACCINE BATCH CONCERNED WAS NOT INTENDED FOR EU MARKET * EMA- SUPERVISORY AUTHORITIES RECOMMENDED NOT RELEASING VACCINE JANSSEN BATCHES CONTAINING ACTIVE SUBSTANCE MADE AT AROUND SAME TIME THAT CONTAMINATION OCCURRED
* EMA SAYS AUTHORITIES WILL CONTINUE TO WORK WITH FDA AND OTHER INTERNATIONAL PARTNERS TO ENSURE THAT VACCINES IN EU MEET HIGHEST STANDARDS OF QUALITY
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
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- CLOTS
- MARYLAND
- UNITED STATES
- European Medicines Agency
- EMERGENT BIOSOLUTIONS
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