BRIEF-EMA Aware Of Contamination In Batch Of Active Substance For COVID-19 Vaccine Janssen

June 11 (Reuters) - 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

06/11/2021 13:12

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