EMA Approves Additional Sites To Boost Output Capacity For mRNA-Based COVID-19 Vaccines

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  • European Medical Agency (EMA) has approved additional manufacturing sites for mRNA-based coronavirus vaccines developed by Pfizer Inc PFEBioNTech SE BNTX and Moderna Inc MRNA to help boost production amid an increase in infections.
  • Related: Pfizer's CEO Says Work In Progress For Specialized Vaccine Targeting COVID-19 Delta Variant.
  • The agency's human medicines committee approved a site at Saint Remy Sur Avre in France for the Pfizer-BioNTech vaccine, Comirnaty.
  • The Delpharm-operated site will help provide up to 51 million additional doses of Comirnaty in 2021.
  • The EMA also approved a new manufacturing line at BioNTech's site at Marburg in Germany, which would help boost capacity for the vaccine's active substance by about 410 million doses this year.
  • The EMA also approved an additional site at Bloomington, Indiana, for Moderna's vaccine, Spikevax, and several other locations involved in testing and packaging.
  • The Bloomington site is operated by Catalent Inc CTLT.
  • The recommendations do not require a decision by the European Commission, and the sites can become operational immediately.
  • Also See: Isreal Study Shows Pfizer Booster Shot Slowing Spread of Delta Variant In Elderly.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: PFE shares are down 0.41% at $48.36, BNTX stock is down 1.18% at $363.85, and MRNA is down 1.67% at $388.33 during the premarket session on the last check Wednesday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
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