EMA aims to start review of Moderna's Omicron BA.4/5 adapted shot by end of September

Sep. 20, 2022 11:37 AM ETModerna, Inc. (MRNA)By: Anuron Mitra, SA News Editor9 Comments

U.S Marines On Okinawa Receive Coronavirus Vaccination

Carl Court

  • The European drug regulator expects to start a review of Moderna's (NASDAQ:MRNA) Omicron-subvariant adapted vaccine by the end of this month.
  • "Discussions are ongoing with Moderna in preparation for an application for a Spikevax BA.4/5 adapted bivalent vaccine," the European Medicines Agency's (EMA) Head of Biological Health Threats and Vaccines Strategy Marco Cavaleri said in a press briefing on Tuesday.
  • The EMA has for now recommended approving Pfizer (PFE) and German partner BioNTech's (BNTX) BA.4/5 adapted COVID-19 vaccine, which it did last week.
  • Moderna (MRNA) has so far received conditional marketing approvals in the European Union for its Spikevax COVID-19 vaccine targeting the original SARS-CoV-2 strain and a bivalent shot targeting the original strain and the Omicron BA.1 variant.
  • The EMA has also recommended converting the conditional approvals for MRNA into standard marketing authorizations.
  • Moderna (MRNA) stock +4.2% to $133.21 in morning trading.

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