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Moderna (MRNA) Submits Filing in EU for Updated COVID-19 Jab
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Moderna (MRNA - Free Report) announced that it has submitted a regulatory application to the European Medicines Agency (“EMA”) seeking approval for mRNA-1273.815, its updated COVID-19 vaccine targeting the XBB descendent lineage viruses.
Unlike the currently-authorized COVID-19 vaccines that are bivalent in nature and target multiple strains of coronavirus, mRNA-1273.815 is a monovalent vaccine containing spike proteins for the XBB.1.5 sublineage of coronavirus.
The regulatory filing is based on the preliminary data from preclinical studies that demonstrated the effectiveness of mRNA-1273.815 in generating an immune response against the current XBB variants of concern.
Management claims that it has built an ample supply for mRNA-1273.815 and is ready to ship doses of the same for the fall vaccination season, provided that the FDA authorizes the vaccine for use.
This submission is based on the guidance from the European Centre for Disease Prevention and Control (“ECDC”) and EMA itself. The guidance recommended using monovalent COVID-19 vaccines updated to target the XBB.1.5 composition.
Shares of Moderna have lost 32.4% year to date compared with the industry’s 10.2% fall.
Image Source: Zacks Investment Research
Last month, Moderna announced the submission of a similar filing for mRNA-1273.815 with the FDA. The submission follows the recently issued guidance from an FDA advisory committee which unanimously recommended updating the COVID vaccine to target the Omicron XBB lineage, the strain currently responsible for the majority of the COVID infections in the country.
Apart from Moderna, other COVID vaccine makers like Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Novavax (NVAX - Free Report) are updating their own vaccines to target the XBB lineages. During the FDA committee meeting held last month, Pfizer/BioNTech, Moderna and Novavax presented their pre-clinical findings supporting the use of their own vaccines, which target the XBB.1.5 variant. The preclinical data from these manufacturers indicate that a monovalent vaccine is more effective against a bivalent vaccine.
Last month, Pfizer and BioNTech submitted filings with both the EMA and FDA seeking approval for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. If approved, the companies intend to launch their vaccine for the 2023-2024 fall and winter season. Pfizer/BioNTech expect to make their updated vaccine ready for supply immediately post-regulatory approvals.
Novavax stated that it is manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, intended to be in the market during the upcoming fall vaccination campaign. This vaccine is yet to be approved by any regulatory authority across the globe. Novavax aims to make its updated vaccine available and accessible on par with other COVID vaccines.
Image: Bigstock
Moderna (MRNA) Submits Filing in EU for Updated COVID-19 Jab
Moderna (MRNA - Free Report) announced that it has submitted a regulatory application to the European Medicines Agency (“EMA”) seeking approval for mRNA-1273.815, its updated COVID-19 vaccine targeting the XBB descendent lineage viruses.
Unlike the currently-authorized COVID-19 vaccines that are bivalent in nature and target multiple strains of coronavirus, mRNA-1273.815 is a monovalent vaccine containing spike proteins for the XBB.1.5 sublineage of coronavirus.
The regulatory filing is based on the preliminary data from preclinical studies that demonstrated the effectiveness of mRNA-1273.815 in generating an immune response against the current XBB variants of concern.
Management claims that it has built an ample supply for mRNA-1273.815 and is ready to ship doses of the same for the fall vaccination season, provided that the FDA authorizes the vaccine for use.
This submission is based on the guidance from the European Centre for Disease Prevention and Control (“ECDC”) and EMA itself. The guidance recommended using monovalent COVID-19 vaccines updated to target the XBB.1.5 composition.
Shares of Moderna have lost 32.4% year to date compared with the industry’s 10.2% fall.
Image Source: Zacks Investment Research
Last month, Moderna announced the submission of a similar filing for mRNA-1273.815 with the FDA. The submission follows the recently issued guidance from an FDA advisory committee which unanimously recommended updating the COVID vaccine to target the Omicron XBB lineage, the strain currently responsible for the majority of the COVID infections in the country.
Apart from Moderna, other COVID vaccine makers like Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Novavax (NVAX - Free Report) are updating their own vaccines to target the XBB lineages. During the FDA committee meeting held last month, Pfizer/BioNTech, Moderna and Novavax presented their pre-clinical findings supporting the use of their own vaccines, which target the XBB.1.5 variant. The preclinical data from these manufacturers indicate that a monovalent vaccine is more effective against a bivalent vaccine.
Last month, Pfizer and BioNTech submitted filings with both the EMA and FDA seeking approval for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. If approved, the companies intend to launch their vaccine for the 2023-2024 fall and winter season. Pfizer/BioNTech expect to make their updated vaccine ready for supply immediately post-regulatory approvals.
Novavax stated that it is manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, intended to be in the market during the upcoming fall vaccination campaign. This vaccine is yet to be approved by any regulatory authority across the globe. Novavax aims to make its updated vaccine available and accessible on par with other COVID vaccines.
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