We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Moderna (MRNA) Seeks FDA Nod for Updated COVID-19 Vaccine
Read MoreHide Full Article
Moderna (MRNA - Free Report) announced that it has submitted a regulatory application to the FDA 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 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.
Shares of Moderna have lost 32.9% year to date compared with the industry’s 7.6% fall.
Image Source: Zacks Investment Research
The submission follows the guidance from an FDA advisory committee issued last week, which unanimously recommended updating the COVID vaccine to target the Omicron XBB lineage, which is 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 also updating their own vaccines to target the XBB lineages. During the FDA committee meeting held last week, 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.
Pfizer/BioNTech expects to make their updated vaccine ready for supply by the end of next month. Novavax stated that it is currently manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, intended to be in the market during the 2023 fall vaccination campaign. However, the FDA is yet to approve/authorize either Novavax’s or Pfizer/BioNTech’s vaccine.
Image: Shutterstock
Moderna (MRNA) Seeks FDA Nod for Updated COVID-19 Vaccine
Moderna (MRNA - Free Report) announced that it has submitted a regulatory application to the FDA 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 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.
Shares of Moderna have lost 32.9% year to date compared with the industry’s 7.6% fall.
Image Source: Zacks Investment Research
The submission follows the guidance from an FDA advisory committee issued last week, which unanimously recommended updating the COVID vaccine to target the Omicron XBB lineage, which is 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 also updating their own vaccines to target the XBB lineages. During the FDA committee meeting held last week, 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.
Pfizer/BioNTech expects to make their updated vaccine ready for supply by the end of next month. Novavax stated that it is currently manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, intended to be in the market during the 2023 fall vaccination campaign. However, the FDA is yet to approve/authorize either Novavax’s or Pfizer/BioNTech’s vaccine.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.