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MRNA Gets Positive CHMP Opinion for Updated COVID-19 Jab
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Moderna, Inc. (MRNA - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) has rendered a positive opinion recommending marketing authorization for its updated formulation of the mRNA-based COVID-19 vaccine, Spikevax, targeting the variant JN.1.
The CHMP recommended marketing approval to Spikevax, targeting the variant JN.1, for active immunization to prevent COVID-19 in individuals aged six months and above.
Pending a decision from the European Commission, the updated COVID-19 mRNA vaccine will be available for the 2024-2025 season.
The CHMP’s decision was based on a combination of manufacturing and preclinical data and previous clinical, non-clinical, and real-world evidence that supported the safety and efficacy of MRNA’s COVID-19 mRNA vaccines.
The above mentioned updated vaccine composition was based on guidance from the EMA's Emergency Task Force, issued in April 2024. The agency recommended that vaccine makers make an updated COVID vaccine tailored to the JN.1 family of Omicron subvariants for the 2024-2025 season.
Shares of Moderna have plunged 26.1% so far this year compared with the industry’s decline of 0.9%.
Image Source: Zacks Investment Research
Recent Developments Related to MRNA's Updated COVID-19 Jab
Spikevax, targeting the variant JN.1., is currently approved in the United States, the United Kingdom, Japan and Taiwan.
Last month, the FDA approved Spikevax, which targets the KP.2 strain of the virus. The regulatory body also approved the updated mRNA-based COVID-19 vaccine of Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) .
While the agency approved the updated formulation of Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax for use in individuals aged 12 years of age and older, it granted emergency use authorization to low-dose formulations of these vaccines for use in individuals aged six months through 11 years.
The updated vaccine composition is based on guidance from the FDA issued in late June 2024.
In June, the FDA's Vaccines and Related Biological Products Advisory Committee recommended that vaccine makers develop an updated COVID vaccine tailored to the KP.2 strain for use in the United States beginning in the fall of 2024.
We note that vaccine makers PFE, BNTX and MRNA are suffering a sharp drop in product sales and market value as COVID-19 cases have significantly dropped compared with the last couple of years. Though the recent rises in COVID-19 infection cases in the United States could somewhat revive demand for vaccines, a substantial gain in revenues and profits that was observed at the peak of the pandemic looks unlikely.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 50%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 49.95%.
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MRNA Gets Positive CHMP Opinion for Updated COVID-19 Jab
Moderna, Inc. (MRNA - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) has rendered a positive opinion recommending marketing authorization for its updated formulation of the mRNA-based COVID-19 vaccine, Spikevax, targeting the variant JN.1.
The CHMP recommended marketing approval to Spikevax, targeting the variant JN.1, for active immunization to prevent COVID-19 in individuals aged six months and above.
Pending a decision from the European Commission, the updated COVID-19 mRNA vaccine will be available for the 2024-2025 season.
The CHMP’s decision was based on a combination of manufacturing and preclinical data and previous clinical, non-clinical, and real-world evidence that supported the safety and efficacy of MRNA’s COVID-19 mRNA vaccines.
The above mentioned updated vaccine composition was based on guidance from the EMA's Emergency Task Force, issued in April 2024. The agency recommended that vaccine makers make an updated COVID vaccine tailored to the JN.1 family of Omicron subvariants for the 2024-2025 season.
Shares of Moderna have plunged 26.1% so far this year compared with the industry’s decline of 0.9%.
Image Source: Zacks Investment Research
Recent Developments Related to MRNA's Updated COVID-19 Jab
Spikevax, targeting the variant JN.1., is currently approved in the United States, the United Kingdom, Japan and Taiwan.
Last month, the FDA approved Spikevax, which targets the KP.2 strain of the virus. The regulatory body also approved the updated mRNA-based COVID-19 vaccine of Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) .
While the agency approved the updated formulation of Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax for use in individuals aged 12 years of age and older, it granted emergency use authorization to low-dose formulations of these vaccines for use in individuals aged six months through 11 years.
The updated vaccine composition is based on guidance from the FDA issued in late June 2024.
In June, the FDA's Vaccines and Related Biological Products Advisory Committee recommended that vaccine makers develop an updated COVID vaccine tailored to the KP.2 strain for use in the United States beginning in the fall of 2024.
We note that vaccine makers PFE, BNTX and MRNA are suffering a sharp drop in product sales and market value as COVID-19 cases have significantly dropped compared with the last couple of years. Though the recent rises in COVID-19 infection cases in the United States could somewhat revive demand for vaccines, a substantial gain in revenues and profits that was observed at the peak of the pandemic looks unlikely.
Zacks Rank & Stock to Consider
Moderna currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Krystal Biotech, Inc. (KRYS - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 50%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 49.95%.