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PFE & BNTX Get Positive CHMP Opinion for Updated COVID-19 Jab
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Pfizer Inc. (PFE - Free Report) along with BioNTech SE (BNTX - 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 their updated formulation of the mRNA-based COVID-19 vaccine, Comirnaty, which targets the currently circulating KP.2 strain of the Omicron JN.1 lineage.
The CHMP recommended marketing approval for Pfizer/BioNTech’s Omicron KP.2-adapted COVID-19 vaccine for individuals aged six months and above.
The European Commission (EC) will review the CHMP’s opinion and a decision is expected soon. Doses of the updated COVID-19 vaccine will be ready to ship immediately in the EU member states following the EC’s authorization.
The CHMP’s decision was based on a combination of manufacturing data and previous clinical, non-clinical, and real-world evidence that supported the safety and efficacy of PFE/BNTX’s COVID-19 mRNA vaccine.
Data from non-clinical studies showed that the updated vaccine composition was also effective against the current circulating strains, including KP.2, KP.3, KP.3.1.1 and LB.1.
The European Commission had earlier authorized the Omicron JN.1-adapted COVID-19 vaccine in July 2024, which is also approved in the United States, United Kingdom, Japan and Taiwan.
Shares of Pfizer have risen 2.1% year to date compared with the industry's rally of 23.5%.
Image Source: Zacks Investment Research
More on PFE & BNTX's Updated COVID-19 Jab
Last month, the FDA approved Pfizer’s Omicron KP.2-adapted COVID-19 vaccine. The regulatory body also approved the updated mRNA-based COVID-19 vaccine of another vaccine maker, Moderna (MRNA - 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 (EUA) to low-dose formulations of these vaccines for use in individuals aged six months through 11 years.
Earlier this month, the FDA granted EUA to an updated version of Novavax’s (NVAX - Free Report) protein-based COVID-19 vaccine for individuals aged 12 years and older.
Following this nod, NVAX’s updated vaccine is the only non-mRNA vaccine option available to people in the United States.
While mRNA-based vaccines have been developed to target the KP.2 strain of the virus, Novavax’s vaccine has been designed to target the JN.1 strain.
Sales of PFE's COVID Products Declining
Sales of Pfizer’s COVID products, Comirnaty and oral antiviral pill, Paxlovid, declined steeply in 2023 due to lower demand following the end of the pandemic. In 2024, Pfizer expects revenues from Paxlovid and Comirnaty to decline further. The 2024 revenue guidance includes $8.5 billion in potential combined revenues for Paxlovid and Comirnaty, significantly lower than the combined revenues of $12.5 billion for 2023.
Image: Bigstock
PFE & BNTX Get Positive CHMP Opinion for Updated COVID-19 Jab
Pfizer Inc. (PFE - Free Report) along with BioNTech SE (BNTX - 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 their updated formulation of the mRNA-based COVID-19 vaccine, Comirnaty, which targets the currently circulating KP.2 strain of the Omicron JN.1 lineage.
The CHMP recommended marketing approval for Pfizer/BioNTech’s Omicron KP.2-adapted COVID-19 vaccine for individuals aged six months and above.
The European Commission (EC) will review the CHMP’s opinion and a decision is expected soon. Doses of the updated COVID-19 vaccine will be ready to ship immediately in the EU member states following the EC’s authorization.
The CHMP’s decision was based on a combination of manufacturing data and previous clinical, non-clinical, and real-world evidence that supported the safety and efficacy of PFE/BNTX’s COVID-19 mRNA vaccine.
Data from non-clinical studies showed that the updated vaccine composition was also effective against the current circulating strains, including KP.2, KP.3, KP.3.1.1 and LB.1.
The European Commission had earlier authorized the Omicron JN.1-adapted COVID-19 vaccine in July 2024, which is also approved in the United States, United Kingdom, Japan and Taiwan.
Shares of Pfizer have risen 2.1% year to date compared with the industry's rally of 23.5%.
Image Source: Zacks Investment Research
More on PFE & BNTX's Updated COVID-19 Jab
Last month, the FDA approved Pfizer’s Omicron KP.2-adapted COVID-19 vaccine. The regulatory body also approved the updated mRNA-based COVID-19 vaccine of another vaccine maker, Moderna (MRNA - 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 (EUA) to low-dose formulations of these vaccines for use in individuals aged six months through 11 years.
Earlier this month, the FDA granted EUA to an updated version of Novavax’s (NVAX - Free Report) protein-based COVID-19 vaccine for individuals aged 12 years and older.
Following this nod, NVAX’s updated vaccine is the only non-mRNA vaccine option available to people in the United States.
While mRNA-based vaccines have been developed to target the KP.2 strain of the virus, Novavax’s vaccine has been designed to target the JN.1 strain.
Sales of PFE's COVID Products Declining
Sales of Pfizer’s COVID products, Comirnaty and oral antiviral pill, Paxlovid, declined steeply in 2023 due to lower demand following the end of the pandemic. In 2024, Pfizer expects revenues from Paxlovid and Comirnaty to decline further. The 2024 revenue guidance includes $8.5 billion in potential combined revenues for Paxlovid and Comirnaty, significantly lower than the combined revenues of $12.5 billion for 2023.
Zacks Rank
Pfizer currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.