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Pfizer (PFE), BioNTech Seek EU Nod for Omicron-Based Booster
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Pfizer (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) completed the submission of a regulatory application to the European Medicines Agency (“EMA”), seeking conditional marketing authorization (”cMA”) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 booster vaccine. The vaccine is targeted toward individuals 12 years of age and older.
Last week, Pfizer and BioNTech also filed an emergency use authorization (“EUA”) to the FDA for the Omicron BA.4/BA.5-adapted bivalent vaccine for the same age group.
The filings include preclinical, quality and manufacturing data from the Omicron BA.4/BA.5 adapted bivalent vaccine and data from the phase II/III study evaluating Pfizer/BioNTech’s bivalent Omicron BA.1-adapted bivalent vaccine of a 30-µg booster dose. Safety data from clinical studies evaluating multiple-variant vaccine candidates based on previous variants of concern (Alpha, Beta and Delta variants) have also been provided.
Pfizer/BioNTech’s BA.4/BA.5-adapted bivalent booster vaccine contains 15-µg of mRNA encoding the spike protein present in the original vaccine and 15 µg of mRNA of the Omicron BA.4/BA.5 spike protein sequence. The booster vaccine exhibited a strong neutralizing antibody response in its preclinical studies compared with Omicron BA.1, BA.2 and BA.4/BA.5 variants as well as the ancestral strain.
Pfizer’s stock is down 18.8% in the year-to-date period against the industry’s increase of 0.4%.
Image Source: Zacks Investment Research
BioNTech’s shares are down 44.1% this year compared with the industry’s decline of 22.9%.
Image Source: Zacks Investment Research
Investors must note that in July, the companies filed an application with the EMA seeking authorization for their Omicron BA.1-adated bivalent COVID-19 vaccine based on the safety, tolerability and immunogenicity data from a phase II/III study. The study revealed that a 30-µg booster dose of the Omicron BA.1 variant demonstrated a superior immune response compared with the original vaccine,Comirnaty. The filing is currently under review by the EMA.
Pfizer/BioNTech already scaled production of the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters and will be ready to ship doses as soon as the EMA grants the respective regulatory authorizations. If authorized, both Omicron BA.1 and Omicron BA.4/BA.5 adapted bivalent vaccines will be available in the European Union by September.
The COVID-19 vaccines developed by Pfizer and BioNTech are based on mRNA technology. Another vaccine based on mRNA technology, which poses stiff competition to the Pfizer/BioNTech vaccine, has been developed by ModernaMRNA.
Moderna’s Spikevax vaccine is authorized for children and adolescents in Europe, the United States, Australia and Canada.
Last week, Moderna submitted a EUA to the FDA for the use ofa 50-µg booster dose of its bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, in individuals 18 years of age and older.
Moderna also ramped up the manufacturing of mRNA-.1273.222 to deliver doses by September, provided the FDA grants a EUA.
In the past 30 days, estimates for Catalyst’s 2022 earnings per share have improved from 67 cents to 70 cents. Earnings estimates for 2023 improved from 79 cents to 85 cents during the same period. Shares of CPRX have returned 107.1% in the year-to-date period.
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Pfizer (PFE), BioNTech Seek EU Nod for Omicron-Based Booster
Pfizer (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) completed the submission of a regulatory application to the European Medicines Agency (“EMA”), seeking conditional marketing authorization (”cMA”) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 booster vaccine. The vaccine is targeted toward individuals 12 years of age and older.
Last week, Pfizer and BioNTech also filed an emergency use authorization (“EUA”) to the FDA for the Omicron BA.4/BA.5-adapted bivalent vaccine for the same age group.
The filings include preclinical, quality and manufacturing data from the Omicron BA.4/BA.5 adapted bivalent vaccine and data from the phase II/III study evaluating Pfizer/BioNTech’s bivalent Omicron BA.1-adapted bivalent vaccine of a 30-µg booster dose. Safety data from clinical studies evaluating multiple-variant vaccine candidates based on previous variants of concern (Alpha, Beta and Delta variants) have also been provided.
Pfizer/BioNTech’s BA.4/BA.5-adapted bivalent booster vaccine contains 15-µg of mRNA encoding the spike protein present in the original vaccine and 15 µg of mRNA of the Omicron BA.4/BA.5 spike protein sequence. The booster vaccine exhibited a strong neutralizing antibody response in its preclinical studies compared with Omicron BA.1, BA.2 and BA.4/BA.5 variants as well as the ancestral strain.
Pfizer’s stock is down 18.8% in the year-to-date period against the industry’s increase of 0.4%.
Image Source: Zacks Investment Research
BioNTech’s shares are down 44.1% this year compared with the industry’s decline of 22.9%.
Image Source: Zacks Investment Research
Investors must note that in July, the companies filed an application with the EMA seeking authorization for their Omicron BA.1-adated bivalent COVID-19 vaccine based on the safety, tolerability and immunogenicity data from a phase II/III study. The study revealed that a 30-µg booster dose of the Omicron BA.1 variant demonstrated a superior immune response compared with the original vaccine,Comirnaty. The filing is currently under review by the EMA.
Pfizer/BioNTech already scaled production of the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters and will be ready to ship doses as soon as the EMA grants the respective regulatory authorizations. If authorized, both Omicron BA.1 and Omicron BA.4/BA.5 adapted bivalent vaccines will be available in the European Union by September.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
BioNTech SE Sponsored ADR Price
BioNTech SE Sponsored ADR price | BioNTech SE Sponsored ADR Quote
The COVID-19 vaccines developed by Pfizer and BioNTech are based on mRNA technology. Another vaccine based on mRNA technology, which poses stiff competition to the Pfizer/BioNTech vaccine, has been developed by Moderna MRNA.
Moderna’s Spikevax vaccine is authorized for children and adolescents in Europe, the United States, Australia and Canada.
Last week, Moderna submitted a EUA to the FDA for the use ofa 50-µg booster dose of its bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, in individuals 18 years of age and older.
Moderna also ramped up the manufacturing of mRNA-.1273.222 to deliver doses by September, provided the FDA grants a EUA.
Zacks Rank and A Key Pick
Currently Pfizer has a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Catalyst Pharmaceuticals (CPRX - Free Report) , which sports a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
In the past 30 days, estimates for Catalyst’s 2022 earnings per share have improved from 67 cents to 70 cents. Earnings estimates for 2023 improved from 79 cents to 85 cents during the same period. Shares of CPRX have returned 107.1% in the year-to-date period.