Pfizer, Inc. PFE and its partner BioNTech BNTX have submitted a variation to the marketing authorization (MA), which seeks to expand the label of their bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine for use in children aged five through 11 years.
This regulatory filing seeks label expansion for using the 10-µg booster dose of Pfizer/BioNTech’s bivalent COVID-19 vaccine in children.
Currently, a 30-µg booster dose of this vaccine is authorized for usein individuals aged 12 years and older. This bivalent vaccine contains 15-µg of an mRNA encoding the spike protein present in the original vaccine and 15 µg of an mRNA encoding the spike protein that is common in the Omicron BA.4 and BA.5 variants.
Pfizer/BioNTech’s submission seeking authorization for using the Omicron BA.4/BA.5 booster in children is based on clinical studies on their bivalent Omicron BA.1-adapted vaccine as well as pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
However, unlike all previously approved/authorized COVID-19 vaccines, the data on the bivalent booster shot is not supported by data from any human clinical studies demonstrating the vaccine’s effectiveness. Though the companies have initiated clinical studies on the Omicron BA.4/BA.5-adapted bivalent vaccine, the results will not be available before some months.
Shares of Pfizer have lost 24.8% in the year so far compared with the industry’s 6.7% decline.
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Earlier this week, Pfizer/BioNTech submitted a regulatory filing to the FDA seeking emergency use authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent vaccine for use in children aged 5 through 11 years. This bivalent vaccine is already authorized for use in individuals aged 12 years and older since last month.
On Sep 1, the European Commission (EC) authorized two new Omicron BA.1-adapted bivalent vaccines developed by Pfizer/BioNTech and Moderna MRNA for use in individuals aged 12 years and above.
The authorization for these bivalent boosters comes in anticipation of a surge in COVID-19 infections in the upcoming winter season. While the original vaccines developed by Pfizer/BioNTech and Moderna helped countries combat the pandemic in record time, their lack of efficacy against emerging variants of the virus poses a concern. Hence, the regulatory bodies had urged the COVID-19 vaccine makers to advance a bivalent vaccine candidate to make an Omicron-adapted vaccine available to various countries as soon as possible.
On Sep 12, the EC authorized Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine in individuals aged 12 years and older. Moderna has also submitted a regulatory filing to the EMA, which was validated by the EMA earlier this week.
Moderna’s Omicron BA.4/BA.5-adapted bivalent vaccine has also been granted EUA in the United States on the same date as Pfizer/BioNTech’s vaccine. However, Moderna’s bivalent booster is currently authorized by the FDA for use in adults aged 18 years and older.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).A better-ranked stock in the overall healthcare sector is Morphic MORF, which sports a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.80. Loss estimates for 2023 have narrowed from $3.91 to $3.62 during the same period. Shares of Morphic have lost 39.3% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
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