Pfizer (PFE) Gets FDA Nod for Bivalent COVID Jab in Infants
Pfizer PFE and partner BioNTech BNTX announced that the FDA broadened the label of their authorized Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for use as a single booster dose in children aged six months through four years.
The bivalent vaccine can now be administered to individuals under five years after at least two months of completion of primary vaccination with three doses of the original Pfizer-BioNTech COVID-19 vaccine.
We note that the bivalent vaccine is already authorized for use in this age group as part of the primary series. Last December, the FDA revised the emergency use authorization (EUA) granted to Pfizer-BioNTech COVID vaccines wherein children under five years would receive a primary two-dose regimen consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine followed by a third 3-µg dose of the bivalent COVID-19 vaccine. Prior to this revision, the children in this age group were being administered all three doses of the original Pfizer-BioNTech COVID-19 vaccine.
The latest label expansion by the FDA will allow children under five years who had received all three doses of the original Pfizer-BioNTech COVID-19 vaccine to update their protection by receiving the bivalent vaccine as a single booster dose.
Shares of Pfizer have lost 22.1% in the year so far compared with the industry’s 7.8% fall.
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The bivalent vaccine contains an mRNA encoding the spike protein in the original/monovalent Pfizer/BioNTech vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.
This Omicron BA.4/BA.5 bivalent vaccine is already authorized for use in individuals aged five years and older.
Last August, the FDA granted EUA to Pfizer/BioNTech and Moderna’s MRNA Omicron BA.4/BA.5-adapted bivalent vaccines for a single booster dose. The Pfizer/BioNTech and Moderna booster vaccines can be given at least two months following primary or booster vaccination.While a 50-µg dose of Moderna’s Omicron booster is authorized for adults aged 18 years and older, a 30-µg dose of Pfizer/BioNTech’s version is authorized for use in adults and adolescents aged 12 and older.
The EUA was further expanded in October 2022 to include children as young as five years. Following the EUA expansion, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is authorized for individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine was also authorized by the FDA for use in children aged six to 11 years and adolescents aged 12 to 17 years, respectively.
Currently, Moderna’s bivalent vaccine is authorized by the FDA for use as a single booster dose in individuals aged six months and older.
Pfizer and BioNTech have also submitted a regulatory filing to the European Medicines Agency (EMA) seeking authorization for the use of their bivalent vaccine in individuals aged under five years. The filing seeks authorization for using the Pfizer-BioNTech bivalent vaccine as both primary series (all three doses) and booster vaccination (fourth dose). Currently, the bivalent vaccine is authorized in Europe as a booster dose for individuals aged five years and older. Similar regulatory filings are planned for submission to other regulatory authorities across the globe.
Pfizer Inc. Price
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Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #5 (Strong Sell).A better-ranked stock in the overall healthcare sector is Novo Nordisk NVO, which sports 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 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43. During the same period, the earnings for 2024 have risen from $4.90 to $5.19. Shares of Novo Nordisk have risen 5.6% in the year-to-date period.
Earnings of Novo Nordisk beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 3.00%, on average. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 2.47%.
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