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Pfizer (PFE), BioNTech Post Data on COVID Jab for Kids Under 5

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Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) announced newly-updated data from a phase II/III study, evaluating the three-dose primary regimen of the Pfizer-BioNTech COVID-19 Vaccine in children aged six months through four years of age.

An updated analysis of phase II/III study showed that the vaccine efficacy was 73.2% in this age group diagnosed between March 2022 and June 2022, during which COVID-19 infections were due to the Omicron BA.2 subvariant.

The phase II/III study divided the study participants into two groups — one aged between six months through 23 months and another aged two years through four years. In the first group, the study achieved a vaccine efficacy of 75.8%, while vaccine efficacy was 71.8% in the second group.

A 3-µg dose of this vaccine was granted emergency use authorization (EUA) by the FDA for use in children aged six months through four years, earlier this year in June based on preliminary data based on 10 symptomatic COVID-19 cases from the same study.

However, a similar application seeking expanded authorization for using their COVID-19 vaccine in children aged six months through four years is under review in the European Union. The vaccine is already authorized for use in individuals aged five years and older at different dose levels in several countries, including the United States and EU.

Pfizer and BioNTech plan to share the abovementioned data with regulatory authorities across the world, including the United States and Europe, in the coming weeks. Pfizer/BioNTech are preparing a EUA application for an Omicron BA.4/BA.5-adapted bivalent vaccine in children six months through 11 years of age.

Shares of Pfizer have lost 18.7% in the year so far against the industry’s 0.4% rise.

Zacks Investment Research
Image Source: Zacks Investment Research

Shares of BioNTech have plunged 42.9% in the year compared with the industry’s 22.3% fall.

Zacks Investment Research
Image Source: Zacks Investment Research

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 - Free Report) .

Like Pfizer/BioNTech’s vaccine, Moderna’s vaccine is also authorized for use in all individuals aged six months and older at varying dose levels.

The Pfizer/BioNTech and Moderna vaccines combined to dominate the U.S. market. In fact, they are the only jabs that have received full approval for use in the country. While Moderna’s vaccine is approved for use in adults aged 18 years and older, the Pfizer/BioNTech vaccine is approved for use in individuals aged 12 years and older. A third and fourth booster dose of Moderna and Pfizer/BioNTech vaccines have also been authorized for use in certain age groups by the FDA.

Earlier this week, Moderna and Pfizer/BioNTech announced that they completed their respective regulatory filings with the FDA seeking approval for their bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine. While Pfizer and BioNTech seek authorization in individuals aged 12 years and older, Moderna seeks authorization in adults aged 18 years and older. These bivalent vaccines have been developed considering the FDA’s recommendation to target the BA.4 and BA.5 subvariants. Pfizer/BioNTech and Moderna have also scaled production of these bivalent vaccines and will be ready to ship doses as soon as the FDA grants its authorization.

 

Zacks Rank & Stock to Consider

Pfizer and BioNTech currently carry a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Morphic (MORF - Free Report) , 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 Morphic’s 2022 loss per share have narrowed from $3.38 to $1.75. Loss estimates for 2023 have narrowed from $3.91 to $3.77 during the same period. Shares of Morphic have lost 35.1% 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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