Pfizer
PFE
and partner
BioNTech
BNTX
announced that the FDA has approved their supplemental biologics license application (sBLA), which sought full approval for its mRNA-based COVID-19 vaccine Comirnaty in adolescents aged between 12 years and 15 years. The FDA had previously granted emergency use authorization (EUA) to the Pfizer/BioNTech vaccine for use in this age group.
Following this label expansion, Comirnaty is the first and currently, the only COVID-19 vaccine, which received full approval for use in individuals aged 12 years and older.
Comirnaty currently enjoys full approval for use in individuals aged 16 years and above, which was granted by the FDA last August.
Shares of Pfizer have lost 10% in the year so far against the
industry
’s 5.2% rise.
Image Source: Zacks Investment Research
The FDA’s decision to grant full approval for adolescents is based on data from a phase III study, which evaluated a two-dose primary regimen of Comirnaty in 2,260 participants aged between 12 years and 15 years.
After a month of completing the two-dose regimen, strong immunogenicity was seen in the study participants. The antibody levels generated in the 12-year to 15-year age bracket were greater than those observed in individuals in the 16-year to 25-year age bracket, who had previously received a two-dose regimen of Comirnaty.
The phase III study showed that a two-dose primary regimen of Comirnaty was 100% effective in preventing COVID-19 infections, as assessed between the periods following one week of completion of the primary regimen and more than four months after the completion of the primary regimen. Notably, this analysis was conducted between November 2020 and May 2021 when the Alpha variant of COVID was highly dominant.
This data was also filed in the European Union and other countries around the globe.
Currently, there is no company as strongly placed in the COVID vaccines/treatment market as Pfizer. PFE also markets Paxlovid, an oral antiviral pill for treating mild-to-moderate COVID-19 infections. During first-quarter 2022, Pfizer generated $13.2 billion from Comirnaty sales while Paxlovid contributed $1.5 billion to the top line. Overall, Pfizer expects to generate a combined $54 billion sales from Comirnaty and Paxlovid in 2022 of its total revenue expectation of around $100 billion.
Comirnaty was developed by Pfizer and BioNTech based on mRNA technology. Another vaccine based on the mRNA technology, which poses stiff competition to the Pfizer/BioNTech vaccine, was developed by
Moderna
MRNA
.
Apart from Comirnaty, Moderna’s vaccine is the only other COVID-19 shot, which received full approval for use in the United States. However, the full approval to the Moderna vaccine is only limited to use in adults aged 18 years and older.
The vaccines developed by Moderna and Pfizer/BioNTech are currently the only ones authorized for use in individuals aged six months and above in the United States. In fact, the booster doses of these vaccines are also authorized for use by the FDA in different age groups.
Additionally, the FDA authorized the use of a second booster dose of Moderna and Pfizer/BioNTech vaccines in older individuals (aged 50 years and beyond) as well as in certain immunocompromised individuals aged 18 years and above.
Zacks Rank & Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is
Merck
MRK
, which carries a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Estimates for Merck’s 2022 bottom line have increased from $7.28 to $7.31 in the past 30 days. Shares of MRK have risen 21.1% in the year-to-date period.
Earnings of Merck beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 13.4%. In the last reported quarter, MRK delivered an earnings surprise of 18.2%.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
