We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
PFE, BNTX's COVID Jab Gets FDA's Full Nod for Adolescents
Read MoreHide Full Article
Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) 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 - Free Report) .
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.
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%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
PFE, BNTX's COVID Jab Gets FDA's Full Nod for Adolescents
Pfizer (PFE - Free Report) and partner BioNTech (BNTX - Free Report) 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 - Free Report) .
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.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Merck (MRK - Free Report) , 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%.