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Pfizer (PFE) Begins Pediatric Study on COVID Pill Paxlovid
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Pfizer (PFE - Free Report) has initiated a phase II/III pediatric study to evaluate the safety and efficacy of its new oral antiviral pill for COVID-19, Paxlovid in non-hospitalized, symptomatic, pediatric COVID-19 patients who are at risk of progressing to severe disease.
Paxlovid was granted emergency use authorization (EUA) in the United States in December 2021 to treat both high-risk adult and high-risk pediatric patients 12 years of age and older weighing at least 40 kg.
Though the pill is authorized for use in pediatric patients, its safety and effectiveness have not yet been directly established in pediatric patients as previous studies on the medicine did not include participants under the age of 18. Data from the EPIC-PEDS pediatric study will suggest the dose recommendations for this patient population and will also help study expanded use in younger age groups and lower weights. Paxlovid is the first oral antiviral pill to be studied in a pediatric clinical study.
This year so far, Pfizer’s stock has declined 16.8% compared with a decrease of 4.1% for the industry.
Image Source: Zacks Investment Research
Paxlovid has already received emergency or conditional authorization for use in certain populations in approximately 50 countries. Paxlovid contributed $76 million to U.S. sales in the fourth quarter of 2021.
Pfizer expects to manufacture up to 120 million treatment courses of Paxlovid by the end of 2022. Paxlovid is expected to generate $22 billion in sales in 2022.
Paxlovid can be prescribed as an at-home treatment to help fight mild-to-moderate COVID-19 infection. Importantly, data from multiple studies have shown that in-vitro efficacy of nirmatrelvir, the active main protease inhibitor of Paxlovid, is maintained against the Omicron variant, suggesting that the pill works against this variant of the virus.
Pfizer expects to generate a combined $54 billion in sales from the COVID-19 vaccine, which it has made in partnership with Germany’s BioNTech (BNTX - Free Report) and Paxlovid in 2022 out of its total revenue expectations of around $100 billion.
Pfizer and partner BioNTech successfully developed their COVID-19 vaccine in record time. It is now approved for emergency/temporary in several countries worldwide and fully approved in the United States. In 2021, Pfizer and BioNTech manufactured more than 3 billion doses of the vaccine and expect to manufacture 4 billion doses by the end of 2022. The vaccine was approved for younger patients (5-17 years) while a booster vaccine dose was also approved in the United States in 2021. The companies are also working on a new Omicron-based vaccine candidate and a bivalent COVID-19 vaccine candidate.
Merck (MRK - Free Report) and partner Ridgeback Biotherapeutics’ oral antiviral pill, molnupiravir oral was also authorized for treating high-risk adults with mild-to-moderate COVID-19 in several countries worldwide in 2021.
Merck has a number of supply and purchase agreements in place for providing approximately 10 million courses of the COVID therapy, expected to generate $5 billion to $6 billion in revenues in 2022. Merck’s molnupiravir generated sales of $952 million during the fourth quarter, primarily from supply to the United States, the United Kingdom and Japan.
Vertex Pharmaceuticals’ stock has risen 8.9% this year so far. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.39 to $14.52 per share, while that for 2023 have increased from $14.10 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong, with the company beating expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
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Pfizer (PFE) Begins Pediatric Study on COVID Pill Paxlovid
Pfizer (PFE - Free Report) has initiated a phase II/III pediatric study to evaluate the safety and efficacy of its new oral antiviral pill for COVID-19, Paxlovid in non-hospitalized, symptomatic, pediatric COVID-19 patients who are at risk of progressing to severe disease.
Paxlovid was granted emergency use authorization (EUA) in the United States in December 2021 to treat both high-risk adult and high-risk pediatric patients 12 years of age and older weighing at least 40 kg.
Though the pill is authorized for use in pediatric patients, its safety and effectiveness have not yet been directly established in pediatric patients as previous studies on the medicine did not include participants under the age of 18. Data from the EPIC-PEDS pediatric study will suggest the dose recommendations for this patient population and will also help study expanded use in younger age groups and lower weights. Paxlovid is the first oral antiviral pill to be studied in a pediatric clinical study.
This year so far, Pfizer’s stock has declined 16.8% compared with a decrease of 4.1% for the industry.
Image Source: Zacks Investment Research
Paxlovid has already received emergency or conditional authorization for use in certain populations in approximately 50 countries. Paxlovid contributed $76 million to U.S. sales in the fourth quarter of 2021.
Pfizer expects to manufacture up to 120 million treatment courses of Paxlovid by the end of 2022. Paxlovid is expected to generate $22 billion in sales in 2022.
Paxlovid can be prescribed as an at-home treatment to help fight mild-to-moderate COVID-19 infection. Importantly, data from multiple studies have shown that in-vitro efficacy of nirmatrelvir, the active main protease inhibitor of Paxlovid, is maintained against the Omicron variant, suggesting that the pill works against this variant of the virus.
Pfizer expects to generate a combined $54 billion in sales from the COVID-19 vaccine, which it has made in partnership with Germany’s BioNTech (BNTX - Free Report) and Paxlovid in 2022 out of its total revenue expectations of around $100 billion.
Pfizer and partner BioNTech successfully developed their COVID-19 vaccine in record time. It is now approved for emergency/temporary in several countries worldwide and fully approved in the United States. In 2021, Pfizer and BioNTech manufactured more than 3 billion doses of the vaccine and expect to manufacture 4 billion doses by the end of 2022. The vaccine was approved for younger patients (5-17 years) while a booster vaccine dose was also approved in the United States in 2021. The companies are also working on a new Omicron-based vaccine candidate and a bivalent COVID-19 vaccine candidate.
Merck (MRK - Free Report) and partner Ridgeback Biotherapeutics’ oral antiviral pill, molnupiravir oral was also authorized for treating high-risk adults with mild-to-moderate COVID-19 in several countries worldwide in 2021.
Merck has a number of supply and purchase agreements in place for providing approximately 10 million courses of the COVID therapy, expected to generate $5 billion to $6 billion in revenues in 2022. Merck’s molnupiravir generated sales of $952 million during the fourth quarter, primarily from supply to the United States, the United Kingdom and Japan.
Zacks Rank & Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
A better-ranked large stock in the drug/biotech sector is Vertex Pharmaceuticals (VRTX - Free Report) which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals’ stock has risen 8.9% this year so far. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.39 to $14.52 per share, while that for 2023 have increased from $14.10 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong, with the company beating expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.