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Pfizer (PFE) to Test 3-Dose COVID-19 Vaccine Regimen in Kids
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Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) announced that they are planning to test a three-dose regimen of their COVID-19 vaccine, Comirnaty (BNT162b), in children aged six months to five years, following routine review of an ongoing clinical study by the external independent data monitoring committee.
Pfizer and BioNTech were evaluating two different two-dose regimens of Comirnaty 21 days apart in three age groups — 5 to under 12 years, 2 to under 5 years and 6 months to under 2 years — in an ongoing phase II/III study. While the oldest age group received two doses of 10 micrograms each, participants in the rest two age groups were administered three microgram doses.
Pfizer and BioNTech will evaluate a third dose of three micrograms at least two months after the second dose in children aged six months to five years.
Please note that data from this ongoing study has supported the emergency use authorization for Comirnaty in individuals aged 5 to under 12 years. The vaccine is also authorized for use in adolescents and adults.
The DMC update was based on a pre-specified immunogenicity analysis of the data from a subset of the study population after one month following the administration of the second dose of Comirnaty. These data demonstrated that immunogenicity was non-inferior in the individuals aged six months to under two years compared to immunogenicity levels following a two-dose regimen in 16 to 25 years aged individuals observed in a previously completed clinical study. However, the COVID-19 vaccine failed to demonstrate non-inferiority in the two to five years age group compared to 16 to 25 years aged individuals.
Moreover, early laboratory data and effectiveness data for three doses of the vaccine in individuals aged 16 to 25 years against several variants of concern, including Delta and Omicron, demonstrated that an additional dose following the primary two-dose regimen may result in a higher degree of protection.
The failure to achieve non-inferiority of immunogenicity in the two to five-year age group and a potential rise in protection following a third dose led Pfizer and BioNTech to the decision of evaluating the third dose of three micrograms in individuals aged six months to under five years of age. The decision to evaluate an additional dose in this study population has been endorsed by the FDA and the European Medicines Agency (“EMA”).
Pfizer and BioNTech are currently evaluating the third dose of 10 µg or 30 µg in adolescents aged 12 to 17 years in a low dose sub-study. The companies are also planning to evaluate the third dose of 10 micrograms in children 5 to under 12 years of age.
Pfizer’s shares have gained 61.6% so far this year compared with the industry’s increase of 18.9%.
Image Source: Zacks Investment Research
In separate press releases, Pfizer announced that the EMA’s Committee for Medicinal Products for Human Use has recommended approval for three drugs — somatrogon for pediatric growth hormone deficiency, pneumococcal 20-valent conjugate vaccine, and Lorviqua as first-line treatment for ALK-positive advanced non-small cell lung cancer.
A decision related to the potential approval for these drugs from the European Commission is expected next year.
Earnings per share estimates for Repligen have moved north from $2.76 to $2.90 for 2021 and from $3.03 to $3.21 for 2022 in the past 60 days.
Repligen delivered an earnings surprise of 49.21%, on average, in the last four quarters. RGEN’s shares are up 38.5% so far this year.
Estimates for Sarepta’s 2021 bottom line have narrowed from a loss of $6.95 to $4.99 in the past 60 days. Estimates for Sarepta’s 2022 bottom line have changed from a loss per share of $4.78 to earnings per share of $3.61 in the past 60 days.
Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
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Pfizer (PFE) to Test 3-Dose COVID-19 Vaccine Regimen in Kids
Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) announced that they are planning to test a three-dose regimen of their COVID-19 vaccine, Comirnaty (BNT162b), in children aged six months to five years, following routine review of an ongoing clinical study by the external independent data monitoring committee.
Pfizer and BioNTech were evaluating two different two-dose regimens of Comirnaty 21 days apart in three age groups — 5 to under 12 years, 2 to under 5 years and 6 months to under 2 years — in an ongoing phase II/III study. While the oldest age group received two doses of 10 micrograms each, participants in the rest two age groups were administered three microgram doses.
Pfizer and BioNTech will evaluate a third dose of three micrograms at least two months after the second dose in children aged six months to five years.
Please note that data from this ongoing study has supported the emergency use authorization for Comirnaty in individuals aged 5 to under 12 years. The vaccine is also authorized for use in adolescents and adults.
The DMC update was based on a pre-specified immunogenicity analysis of the data from a subset of the study population after one month following the administration of the second dose of Comirnaty. These data demonstrated that immunogenicity was non-inferior in the individuals aged six months to under two years compared to immunogenicity levels following a two-dose regimen in 16 to 25 years aged individuals observed in a previously completed clinical study. However, the COVID-19 vaccine failed to demonstrate non-inferiority in the two to five years age group compared to 16 to 25 years aged individuals.
Moreover, early laboratory data and effectiveness data for three doses of the vaccine in individuals aged 16 to 25 years against several variants of concern, including Delta and Omicron, demonstrated that an additional dose following the primary two-dose regimen may result in a higher degree of protection.
The failure to achieve non-inferiority of immunogenicity in the two to five-year age group and a potential rise in protection following a third dose led Pfizer and BioNTech to the decision of evaluating the third dose of three micrograms in individuals aged six months to under five years of age. The decision to evaluate an additional dose in this study population has been endorsed by the FDA and the European Medicines Agency (“EMA”).
Pfizer and BioNTech are currently evaluating the third dose of 10 µg or 30 µg in adolescents aged 12 to 17 years in a low dose sub-study. The companies are also planning to evaluate the third dose of 10 micrograms in children 5 to under 12 years of age.
Pfizer’s shares have gained 61.6% so far this year compared with the industry’s increase of 18.9%.
In separate press releases, Pfizer announced that the EMA’s Committee for Medicinal Products for Human Use has recommended approval for three drugs — somatrogon for pediatric growth hormone deficiency, pneumococcal 20-valent conjugate vaccine, and Lorviqua as first-line treatment for ALK-positive advanced non-small cell lung cancer.
A decision related to the potential approval for these drugs from the European Commission is expected next year.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the pharma/biotech sector include Repligen (RGEN - Free Report) and Sarepta Therapeutics (SRPT - Free Report) . While Repligen sports a Zacks Rank #1 (Strong Buy), Sarepta carries a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings per share estimates for Repligen have moved north from $2.76 to $2.90 for 2021 and from $3.03 to $3.21 for 2022 in the past 60 days.
Repligen delivered an earnings surprise of 49.21%, on average, in the last four quarters. RGEN’s shares are up 38.5% so far this year.
Estimates for Sarepta’s 2021 bottom line have narrowed from a loss of $6.95 to $4.99 in the past 60 days. Estimates for Sarepta’s 2022 bottom line have changed from a loss per share of $4.78 to earnings per share of $3.61 in the past 60 days.
Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.