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Pfizer's (PFE) COVID-19 Vaccine Successful in Children Study
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Pfizer Inc. (PFE - Free Report) and BioNTech (BNTX - Free Report) announced data from a pivotal phase II/III study evaluating its COVID-19 vaccine, Comirnaty, in children aged 5 to 11 years of age in the United States. The data reported from the cohort included children aged 5 to 11 years of age.
Data from the study cohort showed that one month of immunization with two doses of Comirnaty resulted in SARS-CoV-2–neutralizing antibody geometric mean titer levels that were non-inferior to the level achieved in individuals aged 16 to 25 years of age in the previously completed clinical study. Data from the study evaluating Comirnaty in individuals aged 16 to 25 years of age formed the basis of the FDA approval for the vaccine. The safety profile of Comirnaty in children aged 5 to 11 years was similar to that achieved in adults.
Please note that Pfizer and BioNTech evaluated a 10-microgram dose of Comirnaty in children aged 5 to 11 years compared to the 30-microgram dose of the vaccine that is authorized/approved for adolescents and adults.
The study continues to evaluate the vaccine in separate cohorts in children aged 6 months to 2 years and 2 years to 5 years. Data from these cohorts is expected in the fourth quarter of 2021.
The companies plan to file for emergency use authorization for Comiranty in children aged 5 to 11 years soon based on the aforementioned pediatric study data. The companies will continue to accumulate data from the study to support a regulatory application, seeking full approval for the vaccine in the aforementioned age group.
Earlier this week, Comiranty became the first COVID-19 vaccine to receive EUA for a third dose for all adults aged 65 years and above in the United States.
Shares of Pfizer have gained 20.1% so far this year compared with the industry’s increase of 8.5%.
Image Source: Zacks Investment Research
Apart from Pfizer and BioNTech, Moderna (MRNA - Free Report) is also evaluating their COVID-19 vaccine in children. The company has completed enrollment in the clinical study evaluating a 50-microgram dose of its COVID-19 vaccine in children aged 5-11 years. It is currently working on evaluating the best dosage of its COVID-19 vaccine to be used in children aged six months or higher. Moderna is likely to have enough data for requesting EUA for use in children aged 5-11 years over the coming weeks.
We note that J&J’s (JNJ - Free Report) single-shot vaccine is also authorized for emergency use in adults in the United States. The company is currently evaluating the vaccine in adolescents but a study on children is yet to be announced.
Image: Bigstock
Pfizer's (PFE) COVID-19 Vaccine Successful in Children Study
Pfizer Inc. (PFE - Free Report) and BioNTech (BNTX - Free Report) announced data from a pivotal phase II/III study evaluating its COVID-19 vaccine, Comirnaty, in children aged 5 to 11 years of age in the United States. The data reported from the cohort included children aged 5 to 11 years of age.
Data from the study cohort showed that one month of immunization with two doses of Comirnaty resulted in SARS-CoV-2–neutralizing antibody geometric mean titer levels that were non-inferior to the level achieved in individuals aged 16 to 25 years of age in the previously completed clinical study. Data from the study evaluating Comirnaty in individuals aged 16 to 25 years of age formed the basis of the FDA approval for the vaccine. The safety profile of Comirnaty in children aged 5 to 11 years was similar to that achieved in adults.
Please note that Pfizer and BioNTech evaluated a 10-microgram dose of Comirnaty in children aged 5 to 11 years compared to the 30-microgram dose of the vaccine that is authorized/approved for adolescents and adults.
The study continues to evaluate the vaccine in separate cohorts in children aged 6 months to 2 years and 2 years to 5 years. Data from these cohorts is expected in the fourth quarter of 2021.
The companies plan to file for emergency use authorization for Comiranty in children aged 5 to 11 years soon based on the aforementioned pediatric study data. The companies will continue to accumulate data from the study to support a regulatory application, seeking full approval for the vaccine in the aforementioned age group.
Earlier this week, Comiranty became the first COVID-19 vaccine to receive EUA for a third dose for all adults aged 65 years and above in the United States.
Shares of Pfizer have gained 20.1% so far this year compared with the industry’s increase of 8.5%.
Image Source: Zacks Investment Research
Apart from Pfizer and BioNTech, Moderna (MRNA - Free Report) is also evaluating their COVID-19 vaccine in children. The company has completed enrollment in the clinical study evaluating a 50-microgram dose of its COVID-19 vaccine in children aged 5-11 years. It is currently working on evaluating the best dosage of its COVID-19 vaccine to be used in children aged six months or higher. Moderna is likely to have enough data for requesting EUA for use in children aged 5-11 years over the coming weeks.
We note that J&J’s (JNJ - Free Report) single-shot vaccine is also authorized for emergency use in adults in the United States. The company is currently evaluating the vaccine in adolescents but a study on children is yet to be announced.
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