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FDA Allows Emergency Use of Omicron-Based COVID Jabs in Kids
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The FDA, on Oct 12, expanded the eligibility of the granted emergency use authorization (EUA) to Omicron BA.4/BA.5-adapted bivalent vaccines developed by Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) . The vaccine would be used as a single booster dose in children as young as five years. These boosters can be given at least two months following primary or booster vaccination.
Following the FDA decision, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is now authorized for use in individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine is authorized for children aged six to 11 years and adolescents aged 12 to 17 years, respectively.
The bivalent vaccines contain an mRNA encoding the spike protein present in the original vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.
The FDA authorized Pfizer/BioNTech and Moderna’s BA.4/BA.5 boosters for people 12 and older for Pfizer and 18 and older for Moderna in late August.
Pfizer/BioNTech and Moderna’s filings seeking authorization of the bivalent vaccines were based on clinical studies on their bivalent Omicron BA.1-adapted vaccines as well as pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines.
Unlike all previously-approved COVID-19 vaccines, the authorization granted to these booster shots is not supported by data from any human clinical studies demonstrating the vaccine’s effectiveness.
Currently, the BA.4 and BA.5 account for more than 80% of COVID-19 infections in The United States. It is expected that these subvariants will lead to increased infection rates later this year during the winter season. To curb the infection rates and motivate people to resume their pre-pandemic activities, the FDA authorized the use of bivalent vaccines in young children to prevent severe consequences like hospitalization and death.
The approved/authorized monovalent COVID-19 vaccines were not very effective against the BA.4/BA.5 subvariants. Though administering a primary vaccination regimen has helped reduce serious outcomes caused by COVID-19 variants, clinical studies have shown the antibody levels to wane over time. While authorized booster doses have restored these antibodies to their previous levels, this protection also weakens over time. As a result, there is a huge need for booster doses, which provide protection against the new emerging variants and thereby prevent serious outcomes caused by the disease.
Moderna and Pfizer/BioNTech also intend to seek FDA’s authorization to use their vaccines in children aged six months and older. Moderna plans to file a EUA application for children aged between six months and five years by this year’s end.
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FDA Allows Emergency Use of Omicron-Based COVID Jabs in Kids
The FDA, on Oct 12, expanded the eligibility of the granted emergency use authorization (EUA) to Omicron BA.4/BA.5-adapted bivalent vaccines developed by Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) . The vaccine would be used as a single booster dose in children as young as five years. These boosters can be given at least two months following primary or booster vaccination.
Following the FDA decision, a 10-µg dose of Pfizer/BioNTech’s bivalent vaccine is now authorized for use in individuals aged between five and 11 years. A 25-µg and 50-µg dose of Moderna’s bivalent vaccine is authorized for children aged six to 11 years and adolescents aged 12 to 17 years, respectively.
The bivalent vaccines contain an mRNA encoding the spike protein present in the original vaccine and an mRNA encoding the spike protein common in the Omicron BA.4 and BA.5 variants.
The FDA authorized Pfizer/BioNTech and Moderna’s BA.4/BA.5 boosters for people 12 and older for Pfizer and 18 and older for Moderna in late August.
Pfizer/BioNTech and Moderna’s filings seeking authorization of the bivalent vaccines were based on clinical studies on their bivalent Omicron BA.1-adapted vaccines as well as pre-clinical data from studies on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines.
Unlike all previously-approved COVID-19 vaccines, the authorization granted to these booster shots is not supported by data from any human clinical studies demonstrating the vaccine’s effectiveness.
Currently, the BA.4 and BA.5 account for more than 80% of COVID-19 infections in The United States. It is expected that these subvariants will lead to increased infection rates later this year during the winter season. To curb the infection rates and motivate people to resume their pre-pandemic activities, the FDA authorized the use of bivalent vaccines in young children to prevent severe consequences like hospitalization and death.
The approved/authorized monovalent COVID-19 vaccines were not very effective against the BA.4/BA.5 subvariants. Though administering a primary vaccination regimen has helped reduce serious outcomes caused by COVID-19 variants, clinical studies have shown the antibody levels to wane over time. While authorized booster doses have restored these antibodies to their previous levels, this protection also weakens over time. As a result, there is a huge need for booster doses, which provide protection against the new emerging variants and thereby prevent serious outcomes caused by the disease.
Moderna and Pfizer/BioNTech also intend to seek FDA’s authorization to use their vaccines in children aged six months and older. Moderna plans to file a EUA application for children aged between six months and five years by this year’s end.