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A few days ago, the U.
S.
FDA granted emergency authorization for the second booster immunization (the fourth dose) of Pfizer/BioNTech and Moderna’s mRNA vaccines
.
Designed to better protect the elderly and immunocompromised populations at higher risk for severe illness, hospitalisation and death
.
The FDA cited data from Pfizer/BioNTech and Moderna showing that the second booster boosted protection against severe COVID-19 cases without causing new safety concerns
.
Specifically, the FDA has amended the existing emergency use authorization for the COVID-19 vaccine booster to allow people over 50 to receive a Pfizer/BioNTech or Moderna's mRNA vaccine serves as a second booster
.
In addition, immunocompromised people 12 years of age and older can receive a second booster dose of Pfizer/BioNTech's mRNA vaccine four months after receiving any FDA-approved first dose of the COVID-19 vaccine booster
.
Immunocompromised people 18 years and older can receive a second booster dose of Moderna's mRNA vaccine four months after the first booster dose of any FDA-approved COVID-19 vaccine
.
The FDA defines an immunocompromised person as someone who has undergone an organ transplant, or has an equivalent level of immune function
.
Dr.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement that current evidence shows that the protective effect of the new crown vaccine in the elderly and immunocompromised populations has diminished over time
.
A second booster dose of Pfizer/BioNTech and Moderna's mRNA vaccines could help improve protection in these high-risk groups of severe illness, new analysis of study data shows
.
The study data also shows that the first booster dose is critical to helping all adults avoid the severe consequences of Covid-19
.
For other age groups, the FDA has authorized only one booster dose, but the FDA will continue to evaluate the second dose for protection in all populations
.
Pfizer/BioNTech's mRNA vaccine received emergency authorization from the FDA on September 22, 2021, for a first booster dose in people over 65 years of age and expanded to 18-year-olds and older adults on November 19
.
Moderna's mRNA received emergency authorization from the FDA on November 11, 2021, for the first booster dose in adults 18 years of age and older
.
About two weeks ago, Pfizer/BioNTech and Moderna applied to the FDA for expanded emergency use authorization to allow a second booster dose of mRNA
.
Their application is based on real-world data from Israel during the Omicron epidemic, which show that the infection rate dropped by a factor of 2 after the first booster dose was administered 4 months after the second booster dose was administered.
The rate dropped 4-fold and neutralizing antibody titers increased 7-8 fold
.
Open reprint welcome to forward to Moments and WeChat groups
S.
FDA granted emergency authorization for the second booster immunization (the fourth dose) of Pfizer/BioNTech and Moderna’s mRNA vaccines
.
Designed to better protect the elderly and immunocompromised populations at higher risk for severe illness, hospitalisation and death
.
The FDA cited data from Pfizer/BioNTech and Moderna showing that the second booster boosted protection against severe COVID-19 cases without causing new safety concerns
.
Specifically, the FDA has amended the existing emergency use authorization for the COVID-19 vaccine booster to allow people over 50 to receive a Pfizer/BioNTech or Moderna's mRNA vaccine serves as a second booster
.
In addition, immunocompromised people 12 years of age and older can receive a second booster dose of Pfizer/BioNTech's mRNA vaccine four months after receiving any FDA-approved first dose of the COVID-19 vaccine booster
.
Immunocompromised people 18 years and older can receive a second booster dose of Moderna's mRNA vaccine four months after the first booster dose of any FDA-approved COVID-19 vaccine
.
The FDA defines an immunocompromised person as someone who has undergone an organ transplant, or has an equivalent level of immune function
.
Dr.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement that current evidence shows that the protective effect of the new crown vaccine in the elderly and immunocompromised populations has diminished over time
.
A second booster dose of Pfizer/BioNTech and Moderna's mRNA vaccines could help improve protection in these high-risk groups of severe illness, new analysis of study data shows
.
The study data also shows that the first booster dose is critical to helping all adults avoid the severe consequences of Covid-19
.
For other age groups, the FDA has authorized only one booster dose, but the FDA will continue to evaluate the second dose for protection in all populations
.
Pfizer/BioNTech's mRNA vaccine received emergency authorization from the FDA on September 22, 2021, for a first booster dose in people over 65 years of age and expanded to 18-year-olds and older adults on November 19
.
Moderna's mRNA received emergency authorization from the FDA on November 11, 2021, for the first booster dose in adults 18 years of age and older
.
About two weeks ago, Pfizer/BioNTech and Moderna applied to the FDA for expanded emergency use authorization to allow a second booster dose of mRNA
.
Their application is based on real-world data from Israel during the Omicron epidemic, which show that the infection rate dropped by a factor of 2 after the first booster dose was administered 4 months after the second booster dose was administered.
The rate dropped 4-fold and neutralizing antibody titers increased 7-8 fold
.
Open reprint welcome to forward to Moments and WeChat groups
