FDA urgently approved fourth dose of mRNA vaccine for elderly and immunocompromised
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FDA urgently approved fourth dose of mRNA vaccine for elderly and immunocompromised
A few days ago, the U.S. Food and Drug Administration 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.
Additionally, immunocompromised individuals 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 suggests that the protective effect of the COVID-19 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 , an analysis of new research data shows . The study data also shows that the first booster dose is critical in 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.
FDA urgently approved fourth dose of mRNA vaccine for elderly and immunocompromised
(source:internet, reference only)
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