By Pamela Cruz. Peninsula 360 Press [P360P].
This Friday, the U.S. Food and Drug Administration (FDA) authorized emergency use of the COVID-19 Moderna and Pfizer-BioNTech vaccines with a single booster dose for all people 18 years of age and older. (FDA) authorized emergency use of the COVID-19 Moderna and Pfizer-BioNTech vaccines, with a single booster dose for all people 18 years of age and older after completing the basic schedule with either vaccine.
Meanwhile, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet later Friday to discuss further clinical recommendations.
"COVID-19 vaccines have been shown to be the best and most effective defense against the disease. Licensing the use of a single booster dose of COVID-19 Moderna or Pfizer-BioNTech vaccine for persons 18 years of age and older helps provide continued protection against the disease, including the serious consequences that can occur, such as hospitalization and death," said FDA Acting Commissioner Janet Woodcock.
Prior to today's approvals, a single booster dose of Moderna and Pfizer-BioNTech COVID-19 vaccines had been cleared for persons 65 years of age and older, persons 18-64 years of age at high risk for severe COVID-19, and individuals 18-64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
This morning's action expands the use of booster doses of both vaccines to include all persons 18 years of age and older at least six months after completing the primary vaccination series of Moderna or Pfizer-BioNTech COVID-19 vaccines or at least two months after completing primary vaccination with Janssen COVID-19 vaccine.
"FDA has determined that currently available data support expanding eligibility for a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to persons 18 years of age and older," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research.
He added that simplifying the eligibility criteria and making booster doses available to everyone 18 and older will help eliminate confusion about who can receive these third doses.
The FDA noted that both Pfizer and Moderna are conducting post-licensing and post-marketing studies to assess known serious risks.
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