WASHINGTON (EFE).— The United States Food and Drug Administration (FDA) approved and granted emergency use authorization to the updated mRNA vaccines against Covid-19 (2024-2025 formula), in order to include a monovalent (single) component that corresponds to the KP.2 omicron variant strain of SARS-CoV-2.
The decision affects the mRNA vaccines launched by Pfizer and Moderna, which have a formula designed to more precisely attack the variants currently circulating and provide better protection against the serious consequences of the virus, including hospitalization and death, as reported by the regulatory body through a statement.
“Vaccination remains the cornerstone of prevention,” stressed the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks.
The updated vaccines, he highlighted, “meet the agency’s rigorous scientific standards for safety, efficacy and manufacturing quality.”
The authorization includes the biologicals Comirnaty and Spikevax, approved for people over 12 years of age, and those from Moderna and Pfizer-BioNTech, for people from six months to 11 years of age.
The FDA warned that those who receive this updated version could experience side effects similar to those reported with the previous versions.
The agency added that, unless a significantly more infectious variant of the virus emerges, the composition of the Covid-19 vaccines will be evaluated annually, as is already the case against flu doses.
For current approvals, the FDA evaluated manufacturing and non-clinical data as support.
The updated biologics are manufactured using a process similar to previous formulations of the same vaccines.
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2024-10-08 01:27:03
