Report: Vaccines Are Having Mixed Effects on Blind Children, Worries Over Legal Questions About Development of the Drug.
Medical officials say there will be almost three million of the latest cold and flu drug, called cov-19, hit US pharmacies by 2020 after the federal agency that approves new medicines for the first time greenlighted the drug.
The drug will come in multiple flu-fighting doses, which the Food and Drug Administration approved Monday, and FDA scientists say it can help health care providers identify patients earlier who need flu treatment in addition to traditional antiviral drugs.
But the agency is recommending a different dose of cov-19 for children who are blind and who have other medical conditions in an effort to help control the drug’s side effects and streamline coverage. The FDA also will allow emergency use of the drug in a wider range of patients than in the previous trial.
Cov-19’s approval is a significant moment in the history of U.S. drug development. The medication breaks new ground by combining two antiviral medications that were previously approved for different conditions.
The FDA approved the combination medicine because it can help health care providers detect older patients who aren’t responding well to other treatments — giving them the chance to have an immediate adjuvant, or boosting drug dose, that could change their course of treatment.
“Providing an adjuvant to people earlier in the course of the disease, when there are medicines that can help, is important. This is where we think you can make a difference,” says Dr. Paul Howard, an infectious diseases specialist at Children’s Hospital Colorado.
In its review of the drug, the FDA wrote that while cov-19’s addition of a third, less potent antiviral drug to traditional flu treatments “is not without risk,” the benefit outweighs the risk.
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