Pfizer seeks FDA approval for vaccine booster dose

The drugmaker announced Wednesday it has started the approval process for Americans ages 16 and older. The company says it expects to complete its application with the Food and Drug Administration by the end of this week.

Pfizer’s vaccine received full regulatory approval this week. U.S. health officials announced last week plans to dispense Covid-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the coronavirus. 

Earlier this month, U.S. regulators said transplant recipients or others with weakened immune systems can get an extra dose of Pfizer or Moderna vaccines.

For FDA approval, the manufacturer must submit a biological license application.  An independent scientific review is conducted, and there must be substantial evidence of safety, effectiveness and whether the manufacturing and facility data will ensure product quality and safety.  For approval, the FDA was requiring 6 months of safety monitoring and follow-up after completion of the clinical trial. 

FDA approval is indefinite unless new evidence emerges that presents any cause for concern.

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. 

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