The US Food and Drug Administration (FDA) has announced it will review a flu vaccine application from pharmaceutical giant Moderna, just one week after declining to do so. The FDA's decision to accept Moderna's revised application marks an abrupt reversal from its earlier stance. Moderna's CEO Stephane Bancel expressed optimism that the new flu shot would be available later this year.
Moderna announced on Wednesday that the FDA had accepted a revised application seeking full approval for a new flu shot to be offered to patients between the ages of 50 and 64 and expedited approval for those over 65. The company had undertaken a 40,000-person clinical trial, focused on adults age 50 and older, that concluded its new vaccine was more effective than a standard shot.
CEO Stephane Bancel said in a statement, “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.” The FDA's vaccine director Vinay Prasad had argued that Moderna should have included a high-dose brand for comparison in its trial process.
The FDA is aiming to reach a decision on the revised application by August 5. The flu shot was created with mRNA technology, a subject of frequent criticism from Health and Human Services Secretary Robert F Kennedy Jr. Last June, Kennedy cancelled nearly $500m in federal research grants and contracts for research into mRNA vaccines.
Authorities said the agency's refusal to consider the company's initial application was an unusual move. The FDA's decision to accept Moderna's revised application has been seen as a significant development in the pharmaceutical industry. The ministry stated that it is committed to enhancing America's leadership in developing innovative medicines.
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