US says that it will review Moderna flu vaccine it previously declined

"The federal agency tasked with regulating drugs in the United States has said it will review a flu vaccine application from the pharmaceutical giant Moderna, one week after it declined to do so in an unusual move. Moderna announced on Wednesday that the Food and Drug Administration (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."

"On February 10, Moderna revealed that the FDA had denied its application to review the new flu vaccine for use among older adults. That announcement sparked concerns in the pharmaceutical industry about how new vaccines would be received under US President Donald Trump, whose administration has rescinded certain vaccine guidelines. Some Trump officials, most notably Health and Human Services Secretary Robert F Kennedy Jr, have also spread false claims about vaccine safety."

The FDA accepted a revised application from Moderna seeking full approval for a flu vaccine for ages 50–64 and expedited approval for those over 65. Moderna had previously announced that the FDA denied its initial application on February 10, a move the company called inconsistent with prior written communications. CEO Stephane Bancel said the company looks forward to making the vaccine available later this year for seniors pending approval and thanked the FDA for engagement. The prior refusal to file was described as unusual and had sparked industry concerns amid shifting federal vaccine guidelines and public statements from some Trump administration officials.

Read at www.aljazeera.com