In reversal, US agrees to review new Moderna flu shot

It was used during the Covid-19 pandemic to swiftly develop an immunisation that global health authorities deemed safe and effective against the fast-spreading illness. It was credited with saving millions of lives.

Moderna’s new shot had already been accepted for review in the European Union, Canada and Australia.

Vinay Prasad, the top US vaccine official, had signed the letter rejecting Moderna’s bid for approval, saying the company’s clinical trial was not “adequate and well-controlled,” and had not tested its experimental shot against the best product on the market.

In the large trial Moderna had compared its new vaccine with Fluarix, an approved flu shot from the company GSK.

Moderna said the rejection was “inconsistent with previous written communications” with the FDA.

In a statement Wednesday Moderna’s CEO, Stephane Bancel, said “we appreciate the FDA’s engagement” in a “constructive” meeting the company had requested following the rejection.

“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.”

Since Trump retook the White House, both he and health chief Kennedy have come under broad criticism from public health and medical experts for sowing doubt about the safety and efficacy of vaccines widely known to be safe, and upending the paediatric immunisation schedule.