The Japan Times - In reversal, US agrees to review new Moderna flu shot

Last week the US firm said the federal vaccine regulator rejected the application for review of the new shot, calling its clinical trial inadequate.

But Moderna said that after a "constructive" meeting the FDA had accepted the application for review based on a regulatory pathway focused on older adults.

The company's application now seeks full approval for adults 50 to 64 and accelerated approval for adults 65 and older, Moderna said in a statement. It also agreed to conduct an additional study after the shot hits the market.

The FDA's rejection had come as the body has called for a reconsideration of approval procedures for certain vaccines, including for influenza -- proposed federal policy changes under President Donald Trump that have triggered widespread alarm among public health and medical professionals.

The new shot uses mRNA technology, which health chief Robert F. Kennedy Jr, a vocal vaccine skeptic, has criticized. He notably cut off federal research grants that funded mRNA development.

That contradicts Trump's position during his first presidential term, when he called mRNA technology a "modern-day miracle."

It was used during the Covid-19 pandemic to swiftly develop an immunization 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 pediatric immunization schedule.

M.Saito--JT