Moderna shares fall after FDA refuses to review influenza vaccine application

The U.S. Food and Drug Administration declined to review Moderna’s application for approval for its new mRNA flu vaccine, sending the company’s shares tumbling late Tuesday.

Moderna said Tuesday that the FDA rejected the application, saying its studies did not compare the experimental vaccine to the “best available standard of care.”

Shares of Moderna fell around 11% in extended trading on Tuesday. so far this

Why did the FDA reject Moderna’s application?

In its rejection letter, the FDA said the company’s approach to comparing mRNA-1010 to an already licensed standard-dose seasonal flu was the only reason it refused to initiate review of the application.

Moderna said the letter specifically cited the lack of an “adequate and well-controlled” study with a comparator arm.

The company said the rejection letter, signed by Vinay Prasad, who leads the FDA’s division that oversees vaccines, was inconsistent with previous written communications from the regulator.

The news was announced by the FDA’s Surgeon General Robert F Kennedy Jr. It comes as the latest sign of his administration’s strict scrutiny of vaccines, especially those using mRNA technology. Kennedy had previously criticized technology, even after assuming the top job.

“This decision by CBER (Center for Biologics Evaluation and Research), which identified no safety or efficacy concerns regarding our product, does not advance our shared goal of increasing America’s leadership in developing innovative medicines,” said Moderna CEO Stephanie Bancel.

In the letter from FDA vaccine director Dr Vinay Prasad, it was stated that FDA officials made some recommendations to Moderna under the Biden administration in 2024, but the company did not comply with them.

In the feedback it received, Moderna stated that it was acceptable to use the standard dose of flu vaccine preferred by the company, but stated that another brand recommended especially for the elderly in the study would be preferred for everyone aged 65 and over.

The FDA still allowed the study to proceed as planned, the company said.

The company said it also shared with the FDA additional data from a separate trial comparing the new vaccine to a licensed high-dose vaccine used for seniors.

“It should not be controversial to conduct a comprehensive review of a flu vaccine rollout using an FDA-approved vaccine as a comparator in a study that was discussed and agreed upon with CBER before it began,” Bancel said. he said.

However, the rejection letter did not close all doors for Moderna. The company may re-apply as a protest if it wishes, after consulting with FDA officials.

Is the USA resisting the vaccine?

This development comes a little more than a month after the Trump administration overhauled vaccination guidelines for children.

Under the new rules, the government has withdrawn its recommendation for routine vaccination against six infectious diseases, including flu.

Last year, FDA officials working under Kennedy rolled back recommendations on COVID-19 vaccines, added extra warnings to two leading COVID vaccines made with mRNA technology, and removed criticism of the administration’s approach from the FDA advisory panel.