Breaking Update: Here’s a clear explanation of the latest developments related to Breaking News:Moderna shares fall after FDA refuses to review influenza vaccine application– What Just Happened and why it matters right now.
The US Food and Drug Administration has declined to review Moderna’s approval application for its novel mRNA flu vaccine, causing a fall in the company’s shares on late Tuesday.
Moderna on Tuesday said in a statement that the FDA had declined the application saying that its studies didn’t compare the experimental shot to the “best-available standard of care.”
The shares of Moderna fell around 11% during extended trading on Tuesday. So far this
Why did the FDA decline Moderna’s application?
The FDA said in its refusal letter that the company’s approach to compare mRNA-1010 to an already licensed standard-dose seasonal influenza was the only reason why it declined to initiate a review of the application.
The letter in particular cited the lack of an “adequate and well-controlled” study with a comparator arm, Moderna said.
The rejection letter signed by Vinay Prasad, who leads the FDA division that oversees vaccines, is inconsistent with previous written communications from the regulator, the company noted.
The news comes as a latest sign of the FDA’s tight scrutiny of vaccines under Health Secretary Robert F Kennedy Jr, particularly those using mRNA technology. Kennedy has previously criticised the technology, even after he took up the top job.
“This decision by CBER (Center for Biologics Evaluation and Research), which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stephanie Bancel.
The letter from FDA vaccine director Dr Vinay Prasad said that FDA officials had given some advice to Moderna in 2024 under the Biden administration but the company did not follow that.
Moderna countered that the feedback it received said it was acceptable to use the standard-dose flu shot the company had opted for, but noted that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study.
The company said that the FDA still allowed the study to proceed further as planned.
The company said it also had shared with FDA additional data from a separate trial comparing the new vaccine against a licensed high-dose shot used for seniors.
“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Bancel said.
However, the rejection letter has not closed all doors for Moderna. The company can file the application again over protest if it chooses, after it meets with FDA officials.
US resists vaccination?
The development comes little over a month after the Trump administration went ahead to overhaul its childhood immunization guidelines.
It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator.
Under the new rules, the government has rolled back recommendation for routine vaccination against six infectious diseases, including influenza.
In the last year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines – which are made with mRNA technology – and removed critics of the administration’s approach from an FDA advisory panel.