Moderna's stock rises after FDA reverses course on flu vaccine
Shares of Moderna, Inc. (MRNA) rose after it said that the US Federal Drug Administration (FDA) has agreed to review its seasonal flu vaccine application after having initially rejected it.
The vaccine, called mRNA-1010, is a first-of-its-kind shot using mRNA technology. The only vaccines currently approved by the FDA using mRNA technology are for Covid-19 and the disease caused by the SARS-CoV-2 coronavirus.
Health Secretary Robert F. Kennedy, Jr., who has been outspoken in his criticism of mRNA technology and the Covid-19 vaccine, pulled $500 million in funding in August that halted the development of vaccines using mRNA.
The FDA's Center for Biologics Evaluation and Research (CEBR) sent Moderna a rare "refusal-to-file" letter earlier this month in which vaccine director Dr. Vinay Prasad cited the lack of an "adequate and well-controlled study" with a comparator arm that does not "reflect the best-available standard of care."
A comparator vaccine is an approved, licensed vaccine used as a benchmark in clinical trials to evaluate the safety and efficacy of a new, experimental vaccine.
Prasad specifically faulted Moderna's trial for not including a competing brand specifically recommended for people 65 and older.
However, Moderna argued that neither the "relevant regulation" nor the FDA's guidance for the industry related to flu vaccines mentions using a comparator in order to "reflect the best-available standard of care."
The drugmaker also noted that the FDA "did not identify any specific safety or efficacy concerns regarding mRNA-1010."
Moderna's 40,000-person clinical trial found that its mRNA-1010 vaccine was more effective in adults aged 50 and older than the standard flu vaccine.
"This decision by CBER, 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 Stéphane Bancel said in a statement.
"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."
Trump pressures FDA on vaccines
The FDA's decision to reverse course just over a week later came after the White House put pressure on the agency and President Trump "expressed frustration to Commissioner Marty Makary over the agency’s handling of vaccine issues," according to Politico.
Politico noted that the decision comes as Republicans are "trying to play down the Trump administration’s controversial moves on vaccines ahead of the midterm elections" in November.
As part of a compromise with the FDA, Moderna is now seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults once the vaccine is on the market.
Bancel said in a statement that the company appreciated "the FDA's engagement" in a meeting that led to the agency moving forward with its review.
"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," he added.
The FDA is targeting a decision on Moderna's application by Aug. 5. The drugmaker is also currently seeking approval in Europe, Canada and Australia.
The company's stock closed up 6% on Wednesday and gained another 6.7% on Thursday. It has surged over 68% so far this year.