Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) seeking approval for its COVID-19 and Influenza combination vaccine for adults aged 50 years and older.
In a brief press release on Wednesday, the company said that it had decided after consultation with the FDA. Moderna, Inc. plans on resubmitting the application later in the year, after it receives efficacy data from an ongoing trial of its influenza shot, mRNA-1010.
A scientist surrounded by vials and beakers in a modern laboratory, proudly displaying a vaccine.
The delay comes as no surprise, given Moderna, Inc.’s statement earlier in the month about the company not anticipating approval of the shot until 2026. However, experts view the pullback as yet another sign of America’s increased regulatory scrutiny of the vaccine approval process.
On May 20, the FDA tightened COVID-19 vaccine requirements by stating that it plans to require new trials for approval of annual booster shots for healthy Americans aged under 65, effectively limiting the usage to older adults and those at risk of severe illnesses.
Moderna, Inc. made a name for itself by quickly developing an effective coronavirus vaccine when the world needed it the most. However, the stock has largely struggled since the pandemic started to recede. The company has also been affected by increased regulatory scrutiny and a volatile political environment.
Shares had plunged by 8% as of 2 PM EDT on Wednesday, taking the year-to-date slump to 38%.
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