Moderna Inc will not be ready to apply for emergency authorization for its potential COVID-19 vaccine before the U.S. presidential election in November, the Financial Times reported on Wednesday, citing the company’s chief executive officer.
Stéphane Bancel told FT that he did not expect to have full approval to distribute the drug to all sections of the U.S. population until next spring.
Moderna did not immediately respond to Reuters request for comment.
Moderna will not be ready to seek emergency use authorization from the Food and Drug Administration before Nov. 25 at the earliest, the report said, citing Bancel.
The company’s experimental vaccine is among the leaders in the race to develop a safe and effective vaccine to tackle the COVID-19 pandemic. The candidate is currently being tested in a large decisive trial.
The race to come up with a vaccine has become a divisive issue for the U.S. presidential election and was of significant importance in the presidential debate on Tuesday between U.S. President Donald Trump and contender Joe Biden.
Bancel earlier this month had said he expects the company to file for an Emergency Use Authorization in 2020, which could occur in November or even as early as October depending on interim analysis.
Results from an early safety study of Moderna’s coronavirus vaccine candidate in older adults on Tuesday showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults.