If Phase 3 Interim Results Are Positive
Possibility of Emergency Approval in December
[Asia Economy Reporter Ki Ha-young] The U.S. biotech company Moderna expects that if the interim results of the Phase 3 clinical trial for its developing novel coronavirus disease (COVID-19) vaccine next month are positive, the U.S. government could grant emergency approval as early as December.
Moderna CEO St?phane Bancel stated this on the 19th (local time) at the annual Tech Live Conference hosted by The Wall Street Journal (WSJ). However, he added, "If it takes more time to obtain sufficient interim results, government approval may not be granted until early next year."
Moderna, along with pharmaceutical company Pfizer, is one of the frontrunners in COVID-19 vaccine development. Since July, it has been conducting a large-scale Phase 3 clinical trial in the U.S. involving 30,000 participants to determine whether the vaccine under development safely protects people from COVID-19 symptoms. In the trial, half of the participants received the vaccine, while the other half were given a placebo. Researchers then tally how many develop COVID-19 symptoms.
The first interim analysis of the vaccine's efficacy will be conducted once 53 participants in the entire sample develop COVID-19 symptoms. According to WSJ, if among these 53 symptomatic individuals, significantly fewer received the vaccine compared to those who did not, Moderna will consider the interim results sufficient to obtain government approval for broader use.
CEO Bancel said, "The first interim analysis will be conducted in November, but it is difficult to predict the exact week," adding, "It depends on how many people get infected."
Before applying for emergency approval from the government, Moderna must monitor the safety of at least half of the Phase 3 trial participants who received the vaccine. Bancel added, "Moderna expects to meet this criterion by late November."
WSJ predicted that if Moderna applies for emergency approval from the U.S. Food and Drug Administration (FDA), the FDA will review the application for several weeks and decide on approval in December.
If the developing vaccine does not show sufficient efficacy in the first interim analysis, Moderna plans to conduct a second interim analysis when the number of symptomatic COVID-19 cases reaches 106. In this case, the FDA's decision on emergency approval will be delayed until late January or early February. CEO Bancel said, "We plan to produce 20 million doses of the vaccine by the end of this year and at least 500 million doses by next year," adding, "Increasing production is a challenge."
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