Moderna will request emergency clearance from the Food and Drug Administration (FDA) after it was found 94% effective in preventing Covid-19.
The latest Moderna clinical trial involved 196 confirmed Covid infections among the 30,000 participants. According to the company, 185 coronavirus cases were assessed in the placebo group versus 11 cases monitored in the group that took its vaccine. Results showed estimated vaccine efficacy of 94.1%, the company said.
Shares of Moderna increased by more than 12% in premarket trading Monday.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death,” Moderna CEO Stephane Bancel said in a statement.
Moderna stressed that their vaccine’s effectiveness showed consistency across age, race, and gender. The 196 coronavirus cases were 33 adults over the age of 65 and 42 people from Black, Latino and other “diverse” communities. The vaccine was found well tolerated with the most common side effects, like muscle pain, fatigue, headache, and pain at the injection site.
The company expects to have children between the ages of 11 and 17 tested later this year. “For younger children, you have to go down in age very slowly and you have to start at a lower dose to make sure it is safe,” Bancel said during an interview on “Squawk Box.”
Moderna’s findings come as drugmakers and public health officials race to produce a safe and effective vaccine to manage the pandemic.
While Moderna requested emergency clearance from the FDA, it may take a few weeks for the decision to come out. The agency is expected to schedule an advisory committee meeting to assess the vaccine on Dec. 17, Moderna said.
Moderna finds “enormous hope” in its preliminary vaccine data, according to Dr. Carlos del Rio of Emory University.
However, del Rio said that it will take time for the effect to be felt due to the complications involved in distributing Covid-19 vaccines to Americans.
“It’s going to take a while to roll them out. … This is a major effort. We probably need to vaccinate close to 200 million to 260 million Americans in order to get to herd immunity,” del Rio told “The Exchange.” “That’s not going to be easy.”
Del Rio’s statements came after Moderna issued its preliminary data showing its Covid-18 vaccine was more than 94% effective in treating Covid-19. The interim analysis revolved around its large-scale trial of 30,000 participants. Emory University was involved in phase one trial as well as in the phase three trial.
The FDA will observe the same standard for the Covid-19 vaccine from Pfizer and German partner BioNTech, according to Azar. The companies presented preliminary data last week showing their vaccine was more than 90% effective in responding to Covid-19.
“We hope those applications from both Pfizer and Moderna will get in as quickly as possible,” Azar told “Squawk Box.” “We will independently call those balls and strikes on the data and evidence, but we’re going to do so as quickly as possible, consistent with just making sure the science, the evidence, and the law support authorization.”
