Moderna’s Covid-19 Vaccine May Be Approved As Soon As December

Moderna of Cambridge, Mass, recently announced that the government may authorize emergency use of their Coronavirus vaccine, as soon as December. The announcement comes as no surprise following the company’s 1.5 Million Dollar vaccine development contract signed back in August with the US Federal Government.

Chief Executive Officer Stéphane Bancel spoke at the Wall Street Journal’s annual Tech Live Conference. He explained that the company is currently expecting positive interim results for their COVID 19 vaccine trial in November.

Moderna is a leading development company. Interim results may still take longer than expected to collect; if this happens the government may not approve usage of the vaccine until next year.

“We expect to produce about 20 million doses by the end of this year and at least 500 million doses next year. Unlike sometimes when you make a recipe at home, if you miss one ingredient, you might decide to still go ahead and make your meal. In our case we cannot do that. We need all the ingredients to be there on time to be able to make a lot of vaccines. If one ingredient is missing, we cannot make a vaccine,” Bancel stated.

Is the vaccine able to safely protect people from symptomatic COVID19 disease ?

The Company’s U.S study began in July and consisted of 30,0000 people. In order to study the vaccine’s efficiency researchers have injected half of the test studies with a placebo. The first interim will consist of 53 cases. The cases are gathered from studies seeing COVID 19 symptoms.

“That first analysis should occur in November. It’s hard to predict exactly which week, it depends on the cases, the number of people getting sick,” Bancel said.

 Vaccinated test studies V. Placebo Test Studies will be the main focus of the interim. The Company is expecting the percentage of the vaccinated test studies among the 53 cases to be significantly fewer. The company is mandated to moderate study subjects safety and health two months post-trial. Moderna will then be able  to request government authorization to distribute for emergency usage.

The initial studies have shown it induced immune responses in test subjects. However, final determination will be left to approval from the Food and Drug Administration, which can take weeks.

“If the vaccine doesn’t demonstrate sufficient efficacy at the first interim analysis, the company will conduct a second analysis in December when 106 cases of symptomatic Covid-19 occur,” Bancel said

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