COVID-19 vaccine: Moderna expects emergency approval in December

By Rahul Vaimal, Associate Editor
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Moderna Vaccine
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Coronavirus vaccine candidate Moderna Inc’s Chief Executive Officer Stephane Bancel anticipates COVID-19 vaccine trial interim results by November and the US government could give an emergency approval in December, reports say.

Mr. Bancel also stated that if the adequate interim results from the study take a longer time to be received, then the government’s permission to use the vaccine may not come until next year.

The report further added that the first interim study of the vaccine’s efficacy will happen when 53 people in the entire analysis get symptomatic COVID-19.

In July, Moderna started a 30,000-person study in the US to test its vaccine candidate and half of the study subjects received the vaccine while the other half received a placebo. The researchers will take a count of how many of them get infected symptomatic COVID-19.

“That first analysis is likely to occur in November, but it’s hard to predict exactly which week because it depends on the cases, the number of people getting sick,” Mr. Bancel was cited as saying in the report.

He further stressed on the challenges in accelerating the production as, “If one ingredient is missing, we cannot make the vaccine.”

US-based Moderna is one of the leading vaccine candidates in development, along with a vaccine co-developed by Pfizer Inc and BioNTech. Last week, Pfizer Inc had said that it could apply in late November for US authorization of the COVID-19 vaccine it is developing.

Last month, Mr. Bancel had announced that Moderna would not be able to apply for emergency use of its COVID-19 vaccine before November 25 at the earliest.

Earlier this month Moderna said that it will soon apply for real-time reviews of its experimental COVID-19 vaccine in Europe. Soon after this the EU health regulator launched rolling reviews of shots.

The vaccine candidate is on track to produce 20 million doses of its experimental vaccine by the end of the year and at least 500 million in next year. The company added that 25,296 participants have enrolled in its late-stage study.

Drugmakers are racing to develop a COVID-19 vaccine, with more than 150 potential vaccines being developed and tested globally.