Published 12:35 IST, October 1st 2020
Moderna's coronavirus vaccine won't be ready before November 25, CEO says
American Biotech firm Moderna won’t seek an emergency use authorization for its coronavirus vaccine before November 25, the company CEO said on September 30.
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American Biotech firm Moderna won’t seek an emergency use authorization for its coronavirus vaccine before November 25, the company CEO said on September 30. The Massachusetts based firm is currently in its third phase trials for its potential vaccine candidate. Recently, it revealed that its vaccine candidate was suited to the older age people as it did to the young.
'Not before November 25'
Speaking to Financial Express, Stephane Bancel confirmed that it was on November 25 that the company would have enough “safety data” to be able to put into a EUA file that we would be sent to the FDA. She added that it would be then that the proposed vaccine would be assumed to be safe.
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However, President Donald Trump who has invested millions of federal money in the vaccine development has constantly claimed a COVID-19 vaccine before November 3 elections. Reiterating his claim at the recently held presidential debate, he said that getting and “answer” to the coronavirus was possible before November 1. His confidence has worried many experts who feel that trump administration might attempt to pressurize the developers to expedite the process compromising on drug safety.
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The statement comes as New trials conducted by Moderna Inc. revealed that its COVID-19 vaccine appeared safe and worked well with older adults. The findings of the trials were published in the New England Journal of Medicine and revealed that the vaccine produced virus-neutralizing antibodies at levels similar to those seen in adults. Moderna is already testing 100 microgram dose of its vaccine in Phase 3, and positive results would make it US’ first vaccine.
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The latest research was conducted as an extension of the company’s Phase I safety trials which were first conducted in individuals aged 18-55. For the purpose, researchers tested two doses of Moderna’s vaccine - 25 micrograms and 100 micrograms - in 40 adults aged 56 to 70 and 71 and older. In the aftermath, they found that in adults who received two injections of 100 microgram dose 28 days apart, the vaccine produced immune responses roughly in line with those produced in young adults.
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12:35 IST, October 1st 2020