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Moderna announced on Monday that it will seek emergency use clearance from the Food and Drug Administration (FDA) for its novel coronavirus vaccine, following new clinical studies that confirmed the vaccine is 94.1%. effective in preventing Covid-19 and being safe, advances CNBC.
This is the second pharmaceutical company to apply for emergency use to the FDA after Pfizer, another pioneer in the Covid-19 vaccine race, applied for the same authorization on November 20. The announcement means that some Americans will be able to receive their first doses of the vaccine within weeks.
Moderna’s new analysis evaluated 196 confirmed Covid infections among 30,000 participants in the final phase study. The company said 185 cases of Covid were seen in the placebo group versus 11 cases seen in the group that received the vaccine, which resulted in 94.1% effectiveness, according to the company.
It is recalled that the company launched on November 16 a preliminary analysis of its phase three study based on only 95 cases of Covid-19 which showed that its vaccine would be at least 94% effective, specifically indicating an efficacy. by 94.5% and is now slightly lower. Monday’s data provides a more complete picture of the vaccine’s effectiveness.
Furthermore, the vaccine also appears to be able to prevent volunteers from becoming seriously ill with the virus. Of the 30 severe cases of Covid-19 in the clinical trial, none were in the group that received the vaccine, according to Moderna. There was also a death due to Covid-19 in the placebo group, according to the company.
On November 16, Secretary of Health and Human Services Alex Azar told CNBC that the FDA would take action “as soon as possible” to approve Pfizer and Moderna vaccines for emergency use. Between the two, around 40 million doses are expected to be available by the end of this year, enough to vaccinate around 20 million people, as both require two injections.
The initial Moderna results published earlier this month were based on the first interim efficacy analysis conducted by an external phase three data review committee of the clinical trial. The independent panel of experts oversees clinical trials in the United States to ensure the safety of participants.
Public health officials and medical experts note that it is not yet known how long vaccines offer immunity and whether and how often people may need periodic booster doses. Moderna’s vaccine, like Pfizer’s, uses messenger RNA or mRNA technology. It is a new approach to vaccines that uses genetic material to elicit an immune response.
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