FDA finds Moderna vaccine 94% effective - clearing way for use by Monday
Outside medical advisors will now review the FDA data, meaning a second vaccine could be approved by the end of the week
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Your support makes all the difference.Staff at the Food and Drug Administration (FDA) have approved emergency use of a Covd vaccination created by Moderna, meaning a second wave of inoculations is likely to begin very soon.
Their decision is a significant step towards securing final approval for the vaccine.
On Thursday their Vaccines and Related Biological Products Advisory Committee, a group of outside medical advisors, will meet to review Moderna’s vaccine.
The group recommended Pfizer’s vaccine for emergency use last Thursday, and the FDA approved it for emergency use the next day.
The FDA determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19,” the staff wrote.
“FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA.”
Moderna submitted its Covid vaccine data to the FDA on 30 November.
It said a final analysis of its phase three clinical trial, with 30,000 participants, found the vaccine was safe and more than 94 per cent effective in preventing Covid.
Its vaccine uses messenger RNA, or mRNA, technology - a new approach to vaccines that uses genetic material to provoke an immune response.
Moderna has said it expects to have 20 million doses available for the US to ship by the end of 2020, enough to inoculate 10 million people with the two-shot regimen.
The company tested the vaccine in people 18 and older, comparing them with subjects who got a placebo injection.
Unlike Pfizer, Moderna has accepted funding from the US government for research and development of its vaccine.
The government committed to making nearly $1 billion available to Moderna for research and other preparations, and has agreed to pay about $3.1 billion to purchase 200 million doses.
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