United States has approved Moderna's COVID-19 vaccine, says Trump
Moderna's COVID-19 vaccine has been approved in the United States, outgoing President Donald Trump announced ahead of the nation's drug regulator. Trump said on Friday that the vaccine has been approved, adding that distribution will start immediately. Earlier on Thursday, the US Food and Drug Administration (FDA) had recommended emergency approval to the vaccine, which has been found at least 94.1% effective.
Moderna vaccine overwhelmingly approved, says Trump
Trump wrote in a tweet on Friday, "Moderna vaccine overwhelmingly approved. Distribution to start immediately." However, the US FDA has made no public announcement about the grant of emergency use authorization (EUA) to the vaccine. Moderna's vaccine, mRNA-1273, is the second one to be approved in the US after Pfizer and BioNTech's vaccine, which was rolled out earlier this week.
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Outside FDA advisors endorsed EUA with 20-0 vote
A panel of outside FDA advisors had met on Thursday to discuss the issuance of EUA to Moderna's vaccine. The advisors had endorsed its use with a 20-0 vote, along with one abstention, that the vaccine's benefits outweighed its risks. The agency has found the vaccine to be highly effective. An announcement on the agency's decision was expected on Friday.
30,000-person study found vaccine 94% effective
Earlier this week, the FDA had released new data from Moderna's 30,000-person clinical study of the vaccine, confirming its 94.1% efficacy. The vaccine was 86.4% effective in people aged over 65, and 95.6% effective in those aged 18-65, the agency said in the report. The agency noted that the vaccine was similarly effective across racial and ethnic groups and those with underlying medical conditions.
Side-effects including fatigue and headaches common
The FDA had also noted that side-effects were common with Moderna's two-dose vaccine, with a majority of trial volunteers experiencing pain at the injection site, fatigue, and headaches. However, it had also observed that some asymptomatic infections start to be prevented after the first dose.
Pfizer vaccinations begin; VP Pence receives shot
Meanwhile, vaccinations with Pfizer-BioNTech's shot had started on Monday. On Friday, outgoing Vice President Mike Pence and Second Lady Karen Pence had received the vaccine at the White House. "Great job," Pence said after receiving the shot, "I didn't feel a thing. Well done." The vaccine has been approved in several other countries including Bahrain, Canada, Mexico, Saudi Arabia, Singapore, and the United Kingdom.