Moderna’s highly-regarded coronavirus vaccine appears to be 94.5% effective, the company announced Monday, the highest efficacy of any COVID vaccine candidate so far, providing yet another surge of hope as cases rise across the country.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters,” said Stephane Bancel, CEO of Moderna in a statement.
Dr. Anthony Fauci, appearing Monday on TODAY, called the data “striking” and “quite impressive.”
Moderna said the vaccine appears to be 94.5% effective based on its Phase 3 trial, which enrolled more than 30,000 participants and was evaluated by the independent Data Safety Monitoring Board which delivered the news to the company.
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Moderna said it plans to submit the vaccine for emergency use authorization with the Food and Drug Administration in the coming weeks.
Fauci said he expects the EUA will be granted.
The first interim analysis included 95 trial participants with confirmed cases of coronavirus. Ninety of those cases were observed among those that received the placebo and only five among those who got the Moderna vaccine.
A secondary endpoint that looked at 11 severe cases of COVID showed all of the cases occurred in the placebo group and none in the vaccine group.
“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Bancel.
The final analysis that will be sent to the FDA will include 151 cases and a median follow-up of more than two months, according to Moderna.
No significant safety concerns were reported and adverse reactions were mild to moderate including fatigue, pain at the injection site, headache and muscle and joint pain.
Moderna also announced Monday that the vaccine is now expected to remain stable at standard refrigerator temperatures for 30 days, up from previous estimate of 7 days, which will allow simpler and more flexible distribution.
By the end of the year, Moderna expects to have 20 million doses of the vaccine ready to ship in the United States.
Monday’s announcement sent Moderna stock skyrocketing, which was trading at more than $100 a share pre-market, well above the company’s 52-week high.
A week ago, competitor Pfizer Inc. announced its own COVID-19 vaccine appeared more than 90% effective.
Dr. Stephen Hoge, Moderna’s president, welcomed the “really important milestone” but said having similar results from two different companies is what’s most reassuring.
“That should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives,” said Hoge.
Fauci said, “Now we have two vaccines that are quite effective so I think this is a really strong step forward to where we want to be about getting control of this outbreak.”
Herald wire services contributed to this report.
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Author: Alexi Cohan
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