On Monday, Moderna Inc. announced that its vaccine for the Wuhan coronavirus pandemic had tested 94.5 percent effective, clearing important hurdles toward production and potential distribution in the coming months. The Moderna vaccine represents a second tremendous victory for the Trump administration’s Operation Warp Speed, which teamed up with medical companies to prepare a vaccine for COVID-19 as soon as possible. Last week, Pfizer announced its vaccine had tested more than 90 percent effective.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna CEO Stéphane Bancel said in a statement. She thanked the study participants, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA). “I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point,” she added.
The NIH-appointed Data Safety Monitoring Board (DSMB) told Moderna that the Phase 3 study of its vaccine candidate had “met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficiacy of 94.5%.” The study on the vaccine’s effectiveness involved more than 30,000 participants. Participants who did not take the vaccine contracted 90 cases of COVID-19, 11 of which were severe, while those who took the vaccine only contracted 5 cases. No one who took the vaccine had a severe case.
“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,” Bancel explained.
While Pfizer’s vaccine tested 90 percent effective, Moderna’s version has a key advantage over the competitor. Pfizer’s vaccine must be stored at temperatures of minus 70 degrees Celsius, and it only lasts for up to five days at standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48 degrees Fahrenheit). By contrast, Moderna announced its vaccine will be stable at standard refrigerator temperatures for 30 days. Moderna’s vaccine can be stored for up to 6 months at -20 degrees Celsius.
Pending more safety data and regulatory review, both the Pfizer and Moderna vaccines could quip the United States with as many as 60 million doses by the end of 2020.
Next year, the U.S. government could have access to more than 1 billion doses of vaccine from just Pfizer and Moderna, much more than the 330 million needed for U.S. citizens and residents.
The Department of Health and Human Services (HHS) announced a partnership with Moderna for Operation Warp Speed back in August. HHS and the Department of Defense partnered with Moderna to manufacture and deliver 100 million doses of the company’s vaccine candidate, doses which the government will own.
President Donald Trump celebrated Pfizer’s success in a speech at the Rose Garden on Friday.
“No medical breakthrough of this scope and magnitude has ever been achieved,” the president declared. “Operation Warp Speed is unequaled and unrivaled anywhere in the world.”
Trump noted that the average vaccine development process takes 8 to 12 years, yet “through operation Warp Speed we’re doing it in less than 1 year. … This is five times faster than the fastest prior vaccine development in history. Five times faster.” That truly is a jaw-dropping and historic accomplishment.
The president insisted that under any other administration, the vaccine “would have taken three, four, five years” to develop, “and it would have been in the FDA forever.”
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Tyler O’Neil is the author of Making Hate Pay: The Corruption of the Southern Poverty Law Center. Follow him on Twitter at @Tyler2ONeil.