William Schaffner: Moderna Covid-19 vaccine shows striking success in US tests

Published: Nov. 16, 2020, 8:40 p.m.

A second experimental COVID-19 vaccine — this one from Moderna Inc. — yielded extraordinarily strong early results Monday, another badly needed dose of hope as the pandemic enters a terrible new phase.
Moderna said its vaccine appears to be 94.5% effective, according to preliminary data from an ongoing study. A week ago, competitor Pfizer Inc. announced its own vaccine looked 90% effective — news that puts both companies on track to seek permission within weeks for emergency use in the U.S.
The results are “truly striking,” said Dr. Anthony Fauci, the U.S. government's top infectious-diseases expert. “The vaccines that we're talking about, and vaccines to come, are really the light at the end of the tunnel.”
A vaccine can’t come fast enough, as virus cases topped 11 million in the U.S. over the weekend — 1 million of them recorded in just the past week — and governors and mayors are ratcheting up restrictions ahead of Thanksgiving. The outbreak has killed more than 1.3 million people worldwide, over 246,000 of them in the U.S.
Stocks rallied on Wall Street and elsewhere around the world on rising hopes that the global economy could start returning to normal in the coming months. Moderna was up 7.5% in the morning, while companies that have benefited from the stay-at-home economy were down, including Zoom, Peloton and Netflix.
Both vaccines require two shots, given several weeks apart. U.S. officials said they hope to have about 20 million Moderna doses and another 20 million of the vaccine made by Pfizer and its German partner BioNTech to use in late December.
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,” Hoge told The Associated Press. He added: “It won’t be Moderna alone that solves this problem. It’s going to require many vaccines” to meet the global demand.
If the Food and Drug Administration allows emergency use of Moderna’s or Pfizer’s candidate, there will be limited, rationed supplies before the end of the year.
Exactly who is first in line has yet to be decided. But Health and Human Services Secretary Alex Azar said the hope is that enough doses are available by the end of January to vaccinate adults over 65, who are at the highest risk from the coronavirus, and health care workers. Fauci said it may take until spring or summer before anyone who is not high risk and wants a shot can get one.
The National Institutes of Health helped create the vaccine Moderna is manufacturing, and NIH's director, Dr. Francis Collins, said the exciting news from two companies “gives us a lot of confidence that we're on the path towards having effective vaccines.”
But “we're also at this really dark time,” he warned, saying people can't let down their guard during the months it will take for doses of any vaccines cleared by the FDA to start reaching a large share of the population.
Moderna’s vaccine is being studied in 30,000 volunteers who received either the real thing or a dummy shot. On Sunday, an independent monitoring board examined 95 infections that were recorded after volunteers’ second shot. Only five of the illnesses were in people given the vaccine.
Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective.
The study is continuing, and Moderna acknowledged the protection rate might change as more COVID-19 infections are detected. Also, it’s too soon to know how long protection lasts. Both cautions apply to Pfizer’s vaccine as well.
But Moderna’s independent monitors reported some additional, promising tidbits: All 11 severe COVID-19 cases were among placebo recipients, and there were no significant safety concerns. The main side effects were fatigue, muscle aches and injection-site pain after the second dose.
Scientists not in...