The vaccination marks a much-anticipated milestone: the official launch of the first in a series of large U.S. clinical trials that will each test experimental vaccines in 30,000 participants, half receiving the shot and half receiving a placebo.
“It’s a truly historic event in the history of vaccinology,” Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a news conference. He noted that the United States has never moved faster to develop a vaccine, from basic science to a large phase 3 trial designed to test safety and effectiveness.
Fauci predicted that researchers could understand whether the vaccine worked by November or December, although he explained that it was a “distinct possibility” an answer could come sooner.
The vaccine requires two doses, nearly a month apart, and then researchers will have to wait to see whether people get sick from the novel coronavirus. What they hope to witness is a clear benefit: People who received the vaccine develop fewer cases of covid-19 or have less severe episodes of the disease caused by the coronavirus. There are many unknowns about how long it could take to see a clear signal of success or failure — including how fast the trial will recruit participants and how long it takes for enough people to become infected to observe whether there is an effect.
Statisticians have been crunching the numbers to predict how many infections would need to occur in the study population to gauge the vaccine’s effectiveness. To show a vaccine is 60 percent effective, Fauci said, there would need to about 150 infections among the 30,000 participants.
The trial is also the biggest test yet of a promising technology that has never been approved for use outside medical research. The vaccine could become the first in a new class of medicines that deliver a snip of genetic material that carries the blueprint for the spiky proteins that cover the surface of the coronavirus and help it enter cells. The body’s cells follow the genetic instructions to build the proteins, and the immune system, confronted with the spike protein, learns how to recognize and mount a defense to the virus without ever being infected.
“I believe it is a historic day: the first phase 3 covid-19 vaccine being run in the U.S.,” Moderna chief executive Stephane Bancel said. “It’s a historic day for science, as well. This is the first phase 3 of a messenger RNA medicine in the world.”
Company and government officials repeatedly underscored that while the effort is moving at record-breaking speed, safety is not being sacrificed.
“There is no compromise at all, with regard to safety or of scientific integrity,” Fauci said.
At least three other large trials facilitated by Operation Warp Speed, the federal effort to speed vaccine development, are expected to follow. Those include an experimental vaccine being developed jointly by the University of Oxford and AstraZeneca, one from Johnson & Johnson, and another candidate from the biotechnology company Novavax. Pharmaceutical giant Pfizer is expected to start its large trial this month.
Interest in the trials is surging in the pandemic, but researchers said it would be essential for volunteers to include those who are most at risk of severe consequences of covid-19, including black, Hispanic, Native American and older people.
“This is going to be a big American opportunity for people to come onboard as our partners, to take part in what is a historic effort to bring to an end [to] the worst pandemic our world has seen in over 100 years,” National Institutes of Health director Francis Collins said.
Moderna is planning to produce 500 million vaccine doses a year, with the possibility of making 1 billion doses annually in 2021. Over the weekend, the U.S. government committed $472 million to support the large trial, doubling the federal investment in Moderna’s vaccine candidate.
Several other vaccine developers have begun large trials designed to test effectiveness, including two candidates from Chinese companies and one being developed by the University of Oxford and AstraZeneca that is being tested in Brazil and South Africa and will soon start U.S. trials.
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