Boston’s Brigham and Women’s Hospital is among 87 study sites and the only one in New England. The hospital hopes to start administering the vaccines later this week.
The researchers may have provisional results for November or earlier, but it is impossible to predict with certainty, Fauci said.
The Modern vaccine employs a genetic technology never before used in a medicine. In an early-phase trial, the vaccine candidate triggered the production of antibodies, immune system proteins that attack intruders in the body, in all 45 volunteers, and their antibodies killed the virus in the laboratory.
Now, the researchers want to administer the experimental vaccine to a large number of people and see if they are less likely to contract the coronavirus than a similar group receiving a placebo.
Such a study is called a phase 3 clinical trial. The Moderna vaccine is one of five candidate vaccines that have advanced to this stage worldwide, but the first in the United States.
Fauci said Moderna and the NIAID had set a record by starting Phase 3, about six months after Chinese scientists shared the genetic sequence of the new coronavirus that causes COVD-19.
Dr. Francis Collins, director of the National Institutes of Health, said researchers “now have an opportunity to discover in the real world” whether Moderna’s vaccine is effective against coronavirus.
About a dozen sites are expected to begin enrollment this week, said Ray Jordan, a spokesperson for Moderna. More than 50 sites are expected to participate by next week, and most of the remaining sites by the following week.
Participants will receive the candidate vaccine or placebo in two injections 28 days apart.
The study is recruiting people who are at risk of exposure to the virus, such as those who live in high-density homes or who work in occupations that involve many interactions with people, said Dr. Lindsey R. Baden, an infectious disease specialist at Brigham and Women’s, one of the top three researchers in the national study, as well as the leader of the New England site.
The study also aims to enroll those at increased risk for serious disease if they become infected, such as people with heart or lung disease or diabetes, Baden said. The researchers hope to find out if the vaccine can prevent serious illness in those who become infected, he said.
But the most important question is whether the vaccine is safe, he said.
“None of this is compromising security,” Baden told the Globe. “There are no shortcuts to security.”
That point was repeatedly emphasized in a Monday press conference by the National Institutes of Health in Bethesda, Maryland, with Fauci, Collins, and others.
“We have focused on speed because every day is important,” said Moderna CEO Stéphane Bancel. “We are losing people every day around the world.” But, he added, “we are doing it without compromising security.”
In addition to receiving two injections of the experimental vaccine, participants will undergo six or seven blood draws, and the researchers will be in frequent contact by phone, Baden said. They plan to follow patients up to two years after administering the medication.
Anyone who develops symptoms, such as a cold or flu-like illness, will have a COVID-19 test. People who don’t feel sick will not be tested for COVID-19 during the study, but blood tests will look for evidence of antibodies to the coronavirus to detect asymptomatic infections.
The researchers will also be on the lookout for side effects, especially in the first few days after the injection. In the previous study, a third of patients suffered short-term side effects including fatigue, chills, headache, muscle pain, or injection site pain.
“I want to get away from the concept that ‘safe’ means you never have a side effect,” said Baden. “We have to make sure of the profit. . . it outweighs any risk. “Many people who receive the herpes zoster vaccine, for example, feel sick for a couple of days afterward, but feel that it is preferable to receive herpes zoster.
Anyone interested in participating in the study can complete a questionnaire at https://rally.partners.org/study/covid_vax.
In addition to online registrations, recruiting will involve advertising on social media and print and reaching directly into “communities that are not usually engaged in research,” said Baden, particularly people of color, who have been disproportionately affected by the virus. . “We want to make sure we have people from underrepresented communities,” he said.
The vaccine will be considered effective if it prevents at least 60 percent of infections, which Fauci said is a standard threshold.
“Obviously, we would like to see much, much higher, but 60 percent is the limit,” Fauci said at the press conference.
Combined with public health measures like social distancing and wearing masks, Fauci said, a vaccine that is 60 percent effective would still have a powerful impact on the pandemic.
If the vaccine works, it probably won’t be implemented until next year. But Bancel, the CEO of Moderna, said at the press conference that the company could seek emergency authorization from the Food and Drug Administration to make the vaccine available earlier to a “subgroup of the population.”
Moderna’s experimental vaccine is one of several that have received hundreds of millions of dollars from the federal government under the Trump administration’s program called Operation Warp Speed.
The others include a collaboration between Johnson & Johnson and Beth Israel Deaconess Hospital, a collaboration between AstraZeneca and the University of Oxford, and one from Novavax, Gaithersburg, Maryland, biotechnology. Neither is as advanced in clinical trials in the United States as the Modern vaccine.
If the vaccine is successful, it would be a significant validation of the genetic technology that Moderna was founded a decade ago to develop. Until now, the company has not brought a single product to market.
Moderna’s technology deploys a molecule known as messenger RNA, or mRNA, a chain of genetic material that enters cells and provides the blueprint for producing the proteins that cells need to function. To create a coronavirus vaccine, Moderna scientists programmed the mRNA to drive the cell to make part of the coronavirus. This triggers an immune response that will theoretically activate and destroy the virus if a person is infected.
On Monday, Moderna’s shares rose as much as 11 percent when the trial began, just after news that the Federal Advanced Biomedical Research and Development Authority had promised up to $ 472 million more for the study, in addition to $ 483 million that was already planned. The stock ended the day up 9.1 percent.
Felice J. Freyer can be contacted at [email protected]. Follow her on Twitter @felicejfreyer Jonathan Saltzman can be contacted at [email protected]
