The United States should have 100 million doses of one candidate coronavirus vaccine by the end of the year, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and a member of the White House Coronavirus Task Force, said Tuesday.
“Then, by the beginning of 2021, we hope to have a couple hundred million doses,” Fauci said during a live Q&A with the Journal of the American Medical Association.
However, it’s still not clear whether the vaccine will be effective against the novel coronavirus.
Fauci said the first vaccine candidate, made by biotech company Moderna in partnership with NIAID, should go into a final stage of trials in volunteers, known as Phase 3, by mid-summer. Preparations at national and international sites are already under way, he said.
“The real business end of this all will be the Phase 3 that starts in the first week of July, hopefully,” Fauci said. “We want to get as many datapoints as we can.”
Phase 3 will involve about 30,000 people. The vaccine will be tested in people ages 18 to 55, as well as in the elderly and in people who have underlying health conditions.
“It’s going to be the entire spectrum,” Fauci said.
Fauci said Phase 2 of the trial started a few days ago. A few hundred volunteers will be involved in that part of the trial.
The plan is to manufacture doses of the vaccine even before it is clear whether it will work, making close to 100 million doses by November or December, Fauci said. If it does work, then it can be deployed quickly.
Scientists should have enough data by November or December to determine if the vaccine works, Fauci said.
The University of Oxford and AstraZeneca vaccine trial under way in the UK will follow a similar schedule. A handful of other vaccine studies should start just one to two months after that, he said.
“I’m cautiously optimistic that with the multiple candidates we have with different platforms, that we are going to have a vaccine that will make it deployable,” Fauci said. He is optimistic, he said, because, while the number of deaths from Covid-19 are “profound,” largely people recover from this disease. Recovery shows that there is an immune response that can clear the virus.
“Which tells us, that if the body is capable of making an immune response to clear the virus of natural infection, that’s a pretty good proof of concept,” Fauci said. “Having said that, there is never a guarantee.”
Indeed, even with 10 vaccines already in clinical trials and more than 120 more in development, many experts are skeptical that a vaccine will be available early next year. Key trial phases can be delayed, and ultimately, the vaccines being tested now may not protect people against the virus. Millions of vaccine doses manufactured ahead of time could be thrown out.
Fauci noted he’s also concerned about what the durability of the immune response will be. People develop antibodies to fight common colds caused by other strains of coronavirus, but that protection generally only lasts about a year. That might mean people would need a fresh vaccine every year, as is the case with influenza.
Fauci said there is also a “major push” under way on programs to develop monoclonal antibodies, convalescent plasma and hyperimmune globulin. These are all treatments that employ antibodies, like vaccines do, but deliver them directly, provide more temporary protection, and can also potentially treat Covid-19 symptoms.
Fauci said he would like to see treatments developed using monoclonal antibodies or convalescent plasma that would protect the elderly and those who are at risk for the worst symptoms of Covid-19.
“That’s a very, very high priority,” Fauci said.