“So in early 2021, we hope to have a couple of hundred million doses,” said Fauci during a live Q&A with the Journal of the American Medical Association.
However, it is not yet clear whether the vaccine will be effective against the new coronavirus.
Fauci said that the first vaccine candidate, created by the modern biotechnology company in collaboration with NIAID, should enter a final phase of testing on volunteers, known as Phase 3, by mid-summer. Preparations on national and international sites are already underway, he said.
“The real commercial end of all of this will be Phase 3 which starts in the first week of July, hopefully,” said Fauci. “We want to get as many data points as possible.”
Phase 3 will involve around 30,000 people. The vaccine will be tested in people aged 18 to 55, as well as in the elderly and people who have basic health conditions.
“It will be the whole spectrum,” said Fauci.
Fauci said phase 2 of the trial started a few days ago. A few hundred volunteers will be involved in that part of the process.
The plan is to produce doses of the vaccine even before it is clear whether it will work, making nearly 100 million doses by November or December, Fauci said. If it works, it can be deployed quickly.
Scientists are expected to have enough data by November or December to determine if the vaccine works, Fauci said.
The University of Oxford and AstraZeneca vaccine study underway in the UK will follow a similar program. A handful of other vaccine studies should only start one or two months later, he said.
“I am cautiously optimistic that with the multiple candidates we have on different platforms, we will have a vaccine that will make it deployable,” said Fauci. He is optimistic, he said, because while the death toll for Covid-19 is “profound”, most people recover from this disease. Recovery shows that there is an immune response that can eliminate the virus.
“Which tells us that if the body is able to provide an immune response to eliminate the virus from natural infection, this is a good proof of concept,” said Fauci. “With that said, there is never a guarantee.”
In fact, even with 10 vaccines already in the clinical trial phase and over 120 more in development, many experts are skeptical that a vaccine will be available early next year. The key stages of the trial may be delayed and, in the end, the vaccines being tested may not protect people from the virus. Millions of previously produced vaccine doses could be eliminated.
Fauci noted that he is also worried about how long the immune response will last. People develop antibodies to fight common colds caused by other coronavirus strains, but protection generally lasts only about a year. This could mean that people would need a new vaccine every year, such as in the case of the flu.
Fauci said that a “big push” is also underway in programs for the development of monoclonal antibodies, convalescent plasma and hyperimmune globulin. These are all treatments that use antibodies, like vaccines do, but provide them directly, provide more temporary protection and can even potentially treat the symptoms of Covid-19.
Fauci said he would like to see treatments developed using monoclonal antibodies or convalescent plasma that would protect the elderly and those at risk for the worst symptoms of Covid-19.
“This is a very, very high priority,” said Fauci.
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