A viral meme falsely suggests Dr. Anthony Fauci supports administering a COVID-19 vaccine before clinical trials are completed. Fauci supports the manufacture of vaccines while trials are underway — but only administering the vaccine once the trials are over and it is deemed effective and safe.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, has become a leading figure in addressing treatments and a vaccine for COVID-19 as a member of the White House Coronavirus Task Force.
But a meme circulating on Facebook, attributing two quotes to Fauci, falsely suggests an inconsistency in his views on the need for clinical trials before approving a COVID-19 treatment and the process needed to ensure the safety of an eventual vaccine.
The first quote in the meme reads, “Just because hundreds of doctors are reporting hydroxychloroquine is curing some COVID-19 patients, it is not valid until we have a major study done.” Fauci has said that controlled clinical trials are required to make sure hydroxychloroquine is “truly safe and truly effective” against COVID-19, and the evidence so far does not show that it is.
The second quote reads, “As soon as a COVID-19 vaccine is manufactured, it must be delivered to healthcare professionals for immediate human injection. Proper studies can be done later.” That’s false. Fauci has said distribution and administration of a vaccine would only occur if the clinical trial shows that “in fact it is effective” and safe.
It is true that Fauci has cautioned against the use of hydroxychloroquine before its effectiveness is proven by a large clinical trial. In March, he explained that the evidence supporting hydroxychloroquine as a treatment for COVID-19 is largely “anecdotal” and that without first undergoing a controlled clinical trial — in which a treatment group is compared with a control group — the effectiveness of the drug cannot be known.
Large trials are still pending, but the evidence so far does not suggest that hydroxychloroquine is effective against COVID-19.
One study, a randomized controlled trial of 150 patients hospitalized with mild to moderate disease in China, did not find the drug helped reduce the chance that patients would test positive for the virus within 28 days — and patients receiving hydroxychloroquine reported more side effects, although most were minor.
In a May 27 interview with CNN, Fauci said, “The scientific data is really quite evident now about the lack of efficacy” of hydroxychloroquine in treating COVID-19, and he noted the likelihood of “adverse events with regard to cardiovascular.”
Regarding a COVID-19 vaccine, Fauci did not say that the vaccine will be administered before “proper studies” are over, as the meme claims.
Fauci, Feb. 25: Now the thing we need to understand, because we want to make sure that people don’t get confused, that getting a vaccine into a Phase 1 trial within a three-month period, you need at least three to four months to determine if it’s safe and whether it induces the kind of response that you would predict will be protective. Once you do that you graduate to a much larger trial. … When you go to a Phase 2 trial, you’re talking about hundreds if not thousands of individuals to determine efficacy. That is a trial that we would have to conduct in those countries, in those areas, where there’s active transmission. That itself, even at rocket speed, would take at least an additional six to eight months. So when you are talking about the availability of a vaccine even to scale it up you’re talking about a year to a year-and-a-half.
That timeline was revised on May 15, when the Trump administration announced “Operation Warp Speed” — a national program “to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” The goal is “to have substantial quantities of a safe and effective vaccine available for Americans by January 2021,” the Department of Health and Human Services said.
In a June 1 interview with STAT News, Fauci explained how the administration would move more quickly to make a vaccine available to the public without compromising public health.
Fauci said manufacture of a COVID-19 vaccine would begin “even before you know it works,” which may be the origin of the second quote in the meme. That would allow the vaccine to be widely distributed more quickly, but only “if in fact it is effective,” Fauci said.
“At the same time you’re finishing your Phase 1 trial, you’re preparing your Phase 3 trial sites, which is very expensive, and then you’re starting to manufacture the vaccine even before you know it works. All of that cuts months off,” said Fauci. However, Fauci elaborated, “We’ve designed the Phase 3 trial to very carefully look at safety, even more so than is done in a regular trial.”
He described the accelerated timeline as “aspirational,” and cautioned that there is “no guarantee” that the vaccine will be proven effective.
Fauci, June 1: If … you’re already manufacturing doses, by December and January, if you’re lucky and if in fact it is effective, you can have a significant number of doses available by the end of the year, the beginning of 2021. So I think it’s aspirational, but it’s certainly doable.
The only thing that’s the big unknown to me is that, is it going to be effective? I think we could do it within the time frame that I’ve outlined. But there’s no guarantee that it’s going to be effective.
Many vaccines are currently undergoing clinical trials. One vaccine that shows promise, developed by Moderna in partnership with NIAID, is scheduled in July to enter Phase 3 — the phase in which a vaccine is given to thousands of people to test for safety. Another vaccine, developed by the University of Oxford and AstraZeneca, recently began recruiting participants for Phases 2 and 3 of the clinical trial.
In a live Q&A with the Journal of the American Medical Association on June 3, Fauci said the plan to manufacture millions of doses of vaccine still undergoing clinical trial is “very unique in vaccine development” and is an investment risk for the companies and the federal government.
Fauci said the plan is to manufacture “close to 100 million doses” by the time clinical trials indicate whether the vaccine is effective, and that “by the beginning of 2021, we hope to have a couple hundred million of doses.”
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