A coronavirus vaccine is coming, just not right away, according to Dr. Francis Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
The two medical experts discussed progress toward a vaccine in a Sept. 3 teleconference with several congressional caucus members, including U.S. Rep. Filemon Vela,D-Brownsville, helping represent the Congressional Hispanic Caucus.
“We’re moving it as fast as we can,” Collins said. “I wish it was even possible to get there faster, but we also have to be sure that we’re doing it in a fashion that is totally safe, and so that when it does get to us as a vaccine you can be confident that it has been under girded by the best science and it will be safe and effective.”
Large-scale vaccine trials by drug companies Moderna and Pfizer have been underway a little more than a month and each has as many as 20,000 volunteer participants enrolled on their way to 30,000, he said. Another trial, by Oxford University and AstraZeneca, just got underway and is expected to enroll 30,000 volunteers as well, Collins said.
All told, there are six different trails underway. Every trial involves two doses of the vaccine, one immediately followed by a booster on the 28th day, then scientists wait for results in terms of preventing infection, Collins said.
“The only way we really know that is to be sure that there’s a control group, and people who get the injection don’t know whether they got the active vaccine or whether they got a placebo,” he said. “That’s the only way we’ll ever really be sure.”
Fauci said he, Collins and other health experts have projected for months that a safe, effective vaccine won’t be ready to distribute until November or December. Fauci said the Centers for Disease Control and Prevention announcement to the states last week ago to prepare for vaccine distribution as early as late October created some confusion about when a vaccine would be available. That said, it’s not unusual to make logistical preparations well in advance, he said.
Fauci said each trial has a data and safety monitoring board, an independent group of experts that periodically look at the data and each time make one of four determinations: Continue the trial because insufficient data has been obtained; stop the trial because the results are too evenly spread over placebo and experimental vaccine, yielding no useful data; stop the trial for ethical reasons because of too many adverse outcomes among participants; declare the vaccine effective now “because the data are so good right now” rather than wait until the scheduled end of the trial, he said.
Fauci said his institute will probably start looking at the data from the Moderna and Pfizer trials in the next few weeks.
“I would say in the next three to four weeks we’ll take a good look and see, so you just need to stay tuned,” he said.
Fauci said he expects there to be more than one safe and effective vaccine when all is said and done, and that the process of approving one or more vaccines will be done transparently.
“Any decision is made, ultimately the data will be public,” he said.
Once a vaccine is deemed to be effective and safe in the short term, safety needs to be evaluated in the long term, Fauci said.
“There’s immediate, intermediate and long term safety issues,” he said. “We know from the phase one and the phase two there are no immediate safety issues that we’re concerned about. We will know at the end of the 30,000 trial whether there’s anything intermediate, namely things that occur after a few months.”
In response to a question from Vela, Fauci said Hispanics are being well represented in vaccine trials though more work needs to be done to enroll more African American participants. In all cases, the vaccines must be found safe and effective for adults before being tested on children and pregnant women,
Asked by another member of Congress whether the Food and Drug Administration could be pressured to issue a premature Emergency Use Authorization for a vaccine before the election, Fauci pointed out that FDA Commissioner Dr. Stephen Hahn has been explicit in saying that any decision on an EUA “will be based solely on science and evidence.” Also, an independent advisory group will be involved in any decisions regarding a EUA, Fauci said.
Responding to another Vela question, he confirmed that the FDA does not require the approval of the advisory committee in any regulatory decision it ultimately makes.
“It’s out there so we might as well just say it,” he said. “That’s what people are asking. The answer is the FDA has promised that that will not be the case, but there is … an advisory committee that’s involved in looking at the same data that the FDA looks at. So I think you have now a buffer there of an independent group of individuals who will be looking at the data. I think when you put those things together, I think we can feel confident that this will be done in a way that’s driven by the science.”