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WASHINGTON -- No shortcuts will be taken in developing a COVID-19 vaccine, and when it is approved or authorized for emergency use it will have been shown to be safe and effective, federal health officials declared at a Senate hearing here Wednesday.

"There will be no shortcuts," Surgeon General Jerome Adams, MD, MPH, said during a Senate Health, Education, Labor & Pensions (HELP) Committee hearing. "This vaccine will be safe, will be effective, or it won't get moved along. And when a vaccine is approved or authorized by the FDA, I and my family will be in line to get it."

Francis Collins, MD, PhD, director of the NIH, agreed. "I can't say strongly enough that decisions about how this vaccine is going be evaluated and assessed are going to be based on science," he said. "That can be the only basis on which this decision is made -- otherwise the public cannot be expected to trust us."

The answers from Adams and Collins came in response to a question from Sen. Bernie Sanders (I-Vt.) who noted that President Trump recently said a vaccine could be approved or authorized before Election Day in early November. "What we need is assurances from scientists and doctors like yourself ... to make it clear that you believe, as I believe, that we need to get that vaccine out as quickly as possible ... but that it's most important that the vaccine is safe and ready to go."

Concerns About Political Interference

Sen. Bob Casey (D-Pa.) noted that many Americans "have grave concerns about how the Trump administration appears to be interfering with the FDA review process for political gain" and are also concerned about institutional racism and injustice in the healthcare system. "It is imperative that any COVID-19 vaccine authorized or approved by the FDA and recommended for widespread dissemination be safe and effective, as evidenced by reliable data from randomized, controlled clinical trials," he said, adding that the White House Coronavirus Task Force "must tell the truth all the time, not play political games, and lead by example."

Sen. Patty Murray (D-Wash.), the committee's ranking member, asked Collins and Adams how they thought the government should go about building trust in the vaccine, especially given polls showing that 35% of those asked said they wouldn't get the vaccine even if it were FDA-approved and available at no cost.

"The best way we can engender that trust is by being as transparent as possible," Collins replied. "There are so many conspiracy theories out there right now; some of those are breathtaking in terms of the stretch to the imagination. The best antidote is to say exactly what we're doing. The number of steps in how the vaccines are evaluated that are going to give that kind of sense of scientific objectivity."

Collins explained how the process will work. "First, none of those vaccines will even go through review" until a Data Safety and Monitoring Board -- an outside committee appointed by the FDA -- looks at the data on vaccine safety and effectiveness. "Only when they say 'Something's happening here that looks like it actually might be worth reviewing' will it get brought forward." Then it will go through the FDA's internal approval process -- including a review and vote from an -- prior to the FDA making a final decision on approval.

Vaccine Storage Issues

Collins said he was pleased that the pharmaceutical manufacturers who were developing the vaccines recently put out a joint statement saying that they won't put forward a vaccine candidate for approval unless it's safe and effective. "If we can put all that information forward in a way that's digestible, I'm hoping it'll turn the tide," he said. "What a heartbreak that would be if we go through all this ... and yet people are afraid to use it. We can't let that happen." Adams said that as a task force member, he has seen "no politicization of the vaccine process whatsoever. We have a process in place that I trust as a doctor -- and as a dad."

Sen. Susan Collins (R-Maine) asked about the issue of storing the vaccine, since at least one of the farthest-along vaccine candidates requires storage at -94° F. "There is intense effort to figure out how to address this," Collins said, adding that Operation Warp Speed -- the Trump administration's effort to speed up development of COVID-19 vaccines and therapeutics -- "is trying to figure out with CDC how to make sure it doesn't become a deterrent to distribution."

Sen Bill Cassidy, MD (R-La.), asked whether any thought was being given to people who have already been exposed to the virus and developed antibodies naturally and don't need a vaccine, or at least need to be put lower on the priority list. "That's one of the questions that came up in the discussion about who gets vaccinated first," said Adams. He said such a person is "someone who would not be put, necessarily, at the front of the line" for vaccination but added, "It's important to remember that this virus has fooled us many times, and we don't know how long immunity will last."

Paul Questions Mandatory Vaccination

But not everyone was on the automatic vaccine bandwagon. "Not every disease is the same," said Sen. Rand Paul, MD (R-Ky.), known for his libertarian views. Although certain populations, such as nursing home residents, should be targeted for vaccination, in general, "each individual in a free society should assess the risks of disease versus the risk of the vaccine" and decide for themselves whether to get it, he said. Paul added that some vaccines, such as Pneumovax, are recommended only for certain age groups, and that children have a very small death rate -- 0.68 per million -- from COVID-19. "I've had all my vaccines but I'm still for choice," Paul said. "It doesn't mean we turn our brains off and say 'Everyone must have it' ... We really, really, really need to think through our fervor before we start mandating."

Collins said it would be "premature" to discuss who should or shouldn't receive the vaccine, although "I do think there's an issue about children getting infected and infecting others around them who have an immune system that can't handle it." And, he added, "0.68 is not zero."

Committee chairman Sen. Lamar Alexander (R-Tenn.) also expressed concern about children -- in particular, the number of children who haven't been getting their scheduled vaccines because their parents are afraid to take them to the doctor's office due to fear of contracting COVID-19. He cited a Wall Street Journal article saying a study had found that routine childhood vaccines declined about 40% from late February through mid-April.

Alexander urged parents to take their children for vaccination, saying that the American Academy of Pediatrics (AAP) "says pediatricians are working to ensure their offices are as safe as possible for children to visit ... according to AAP's Dr. Sean O'Leary, 'Medical offices are among the safest places you can be right now given the really extensive measures they've taken to prevent spread of COVID-19 both to themselves and their patients. Parents shouldn't be afraid to go to their doctor.'"

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