Senators Press NIH Director on COVID-19 Vax Timeline

WASHINGTON -- As President Trump on Thursday was praising his administration's accomplishments during the COVID-19 pandemic, a Senate Appropriations subcommittee was voicing concern over the surge in cases nationwide and asking government scientists for more details on the development of vaccines and treatments.

"The crisis is being handled," Trump said at a morning press conference. "Some areas that were very hard-hit are now doing very well. Some were doing very well, and we thought they may be gone and they flare up, and we're putting out the fires."

He noted that when the White House had a conference call Wednesday with the governors to ask them what they needed, "Not one governor needed anything. They don't need anything. They have all the medical equipment they can have."

But that wasn't the feeling at the hearing held by the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. "The United States is currently experiencing its worst large-scale public health outbreak in a generation," said subcommittee chairman Sen. Roy Blunt (R-Mo.). "Yesterday, new coronavirus cases in the U.S. passed 50,000 for the first time to reach a single-day record. As of this morning, 128,000 Americans have died and nearly 2.7 million have tested positive for COVID-19."

That was the reason, Blunt said, that the committee was holding a hearing about the pace of COVID-19 vaccine and treatment development. "The mantra underlying this pandemic is that we need a vaccine to truly get this pandemic under control," he continued. "And I think that is right -- that life will not return to resembling pre-outbreak normal until there is an effective and widely available coronavirus vaccine. But how do we get there?"

Praise, Criticism for Operation Warp Speed

Blunt praised the Trump Administration's Operation Warp Speed project to jump-start vaccine and therapeutic candidates. "There are over 100 vaccines in development worldwide and Operation Warp Speed, I believe, is beginning to focus in on about seven, that we would encourage the advancement of in clinical trials and for further development," he said. "Importantly, as NIH [the National Institutes of Health] and the Biomedical Advanced Research and Development Authority [BARDA] continue to oversee the development of these vaccines, we'll also be talking today about how manufacturing -- for maybe the first time ever -- would begin while the vaccine is going through the other process" of a clinical trial.

Sen. Patty Murray (D-Wash.), the subcommittee's ranking member, expressed skepticism about efforts so far. "If we want to get out of this mess anytime soon, the Trump administration has to do better -- particularly when it comes to developing a safe, effective vaccine that is widely available," she said. "What I hear from experts, is that while we all want a vaccine fast, a vaccine that's fast but ineffective will fall far short of what is needed to turn the tide on this pandemic. That's why it is more than concerning that the Trump administration sidelined our leading scientists at CDC, removed the head of BARDA, reportedly for putting science and public health over allegiance to President Trump, and took BARDA experts off leadership of contracts related to the search for a COVID-19 vaccine."

"I also have concerns about why BARDA has chosen to invest solely in new vaccine technologies that have only been studied experimentally and never made it to market, while not pursuing older, proven technologies," she continued. "Meanwhile, the administration still hasn't provided any explanation of how it is selecting vaccine candidates ... and it still hasn't provided a comprehensive national vaccine plan."

Details on a Vaccine Timeline

Senators pressed committee witnesses for details. "Where are we today?" Sen. Richard Shelby (R-Ala.), chairman of the full Senate Appropriations Committee, asked NIH Director Francis Collins, MD, PhD. "Tell us exactly where we are on coming up with a vaccine."

"It generally takes 5 to 10 years to develop a vaccine from a new infectious agent; we don't have that time," replied Collins, noting that it took only 63 days -- "a world record by a long shot" -- from when scientists were given the virus's DNA sequence to the injection of a vaccine candidate into a volunteer as part of a Phase I trial being conducted by Moderna. Phase II of that trial started May 29th, and Phase III is expected to begin this month.

"We need to enroll 30,000 volunteers," which will take some months, and "we are all optimistic that the goal we've set is to have a vaccine that's safe and that works by the end of 2020, will be met by one of the vaccines, and we would then have, by early 2021, 300 million doses of a vaccine that would be safe and effective," he said. "That's really a stretch goal, but it's the right goal for the American people."

Sen. Dick Durbin (D-Ill.) questioned that timeline: "When I'm told that the Phase III clinical trial of the Moderna vaccine will kick off in about a week and they anticipate it will last for 2 years before they've completed it ... I find that difficult to square that reality that's been announced with the promises I'm hearing over and over again" that a vaccine will be ready within 12 months of when the process started, Durbin said. "It suggests to me that the Phase III clinical trial, which ordinarily takes 2 years, is going to be somehow abbreviated."

CNBC reported Thursday that Moderna announced it was pushing the start of the Phase III trial back, "possibly by a few weeks," although the company CEO reiterated that it still plans to start the trial in July.

Collins said the issue was that the vaccine assessment would continue even after the vaccine was approved, to monitor those who took it for any unexpected long-term side effects. "What we need to know as soon as possible is, does this vaccine ... protect people from becoming infected?" he said.

"Each of the vaccine trials will aim to enroll 30,000 participants -- half will get the vaccine and half will get a placebo. It will only take about 126 episodes where somebody with the placebo gets infected and somebody with the vaccine doesn't, to know that this has worked ... The reason to prolong the study after that has already been achieved is a number of other things -- are there any long-term side effects that weren't anticipated? And how durable is the immunity?"

Sen. John Kennedy (R-La.) wondered why, if this expedited process for developing vaccines and therapeutics was safe, that researchers didn't use it all the time. It's because the process involves ramping up vaccine production even before a trial is completed in order to distribute the vaccine as fast as possible, increasing the likelihood that billions of dollars will be wasted on producing vaccines that don't work, Collins said.

"We can't usually afford to justify billions of dollars ... but this time we can, given the public health emergency," he said.

Risk of Mutation

Sen. Jeff Merkley (D-Ore.) asked about the risk that the virus would mutate later on, rendering any vaccine developed now ineffective.

"The somewhat reassuring news is that this particular virus does not have a rapid mutation rate," like influenza or HIV, said Collins. He added, however, that "at least one significant variant in the virus that's already happened that may have made it somewhat more infectious than the original strain coming out of Wuhan. The good news is those variants do not seem to interfere with current vaccines being tested, but we're going to watch that very carefully."

Overall, he said, "this is a fairly well-behaved virus that we ought to be able to tackle effectively with a vaccine strategy."

Sen. Joe Manchin (D-W.Va.) asked whether the federal government would be likely to recoup any of the money it is spending on vaccine development if a successful vaccine is found. Yes it would, said BARDA Acting Director Gary Disbrow.

"When we're doing contracting for acquisition, we seek consideration for our previous investment ... also for the cost of capital," he said. For example, if a company planned to charge $10 per dose of vaccine it sold outside the U.S., "the U.S. government would buy it at a reduced price" because of the money invested in the vaccine's development.

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