There’s growing concern among health experts and Democrats that President Donald Trump will rush a potentially faulty coronavirus vaccine before the election to save his presidency.
But it’s highly unlikely even the bare minimum of clinical trial data from the administration’s “Operation Warp Speed” candidates will be available by November, making any possible attempt to speed up a vaccine before the election extremely difficult.
“I think there is a sense among many people on the inside that this is such a tempting thing to do, to put your hands in the Warp Speed bucket, pull out one or two vaccines and say, ‘Look, these are safe,’” vaccine expert Paul Offit of Children’s Hospital of Philadelphia, who sits on the FDA vaccine advisory committee, told BuzzFeed News. “I cannot imagine that you would have data that shows efficacy and in a period of time that would be over the next few months.”
On Monday, Moderna began its first injections of 30,000 people as part of its Phase 3 clinical trial for its mRNA vaccine candidate. Trump and Vice President Mike Pence visited two of the 89 vaccine development sites across the country, where Moderna will monitor for signs that people who receive the vaccine are less likely to get infected or have severe illness than those injected with a placebo.
The vaccine is one of five Operation Warp Speed candidates, so far supported by around $6 billion in federal funding. In May, Trump unveiled the new effort promising that vaccines would be available by the end of the year. “We’re all set to deliver them as soon as we have them — and that’s going to be very soon,” Trump said at a press briefing on Thursday.
Trump’s emphasis on speed and his public fixation on vaccines as his reelection campaign falters has raised concern among public health experts and presumptive Democratic presidential nominee Joe Biden that the administration will jump safety guardrails.
Biden has in the last week repeatedly called for transparency in showing vaccine candidates are proven safe and effective before they are rolled out to the public. And he has cast doubt on whether Trump is capable of providing that. “The development of a new vaccine requires a dedication to science, coordination, transparency, truth, and fairness to all — and we have a President who stands for none of these things,” Biden said in a statement from his campaign.
The vaccine safety guardrails that do exist may be too high for Trump to get around, though, even if he tries to ignore them.
Trump administration officials, including Anthony Fauci and FDA chief Stephen Hahn, have repeatedly said that safety rather than speed would be the determining factor for releasing a vaccine to tens of millions of people. In June, Fauci told McClatchy News there would be “no chance” he would agree to a vaccine that he doesn’t think passes muster. At a press briefing on Monday, Fauci said a rushed timeline would only work if there were big outbreaks in areas where people were already being administered the test vaccines, which would quickly make clear whether they were effective. He added that he doubted that scenario would happen.
The Trump administration, though, has already cut medical corners during the coronavirus pandemic. Public health experts have pointed to the administration’s handling of hydroxychloroquine — which was rushed as a COVID-19 treatment under public pressure by Trump but ultimately found to be ineffective — to raise questions about the FDA’s role in safeguarding the public.
“I think anyone who is listening and anyone who has watched how he has dealt with the pandemic since the beginning has pause about whether politics plays in this,” Sen. Patty Murray, the lead Democrat on the Senate’s Health Committee, told BuzzFeed News when asked if there’s a question about the president rushing a vaccine for political purposes.
“If there is not confidence in having this vaccine, we will be where we are today with this virus two, three, four years from now,” she said.
The hydroxychloroquine saga has given a glimmer of optimism for some public health experts, however. Although the administration steamrolled the FDA to authorize hydroxychloroquine in March, the agency subsequently withdrew the emergency authorization in June and has withstood Trump’s continued public complaints about the decision and evangelism for the drug since then.
“I feel a little better now, as the FDA has made clear they will handle this in the right way,” infectious disease expert Carlos del Rio of Emory University told BuzzFeed News. Del Rio had previously raised alarm about the possibility of an October vaccine shortcutting safety steps.
Early release of an unvetted vaccine could lead to a public health fiasco similar to the October 1976 release of a hurried swine flu vaccine ahead of the election, which had side effects that included cases of a paralytic syndrome, and spurred the anti-vaccine movement. And as Democrats have argued, a faulty vaccine could cripple the country’s ability to ultimately defeat the coronavirus by destroying Americans’ remaining faith in vaccination.
“If a vaccine or any medication is pushed out there and you find out 6 or 12 months later that there are health consequences or that it doesn’t work, we will lose the confidence in our scientific ability — not just on this but on anything in the future,” Murray told BuzzFeed News. “There is high stakes on this. We’ve got to get it right.”
Murray published a report on July 13 that expressly asked the administration to set rigorous standards for vaccine development and scientific review. The report calls on, among other things, the administration to protect the clinical review process from “political interference” and “require inclusive clinical trial designs, and engage with the international community.” Murray’s hoping Congress will introduce similar language in the coronavirus stimulus package Congress is currently negotiating.
On Tuesday, Sen. Roy Blunt of Missouri said he asked the administration for a vaccine distribution plan by Oct. 1, with or without a proven vaccine. Murray thinks that’s too late.
“You need to plan now,” Murray told BuzzFeed News. “If a vaccine is available and it’s safe and effective in October, you have to have a supply chain ready. You have to have the distribution points in place. People need to know where to go. People need to know who can take and who gets it first. We need to have the plan in place and we need to have a transparent process of this vaccine and what’s going on.”
The sheer biology of testing a vaccine makes an Election Day deadline very unlikely.
The Moderna vaccine comes in two shots spaced 28 days apart, which puts the true start of the company’s current Phase 3 trial into September. Then there is the time needed for both the placebo group and those given the vaccine to be exposed to the coronavirus. It takes around 5 days for symptoms to start to develop, and 14 days for serious illness, hospitalizations, and deaths. Even if enough people in the placebo group were instantly infected to provide a statistical basis to say the vaccine prevents the disease or severe symptoms, around 150 people according to Fauci, that would carry the trial well into October.
Meanwhile, people are being told to keep distant, wear masks, and avoid indoor settings to avoid the very infections the clinical trial needs to observe to prove the effectiveness of a vaccine. “All of that works against a fast result,” said Offit. “The only thing arguing for a fast result is that this country is the right place to do those trials because we have outbreaks across the land.”
As on Thursday, more than 4.4 million people have been diagnosed with COVID-19 in the US, and more than 150,000 have died.
“I can’t see how this is done, frankly, before the middle of next year,” Offit added. Nevertheless, the FDA has scheduled a meeting of its vaccine advisory committee, whose vote is usually requested before the licensing of a new vaccine, for late October, said Offit, right ahead of the election. “I would assume that is going to be about coronavirus,” he said
The FDA would not confirm the meeting date or its purpose with BuzzFeed News. By law, the agency only needs to provide 15 days’ notice for meetings in the Federal Register.
Normally, before they end up in people's arms, vaccines must prove safe and effective in large clinical trials, receive FDA approval, and then recommendation from an immunization expert panel at the CDC, the agency that coordinates inoculations in the US. The federal government has not released a final plan for the distribution of coronavirus vaccines, but on Wednesday, CDC officials presented the immunization panel with its early thinking. The earliest bottleneck foreseen is an initial 10 to 20 million vaccine doses needed for 9 million people in healthcare, 16 million people with essential jobs, and 79 million people with “high-risk” health conditions.
The CDC’s Sarah Mbaeyi asked the panel which healthcare and essential workers to prioritize for those first, limited doses by its next meeting in late August. The US National Academy of Medicine was also asked to answer that question, and to look at ways to get vaccines to Black, Latinx, and other communities that have borne a disproportionate weight of COVID-19 cases and deaths. A report is due by early Fall.
In its June guidance to vaccine makers, the FDA said that to qualify for a license an inoculation would be expected to “prevent disease or decrease its severity in at least 50% of people” in clinical trials. That standard is a much lower bar than past requirements for inoculations. Even the yearly flu vaccine is in some years able to prevent disease in about a third of its takers, but protects a much higher percentage of people from severe symptoms.
On Monday, federal health officials announced the first enrollment of volunteers in the Moderna trial and said the goal was 60% or better efficacy at preventing disease altogether.
A faster option for distributing a vaccine would be for the FDA to authorize its use under the same emergency rules that initially greenlit hydroxychloroquine, a possibility raised by the agency. Instead of taking into account data showing a treatment is more effective, an emergency use authorization is allowed if a candidate looks promising and is vetted by internal agency review, not a panel of outside experts.
Another key scientific meeting to watch for will be a separate Department of Health and Human Services’ vaccine panel, which has one session left this year, said former HHS official Howard Koh of Harvard’s T.H. Chan School of Public Health. “That’s where a lot will be decided.”
Koh argued that so many scientific watchdogs oversee vaccine safety that the Trump administration would be hard-pressed to jump over safeguards without creating blowback that wrecks public confidence in the vaccine. Koh oversaw federal safety monitoring of the 2009 swine flu outbreak vaccine, where communicating the vaccine’s safety was essential to getting people to get inoculated, something more true than ever today.
“Not just the nation, but the whole world is going to be watching the safety data from these trials,” Koh said. “This will be the most scrutinized safety data ever.” ●