In a meeting last month with Health and Human Services Secretary Alex Azar — who is overseeing the effort called Operation Warp Speed, along with Defense Secretary Mark T. Esper — Trump pushed Azar repeatedly to speed up the already unprecedented timeline, according to two senior White House officials familiar with the meeting who spoke on the condition of anonymity to discuss private conversations. Trump wants some people to be able to get the vaccine sooner than the end of the year to demonstrate that an end to the pandemic is within reach, according to those officials and two others.
Trump is hardly the only world leader racing to deliver a vaccine as a way to save lives, get people back to work and fully reopen the economy. But some scientists and even several people close to the White House worry that his fixation on the timeline, combined with his past dismissal of scientists’ recommendations, could put regulators under intense pressure to approve some sort of limited use of a vaccine before it has been adequately vetted for safety and effectiveness.
Some go so far as to raise concerns about an “October surprise” in which the administration issues an emergency authorization for a vaccine right before the Nov. 3 election, regardless of whether the research justifies it.
“What worries me is we are coming up to an election, and the administration might be tempted to put its hand into the Warp Speed bucket, and say we have enough information, let’s just give it now,” said Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia who is an adviser to the National Institutes of Health effort on vaccines.
“This will be a huge issue … when we have the first application for a vaccine and people will wonder and worry, ‘Is the FDA using science and evidence here, or is it trying to meet some political timeline?’” said Ashish Jha, director of the Harvard Global Health Institute. “I think the FDA has lost a lot of credibility the last few months.”
Unlike a rare cancer treatment or a drug for a debilitating disease, vaccines are given to healthy people, so there is little tolerance for side effects or risks, vaccine experts say. Another concern is that those who have been immunized may return to behaviors that put them at risk, only to have a vaccine turn out to be ineffective.
Trump administration officials insist the process will be driven by science.
“Under no circumstances will we allow political pressure to affect our decision-making and, importantly, that has not occurred on my watch,” said FDA Commissioner Stephen Hahn, who has denied the White House influenced the agency’s emergency authorization of antimalarial drugs.
“Any new vaccine must be thoroughly tested to ensure it is safe and effective, and that is why Operation Warp Speed is being led by expert scientists focused on saving lives,” said White House spokesman Judd Deere.
Trump has eschewed the advice of many scientists throughout his presidency, but now he finds himself reliant on an extraordinary scientific experiment to end a global pandemic. Even as he spends far less time dealing with the coronavirus crisis, the president has convened several meetings on vaccines in recent weeks, telling officials to move faster on making a vaccine available.
If a vaccine were approved as early as the fall, it would most likely come in the form of a so-called emergency-use authorization issued by the FDA. Such authorizations require a lower level of evidence of effectiveness than formal approvals. They may be issued if the agency believes a product “may be effective” to prevent or treat a serious or threatening disease, and that its “known and potential benefits” outweigh the risks.
National Institutes of Health Director Francis Collins said delivering an emergency-use authorization by the fall is one of the administration’s “stretch goals.”
“We have for the most part been focused on the stretch goals and trying to inspire everyone” to do things that previously did not seem possible, Collins said in an interview. “Hopefully at least having an EUA for one or more of [the vaccines] by sometime in the fall — that is a stretch goal, and even beyond belief. It has my knuckles white.”
An emergency-use authorization might allow a vaccine to be distributed to certain high-risk groups. Two senior administration officials said groups that are likely to be prioritized are the elderly, those with preexisting conditions and front-line essential workers, such as those in health care and food safety.
It remains unclear, however, just how broad or narrow such an authorization could be, and the number of people who would be eligible to receive it under those circumstances.
National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci said recently that Operation Warp Speed, unveiled last month, was set up to remove the financial disincentives to manufacture vaccines before a drugmaker knows they will work. On a telecast hosted by the Journal of the American Medical Association, he said officials may know whether potential vaccines are effective by November or December and hoped to have “close to” 100 million doses by then. The goal is to have “a couple of hundred million doses” by early next year, he said.
Under the initiative, the administration is providing extensive financial support to 14 vaccine candidates to accelerate the timeline by enabling them to proceed simultaneously through the normally sequential steps — testing, then manufacturing. Officials will eventually narrow the list to the seven most promising candidates, two senior administration officials said on a call with reporters Tuesday.
Moncef Slaoui, a pharmaceutical industry veteran and the chief adviser for Warp Speed, has been convening calls with private companies and meeting with Jared Kushner, a White House senior adviser and Trump’s son-in-law, who played a role in selecting him, several senior administration officials said.
The administration also has a public-private partnership spearheaded by the National Institutes of Health and has hundreds of millions of dollars in funding going to various drug companies from the Biomedical Advanced Research and Development Authority to help them more quickly move through the process. The administration is working closely with several companies, including AstraZeneca, Moderna, Johnson & Johnson and Merck.
Three companies are expected to begin late-stage 30,000-person vaccine trials this summer, which could provide health officials with several months worth of safety data, but many scientists are doubtful there would be definitive data on effectiveness by then.
Some vaccine experts said it could take eight to 12 months to know whether a vaccine is effective, but they have expressed concerns that the FDA might be pressured to authorize it earlier if it appeared safe and showed it produced antibodies in clinical trial participants — even though such antibodies wouldn’t necessarily prove effectiveness because it is not yet clear whether they prevent people from getting covid-19, the disease caused by the novel coronavirus.
Peter Lurie, a former top FDA official who has been intensely critical of the FDA’s performance on hydroxychloroquine, said he doesn’t believe the agency would make a similar mistake on a vaccine.
“I like to believe the people I worked with would not let loose an ineffective vaccine on the American people because the consequences could be catastrophic,” Lurie said.
Fauci, asked about the possibility of White House pressure to move quickly for political reasons, replied that is he is focused on the work.
“I’m going to do the best possible science to develop what I consider convincing evidence that it works and is safe, or does not work and is not safe,” Fauci said. “That’s what I’m focused on trying to definitively show.”
