President Donald Trump, who seems determined to announce a vaccine for COVID-19 before Election Day, could legally authorize it despite objections from experts, Food and Drug Administration (FDA) officials, and even manufacturers, who have pledged not to launch anything unless it has proven safe and effective.
Chief of Staff Mark Meadows says WH aiming to have 100 million doses of Coronavirus vaccine ready to go by end of October. Says goal is to make the the most vulnerable and highest risk people are vaccinated in that first group. Says up to 300 million doses would be ready in Jan. pic.twitter.com/7YHttsd5au
— Mark Knoller (@markknoller) September 17, 2020
In podcasts, public forums, social media, and medical journals, a growing number of health leaders say they fear that Trump, who has repeatedly pointed out his desire for the vaccine to pass quickly, will take matters into their own hands, ignoring the usual process.
This would reflect another attempt to inject policy into sensitive public health decisions. Trump has repeatedly contradicted the advice of high-level scientists on COVID-19 and endorsed controversial treatments to treat the disease.
Concerns intensified this weekend, after Alex Azar, Secretary of Health and Human Services (HHS), asserted his agency’s authority over the FDA to set standards.
The FDA usually approves vaccines. But Azar, who reports directly to Trump, can issue an emergency use authorization, even before the vaccine has been shown to be safe and effective in advanced clinical trials.
“Yes, this scenario is certainly possible legally and politically”
Said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, who described this scenario in the New England Journal of Medicine. He said it “seems scarier and more possible every day.”
Experts and public health officials are particularly upset about the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It could put scientific authorities in the position of urging people not to get vaccinated after years of trying to persuade undecided parents to ignore unfounded fears.
Doctors may refuse to administer an approved vaccine with inadequate data, said Dr. Preeti Malani, director of health and professor of medicine at the University of Michigan at Ann Arbor, at a virtual seminar. “You could have a safe and effective vaccine that no one wants to use.”
A recent KFF survey found that 54% of Americans would not get an authorized COVID-19 vaccine before Election Day.
White House spokesman Judd Deere dismissed scientists’ concerns and said Trump cared only about the safety and health of the public.
The FDA typically approves vaccines only after companies present years of data showing that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, provided that the vaccine “can be effective” and its “known and potential benefits” outweigh its “known and potential risks.”
Many scientists doubt that a vaccine can meet those criteria before the election. But the terms can be legally vague enough to allow the administration to take such measures.
Moncef Slaoui, Chief Scientific Advisor to Operation Warp Speed, the government program aimed at developing COVID-19 vaccines more quickly, said it is “extremely unlikely” that the results of a vaccine trial will be ready by the end of October.
However, Trump has repeatedly insisted that from next month a pandemic-fighting vaccine that has already claimed nearly 200,000 lives in the country will be distributed. He reiterated that claim on Saturday, September 19, at a campaign mutiny in Fayetteville, North Carolina.
The vaccine will be ready “in a matter of weeks,” he said. “We will put an end to China’s pandemic.”
Although pharmaceutical companies have launched three clinical trials in the United States, no one can say for sure when they will have enough data to determine whether vaccines are safe and effective.
Modern officials, whose vaccine is being tested on 30,000 volunteers, have said their studies could produce results by the end of the year, although the final analysis could be done next spring.
Pfizer executives, who have expanded their clinical trial to 44,000 participants, say they will know if their vaccine is working by the end of October.
The AstraZeneca vaccine trial in the United States, which was scheduled to enroll 30,000 volunteers, is in parentheses for a possible vaccine-related disease.
Scientists have warned for months that the Trump administration could try to win the election with an “October surprise“, authorizing a vaccine that hasn’t been fully tested.
In an opinion paper published in The Wall Street Journal, former conservative FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the “full and transparent FDA process does not lend itself to meddling. Any deviation would become apparent very quickly.”
But the administration has demonstrated its willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted, by the president, but who lacked solid evidence to support them: hydroxychloroquine and convalescent plasma.
Azar has set aside the FDA in other ways, such as preventing the agency from regulating laboratory-developed tests, including those of the new coronavirus.
Although FDA Commissioner Stephen Hahn told the Financial Times that he would be willing to approve the emergency use of a vaccine before large-scale studies were completed, agency officials have also pledged to ensure the safety of any COVID-19 vaccine.
Dr. Peter Marks, a senior FDA official overseeing vaccine approvals, has said he will resign if his agency approves a vaccine for COVID-19 that is not well tested.
“I think there would be an insurmountable protest from the public health community, which is my worst nightmare, my worst nightmare, because we will confuse the public,” said Dr. Michael Osterholm, director of the Center for Infectious and Political Disease Research at the University of Minnesota, in his weekly podcast.
Still, “even if a company didn’t want it done, even if the FDA didn’t want it done, he could do it,” Osterholm said, on his podcast. “I hope we never see that happen, but we have to consider it a possibility.”
In the New England Journal editorial, Avorn and the co-author, Dr. Aaron Kesselheim, wondered if Trump could invoke the Defense Production Act of 1950 to force reluctant pharmaceutical companies to manufacture their vaccines.
But Trump would have to sue a company to enforce this law, and the company would have a solid case to refuse, said Lawrence Gostin, director of the O’Neill Institute for georgetown’s National and Global Health Act.
In addition, he noted that Trump could not invoke the law unless a vaccine was “scientifically justified and approved by the FDA.”
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.