Omicron boosters: Is salesmanship trumping science?
Moderna headquarters in Cambridge, Mass.
Last month, the Food and Drug Administration authorized Omicron-specific vaccines (with Moderna’s the best known), accompanied by breathless science-by-press release and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed, recommending updated boosters for anyone age 12 and up who had received at least two doses of the original COVID-19 vaccines. The message to a nation still struggling with the COVID pandemic: The cavalry — in the form of a shot — is coming over the hill.
But for those familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — combined with the lack of completed studies — has caused considerable heartburn and raised an array of unanswered concerns.
The updated shots easily clear the “safe and effective” bar for government authorization. But in the real world, are the Omicron-specific vaccines significantly more protective — and in what ways — than the original COVID vaccines so many have already taken? If so, who would benefit most from the new shots? Since the federal government is purchasing these new vaccines — and many of the original, already purchased vaccines may never find their way into taxpayers’ arms — is the $3.2 billion price tag worth the unclear benefit? Especially when these funds had to be pulled from other covid response efforts, like testing and treatment.
Several members of the CDC advisory committee that voted 13-1 for the recommendation voiced similar questions and concerns, one saying she only “reluctantly” voted in the affirmative.
Some said they set aside their desire for more information and better data and voted yes out of fear of a potential winter COVID surge. They expressed hope that the new vaccines — or at least the vaccination campaign that would accompany their rollout — would put a dent in the number of future cases, hospitalizations, and deaths.
That calculus is, perhaps, understandable at a time when an average of more than 300 Americans are dying of COVID each day.
But it leaves front-line health care providers in the impossible position of trying to advise individual patients whether and when to take the hot new vaccines without complete data and in the face of marketing hype.
Don’t get us wrong. We’re grateful and amazed that Pfizer-BioNTech and Moderna (with assists from the National Institutes of Health and Operation Warp Speed) developed an effective vaccine in record time, freeing the nation from the deadliest phase of the covid pandemic, when thousands were dying each day. The pandemic isn’t over, but the vaccines are largely credited for enabling most of America to return to a semblance of normalcy. We’re both up-to-date with our covid vaccinations and don’t understand why anyone would choose not to be, playing Russian roulette with their health.
But as society moves into the next phase of the pandemic, the pharmaceutical industry may be moving into more familiar territory: developing products that may be a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness in the absence of adequate controlled studies or published data, advertising them as desirable for all when only some stand to benefit significantly, and in all likelihood raising the price later.
This last point is concerning because the government no longer has funds to purchase COVID vaccines after this autumn. Funding to cover the provider fees for vaccinations and community outreach to those who would most benefit from vaccination has already run out. So updated boosters now and in the future will likely go to the “worried well” who have good insurance rather than to those at highest risk for infection and progression to severe disease.
The FDA’s mandated task is merely to determine whether a new drug is safe and effective. However, the FDA could have requested more clinical vaccine effectiveness data from Pfizer and Moderna before authorizing their updated omicron BA.5 boosters.
Yet the FDA cannot weigh in on important follow-up questions: How much more effective are the updated boosters than vaccines already on the market? In which populations? And what increase in effectiveness is enough to merit an increase in price (a so-called cost-benefit analysis)? Other countries, such as the United Kingdom, perform such an analysis before allowing new medicines onto the market, to negotiate a fair national price.
The updated booster vaccine formulations are identical to the original covid vaccines except for a tweak in the mRNA code to match the omicron BA.5 virus. Studies by Pfizer showed that its updated Omicron BA.1 booster provides a 1.56 times higher increase in neutralizing antibody titers against the BA.1 virus as compared with a booster using its original vaccine. Moderna’s studies of its updated Omicron BA.1 booster demonstrated very similar results. However, others predict that a 1.5 times higher antibody titer would yield only slight improvement in vaccine effectiveness against symptomatic illness and severe disease, with a bump of about 5 percent and 1 percent, respectively. Pfizer and Moderna are just starting to study their updated Omicron BA.5 boosters in human trials.
Though the studies of the updated Omicron BA.5 boosters were conducted only in mice, the agency’s authorization is in line with precedent: The FDA clears updated flu shots for new strains each year without demanding human testing. But with flu vaccines, scientists have decades of experience and a better understanding of how increases in neutralizing antibody titers correlate with improvements in vaccine effectiveness. That’s not the case with COVID vaccines. And if mouse data were a good predictor of clinical effectiveness, we’d have an HIV vaccine by now.
As population immunity builds up through vaccination and infection, it’s unclear whether additional vaccine boosters, updated or not, would benefit all ages equally. In 2022, the U.S. has seen COVID-hospitalization rates among people 65 and older increase relative to younger age groups. And while COVID vaccine boosters seem to be cost-effective in the elderly, they may not be in younger populations. The CDC’s Advisory Committee on Immunization Practices considered limiting the updated boosters to people 50 and up, but eventually decided that doing so would be too complicated.
Unfortunately, history shows that — as with other pharmaceutical products — once a vaccine arrives and is accompanied by marketing, salesmanship trumps science: Many people with money and insurance will demand it whether data ultimately proves it is necessary for them individually or not.
We are all likely to encounter the SARS-CoV-2 virus again and again, and the virus will continue to mutate, giving rise to new variants year after year. In a country where significant portions of at-risk populations remain unvaccinated and unboosted, the fear of a winter surge is legitimate.
But will the widespread adoption of a vaccine — in this case yearly updated COVID boosters — end up enhancing protection for those who really need it or just enhance drugmakers’ profits? And will it be money well spent?
The federal government has been paying a negotiated price of $15 to $19.50 a dose of mRNA vaccine under a purchasing agreement signed during the height of the pandemic. When those government agreements lapse, analysts expect the price to triple or quadruple, and perhaps even more for updated yearly COVID boosters, which Moderna’s CEO said would evolve “like an iPhone.” To deploy these shots and these dollars wisely, a lot less hype and a lot more information might help.
Elisabeth Rosenthal (erosenthal@kff.org, @rosenthalhealth) and Céline Gounder (cgounder@kff.org) are Kaiser Health News journalists.
Jill Richardson: How do we get skeptics to get COVID shots?
U.S. airman Ramón Colón-López receives Pfizer COVID-19 vaccine at Walter Reed National Military Medical Center this month.
Via OtherWords.org
With the new COVID-19 vaccine available, Dr. Anthony Fauci says Americans can begin to achieve herd immunity by next summer. Herd immunity occurs when so many people are immune to the virus that it can’t spread, because an infected person won’t have anyone left to spread it to.
Yet as of last month, four in ten Americans said they definitely or probably won’t get the vaccine (although about half of that group said they would consider it once a vaccine became available and they could get more information about it).
Why, after living in quarantine for almost 10 months while the economy and our mental health crashes around us, after over 300,000 Americans are dead, is getting the vaccine even a question?
There are two ways to approach this question. The first is to dismiss it: Call vaccine skeptics derogatory names, post memes on social media about how stupid they are, and make rules requiring the vaccine.
The second way to approach the question is to try to understand vaccine skepticism in order to address Americans’ concerns.
Sociologist Jennifer Reich tied vaccine refusal to messages that treat health like a personal project, in which consumers must exercise their own discretion, and a culture of individualism in a world where there is not enough of anything to go around — jobs, money, health care, etc.
In this view, everyone must look out for themselves so they can get ahead, and that’s more important than doing your part to achieve herd immunity for our collective wellbeing.
Reich’s research on anti-vaxxers comes from before the current pandemic. She studied parents who refused to vaccinate their children for preventable diseases like measles. But it’s still worth considering in this new context. Reich believes it is unsurprising that some people do treat vaccines like a consumer choice and disregard that when they decline a vaccine, they endanger others too.
Another take on COVID vaccine refusal comes from Zakiya Whatley and Titilayo Shodiya, who are both women of color with PhDs in natural sciences. They focus on Black, Latinx and indigenous communities, who often distrust doctors. Their suspicion is not unfounded, given how much racism in medicine has harmed people of color, historically and in the present.
Scientists hold the power to define what is true and what is not in a way that non-scientists do not. Consider the power relations within medicine: When a patient goes to the doctor because they are ill, the doctor assesses their symptoms, makes a diagnosis, and prescribes a treatment.
Scientists determine what is recognized as a diagnosis and which treatments are available. Powerful financial interests (like pharmaceutical and insurance companies) play a major role too. The patient’s power is more limited: they can look up their symptoms on WebMD, accept or refuse the treatment prescribed, or go to a different doctor.
Sometimes lay people react to being on the less powerful end of the relationship by simply refusing to believe scientists. They might resist by embracing conspiracy theories or “barstool biology” that uses the language of science but not the scientific method.
Natural scientists have done their part by creating vaccines that are safe and highly effective. To get people to take the vaccine, we need social science. We must learn how to rebuild trust with people who have lost it. And we will do that by listening to them and understanding them, not by calling them stupid.
Jill Richardson, a sociologist, is an OtherWords.org columnist.
Headquarters of a COVID-19 vaccine inventor and maker, Moderna, in Cambridge, Mass. Greater Boston is one of the world’s centers of biotechnology.
Rachana Pradhan: How big pharma money colors Operation Warp Speed
April 16 was a big day for Moderna, the Cambridge, Mass., Massachusetts biotech company on the verge of becoming a front-runner in the U.S. government’s race for a coronavirus vaccine. It had received roughly half a billion dollars in federal funding to develop a COVID shot that might be used on millions of Americans.
Thirteen days after the massive infusion of federal cash — which triggered a jump in the company’s stock price — Moncef Slaoui, a Moderna board member and longtime drug-industry executive, was awarded options to buy 18,270 shares in the company, according to Securities and Exchange Commission filings. The award added to 137,168 options he’d accumulated since 2018, the filings show.
It wouldn’t be long before President Trump announced Slaoui as the top scientific adviser for the government’s $12 billion Operation Warp Speed program to rush COVID vaccines to market. In his Rose Garden speech on May 15, Trump lauded Slaoui as “one of the most respected men in the world” on vaccines.
The Trump administration relied on an unusual maneuver that allowed executives to keep investments in drug companies that would benefit from the government’s pandemic efforts: They were brought on as contractors, doing an end run around federal conflict-of-interest regulations in place for employees. That has led to huge potential payouts — some already realized, according to a KHN analysis of SEC filings and other government documents.
Slaoui owned 137,168 Moderna stock options worth roughly $7 million on May 14, one day before Trump announced his senior role to help shepherd COVID vaccines. The day of his appointment, May 15, he resigned from Moderna’s board. Three days later, on May 18, following the company’s announcement of positive results from early-stage clinical trials, the options’ value shot up to $9.1 million, the analysis found. The Department of Health and Human Services said that Slaoui sold his holdings May 20, when they would have been worth about $8 million, and will donate certain profits to cancer research. Separately, Slaoui held nearly 500,000 shares in GlaxoSmithKline, where he worked for three decades, upon retiring in 2017, according to corporate filings.
Carlo de Notaristefani, an Operation Warp Speed adviser and former senior executive at Teva Pharmaceuticals, owned 665,799 shares of the drug company’s stock as of March 10. While Teva is not a recipient of Warp Speed funding, Trump promoted its antimalarial drug hydroxychloroquine as a COVID treatment, even with scant evidence that it worked. The company donated millions of tablets to U.S. hospitals and the drug received emergency use authorization from the Food and Drug Administration in March. In the following weeks, its share price nearly doubled.
Two other Operation Warp Speed advisers working on therapeutics, Drs. William Erhardt and Rachel Harrigan, own financial stakes of unknown value in Pfizer, which in July announced a $1.95 billion contract with HHS for 100 million doses of its vaccine. Erhardt and Harrigan were previously Pfizer employees.
“With those kinds of conflicts of interest, we don’t know if these vaccines are being developed based on merit,” said Craig Holman, a lobbyist for Public Citizen, a liberal consumer advocacy group.
An HHS spokesperson said the advisers are in compliance with the relevant federal ethical standards for contractors.
These investments in the pharmaceutical industry are emblematic of a broader trend in which a small group with the specialized expertise needed to inform an effective government response to the pandemic have financial stakes in companies that stand to benefit from the government response.
Slaoui maintained he was not in discussions with the federal government about a role when his latest batch of Moderna stock options was awarded, telling KHN he met with HHS Secretary Alex Azar and was offered the position for the first time May 6. The stock options awarded in late April were canceled as a result of his departure from the Moderna board in May, he said. According to the KHN analysis of his holdings, the options would have been worth more than $330,000 on May 14.
HHS declined to confirm that timeline.
The fate of Operation Warp Speed after President-elect Biden takes office is an open question. While Democrats in Congress have pursued investigations into Warp Speed advisers and the contracting process under which they were hired, Biden hasn’t publicly spoken about the program or its senior leaders. Spokespeople for the transition didn’t respond to a request for comment.
The four HHS advisers were brought on through a National Institutes of Health contract with consulting firm Advanced Decision Vectors, so far worth $1.4 million, to provide expertise on the development and production of vaccines, therapies and other COVID products, according to the federal government’s contracts database.
Slaoui’s appointment in particular has rankled Democrats and organizations such as Public Citizen. They say he has too much authority to be classified as a consultant. “It is inevitable that the position he is put in as co-chair of Operation Warp Speed makes him a government employee,” Holman said.
The incoming administration may have a window to change the terms under which Slaoui was hired before his contract ends, in March. Yet making big changes to Operation Warp Speed could disrupt one of the largest vaccination efforts in history while the American public anxiously awaits deliverance from the pandemic, which is breaking daily records for new infections. Warp Speed has set out to buy and distribute 300 million doses of a COVID vaccine, the first ones by year’s end.
“By the end of December we expect to have about 40 million doses of these two vaccines available for distribution,” Azar said Nov. 18, referring to front-runner vaccines from Pfizer and Moderna.
Azar maintained that Warp Speed would continue seamlessly even with a “change in leadership.” “In the event of a transition, there’s really just total continuity that would occur,” the secretary said.
Pfizer, which didn’t receive federal funds for research but secured the multibillion-dollar contract under Warp Speed, on Nov. 20 sought emergency authorization from the FDA; Moderna just announced that it would do so. In total, Moderna received nearly $1 billion in federal funds for development and a $1.5 billion contract with HHS for 100 million doses.
While it’s impossible to peg the precise value of Slaoui’s Moderna holdings without records of the sale transactions, KHN estimated their worth by evaluating the company’s share prices on the dates he received the options and the stock’s price on several key dates — including May 14, the day before his Warp Speed position was announced, and May 20.
However, the timing of Slaoui’s divestment of his Moderna shares — five days after he resigned from the company’s board — meant that he did not have to file disclosures with the SEC confirming the sale, even though he was privy to insider information when he received the stock options, experts in securities law said. That weakness in securities law, according to good-governance experts, deprives the public of an independent source of information about the sale of Slaoui’s stake in the company.
“You would think there would be kind of a one-year continuing obligation [to disclose the sale] or something like that,” said Douglas Chia, president of Soundboard Governance and an expert on corporate governance issues. “But there’s not.”
HHS declined to provide documentation confirming that Slaoui sold his Moderna holdings. His investments in London-based GlaxoSmithKline — which is developing a vaccine with French drugmaker Sanofi and received $2.1 billion from the U.S. government — will be used for his retirement, Slaoui has said.
“I have always held myself to the highest ethical standards, and that has not changed upon my assumption of this role,” Slaoui said in a statement released by HHS. “HHS career ethics officers have determined my contractor status, divestures and resignations have put me in compliance with the department’s robust ethical standards.”
Moderna, in an earlier statement to CNBC, said Slaoui divested “all of his equity interest in Moderna so that there is no conflict of interest” in his new role. However, the conflict-of-interest standards for Slaoui and other Warp Speed advisers are less stringent than those for federal employees, who are required to give up investments that would pose a conflict of interest. For instance, if Slaoui had been brought on as an employee, his stake from a long career at GlaxoSmithKline would be targeted for divestment.
Instead, Slaoui has committed to donating certain GlaxoSmithKline financial gains to the National Institutes of Health.
Offering Warp Speed advisers contracts might have been the most expedient course in a crisis.
“As the universe of potential qualified candidates to advise the federal government’s efforts to produce a COVID-19 vaccine is very small, it is virtually impossible to find experienced and qualified individuals who have no financial interests in corporations that produce vaccines, therapeutics, and other lifesaving goods and services,” Sarah Arbes, HHS’s assistant secretary for legislation and a Trump appointee, wrote in September to Rep. James Clyburn (D.-S.C.), who leads a House oversight panel on the coronavirus response.
That includes multiple drug-industry veterans working as HHS advisers, an academic who’s overseeing the safety of multiple COVID vaccines in clinical trials and sits on the board of Gilead Sciences, and even former government officials who divested stocks while they were federal employees but have since joined drug company boards.
Dr. Scott Gottlieb and Dr. Mark McClellan, former FDA commissioners, have been visible figures informally advising the federal response. Each sits on the board of a COVID vaccine developer.
After leaving the FDA in 2019, Gottlieb joined Pfizer’s board and has bought 4,000 of its shares, at the time worth more than $141,000, according to SEC filings. As of April, he had additional stock units worth nearly $352,000 that will be cashed out should he leave the board, according to corporate filings. As a board member, Gottlieb is required to own a certain number of Pfizer shares.
McClellan has been on Johnson & Johnson’s board since 2013 and earned $1.2 million in shares under a deferred-compensation arrangement, corporate filings show.
The two also receive thousands of dollars in cash fees annually as board members. Gottlieb and McClellan frequently disclose their corporate affiliations, but not always. Their Sept. 13 Wall Street Journal op-ed on how the FDA could grant emergency authorization of a vaccine identified their FDA roles and said they were on the boards of companies developing COVID vaccines but failed to name Pfizer and Johnson & Johnson. Both companies would benefit financially from such a move by the FDA.
“It isn’t a lower standard for FDA approval,” they wrote in the piece. “It’s a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine.”
About the inconsistency, Gottlieb wrote in an email to KHN: “My affiliation to Pfizer is widely, prominently, and specifically disclosed in dozens of articles and television appearances, on my Twitter profile, and in many other places. I mention it routinely when I discuss Covid vaccines and I am proud of my affiliation to the company.”
A spokesperson for the Duke-Margolis Center for Health Policy, which McClellan founded, noted that other Wall Street Journal op-eds cited his Johnson & Johnson role and that his affiliations are mentioned elsewhere. “Mark has consistently informed the WSJ about his board service with Johnson & Johnson, as well as other organizations,” Patricia Shea Green said.
Johnson & Johnson’s vaccine is in phase 3 clinical trials and could be available in early 2021.
Still, while they worked for the FDA, Gottlieb and McClellan were subject to federal restrictions on investments and protections against conflicts of interest that aren’t in place for Warp Speed advisers.
According to the financial disclosure statements they signed with HHS, the advisers are required to donate certain stock profits to the NIH — but can do so after the stockholder dies. They can keep investments in drug companies, and the restrictions don’t apply to stock options, which give executives the right to buy company shares in the future.
“This is a poorly drafted agreement,” said Jacob Frenkel, an attorney at Dickinson Wright and former SEC lawyer, referring to the conflict-of-interest statement included in the NIH contract with Advanced Decision Vectors, the Warp Speed advisers’ employing consulting firm. He said documents could have been “tighter and clearer in many respects,” including prohibiting the advisers from exercising their options to buy shares while they are contractors.
De Notaristefani stepped down as Teva’s executive vice president for global operations in October 2019, but according to corporate filings he would remain with the company until the end of June 2020 in order to “ensure an orderly transition.” He’s been working with Warp Speed since at least May overseeing manufacturing, according to an HHS spokesperson.
When Erhardt left Pfizer in May, U.S. COVID infections were climbing and the company was beginning vaccine clinical trials. Erhardt and Harrigan, whose LinkedIn profile says she left Pfizer in 2010, have worked as drug industry consultants.
“Ultimately, conflicts of interest in ethics turn on the mindset behavior of the responsible persons,” said Frenkel, the former SEC attorney. “The public wants to know that it can rely on the effectiveness of the therapeutic or diagnostic product without wondering if a recommendation or decision was motivated for even the slightest reason other than product effectiveness and public interest.”
Rachana Pradhan is a Kaiser Health News correspondent.
Looking across the Charles River toward Kendall Square, Cambridge, headquarters of Moderna and other tech companies.
Liz Szabo/JoNel Alecia: Trump may try to rush in COVID-19 vaccine before election
It “seems frighteningly more plausible each day.’’
— Dr. Jerry Avorn, Harvard Medical School
President Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.
In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.
It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.
If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.
Vaccines are typically approved by the FDA. Alternatively, Azar — who reports directly to Trump — can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.
“Yes, this scenario is certainly possible legally and politically,” said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”
Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.
Physicians might refuse to administer a vaccine approved with inadequate data, said Dr. Preeti Malani, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent Webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54 percent of Americans would not submit to a COVID-19 vaccine authorized before Election Day.
After this story was published, an HHS official said that Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.
“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.
White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.
Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”
Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.
Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.
The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”
Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.
Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.
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. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.
“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”
In an opinion piece published in The Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”
But the administration has demonstrated a 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 lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.
Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.
Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.
A senior FDA official who oversees vaccine approvals, Dr. Peter Marks, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.
“I think there would be an outcry from the public health community second to none, which is my worst nightmare — my worst nightmare — because we will so confuse the public,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.
Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”
In the New England Journal editorial, Avorn and co-author Dr. Aaron Kesselheim wondered whether Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.
But Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.
Also, he noted that Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”
Liz Szabo and JoNel Aleccia are Kaiser Health News reporters.
Liz Szabo: lszabo@kff.org, @LizSzabo
JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia