The Health 202: Emergency approval for a coronavirus vaccine could undermine efforts to keep researching it

This type of meeting would normally only attract interest from Wall Street analysts and those closely involved with vaccine development. But today’s gathering is attracting widespread attention given the pandemic’s high stakes and lagging public trust in the vaccine development process. 

The meeting, which will be live-streamed today, is widely viewed as reassurance that science, not the White House, is guiding the endeavor.

Instead of waiting months or years to fully collect data on trial participants, developers are expected to apply to the FDA through an alternative pathway known as emergency use authorization. If an EUA is granted for a coronavirus vaccine, the vaccine could be given to certain high-risk populations to be spelled out by regulators.

The plan is to continue Phase 3 trials even while the vaccine is being distributed to select people, so researchers can get a fuller picture of how long the vaccine works and whether it causes side effects — and eventually apply for full authorization. 

But continuing the trials requires maintaining a placebo group of patients. One question the panel is likely to consider today is whether to allow the placebo group to get the vaccine once it’s available. 

If an EUA is approved, participants in that trial may want to know whether they received the vaccine – and if they didn’t, to get inoculated. 

But vaccinating the placebo group could undermine the ability of researchers to make ongoing, longer-term comparisons that help determine the efficacy and safety of the vaccine. 

There’s another challenge, too. There are currently 10 vaccine candidates in final-stage trials, according to The Washington Post’s tracker. If one gets emergency approval, patients in the other clinical trials may also want to know whether they received a placebo. If so, they also may be tempted to drop out of that trial so they could receive the approved vaccine.

“Issuance of EUA will likely slow down the trials,” said former FDA scientist Luciana Borio.

The Biotechnology Innovation Organization wrote that it has an ethical obligation to inform trial participants that a vaccine may be available, saying “additional discussion is needed to determine how placebo-controlled trials can be maintained after an EUA is granted.”

“It is likely that any EUA issued for a covid-19 vaccine will have a broad impact on other covid-19 vaccines in development,” BIO wrote in comments submitted to the review panel.

Janssen Pharmaceuticals, owned by coronavirus vaccine developer Johnson & Johnson, submitted a letter outlining similar concerns.

“Once the first vaccines are licensed/authorized, this may lead willing volunteers to seek available vaccines over participating in ongoing trials,” the company wrote.

If the FDA approves use of the vaccine only for a narrow group of people, it could potentially minimize this risk. For example, if it was only authorized for front-line medical workers, that may not affect the clinical trials much, said Miles Braun, an adjunct professor at Georgetown University who formerly worked for the FDA.

“The likelihood they would be a proportion of the critical trial population is low so that probably wouldn’t damage the clinical trials in a significant way,” Braun said.

As vaccine developers race toward gaining FDA approval, the nation is grappling with a pandemic that has killed more than 221,000 people in the United States, upended the lives of millions of Americans and appears to be worsening as the winter months approach. 

While federal health officials have repeatedly insisted they are shepherding the development of coronavirus vaccines in a responsible, effective and safe manner, President Trump has routinely undermined trust in public health officials and pressured them to speed up the process so a vaccine can land before the election.

Experts, including those critical of the Trump administration, say they’re massively encouraged that the panel is meeting and even encouraging people to watch by live-streaming it. The panel can’t require the FDA to change anything, but it does submit recommendations to the agency as a way of bringing further scientific rigor and transparency to the process of getting new vaccines approved.

Sarah Karlin-Smith, a reporter for Pink Sheet:

“I’m reassured there is a level of humility,” Braun said. “The FDA is coming to its advisers, and I think that’s a good thing. If they find out they’ve missed some important things, they’ll address those.”

Typically, vaccine developers don’t apply to the FDA for authorization until they’ve observed trial participants — both those who got the vaccine and those given a placebo — for years and collected information about its effectiveness and safety.

The panel is likely to consider whether the agency’s existing requirements for applying for an EUA for a coronavirus vaccine are sufficient. Today’s meeting is “really critical,” said Borio, the former FDA scientist.

“What is still missing, what needs to be addressed, what are the implications of issuing the first [emergency use authorization] to a vaccine, what are the implications of issuing an EUA based on very limited data,” Borio said. “That is what I expect to be the bulk of the discussion.”

The FDA recently approved stricter standards for applying for emergency use, including a requirement that researchers observe participants for a median of two months. Ronny Gal, a financial analyst with investment research firm Sanford C. Bernstein and Co., said he expects approval by the end of the year even under the longer timeline.

“I think the submission is basically Thanksgiving and approval is our Christmas gift,” Gal told me.

“The pandemic would’ve been tough for any president,” former president Barack Obama said. “But the degree of incompetence and misinformation, the number of people who might not had died had we just done the basics, the degree to which it has impacted low-income communities so disproportionally, that’s something that I’m not just confident that it can be fixed; there’s proof.”

Obama spoke at a drive-in rally in South Philadelphia, highlighting the crucial role that Pennsylvania’s 20 electoral votes could play in deciding the presidential election. Though a Post average of October polls show Biden with an eight-point lead in Pennsylvania, Obama urged against complacency, pointing out that Trump outperformed his polls in 2016, David Nakamura reports.

“The format of the event, in which supporters remained in their vehicles to maintain social distancing, offered a stark reminder of the nation’s health crisis. As Obama spoke, supporters could be heard cheering but also honking their horns in support,” David writes.

Obama referred to the nationwide rise in coronavirus cases, as well as Trump’s own infection with the virus. Trump “isn’t going to suddenly protect all of us. He can’t even take the basic steps to protect himself,” Obama said, adding that Biden “is not going to screw up testing. He’s not going to call scientists idiots. He’s not going to hold a superspreader event at the White House.”

The maker of OxyContin agreed to plead guilty to three federal criminal charges for defrauding the United States and violating an anti-kickback statute. The Justice Department described the settlement as “the largest penalties ever levied against a pharmaceutical manufacturer.”

“While numerous other lawsuits and court fights over opioids will continue, the Purdue Pharma settlement highlights how, for more than two decades, the widespread problem of overprescribing, diverting and abusing pain pills raged across America while drug manufacturers, distributors, pharmacists and doctors profited from the problem and largely deflected responsibility,” The Post’s Meryl Kornfield, Christopher Rowland, Lenny Bernstein and Devlin Barrett report.

Federal prosecutors allege that the company paid two doctors and an electronic health records company to drive up prescriptions for OxyContin. Members of the Sackler family, who own Purdue Pharma, denied criminal culpability in the kickback scheme, even as they agreed to a related $225 million civil settlement with the government related to their push to increase sales of the highly addictive opioid. Many families who have lost loved ones to Purdue Pharma’s products, however, said the Justice Department’s terms are too lenient.

“The $8 billion figure is largely symbolic — the bankrupt drugmaker is already indebted to states, communities and other creditors. The company is among several drugmakers and distributors embroiled in litigation over the deaths and economic devastation inflicted by the opioid epidemic. In the past two decades, more than 400,000 Americans have died of opioid overdoses,” Kornfield and Rowland write.

The previous guidance, which is used in contact tracing and in decisions about testing and quarantining, defined a close contact as someone who spent 15 consecutive minutes within six feet of another person confirmed to have coronavirus. Now, the public health agency says anyone who spends 15 minutes over a 24-hour period in close proximity to someone with the virus should be considered a “close contact.”

“The change by the Centers for Disease Control and Prevention is likely to have its biggest impact in schools, workplaces and other group settings where people are in contact with others for long periods of time. It also underscores the importance of mask-wearing to prevent spread of the virus, even as President Trump and his top coronavirus adviser continue to raise doubts about such guidance,” Lena H. Sun reports.

A recent report found that a prison employee tested positive after multiple encounters with incarcerated men who later tested positive for the virus. While the employee’s interactions with the asymptomatic prisoners were brief, only totaling 17 minutes throughout the correctional officer’s shift, the report concluded that the interactions were the most likely source of virus’s transmission.

“Both presidential campaigns have relied on the CDC’s previous definitions of ‘close contact’ to determine when candidates and staff members need to be quarantined,” Lena reports. “In the last week, both Democratic presidential nominee Joe Biden and Sen. Kamala D. Harris have been near charter airline workers who have tested positive for the virus. Harris also had a staff member test positive. Biden campaign manager Jen O’Malley Dillon said previously that none of those interactions qualified as ‘close contacts’ under the old guidelines.”

“Several firms are vying to be the first to market a test that Americans could buy over the counter with results delivered in minutes at a bedside or a breakfast table. That could allow people to screen themselves before heading to the office or school, relieving pressure on overburdened testing laboratories and quickly identifying new infections,” Politico’s David Lim writes. “But concerns about the tests’ reliability, how consumers might react to their results and how public health departments will track them have slowed their development.”

Experts worry that false negatives could result in people going out and infecting others, potentially taking a negative result as a pass to go to parties or to ignore other public health guidelines. Even a true negative result could simply mean that someone is in the early stages of an infection. False positives are less concerning, experts say, because they could be followed up with lab-based testing.

“Companies formulating such tests say they won’t seek emergency authorization from the Food and Drug Administration until later this year or early next — in part because the agency wants them to prove that adults of different ages, education levels and English proficiency can successfully use their products,” Lim writes.

The FDA said in July that the tests should be able to detect at least 90 percent of infections with a false negative rate of less than one percent. The agency has also told companies, however, that it might be open to approving less accurate tests if they are used in such a way to mitigate lower accuracy, for instance through repeated screenings. Some public health experts have advocated that the FDA to approve tests for the purpose of broad surveillance — for instance, detecting new clusters of coronavirus transmission — rather than focusing on a clinical diagnostics standard.

Another obstacle is ensuring that the results from at-home testing can be consistently tracked by local health officials. So far, the FDA is not requiring companies to build in automated systems for reporting positive test results to local health departments. 

An increasingly competitive race for an open Senate seat in Kansas is pitting Rep. Roger Marshall (R-Kan.), an obstetrician, against state Sen. Barbara Bollier, a physician who is running on the Democratic ticket after recently leaving the Republican Party. While Marshall is favored to win the seat, which has been held by Republicans since 1932, polls show a tight race, Annie Gowen reports. 

“Health care has been a central issue between the two doctors: Bollier supports expanding Medicaid for low-income residents — Kansas is one of 12 states without the expansion — and Marshall opposes it, saying it is too costly. Marshall’s former ownership of a for-profit hospital also has come under fire; one attack ad noted its rise forced a nonprofit hospital in the same town to limit services,” Gowen writes.

Bollier has also criticized her Republican opponent’s support for Trump’s coronavirus response. Marshall at one point said he had put his family on hydroxychloroquine, an anti-malarial drug touted by the president without evidence. 

Contributing to the tight race is the fact that Bollier has capitalized on national attention, raising $20 million compared to $5 million raised by Marshall.