“It’s not the adverse side effects that you’re worried about two, three, four years down the road, but really in the first 24 to 48 hours and in the weeks after the vaccine,” Markel said.
If tests go well, the sped-up process could actually upend long-standing norms for vaccine development.
It could lay the groundwork for rolling out other vaccines in the future, experts say. “I think it is possible that the covid vaccine experience will demonstrate how fast vaccines can be developed when made a global priority,” said Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health. He did add the caveat, however, that the government doesn’t typically spend $10 billion on a vaccine, as it’s doing for the novel coronavirus.
Public trust is another matter, as President Trump continues to suggest he's pushing hard for a vaccine by Election Day.
Top health officials are vowing that politics aren’t influencing the rush to get a vaccine, as Trump's comments continue to fuel speculation he might put pressure on the Food and Drug Administration to give the go-ahead before the vaccine is truly ready.
At a Senate hearing yesterday, Francis Collins, director of the National Institutes of Health, and Surgeon General Jerome Adams tried to reassure lawmakers the process isn’t being politicized.
Collins pointed to groups of independent scientists, doctors and statisticians — called Data and Safety Monitoring Boards — that evaluate the progress of each clinical trial. These boards have the authority to halt a trial if there’s evidence of any harm to patients on which a vaccine is being tested.
“Science and science alone will be the way in which this decision is made,” Collins said at the hearing. “Otherwise, I’ll have no part in it.”
Collins also said an announcement by AstraZeneca that it is pausing its trial for a safety concern proves protocols are being followed. An independent panel is investigating whether a case of spinal inflammation in a single British participant is linked to the vaccine AstraZeneca is testing.
The FDA will probably give a coronavirus vaccine a nod without knowing whether there are extremely rare side effects.
The agency is expected to approve a vaccine for certain Americans under what's known as an emergency use authorization (EUA), which can be granted amid clinical trials.
The two final-stage trials being conducted by Pfizer and Moderna involve 60,000 patients. That group is large enough for researchers to detect any common or even relatively common side effects that might come from the vaccine.
But it's not large enough to detect extremely rare side effects that could manifest in, say, 1 out of every 1 million patients. “That’s what I worry about with EUA the most,” Markel told me.
It's a concerning risk — but one that scientists will balance against the need to quickly distribute an effective vaccine for a virus that has killed about 900,000 people worldwide and crippled the U.S. economy.
There have certainly been vaccine botches in U.S. history.
In the infamous 1955 “Cutter incident,” the government was forced to abandon a polio vaccine program after 200,000 children had been vaccinated. Forty thousand of them got polio after batches made by Cutter Labs accidentally contained live polio virus.
And in 1976, President Gerald Ford’s administration hastily launched but then suspended a vaccination program for the swine flu — a disease that never even ended up reaching epidemic proportions.
About eight months in, a small association was discovered between getting the vaccine and a neurological disorder called Guillain-Barre syndrome. It’s not definitive that the two were linked, but scientists concluded there was an increased risk of one additional case of Gullain-Barre for every 100,000 people who got vaccinated.
If the proof of concept works during the coronavirus crisis, other drugs and vaccines could be released more quickly.
This is what happened during the AIDS crisis of the 1980s. The FDA eased up on some procedures and rules to speed up consideration of new drugs, under heavy pressure from advocates. It also started allowing fatally ill patients to take some risks with unproven drugs.
“Negotiations with drug companies are done in a day, in person, rather than over months by mail,” the New York Times reported in 1989. “Companies will soon be allowed to deliver records on computer disks instead of sending truckloads of paper. In the sharpest break with tradition, some patients are now beginning to get drugs even before clinical trials have explored toxic side effects, or determined just how effective they might be.”
Anthony Fauci, who has directed the National Institute of Allergy and Infectious Diseases since 1984, and AIDS activist Larry Kramer were key in changing once-sacrosanct rules, Markel said.
Ahh, oof and ouch
AHH: Trump knew the pandemic was deadlier than he let on, according to a new book by Bob Woodward.
The president acknowledged in private interviews with Post associate editor Woodward the coronavirus was deadlier than the flu, even as he said the opposite publicly, according to a summary of the book by Bob Costa and Philip Rucker.
“You just breathe the air and that’s how it’s passed,” Trump said in a Feb. 7 call with Woodward, one of 18 interviews that formed the basis for the reporter’s book “Rage.” “And so that’s a very tricky one. That’s a very delicate one. It’s also more deadly than even your strenuous flus.”
Trump responded on Twitter:
At the time of that conversation, Trump was telling the public that the virus would disappear with the summer months, despite warnings from top officials of a national security and health emergency. In March, he compared it to the seasonal flu during a Fox News interview. That same month, he told Woodward he was purposefully playing down the virus to avoid creating panic.
But Anthony Fauci, the nation’s leading infectious-disease expert, disputed characterizations in the book during a Fox News interview on Wednesday, saying that he did not recall the president distorting information provided to him by public health experts.
“I didn't get any sense that he was distorting anything. I mean in my discussions with him, they were always straightforward about the concerns that we had,” Fauci said. “We related that to him. And when he would go out, I'd hear him discussing the same sort of things.”
The revelations have also sparked questions about whether Woodward should have reported details from his conversations months earlier. New York Times opinion columnist Jamelle Bouie:
Post media reporter Erik Wemple also weighed in:
“Woodward said his aim was to provide a fuller context than could occur in a news story,” Post media columnist Margaret Sullivan writes. “I knew I could tell the second draft of history, and I knew I could tell it before the election,” Woodward told her. (Former Washington Post publisher Phil Graham famously called journalism 'the first rough draft of history,'” Margaret writes.)
OOF: A top aide at the Department of Health and Human Services has been trying to dictate what Fauci says in interviews.
“Emails obtained by POLITICO show Paul Alexander — a senior adviser to Michael Caputo, HHS’s assistant secretary for public affairs — instructing press officers and others at the National Institutes of Health about what Fauci should say during media interviews,” Politico’s Sarah Owermohle reports.
On Tuesday, Alexander, a part-time professor of health research methods at McMaster University in Canada, told Fauci’s press team that the scientist should not recommend that children wear masks in an MSNBC interview, claiming that there was “little, if any evidence” that children spread the disease.
But epidemiologists who reviewed excerpts of Alexander’s messages told Politico that the statements were inaccurate and could cause harm. It's not the first such dispute. In June, Alexander sent an email accusing the CDC of “undermining the President” by issuing a report on health risks from the coronavirus for pregnant women.
It’s part of a larger pattern in which Alexander’s messages “often contradict mainstream science while promoting political positions taken by the Trump administration on hot-button issues,” Owermohle writes.
Caputo told Politico that Alexander’s job is to share his opinions with other scientists. Meanwhile, Fauci said he had not seen the emails and had not been instructed to minimize the risk that coronavirus poses to children.
“No one tells me what I can say and cannot say,” Fauci told Politico.
OUCH: As Florida sees a surge in coronavirus cases among children, the state is hiding data.
“A month into the forced reopening of Florida’s schools, dozens of classrooms — along with some entire schools — have been temporarily shuttered because of coronavirus outbreaks, and infections among school-age children have jumped 34 percent,” Lori Rozsa and Valerie Strauss report. “But parents in many parts of the state don’t know if outbreaks of the virus are related to their own schools because the state ordered some counties to keep health data secret.”
Florida Gov. Ron DeSantis (R) aggressively pushed to reopen schools, threatening to withhold funding for schools that did not open before the end of August, even as the state became a national hot spot for the coronavirus.
Public health guidelines do not require schools to report cases, and DeSantis’s administration has even ordered some school districts to stop releasing school specific coronavirus information, citing privacy concerns. When the Florida Department of Health released a report that detailed cases linked to schools on Aug. 24, it was quickly removed from the website, with officials claiming it had been posted inadvertently.
In the absence of official information, anonymous social media accounts run by teachers and parents have attempted to fill in the gap by crowdsourcing school specific outbreak information.
The death rate from the coronavirus is higher in majority-Black nursing homes.
A Washington Post analysis of data from more than two dozen states found that the death rate was more than 20 percent higher in majority-Black nursing homes compared with majority-White facilities, Sidnee King and Joel Jacobs report. “Homes where at least 7 in 10 residents were Black saw a death rate that was about 40 percent higher than homes with majority-White populations.”
More than 2,200 residents at 250 predominantly Black nursing homes across the country have died.
The Post's analysis is further evidence of racial disparities in the impact of the virus. Black people are 13 percent of the U.S. population but account for 21 percent of coronavirus deaths in cases where race is known.
Long-term care facilities account for 40 percent of the coronavirus deaths in the country, but there is little comprehensive data on the demographics of those who have died. In July, Sens. Robert P. Casey Jr. (D-Pa.), Elizabeth Warren (D-Mass.), Ron Wyden (D-Ore.) and Patty Murray (D-Wash.) wrote a letter to the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services calling for more-robust data collection.
- The United States will stop enhanced coronavirus screenings for international travelers. Since March, travelers from certain high-risk countries have been funneled into designated airports where they have their temperature checked, respond to questions about virus symptoms and report detailed contact information, Yahoo News reports.
- D.C. public schools were expected to remain virtual until at least November, but Mayor Muriel E. Bowser (D) said Wednesday that she intends to resume in-person instruction this month for small groups of students in at least a few schools, Julie Zauzmer, Michael Brice-Saddler, Perry Stein and Dana Hedpeth report.
- New York Gov. Andrew Cuomo announced that a prohibition on indoor dining in New York City would be lifted on Sept. 30. The move comes as the infection rate in the state, once the epicenter of the pandemic, has remained stabilized at under 1 percent, the New York Times's Jesse McKinley, Sharon Otterman and Joseph Goldstein report.
- British Health Secretary Matt Hancock sparked a heated debate when he said Wednesday that those without symptoms of the coronavirus don't need tests. Many public health officials have said that asymptomatic people play a major role in spreading the virus, but Hancock warned that requests for widespread testing risked overwhelming the system. The debate reflects a similar controversy in the United States last month after the CDC changed testing guidelines. It also comes as Britain imposes a ban on gatherings of more than six people in an effort to prevent a second surge in virus cases, Jennifer Hassan reports.
- In Bergamo, Italy, which was hit early and hard by the pandemic, doctors are calling back survivors in an effort to measure the long-term effects of covid-19. The findings are startling: About half of those infected in March and April say that they have lingering health problems, even though the virus is officially gone from their systems, Chico Harlan and Stefano Pitrelli report.
Elsewhere in healthcare
A Senate investigation found that Americans may have experienced Postal Service delays in receiving prescription medicines.
“Several major U.S. pharmacies told the two Democratic senators leading the investigation — Elizabeth Warren (Mass.) and Robert P. Casey Jr. (Pa.) — that average delivery times have ticked up since the spring, leading to a flood of angry calls from customers and costly requests to resend their medications,” Tony Romm reports.
In a report released Wednesday, the lawmakers lay much of the blame for mail delays on changes made under U.S. Postmaster General Louis DeJoy, who implemented policies to reduce mail trips and overtime pay as part of a cost-cutting initiative.
Democrats have claimed DeJoy's initiatives — which also included planned service reductions and the removal of mailboxes — could cause disruptions in voting by mail during the pandemic. DeJoy has since announced he won't implement the changes before the November election.
DeJoy has blamed delays on the pandemic rather than on operational changes made under his departure, and the report found that some medicine delivery delays started in May, before he officially took office.
Of the 23 nonprofit health insurance co-ops that sprang from Obamacare, only three remain.
“Lauded as a way to boost competition among insurers and hold down prices on the Obamacare exchanges, the co-ops had more than 1 million people enrolled in 26 states at their peak in 2015. Today, they cover about 128,000 people, just 1% of the 11 million Obamacare enrollees who get coverage through the exchanges,” Kaiser Health News’s Phil Galewitz reports.
The nonprofits were a last-minute addition to the Affordable Care Act to appease Democratic lawmakers who failed to secure a public option in the marketplaces. But nearly all of the co-ops struggled to compete with established carriers, Galewitz writes. Now, with New Mexico Health Connections planning to close at the end of the year, health experts hope the last holdouts — one in Maine, another in Wisconsin, and a third in Idaho and Montana — can survive.
The percentage of U.S. high-schoolers smoking e-cigarettes is down.
The CDC reported on Wednesday that the percentage of high-schoolers using e-cigarettes has declined from 27.5 percent in 2019 to about 20 percent this year, according to Reuters. The agency’s report, based on a survey conducted between January and mid-March, finds that 3.6 million middle school and high school students still use the devices.
Surging sales of e-cigarettes to youth in recent years have caused regulators to crack down on some device companies, and earlier this year the Trump administration banned some flavors popular among children and teens.
A New York gynecologist faces a federal indictment for sexually assaulting patients.
“The gynecologist accused of sexual assault by the wife of former Democratic presidential candidate Andrew Yang was indicted on federal charges for the sexual abuse of six women over nearly two decades, according to federal prosecutors,” Meryl Kornfield reports. “Prosecutors allege that [former Manhattan doctor Robert A.] Hadden sexually assaulted dozens of women who were his patients at his OB/GYN practice from 1993 and 2012.”
Hadden faces six counts of enticing women to engage in illegal sexual acts. More than 100 women have accused the doctor of sexual assault under the guise of medical examinations. The doctor targeted women who were unfamiliar with gynecological exams or who were experiencing their first pregnancy, according to the indictment.
Evelyn Yang responded to the charges on Twitter: