Northwest Arkansas Democrat-Gazette
U.S. OKs extra doses for some immune-weak
Decision covers about 3% of adults seen as vulnerable
WASHINGTON — U.S. regulators said Thursday that transplant recipients and others with weakened immune systems can get an extra dose of a covid-19 vaccine to better protect them as the delta variant continues to surge.
The announcement by the Food and Drug Administration applies to millions of Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.
It’s harder for vaccines to rev up an immune system suppressed by certain medications or diseases, so those patients don’t always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.
“This action is about ensuring our most vulnerable … are better protected against covid-19,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said ahead of the FDA’s announcement.
Importantly, the decision applies only to this highrisk group, about 3% of U.S. adults. It’s not an opening for booster doses for the general population.
Instead, health authorities consider the extra dose part of the initial covid-19 vaccine prescription for the immuno-compromised. For example, France since April has encouraged that such patients get a third dose four weeks after their regular second shot.
Separately, U. S. health officials are continuing to closely monitor if and when average people’s immunity wanes enough to require boosters for everyone — but for now, the vaccines continue to offer robust protection for the general population.
Making such patients eligible for an extra shot, doctors say, is preferable to having worried patients seek out additional inoculations illicitly — which is already happening.
It’s not clear how many vaccinated Americans have already sought out extra shots because they fear their current doses aren’t enough
to ward off the virus again raging in all 50 states. For Pfizer and Moderna recipients alone, the CDC estimates that 1.1 million have received additional shots, according to an internal document reported Wednesday by ABC News.
Frustrated by what they consider murky guidance from health authorities, people have received third or even fourth immunizations from local pharmacies and vaccination sites, where their previous appointments haven’t caught the attention of health workers. Some say they’ve bucked advice from their own doctors, turning instead to Google for information on whether the extra shots are worthwhile.
“The chaos is, in part, due to lack of guidance and trust,” Eric Topol, director of the Scripps Research Translational Institute, said in an email.
People are seeking out extra doses — a phenomenon Topol dubbed “booster-mania.”
Terry Deneen, who received a double lung transplant in 2016, got the Moderna shots in the spring after struggling to find an appointment. The 70-year-old from Chicago said he was just starting to enjoy a taste of normalcy — visiting family, going out to dinner with friends — when doctors warned him that the vaccines offered little protective value for many transplant patients.
Deneen had read about how Israel had begun administering boosters to senior citizens and figured officials would soon do the same here. So he decided to “beat the rush” and seek another round, he said, even though his doctors equivocated about whether it was a wise decision. Last week he got another Moderna injection at a CVS. Workers there didn’t ask about his vaccination history, and he didn’t volunteer anything, he said.
Afterward, Deneen reflected on how lucky he was to have received transplant lungs that his body accepted. “It was like somebody had grown a set of lungs just for me,” he said. “I’m not going to throw it away by not getting a third shot.”
HAWAII, OREGON RISES
The covid-19 surge that is sending hospitalizations to all-time highs in parts of the South also is clobbering states like Hawaii and Oregon that were once seen as pandemic success stories.
After months in which they kept cases and hospitalizations at manageable levels, they are watching progress slip away as record numbers of patients overwhelm bonetired health care workers.
Oregon — like Florida, Arkansas, Mississippi and Louisiana in recent days — has more people in the hospital with covid-19 than at any other point in the pandemic. Hawaii is about to reach that mark, too.
This is despite Hawaii and Oregon having vaccination levels higher than the national average as of last week. Arkansas and Louisiana were significantly below average, while Florida was about even. Mississippi, meanwhile, ranks at the bottom for vaccination rates.
“It’s heartbreaking. People are exhausted. You can see it in their eyes,” said Dr. Jason Kuhl, chief medical officer at Oregon’s Providence Medford Medical Center, where patients are left on gurneys in hallways, their monitoring machines beeping away. Others needing treatment for cancer or heart disease are being turned away.
The fresh wave is driven by a combination of the highly contagious delta variant and lagging vaccination rates, especially in the South and other rural parts of the country.
New cases nationwide are averaging about 123,000 per day, a level last seen in early February, and deaths are running at more than 500 a day, turning the clock back to May.
For the most part during the pandemic, Hawaii had one of the lowest infection and death rates in the nation. In recent days, though, it reported record highs of more than 600 new virus cases daily.
On its worst day in 2020, Hawaii had 291 patients hospitalized with the coronavirus. Officials expect to hit 300 by the end of this week.
Despite the promising demand for covid-19 shots early on, it took three weeks — much longer than expected — to get from 50% to 60% of the vaccine-eligible population fully vaccinated. Vaccinations have since plateaued. Nationally, the rate is about 59%.
The biggest hospital on Hawaii’s Big Island is feeling the pressure. Out of 128 acute beds, 116 were taken Wednesday at Hilo Medical Center, and the hospital’s 11 intensive-care beds are almost always full these days, spokeswoman Elena Cabatu said.
“If someone out there has a heart attack or a sepsis or gets into a bad accident that requires intensive care, we will have to hold that person in the emergency department,” Cabatu said.
Hilton Raethel, president and CEO of the Healthcare Association of Hawaii, disputed any notion that the rebound in tourism in Hawaii is largely to blame.
“The tourists have been a source for infection, but they’ve never been the predominant source of infection,” Raethel said. “There’s a lot more concern about people from Hawaii, residents who go to the South, go to Vegas, to other places, and they come back and spread it.”
In Oregon, a record number of covid-19 hospitalizations — 670 — was reported for a third- straight day Thursday. ICU beds across the state remain about 90% full with covid-19 patients occupying 177 of them, the Oregon Health Authority said. The previous peak of 622 hospitalizations came during a November surge.
“Our doctors and nurses are exhausted and rightfully frustrated because this crisis is avoidable. It is like watching a train wreck coming and knowing that there’s an opportunity to switch tracks, yet we feel helpless while we watch unnecessary loss of life,” said David Zonies, associate chief medical officer at Portland’s Oregon Health & Science University.
Public health officials in the southern part of the state said they fear that the situation will get worse as the delta variant spreads through a region where fewer than half of the residents have been fully vaccinated.
“I’m fearful that the darkest days of this pandemic may still be ahead of us,” said Chris Pizzi, CEO of Providence Medical Center in Medford.
In a renewed effort to stop the spread, Gov. Kate Brown announced this week that nearly everyone will have to wear masks again in indoor public spaces, regardless of their vaccination status.
AT THE HIGH COURT
Supreme Court Justice Amy Coney Barrett on Thursday refused to block a plan by Indiana University to require students and employees to get vaccinated against covid-19.
Barrett’s action was in response to an emergency request from eight students, and it marked the first time the high court has weighed in on a vaccination mandate. Some corporations, states and cities have adopted vaccine requirements for workers or even to dine indoors, and others are considering doing so.
The students said in court papers that they have “a constitutional right to bodily integrity, autonomy, and of medical treatment choice in the context of a vaccination mandate.” They wanted the high court to issue an order barring the university from enforcing the mandate. Seven of the students qualify for a religious exemption.
Similar lawsuits against student vaccine requirements have been filed in other states.
The court’s newest justice rejected the plea without even asking the university for a response or getting her colleagues to weigh in. Justices often act on their own in such situations when the legal question isn’t particularly close. Barrett handles emergency matters from the U.S. Court of Appeals for the 7th Circuit, which includes Indiana.
Students who don’t comply will have their registrations canceled, and workers who don’t will lose their jobs. The policy does have religious and medical exemptions, but exempt students must be tested twice a week.
FEDERAL AGENCY
The federal Health and Human Services Department is requiring employees who provide care or services for patients to get their covid-19 shots, officials announced Thursday.
The order from Secretary Xavier Becerra will affect more than 25,000 clinicians, researchers, contractors, trainees and volunteers with the National Institutes of Health, the Indian Health Service, and the U.S. Public Health Service Commissioned Corps. It applies to employees who regularly interact with patients or whose duties could put workers in contact with patients.
“Requiring our HHS health care workforce to get vaccinated will protect our federal workers, as well as the patients and people they serve,” Becerra said in a statement.
From the Pentagon to the Department of Veterans Affairs and the state of California, and from Google to United Airlines, government agencies and large companies are requiring employees to get vaccinated.
The Health and Human Services Department has more than 80,000 employees. Those not covered by Becerra’s order would fall under President Joe Biden’s recent policy change that requires federal workers and contractors to attest to their vaccination status and imposes regular covid-19 testing and certain workplace restrictions on the unvaccinated. But this is short of a direct order to get vaccinated.
The new requirement at the department will provide for medical and religious accommodations.
Information for this article was contributed by Jennifer Sinco Kelleher, Andrew Selsky, Sara Cline, Adriana Gomez Licon, Eileen Putman, Terry Tang, Emily Wagster, Ricardo Alonso-Zaldivar, Lauran Neergaard and Matthew Perrone of The Associated Press; and by Derek Hawkins, Laurie McGinley, Lena H. Sun, Bryan Pietsch and Adela Suliman of The Washington Post.