FDA approves updated vaccine to fight COVID variants as cases rise
An updated COVID vaccine has been approved by the FDA, paving the way for a fight against variants as cases rise across the country.
Ryan Ross, USA TODAY
Americans eager to get jabbed with the updated COVID-19 vaccine in September were disappointed when they began looking for doses.
Some pharmacies weren’t posting enough appointments, others didn’t have enough vaccines. Most hospitals and clinics hadn’t gotten their shipments, yet.
Patients who had been through the motions with previous rollouts swiftly realized they were going to have a harder time finding shots this time around.
This season’s rollout was the first time the COVID-19 vaccine had entered the commercial market. During the three years the virus was considered a public health emergency, the government was paying for and distributing the shots.
Now that the emergency phase has ended, new actors have stepped into the rollout. No one expected a perfectly smooth transition, but problems seem to persist more than a month after the vaccine’s approval.
One element has remained constant: the making of the vaccine is fluid. For manufacturers, it’s mostly business as usual.
However, industry experts say problems have arisen in every other stage of the process – with wholesalers and distributors, pharmacies and insurance companies.
Representatives at each of these phases said they hope the major kinks have been ironed out – as the White House reports more than 7 million Americans vaccinated with the updated jab as of last week – but the growing pains are far from over as vaccine distribution becomes a commercial enterprise.
Prashant Yadav, a medical supply chain expert and senior fellow at the Center for Global Development, said the whole process is still coming together. He noted, “The COVID infrastructure is still a question mark.”
This season’s COVID-19 vaccine rollout has put immense pressure on pharmacies during a time when they’re typically busy administering other vaccines required for children headed back to school, industry experts say.
In addition to the updated COVID-19 vaccine, federal regulators also recently approved and recommended a new RSV vaccine for older Americans.
Pharmacists at chains like CVS and Walgreens have had little control over the barrage of appointments their employers set up since the first rollout in 2020. After weeks of administering the fall 2023 vaccines with little reprieve, they staged a walkout citing concerns over working conditions as staffing dwindled.
The companies responded by promising additional staffing, agreeing to pay overtime, and allowing employees to control when they’re expected to cover vaccination appointments.
The walkouts were vital to protecting pharmacists’ and patients’ safety but the upshot of the improvements was a significant drop in the number of appointments available on any given day, right as vaccination season began ramping up, said Karen Winslow, a grant supervisor and the former interim executive director at Virginia Pharmacy Association.
All these things happening at once, she said, makes it a “perfect storm.”
Delayed shipments and orders
As patients struggled to find appointments at chain pharmacies, others tried turning to local hospitals, community health clinics and independent pharmacies. But they didn’t have vaccines on hand.
Providers at some facilities said they’ve just begun receiving their first shipments of vaccine in the past few weeks. Others say they’re still waiting for supplies they’ve ordered or they have been unable to order shots altogether.
Confusion pervades for leaders at many facilities and information is slow to come.
By mid-October, Dr. Luisa Perez, a provider for SOMOS Community Care, a nonprofit network of providers and community-based organizations, didn’t know what to tell patients: “I have not been able to get any vaccines for COVID or know when it’s going to be given to us.”
SOMOS providers who have tried to access COVID-19 vaccines through their typical, commercial channels have been told by wholesalers that there are no shots available, Perez said.
One problem is that wholesalers and distributors prioritized larger accounts with chain pharmacies, such as Walgreens and CVS, before satisfying smaller orders from other healthcare facilities, industry experts said.
“When the market mechanism takes over… bigger accounts get priority,” Yadav said. “They may not be doing it knowingly.”
The largest U.S. wholesalers – Cencora, Cardinal Health and McKesson – did not respond to USA TODAY’s questions regarding account prioritization but Cencora said in an emailed statement the company recently began receiving and shipping out orders of the updated COVID-19 vaccines, and promised to work with customers amid the rollout.
It remains to be seen whether wholesalers can satisfy smaller accounts as these facilities have already begun running out of their first doses.
Limited vaccine doses
The next piece of this complicated rollout has been ensuring that enough doses are present at pharmacies and clinics. During the first years of the public health emergency, the government paid for and distributed COVID-19 vaccines to the millions of Americans who wanted and needed them.
Private companies are now shouldering those costs. Wholesalers purchase vaccines, pharmacies buy them and insurance companies reimburse the pharmacies once the vaccines have been administered.
Unfortunately, the cash flow hasn’t been as seamless as the companies involved had hoped.
“In many cases, pharmacies are getting underpaid (by insurance companies) for the vaccine or won’t be paid for a matter of months,” said Amanda Applegate, director of practice development at the Kansas Pharmacists Association.
The limited cash flow has forced pharmacies to be conservative when ordering vaccines from wholesalers, industry experts say, which is why some pharmacies had limited doses despite the high demand at the beginning of the season.
“A lot of stores are afraid of leveraging more cash in a vaccine they don’t know they can sell,” said Winslow, from the Virginia pharmacists group. “They have to think about how many doses they can order and when they’re going to have to pay their wholesaler back and compare it to when they get paid with insurance to make sure they have the cash flow to keep the whole model going.”
Health insurance associations said companies have been preparing for the new COVID-19 vaccine distribution “for months” and have “largely, if not completely, resolved” any systemic technical issues that had been limiting patient access to vaccines, according to a letter to Health and Human Services Secretary Xavier Becerra.
“Should further issues arise, we stand ready to swiftly implement system improvements,” the letter read.
Vaccine inequity: Who really suffers?
Americans expressed frustrations in the first few weeks of the rollout about not being able to secure vaccine appointments at the locations and times they wanted. Many complaining were among the healthiest and most technologically savvy consumers around, the people who immediately took note of the backlog.
But industry experts said people who really suffer are residents living in marginalized communities, who, according to research, were most impacted by the pandemic.
These are the patients that Perez sees at her SOMOS facility in the Bronx: People who are underinsured or uninsured, don’t speak English, work multiple jobs and can’t navigate the health system with as much ease as their mostly white and affluent counterparts.
“Our patients trust us,” she said. “When I tell them to go to a pharmacy like Walgreens, they look at me like I just grew another head.”
“’What do you mean?’ ‘Do I have to give them my information?’ ‘I don’t know them.’ ‘Do they speak Spanish?’” the SOMOS patients ask.
This deficit of service is well known among public health experts and the Centers for Disease Control and Prevention set out to address it preemptively through the Bridge Access Program, a partnership with state and local health departments and other points of care that provides vaccines for uninsured and underinsured Americans.
This Bridge Access Program is not the same massive initiative that helped fund the previous COVID vaccine rollouts, but rather a much smaller and temporary program focused on expanding vaccine access, said Dr. Evelyn Twentyman, the program’s lead at the CDC’s National Center for Immunization and Respiratory Diseases.
The government also partnered with eTrueNorth to implement the program in other healthcare facilities.
Regardless of the government’s intentions, critics are skeptical that vulnerable people will actually benefit. The program partners with the same chain pharmacies – Walgreens and CVS – that are already strained by the growing demand and Perez’s patients seem hesitant to visit.
“Will the vaccine actually be received by those individuals? Will they be able to find the locations, the pharmacies and the health departments where these Bridge Access vaccines are available?” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University.
Government outreach efforts could have been better applied elsewhere, said Yadav, from the Center for Global Development. For example, wholesalers and distributors could have benefited from a more hands-on transition where health officials shared vital information about what they learned distributing the vaccine over the past three years.
That could have bypassed some of the growing pains, but industry experts warn to expect more problems to pop up this season. Yadav said it took decades for the commercial market to perfect the flu vaccine rollout each year.
“It will take some time before the COVID vaccine market will operate like the flu vaccine market,” he said. “It’s still in its infancy.”
Follow Adrianna Rodriguez on X, formerly Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.