Federal officials have authorized an extra dose of COVID-19 vaccine for certain Americans whose immune systems are compromised — an estimated 7 million people.
But hundreds of thousands of others, worried that they need extra protection against a virus still raging, are looking for ways to get that extra shot, too.
What happens next could involve uncertainty over who exactly qualifies for that third shot.
"There will be a lot of confusion and concern and discussion, and doctors will wonder how much leeway they have in putting their patients into the immunocompromised group," said infectious disease expert Dr. William Schaffner, professor of preventive medicine at the Vanderbilt University School of Medicine in Nashville, Tennessee.
Local and national experts say people with healthy immune systems should not need the extra dose, that the vaccines they had months ago are still keeping them out of the hospital.
But as so-called "breakthrough" infections show up in people who are vaccinated, and the highly contagious delta variant continues its surge, some people aren't waiting. They have already sought out pharmacies that would give them the vaccine, no questions asked.
On Saturday, Hy-Vee pharmacies were among those that began offering that third vaccine, for free, to immunocompromised people who qualify — and they won't have to show proof of their condition.
An internal Centers for Disease Control and Prevention document estimated that 1.1 million people who got the Moderna or Pfizer vaccine have already gone back for a third shot, even before federal regulators made their recommendations on who should get one, ABC reported last week.
And that could be a conservative estimate, because it didn't include people who got the one-shot Johnson & Johnson vaccine and have gone back for another. Federal officials haven't approved an extra dose of that.
Dr. Chad Johanning and his family physician colleagues in Lawrence are fielding questions from patients asking about that third shot.
One was a grade-school teacher who got two Moderna shots in January and February, but now worries about being around children too young themselves to be vaccinated.
"She's concerned about her waning potential immunity and being exposed to kids in the classroom, and I think it's a reasonable concern and it is coming up a lot," said Johanning, chairman of the board of the Kansas Academy of Family Physicians.
Swope Health in Kansas City is getting the questions, too, said Jeron Ravin, president and CEO.
"There is some interest. There are some questions about the booster shot and we are responding to that, waiting on some CDC guidance," he said last week.
The people wanting information are the ones who "stepped up to the plate" and didn't hesitate to get vaccinated months ago, Ravin said.
But even as the discussion turns toward booster shots, Ravin and his staff, who have led more than 250 community vaccination events, are still trying to get people to take the first dose.
"Looks like these events are going to go well into 2022," he said.
Waiting for CDC guidance
Kansas City area public health officials said they, too, were fielding questions about the third dose but were waiting for federal guidance. That came at the end of the week.
The Food and Drug Administration on Thursday approved the third dose of vaccines for Americans whose immune systems are compromised.
On Friday, after a unanimous endorsement by an expert advisory panel, the CDC followed suit, OKing the Pfizer-BioNTech vaccine for eligible people 12 and older, and the Moderna vaccine for those 18 and older.
Also on Friday, the Kansas Department of Health and Environment said Kansas vaccine providers could immediately begin administering that additional dose. A spokeswoman for the Missouri Department of Health and Senior Services expected the department to have more information on extra doses this week.
The federal recommendations are non-binding and serve as guidance for public health officials and physicians. The CDC says people are eligible if they have:
— Been receiving active cancer treatment for tumors or cancers of the blood
— Received an organ transplant and are taking medicine to suppress the immune system
— Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system
— Moderate or severe primary immunodeficiency
— Advanced or untreated HIV infection
— Active treatment with high-dose corticosteroids or other drugs that may suppress immune response
Schaffner expects there still might be questions about who exactly is immunocompromised and technically qualifies for the third shot.
One category is broadly defined by the FDA as this: "People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation."
It's "a bit of a wastebasket category, this and that, and anybody else who is thought to be seriously immunocompromised," Schaffner said.
"Doctors will be very interested in how much leeway they have in identifying which patients are immune compromised, and the patients themselves will want to know whether they can self-define themselves as immunocompromised," said Schaffner.
The CDC will not require patients to get a prescription or a letter from a doctor for the third shot, officials said. Consumers will have to attest only that they have impaired immune systems. The goal is to minimize barriers to vaccination, they said. Additional doses will be free, and people will be able to get them in the same way they got earlier shots — through pharmacies and other health-care providers.
Hy-Vee's announcement said people won't have to show proof of their condition, but they will be required to get their shot from the same manufacturer of their first two doses.
During a Friday COVID-19 briefing, physicians with the University of Kansas Health System said people should talk to their doctor about what to do next.
Why a third shot?
For now, healthier people are supposed to wait for federal regulators to sign off on a booster shot for them.
"The CDC and the FDA say the vaccines you received, if you have a normal immune system, are still hanging tough, they're getting their job done. So be content at the moment," Schaffner said.
But growing evidence suggests the vaccines have been less effective for people with compromised immune systems than among the general population, prompting the FDA's declaration that a third dose "may increase protection in this population."
It also urged close contacts of immunocompromised people to give them extra protection by getting vaccinated.
Drug makers and researchers, including the National Institutes of Health, are studying the effectiveness of third doses in immunocompromised people. The NIH study will examine the antibody response to a third shot in kidney transplant patients who didn't respond to two doses of the Moderna or Pfizer vaccines.
A group of Canadian researchers at Toronto's University Health Network, who studied 120 transplant recipients, found that a third dose of Moderna's vaccine substantially improved their immunity.
Fifty-five percent of third-dose recipients had high levels of antibodies in their blood after the extra dose, compared to 18% who got two shots and a placebo.
Immunocompromised people "never had a good (immune) response to the initial two doses, or one dose, of the vaccine," said Schaffner.
The authorized additional shot is "an attempt to help them build an immune response closer to what a normal person would have," he said.
Breakthrough infections
For the much larger group of people with better immune systems, a third dose would be like a booster shot, Schaffner said.
"Obviously if it's going to boost, you have to boost something," he said. "They had an initial response, they think it might be waning ... so they want to boost that protection up again."
Health care workers are a "perfect example," Johanning said, of people who were at the front of the vaccine line because of their high-risk jobs who now wonder if they're still protected.
Breakthrough infections — when fully vaccinated people get infected — among hospital staff raise the question: Is that happening because the delta variant is so infectious or because their immunity is waning, Johanning said.
"At-risk people and the people at the front of the line seven, eight months ago, those are the people you're wondering about now," Johanning said.
White House chief medical adviser Dr. Anthony Fauci said last week that someday everybody will "likely" need a booster shot. "We are already starting to see indications in some sectors about a diminution over time" in vaccines' durability, Fauci told "CBS This Morning."
But he said it's not likely that boosters will be widely administered soon. "We don't feel at this particular point that, apart from the immune-compromised, we don't feel we need to give boosters right now," he said.
The vaccines being used now "all provide very good protection from all the variants we've identified so far, including delta variant," Dr. Dana Hawkinson, medical director of infection prevention and control for the KU Health System, said last week.
That's reflected in current hospitalizations and deaths, he said: In the hospital, 95% of COVID-19 patients are unvaccinated, and 97% or more of the people dying from the virus are unvaccinated.
So unless you're among the immunosuppressed — taking drugs that suppress your immune system, are on chemotherapy for cancer or have blood cancer — "you really should be OK," said Hawkinson.
"Right now ... anyone not in those categories should be OK because the vaccines we have right now still provide that great protection against the whole spectrum of COVID-19, but especially that severe disease and death."
Crossing state lines for boosters
The FDA was clear on that point: People who are not immunocompromised, who are fully vaccinated, "are adequately protected and do not need an additional dose of COVID-19 vaccine at this time."
Yet some places didn't wait for the feds to sign off before providing additional doses. Zuckerberg San Francisco General Hospital and San Francisco's Department of Public Health announced earlier this month they were giving extra vaccine to people who got the single-dose Johnson & Johnson.
The states with the highest number of people triple-dipping included Florida, Ohio, California, Illinois and Tennessee, according to ABC.
Talking with patients about third shots and boosters is a difficult conversation, Johanning said, "because I've heard of people getting them, but unofficially.
"And there's a fair amount of people who are scientifically based, who are like, 'look, I got the J&J for my first shot. I know that that's not good against delta with that shot. Can I get ... a supplemental Pfizer one-shot?"
Some people have already found those extra doses.
"We know it's been happening, and it's clear that some locations are more permissive than others," said Schaffner. "Also, if you live near a state's border, or somehow you found yourself in the next state, there are some people who have gone in and presented themselves as though they were brand new (vaccine recipients) ... to get that third dose.
"The vaccine registries don't talk to each other very well, if at all, across states. So there have been people out there already gaming the system."
Johanning worries the FDA and CDC are going to be far behind in their vaccine recommendations "because they're going to want studies to make recommendations, right? And we're in a real time situation here where you could easily give the vaccines today.
"Well, the studies ... won't come out until delta's run its rampant course. So these patients are left with a decision about which is worse: an unstudied off-label way of getting my vaccine, which in medicine happens on all kinds of areas, not just in vaccination, or do I run the risk of just going with, 'what the CDC says and I should be fine'?
"It's a very difficult balance for some of my patients. ... If I have someone who's high risk, who's had the J&J before — real high risk — I might suggest that potential to them because they're concerned and that does leave me concerned as well.
"If they're a healthy 20- to 50-year-old, I don't think there's a whole lot of value to be gained from that, probably."
