Kavita Patel, a primary care physician at Mary’s Center in the Washington area, routinely throws away perfectly good doses of coronavirus vaccine. When she opens a new multidose vial, any shots that don’t go into arms that day have to be discarded.
In recent days, she was tempted to do something different: use one of those soon-to-be wasted doses to boost her own immunity.
It might seem a no-brainer, but nothing is simple when it comes to coronavirus vaccine boosters. The Biden administration’s coronavirus task force wants to roll out boosters the week of Sept. 20. Too soon, some experts have declared. Not soon enough, others say.
Meanwhile, officials at the Food and Drug Administration, which has regulatory authority over such matters, have warned the White House they may need to limit the boosters initially to people who received the Pfizer-BioNTech vaccine because they have not yet received the data they need to make decisions on Moderna and Johnson & Johnson vaccine boosters.
There’s even a debate over whether to call a third shot a “booster” or to declare that it’s just part of the initial immunization series.
“It shouldn’t be this confusing,” Patel said.
Booster confusion appears to have reached epidemic proportions amid a flood of new scientific studies that are not always consistent with one another. “Fully vaccinated” is suddenly a squishy concept. People who felt relatively bulletproof after two shots have been forced to rethink what’s safe, what’s risky and whether they’re truly protected from the coronavirus - especially in this summer of the delta variant, with new infections having risen to an average of more than 150,000 a day.
“You know what’s happening: People are just doing what they want,” Patel said. “I know of patients who have gotten a booster four months after their second dose.”
The booster confusion dates to Aug. 18, when the top doctors in the administration, and then President Joe Biden, revealed they want adults to get a third shot of an mRNA vaccine - that’s the Pfizer-BioNTech or Moderna vaccines - eight months after receiving their second.
But the booster plan is not a done deal: It requires approval from the FDA and the Centers for Disease Control and Prevention. Two top FDA regulators in recent days announced their departure later this year. An FDA advisory committee is expected to discuss the booster plan - specifically the Pfizer-BioNTech shot - in a Sept. 17 meeting. After that, the FDA will decide whether to approve the booster, and a CDC advisory committee will weigh in.
Administration officials concede the eight-month timeline is somewhat arbitrary and could be altered. Biden recently floated the possibility of speeding up the process, with boosters as early as five months after completion of the initial two-dose regimen.
Another quirk of the booster plan is that there are already third shots going into arms - 1.33 million by the CDC’s latest count - because the FDA in August approved an additional dose for people who are moderately to severely immunocompromised and may not have mounted a sufficient immune response.
“Immunocompromised” is a term that encompasses a wide range of medical conditions. There is no system for enforcement of the eligibility standard. There is no national vaccine registry that tracks who has and hasn’t had a vaccine. A third shot to protect against the coronavirus largely pivots on the discretion of doctors and pharmacists and perhaps the persuasiveness of the person seeking the booster.
Left somewhat in limbo for the moment, but likely to be included in the administration’s booster plan eventually, are people who got the single-shot Johnson & Johnson vaccine.
This is a lot for ordinary people to process.
“We’ve gone through a patch of very confusing guidance,” said J. Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies, a D.C. think tank. “People are taking matters into their own hands.”
No one doubts that protection against mild to moderate disease gradually wanes. And the delta variant replicates so fast in a person’s nose that an infection can take hold before the immune system can deploy all of its virus-clearing elements. But multiple studies have shown that protection against severe cases - the main purpose of vaccination - has been relatively steady.
Breakthrough cases among the vaccinated are often asymptomatic and usually do not require hospitalization. Still, a “mild” case can flatten a person for days, and the illness may not feel mild to the person suffering - but recovery can happen at home, as with most cases of the flu. The vaccines offer protection against all the variants that have emerged so far.
That has led some critics of the booster plan to argue that the administration isn’t following the science but instead guessing what the science is going to show at some point in the future. Administration officials have effectively acknowledged as much: Surgeon General Vivek Murthy has said the plan was being rolled out to get ahead of a possible drop-off in vaccine effectiveness against severe disease.
Much of the debate has focused on data from Israel, which was early to vaccinate and has abundant research on vaccine effectiveness. Biden’s top medical adviser on the pandemic, Anthony Fauci, on Thursday cited new studies from Israel, not yet peer-reviewed, showing rising numbers of severe breakthrough infections and a protective benefit against infection and severe disease from a third shot of the Pfizer vaccine.
“There’s no doubt from the dramatic data from the Israeli study that the boosts that are being now done there and contemplated here support, very strongly, the rationale for such an approach,” Fauci said.
While acknowledging that the FDA has to make the decision on whether a person will need three shots to be considered “fully vaccinated,” Fauci said he thinks the three-shot regimen is poised to become the standard.
As public health officials debate the need for boosters, they are wrestling with broad strategic questions about how best to end the pandemic. Is the goal to crush the virus, or adapt to it?
How much should the country lean on vaccinations to bring the virus under control, versus a strategy that supplements the vaccination campaign with layers of other interventions, such as mask-wearing, social distancing and restrictions on gatherings?
The public may need to adjust its expectations and risk-tolerance. Vaccines remain a powerful tool to combat the virus, but breakthrough infections - mostly not severe - have been a fact of summer 2021 life.
Vaccines, even when boosted, can’t eliminate all risk of a coronavirus infection, said Celine Gounder, an infectious-disease specialist and epidemiologist at New York University and Bellevue Hospital.
“You’re not going to be able to prevent breakthrough infections indefinitely unless you want to boost people every three to six months, and you’re never going to do that,” Gounder said.
She felt the Biden administration’s booster plan was premature and may have been more of a response to public concerns than to scientific ones: “It seems like this is just caving in to anxiety about breakthrough infections.”
Boosters may make individuals more protected against infection, but those extra shots may not be the best use of a precious resource, some experts argue.
There is the ethical issue of giving a third dose to people when most of the world’s population hasn’t had the first. Patel is conscious of that when she ponders getting a third shot - which is why she would use a dose already destined to be discarded.
Morrison, for one, believes the administration needs to pressure vaccine makers to distribute more of their doses to poor and middle-income countries even though the companies will make more money selling a third dose to people in wealthy countries.
The biggest challenge for the United States is the unanticipated and tragic summer wave of infections, hospitalizations and deaths, driven by the delta variant. The best way to tamp down the spread of the virus is to get a first shot to the unvaccinated, because they are more likely to contract the virus and shed it for a longer period when sick, experts argue.
That, in turn, may protect individuals more than a booster shot. Less virus means less risk, regardless of how many shots a person has had.
The Biden administration’s booster plan includes everyone 18 and older, even though younger people are much less likely to have severe illness. Boosters are “not unreasonable” for some groups of people, such as those who are immunocompromised, “but for younger people, it’s extraordinarily strange,” said William Hanage, an epidemiologist at the Harvard T. H. Chan School of Public Health. “If you have somebody who is 85% protected from hospitalization and increase that to 90%, that’s not actually a large benefit.”
The best approach to crushing the pandemic won’t rely simply on vaccinations, said David Dowdy, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.
“We should not be thinking of booster shots as our way out of the pandemic,” Dowdy said. Taking the virus seriously, he said, “doesn’t mean everyone has to be isolated at home all the time. But it means you have to think twice about going to big events where there are going to be thousands of other people, or having parties with lots of unmasked people who are sharing a room for a long period of time - these sorts of high-transmission events.”
Another way of saying this is: The pandemic isn’t over. Being “fully vaccinated” - an iffy designation, it turns out - doesn’t mean anything goes. Many people who were hoping otherwise may feel as if the rules of engagement with the virus keep changing, and that the finish line keeps moving farther away.
“Why should we be surprised if the goal post is moving?” Morrison said. “We’re dealing with an incredibly wily and pernicious virus.”
The virus is continuing to mutate. Although almost every new infection in America is caused by the delta variant, there are other variants popping up globally, including a new “variant of interest,” first identified in Colombia and named mu by the World Health Organization. It has not gained a significant foothold in the United States.
The vaccines are also not entirely static, and that could generate a new set of confusing issues. Pharmaceutical companies are in the process of making “next generation” vaccines more customized to the delta variant or, possibly, to a wide range of mutated coronaviruses.
Patel says colleagues have asked her, “Should I even get a booster, or should I wait to get one of these next-generation vaccines, because it might be better?”
She advises them not to wait. She says she’s going to get her booster, because she has kids at home who are unvaccinated, it has been almost eight months since her second shot, and she’s worried about delta - “and potentially what’s coming after delta.”
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The Washington Post’s Laurie McGinley and Frances Stead Sellers contributed to this report.