FDA authorizes COVID-19 vaccine boosters for the immunocompromised
The less than 3% of Americans who are severely immunocompromised should be able to get an extra dose of the Pfizer or Moderna COVID-19 vaccine, the federal government decided Thursday.
People who are on medications or have diseases that suppress their immune system may not have gotten adequate protection from their earlier doses of COVID-19 vaccine and are more likely to mount a response to an additional dose, the Food and Drug Administration determined.
“Making the booster shots available to us is imperative,” said Michele Nadeem-Baker, a patient with chronic lymphocytic leukemia, a type of blood cancer. “The immunocompromised community has felt forgotten This gives us hope that we have not been.”
A study in people with solid organ transplants, for instance, showed only about 15% had an immune response to the first dose and roughly half mounted one to a second dose. Later research found a quarter of those with no response to the first two doses responded to a third. Even those who had an antibody response had a lower one than those with normal immune systems.
And a study published Wednesday confirmed the benefit of a third dose among transplant patients.
It’s not clear how many of those infected after vaccination are transplant patients or otherwise immunocompromised, but anecdotally, doctors have reported that they make up a large percentage of those hospitalized with so-called breakthrough infections.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement. “As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time.”
The FDA did not mention the immune-compromised patients who received the single-dose Johnson & Johnson vaccine.
At City of Hope, a private, nonprofit hospital and research center in Duarte, California, for example, “we are seeing more and more immunosuppressed people,” said Dr. John Zaia, a professor of pediatrics.
People with weakened immune systems are also more likely to have a serious bout of COVID-19.
The risk of a vaccinated transplant patient getting a breakthrough infection is 82-times higher than the general population’s and their risk of hospitalization or death is 485-times greater, according to a recent study.
“The take-home message is that vaccine protection is much lower in transplant patients,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins Medicine who led the recent research.
Dr. Anthony Fauci told USA TODAY’s Editorial Board last week that he thought the rules should be changed for the immunocompromised, allowing them to get an additional vaccine dose.
“Some mechanism needs to be done quickly to get those people protected,” said Fauci, a presidential adviser and director of the National Institute of Allergy and Infectious Diseases.
He and other officials have said booster doses are not needed yet by the general public. Although protection is expected to begin waning between 6-12 months, the vaccines still seem to be working well in preventing serious disease and the vast majority of hospitalized patients are unvaccinated.
Sooner or later, everyone is likely to need a booster shot, Fauci said at a Thursday White House briefing, but “apart from the immunocompromised, we do not believe that others, elderly or non-elderly, need a vaccine at this moment,” he said.
Dr. Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, has asked countries to hold off on booster doses for otherwise healthy people until after the more vulnerable worldwide receive their initial shots.
A number of immunocompromised were already taking the matter into their own hands, quietly getting an extra dose of vaccine, though it is not known how many.
At Thursday’s White House briefing, Centers for Disease Control and Prevention Director Dr. Rochelle Walensky asked people to please not get a booster out of turn, because “it does undermine our ability to monitor safety.”
Dr. Gwen Nichols, chief medical officer of the Leukemia and Lymphoma Society, a research and advocacy group, said she’s concerned that so little is known about how immunocompromised people will respond to an additional shot.
“We’re a science-based organization,” she said. “To not do this in a way where we can actually find out if it works, find out if it’s safe, is disturbing.”
The LLS has been tracking members who volunteer information, but it’s not clear how to stratify who should get a booster and who will not benefit from an additional dose.
Her organization has launched a small study, but that won’t be adequate to parse out differences among people with a variety of diseases, who got vaccinated at different times and with one of three vaccines.
“We have no reason to think safety will be an issue, but again, it’s all new,” she said. “The data needs to be collected.”
People with blood cancers often have impaired B or T cells — the exact immune cells needed to fight off viruses like COVID-19.
Doses should not be wasted on those who won’t get any benefit from an extra shot, Nichols said, particularly as people are desperate for vaccines in other parts of the world.
Presumably, she said, those who meet the government’s criteria for a booster dose will not have to pay for the extra shot.
Dr. Teresa Murray Amato, chair or emergency medicine at Long Island Jewish Forest Hills, in Queens, New York, said she doesn’t know anyone who already got a booster, but has fielded lots of questions from at-risk patients.
“I’m glad the FDA is putting out this guideline as it will help physicians with guiding their patients,” she said. “We encourage people to talk to their doctor as soon as possible to see if they are in a group identified as needing a booster.”
There is no perfect way to determine if someone mounted an immune response to a COVID-19 vaccine, so the recommendation is for everyone in certain categories to consider an additional shot.
The CDC does not recommend antibody testing, because it’s not yet clear what level of antibodies is protective enough and because different tests yield different results.
“We’re still in the dark,” Zaia, of City of Hope, said.
Segev, of Hopkins, said he thinks the general public should not get antibody tests, but that the tests can be useful among the immunocompromised to see if they’ve mounted any kind of immune response to a shot.
A CDC advisory committee plans to meet Friday to discuss these booster doses. The Advisory Committee on Immunization Practices presented data at its July 23 meeting suggesting an additional shot was unlikely to cause harm and might be helpful to people who are immunocompromised.
Amato said she does not recommend a specific vaccine as a booster.
The Pfizer-BioNTech and Moderna vaccines are given in a two-dose sequence, so an extra dose would be the third; while the regular Johnson and Johnson regimen is a single dose, so a booster would be a second dose.
Segev found that transplant patients were more likely to mount a response after the Pfizer-BioNTech and Moderna shots than after the single-dose J&J vaccine. But he saw no difference in response to booster shots.
He is now running a $40 million federally funded trial to test a third vaccine dose in transplant patients and includes modifying their medications to see if it’s possible to trigger a stronger response. The National Institutes of Health is running a separate trial in people with other immunocompromising conditions.
Segev began studying third doses, he said, because so many in the transplant community were already getting them and he wanted to learn from their experiences. In a small study, the additional dose appeared safe, though one of 30 participants did have a mild rejection episode around the ti her transplanted organ.
“That reminds us we need to be cautious” Segev said. “Every time we activate the immune system we risk activating it against the transplanted organ, so we need to be very carefully studying these things.”
In the meantime, Nadeem-Baker and others who are immunocompromised have been told to “get vaccinated but act unvaccinated.”
Zaia, Segev and other experts said people who are immune compromised should surround themselves with others who are vaccinated and should continue to wear well-fitting masks and avoid crowds.
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