Immunocompromised individuals ought to obtain booster vaccinations towards COVID-19
The less than 3% of Americans who are severely immunocompromised should be able to receive an extra dose of the Pfizer or Moderna COVID-19 vaccine, the federal government decided Thursday.
People taking medications or suffering from diseases that suppress their immune systems may not have received adequate protection from their previous doses of the COVID-19 vaccine and are more likely to respond to an extra dose, the Food and Drug Administration noted.
“It is imperative to provide us with the booster vaccination,” said Michele Nadeem-Baker, a patient with chronic lymphocytic leukemia, a type of blood cancer. “The immunocompromised community felt forgotten. That gives us hope that we weren’t.”
For example, a study in people with solid organ transplants showed that only about 15% had an immune response to the first dose, and about half increased one to the second dose. Later research found that a quarter of those who did not respond 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 in 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 what are known as breakthrough infections.
“Today’s move enables doctors to boost immunity in certain immunocompromised individuals who need additional protection from COVID-19,” said Dr. Janet Woodcock, acting commissioner of the FDA, in a statement, vaccinated people are adequately protected and currently do not need an additional dose of the COVID-19 vaccine. “
The FDA made no mention of the immunocompromised patients who received the Johnson & Johnson single-dose vaccine.
For example, at City of Hope, a private, nonprofit hospital and research center in Duarte, California, “we’re seeing more and more people who are immunocompromised,” said Dr. John Zaia, Professor of Pediatrics.
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People with weakened immune systems are also more likely to have severe attacks of COVID-19.
According to a recent study, the risk of a vaccinated transplant patient getting a breakthrough infection is 82 times higher than that of the general population and the risk of hospitalization or death is 485 times higher.
“The takeaway message is that vaccination protection is much lower in transplant patients,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins Medicine who led the latest research.
Dr. Anthony Fauci told the USA TODAY Editorial Committee last week that he believed the rules for immunocompromised people should be changed to allow them to receive an extra dose of vaccine.
“A mechanism must be put in place quickly to protect these people,” said Fauci, an adviser to the president and director of the National Institute for Allergies and Infectious Diseases.
He and other officials said the public does not yet need booster doses. Although protection is expected to wear off between 6 and 12 months, the vaccines still appear to work well in preventing serious illnesses, and the vast majority of hospitalized patients are unvaccinated.
Sooner or later everyone is likely to need a booster vaccine, Fauci said at a White House briefing Thursday, but “other than the immunocompromised, we don’t think anyone, elderly or non-elderly, needs a vaccine right now.” he said.
Dr. Tedros Adhanom Ghebreyesus, director general of the World Health Organization, has asked countries to suspend booster doses for otherwise healthy people until the more at-risk people around the world have received their first vaccinations.
A number of immunocompromised people were already taking matters into their own hands and were quietly given an extra dose of the vaccine, although it is not known how many.
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At the White House briefing on Thursday, Dr. Rochelle Walensky, director of the Center for Disease Control and Prevention, asked people not to get freshened up as “it undermines our ability to monitor safety”.
Dr. Gwen Nichols, chief medical officer of the Leukemia and Lymphoma Society, a research and advocacy group, said she was concerned that so little was known about how immunocompromised people would react to an extra vaccination.
“We are a science-based organization,” she said. “Not to do this in such a way that we can actually find out whether it works, whether it is safe, is worrying.”
The LLS has tracked members who volunteer to provide information, but it is not clear how to stratify who should receive a booster and who will not benefit from an extra dose.
Your organization has started a small study, but that won’t be enough to analyze differences between people with a variety of diseases who were vaccinated at different times and with one of three vaccines.
“We have no reason to believe that security will be an issue, but again, everything is new,” she said. “The data must be collected.”
People with blood cancer often have impaired B or T cells – the very immune cells that are needed to fight off viruses like COVID-19.
Doses shouldn’t be wasted on those who don’t get benefit from an extra vaccination, Nichols said, especially as people in other parts of the world are desperate for vaccines.
Presumably, she said, those who meet the government’s criteria for a booster dose will not have to pay for the additional dose.
Dr. Teresa Murray Amato, chairwoman or emergency medic at Long Island Jewish Forest Hills in Queens, New York, said she doesn’t know anyone who has already had a booster, but has answered many questions from people at risk.
“I’m glad the FDA is issuing this guideline as it will help doctors guide their patients,” she said. “We encourage people to speak to their doctor as soon as possible to see if they belong to a group that needs a refresher.”
There is no perfect way to tell if someone has developed an immune response to a COVID-19 vaccine, so anyone in certain categories is advised to consider an additional vaccination.
The CDC does not recommend antibody testing because it is not yet clear which antibody level will provide adequate protection and because different tests will give different results.
“We’re still in the dark,” said City of Hope’s Zaia.
Hopkins’ Segev said he believed the general public shouldn’t get antibody tests, but that the tests can be useful in the immunocompromised individuals to see if they have built up any type of immune response to a shot.
A CDC advisory committee plans to meet on Friday to discuss these booster doses. The Advisory Committee on Vaccination Practices, at its July 23 meeting, presented data suggesting that extra vaccination is unlikely to do any harm and could be helpful to immunocompromised people.
Amato said she doesn’t 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 regular Johnson and Johnson therapy is a single dose, a booster dose would be a second dose.
Segev found that transplant patients were more likely to react after the Pfizer BioNTech and Moderna shots than after the single-dose J&J vaccine. But he saw no difference in reaction to booster shots.
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He’s now conducting a federally funded $ 40 million study to test a third dose of vaccine in transplant patients and modify their medication to see if it’s possible to produce a stronger response. The National Institutes of Health is conducting a separate study in people with other immunosuppressive disorders.
Segev started 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 one small study, the additional dose seemed safe, although one in 30 participants had a mild episode of rejection around the first organ transplanted.
“It reminds us that we have to be careful,” said Segev. “Every time we activate the immune system, we risk activating it against the transplanted organ, so we have to study these things very carefully.”
Meanwhile, Nadeem-Baker and other immunocompromised people have been told to “get vaccinated but act unvaccinated”.
Zaia, Segev, and other experts said people with compromised immune systems should surround themselves with others who are vaccinated and continue to wear well-fitting masks and avoid crowds.
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