Who Will Be Eligible for COVID Vaccine Booster Shots If the FDA Authorizes?
With the FDA expected to OK a third dose of the Pfizer and Moderna vaccines for people with compromised immune systems, who will be included and what does that mean for those who got the Johnson & Johnson vaccine?
The FDA is poised to amend the emergency use authorizations for the Pfizer and Moderna COVID-19 vaccines to allow people with compromised immune systems to get a third dose, according to two sources familiar with the plans.
The move would come after a panel of advisors to the Centers for Disease Control and Prevention met in July and urged action on extra doses for immunocompromised adults.
The U.S. government’s top infectious disease expert, Dr. Anthony Fauci, said Thursday that an additional COVID-19 booster shot will be recommended “imminently” for previously vaccinated people with weakened immune systems.
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In an interview on the “TODAY” show, Fauci said it is increasingly clear that many such patients are still vulnerable to COVID following vaccination because months after receiving the shots, their bodies are producing little to no antibodies. He said the purpose of the booster shot is to get their protection level up to where it should be.
An estimated 2.7 percent of adults in the United States are immune-compromised, according to the CDC.
Who Would Be Eligible for Boosters?
It is unclear which groups would be covered under the expected FDA action. Immune-compromised patients include organ transplant recipients, people undergoing cancer treatment and people with HIV, among others.
According to recent data from the Centers for Disease Control and Prevention, considerations for a booster vaccine could include:
- Conditions and treatments associated with moderate to severe immune compromise
- Active or recent treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ or recent hematopoietic stem cell transplant
- Severe primary immunodeficiency
- Advanced or untreated HIV infection
- Treatment with immunosuppressive medications such as cancer chemotherapeutic agents, TNF blockers, certain biologic agents (e.g., rituximab), and high-dose corticosteroids
- Chronic conditions associated with varying degrees of immune deficit, such as asplenia and chronic renal disease
The CDC noted, however, that “different medical conditions and treatments can result in widely varying degrees of immunosuppression.
“A patient’s clinical team is best able to assess the degree of altered immunocompetence and optimal timing of vaccination,” the agency stated.
What About People Who Got the Johnson & Johnson Vaccine?
According to the CDC report, a recent UK study found that one dose of the AstraZeneca vaccine paired with one dose of the Pfizer vaccine offered more protection than two doses of the AstraZeneca vaccine. The report, however, stated that more “evidence is needed” to determine if people with compromised immune systems who received the Johnson & Johnson vaccine should also get a dose of the mRNA vaccines.
What About Everyone Else?
Fauci said “at this moment, other than the immunocompromised, we’re not going to be giving boosters.” However, he acknowledged that “inevitably there will come a time where we’ll have to get boosts” because “no vaccine, at least not within this category, is going to have an indefinite amount of protection.”
An untold number of Americans have already managed to get COVID-19 booster shots even though the U.S. government hasn’t approved them. They’re doing so by taking advantage of the nation’s vaccine surplus and loose tracking of those who have been fully vaccinated.
An Associated Press review of a database run by the CDC found health care providers have reported more than 900 instances of people getting a third dose. However, because reporting is voluntary, the full extent of people who have received third doses is unknown. It’s also unknown if all of those people were actively trying to get a third dose as a booster.
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