CDC: Some Immunocompromised People Can Get a Fourth Dose

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“Moderately or severely immunocompromised” adults ages 18 and up who received an additional dose of Pfizer or Moderna’s mRNA vaccines may now receive a booster dose of Pfizer, Moderna, or Johnson & Johnson at least 6 months after completing their third dose, the agency said.

They added that if a moderate to severely immunocompromised adult has received a two-dose series of Pfizer or Moderna, and more than 28 days has elapsed, that person should “immediately” receive an additional dose of Pfizer or the full-dose volume of 100 μg for Moderna, followed by a single booster dose with any of the three authorized vaccines at least 6 months later.”

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U.S. FDA authorizes COVID-19 vaccine boosters for the immunocompromised

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“The U.S. Food and Drug Administration authorized a third dose of COVID-19 vaccines from Pfizer Inc (PFE.N) and Moderna Inc (MRNA.O) for people with compromised immune systems.

The amended emergency use authorization paves the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose.

“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines,” Janet Woodcock, U.S. FDA’s acting commissioner, said in a tweet on Thursday.”

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NIH launches study of third COVID-19 vaccine dose in kidney transplant recipients

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“A pilot study has begun to assess the antibody response to a third dose of an authorized COVID-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The lifelong immunosuppressive therapy that organ transplant recipients must take to prevent organ rejection blunts their immune response to both pathogens and vaccines. Research has shown that many organ transplant recipients do not develop antibodies against SARS-CoV-2, the virus that causes COVID-19, after receiving an authorized COVID-19 vaccine regimen. The purpose of the new study is to determine whether a third dose of one of the mRNA COVID-19 vaccines could overcome this problem for at least some kidney transplant recipients. This is particularly important because this population has a high prevalence of conditions that are risk factors for severe COVID-19, such as cardiovascular disease and diabetes.”

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Should You Recommend a COVID Booster to Patients?

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“Certain at-risk groups need to consider extra protection now.”

What’s the Current Booster Landscape?

“Several studies offer preliminary evidence on the benefits of boosters, especially for certain populations. A recent French study in JAMA showed that about 50% of 159 kidney transplant patients with low or no measurable antibodies after two doses of an mRNA vaccine mounted a response with a third shot, and with no serious side effects or rejection episodes. A study in the Annals of Internal Medicine also showed the benefits of a third dose in solid organ transplant patients. Pfizer data (that has not yet been peer reviewed) show antibody levels rise 11-fold in patients ages 65 to 75 after a booster.

Around the world, some countries and localities have gotten an early start on boosting. Boosters are being offered to patients over 60 years old in Israel. France is giving a booster dose to the severely immunocompromised 4 weeks after the second dose, and Hungary, Turkey, Thailand, Bahrain, and the United Arab Emirates are starting booster programs. The Mississippi Health Department is now recommending physicians consider boosters for the immunocompromised.”

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