Infectious Disease

FDA approves third dose of COVID-19 vaccine for immunocompromised patients

August 13, 2021

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Walensky does not report any relevant financial information

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The FDA approved a third dose of the COVID-19 vaccine for certain immunocompromised patients, but continued to say that other fully vaccinated people do not need one.

The agency updated its emergency approval for the Pfizer-BioNTech and Moderna messenger RNA vaccines to include a third dose “in certain immunocompromised individuals, particularly those who have received solid organ transplants or who are diagnosed with diseases considered to be equivalent”, allow immunodeficiency. “

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The FDA said the third dose should be given at least 28 days after a second dose of the same vaccine to eligible patients 18 years of age or older for the Moderna vaccine and 12 years or older for the Pfizer BioNTech vaccine.

The approval does not apply to the Johnson & Johnson vaccine.

On Friday afternoon, the CDC Advisory Committee on Immunization Practices voted 11-0 to recommend a third dose of the two vaccines in patients with moderate or severe immunodeficiency.

The ACIP working group that studied and recommended the intervention said that the “desirable effects” of adding a third dose “clearly outweigh the undesirable effects in most situations”.

One caveat, according to an FDA official, is that a third dose has been shown to be only moderately effective in increasing protection against COVID-19.

“Patients should be instructed to take physical precautions to prevent COVID-19, and people in close contact with immunocompromised people should be vaccinated.” Peter Marks, MD, PhD, who directs the FDA’s Center for Biologics Evaluation and Research, said during the ACIP meeting.

Yvonne A. Maldonado

Yvonne A. Maldonado, MD, FAAP, Chairman of the American Academy of Pediatrics’ Infectious Diseases Committee, expressed concerns about an additional dose in immunocompromised adolescents.

“While there is legitimate concern about certain cases of myocarditis, these are extremely rare and we know that the severity of the infections at the moment and in the events we have seen have shown no evidence of adverse immunological reactions. either clinically or in laboratory studies, ”Maldonado said during the meeting.

“We are concerned about the safety of our children and the fact that they are so vulnerable, even healthy children and especially the immunocompromised,” she said. “[The AAP] Strongly supports all efforts to make vaccines available to children when indicated. “

Rochelle P. Walensky

CDC director on Thursday Rochelle P. Walenksy, MD, MPH, said that the population eligible for a third dose is approximately 3% of adults. The extra dose could help increase protection, which is “especially important” as the delta variant continues to spread, she said.

Research has shown that immunocompromised patients do not respond optimally to the COVID-19 vaccination and could benefit from an additional dose. The results of the first randomized, placebo-controlled study of a third dose of vaccine in transplant recipients were published this week in the New England Journal of Medicine and showed that an additional dose increased protection.

“We have been working to find out how we can best offer better protection to these vulnerable people who are disproportionately affected by the severe consequences of COVID-19,” said Walensky.

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Peter Chin-Hong, MD

Peter Chin-Hong

FDA approval of a third dose of the Pfizer or Moderna vaccine for immunocompromised patients has been welcomed with open arms by clinicians and patients. Giving these patients a third dose of vaccine reflects what has already happened in other countries – France, Germany and Israel, for example, have all given third vaccinations to immunocompromised patients. Although the lion’s share of hospital admissions in the U.S. and elsewhere have been unvaccinated, transplants and other immunocompromised individuals have a lower chance of responding to vaccines – as measured by antibody response – and most importantly, we’ve seen them admitted to our hospitals with serious breakthrough infections. During my service last week in the inpatient infectious disease service, I myself looked after several of these patients, some of whom were seriously ill.

Several small observational studies have shown that transplant patients can safely benefit from a third shot because they are more likely to have an antibody reaction. In addition, a recent small Canadian placebo-controlled randomized controlled trial showing the benefit of a third dose in transplant patients gives us more credible evidence that this is the right step. Ideally, we would prefer larger randomized controlled trials reporting clinical endpoints such as symptomatic illness, hospitalizations, and averted deaths. But in the midst of a fast-paced pandemic and delta surge right now in the US, time is everything.

The devil is, of course, in the details: who is considered to be immunocompromised? What about immunocompromised patients who have received the Johnson & Johnson injection? How long does protection last in this population after a third dose? What if a patient does not respond to a third dose? Do you give a fourth or a fifth? Recommending an additional dose of vaccine in this population is a great move, but we need to set parameters and then refine who is eligible from the large group of potential patients with some degree of immunodeficiency.

Peter Chin-Hong, MD

Member of the editorial board of Infectious Disease News

Professor of Medicine

Director, Transplant Infectious Disease Program

University of California, San Francisco

Disclosure: Chin-Hong does not report any relevant financial information.

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