FDA allows third dose of COVID-19 vaccine for immunocompromised patients
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The FDA authorized a third dose of 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 use authorization for the Pfizer-BioNTech and Moderna messenger RNA vaccines to allow a third dose “in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.”
The FDA said third doses should be administered at least 28 days after a second dose of the same vaccine to eligible patients aged 18 years or older for the Moderna vaccine and 12 years or older for the Pfizer-BioNTech vaccine.
The authorization does not apply to the Johnson & Johnson vaccine.
On Friday afternoon, the CDC’s Advisory Committee on Immunization Practices voted 11-0 in favor of recommending a third dose of the two vaccines in patients who are moderately or severely immunocompromised.
The ACIP work group that studied and recommended the intervention said the “desirable consequences” of adding a third dose “clearly outweigh undesirable consequences in most settings.”
One caveat, an FDA official noted, is that a third dose has been shown to be only moderately effective at increasing protection against COVID-19.
“Patients should be counselled to maintain physical precautions to help prevent COVID-19, and close contacts of immunocompromised persons should be vaccinated,” Peter Marks, MD, PhD, who leads the FDA’s Center for Biologics Evaluation and Research, said during the ACIP meeting.
Yvonne A. Maldonado, MD, FAAP, chair of the American Academy of Pediatrics’ committee on infectious diseases, addressed concerns regarding an additional dose in immunocompromised adolescents.
“While there is justifiable concern on certain cases of myocarditis, these are extremely rare, and we know that the severity of the infections right now and in the events that we've seen, that vaccines have not shown any evidence of adverse immunological responses, 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 stands behind any efforts to provide vaccines for children when they are indicated.”
On Thursday, CDC Director Rochelle P. Walenksy, MD, MPH, said the population eligible for a third dose represents around 3% of adults. The additional 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 COVID-19 vaccination and could benefit from an additional dose. The results of the first randomized, placebo-controlled trial of a third vaccine dose in transplant recipients were published this week in The New England Journal of Medicine and showed that an additional dose enhanced protection.
“We've been working to identify how best to provide an increased protection to these vulnerable people who are disproportionately impacted by severe outcomes due to COVID-19,” Walensky said.
Perspective
Back to TopPeter Chin-Hong, MD
The FDA authorization of a third vaccine dose of the Pfizer or Moderna vaccine for immunocompromised patients is being welcomed with open arms by clinicians and patients. Giving a third vaccine dose to these patients mirrors what has already been happening in other countries — France, Germany and Israel, for example, have all been administering third shots in immunocompromised patients already. Although the lion’s share of hospitalized cases in the U.S. and elsewhere have been in the unvaccinated, transplant and other immunocompromised individuals have a lower chance of responding to vaccines — as measured by antibody response — and most importantly, we have been seeing them get admitted to our hospitals with serious breakthrough infections. While on service last week in the inpatient infectious disease service, I myself took care of several of these patients, some of whom were severely ill.
There have been several small observational studies already demonstrating that transplant patients may safely benefit from a third shot due to a higher probability of antibody response. In addition, a recent small Canadian placebo-controlled randomized controlled study showing a benefit of a third dose in transplant patients gives us more credible evidence that this is the right move. We would ideally prefer to have larger randomized controlled studies that report clinical endpoints such as symptomatic disease, hospitalizations and deaths averted. But in the middle of a fast-moving pandemic and a delta surge currently in the U.S., time is everything.
Of course, the devil is in the details: Who counts as immunocompromised? What about immunocompromised patients who received the Johnson & Johnson shot? How long will protection last in this population, even 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 vaccine dose in this population is a great move, but we will need to set, then refine parameters for who among the large swath of potential patients with some degree of immune compromise is eligible.
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