23-valent pneumococcal vaccine linked to necrosis, but risks do not outweigh benefits

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Key takeaways:

• There were less than 0.2 cases of injection site necrosis per million 23-valent pneumococcal vaccine doses.
• Researchers said the overall benefit-risk balance for the vaccine is still favorable.

There have been some reports of necrosis at the injection site following receipt of the 23-valent pneumococcal vaccine, but the vaccine’s overall benefit-risk balance “remains favorable,” researchers wrote in JAMA Internal Medicine.

Once a vaccine has been approved by the FDA and administered to a large, diverse population, rare safety events that clinical trials are not typically equipped to detect may emerge, Brendan Day, MD, MPH, of the FDA’s Office of Biostatistics and Pharmacovigilance at the Center for Biologics Evaluation and Research, and colleagues wrote. Therefore, postmarketing surveillance is critically important when it comes to characterizing the safety profile of licensed vaccines.

Data derived from Day B, et al. JAMA Intern Med. 2023; doi:10.1001/jamainternmed.2023.2146.

In 2020, the FDA detected a safety signal of injection site necrosis — “a rare complication for many vaccines and injectable drugs,” the researchers wrote — after receiving the 23-valent pneumococcal vaccine. Day and colleagues conducted a study to describe the evaluation and outcomes of this safety signal.

The CDC and FDA use the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system that relies on individuals to report adverse events, to monitor postmarketing safety of US-licensed vaccines.

The researchers queried the VAERS database in May 2020 and performed a case series review of reports, including submitted medical records such as pathology reports and clinician notes. They defined a case using adapted criteria for a local reaction at or near the injection site. They also used vaccine distribution data from the manufacturer to calculate a reporting rate.

Day and colleagues found that the injection site necrosis reporting rate was less than 0.2 cases per million vaccine doses distributed.

“Often, skin necrosis developed after a progression of typical local symptoms (eg, redness, swelling, and pain),” they wrote. “These reports are consistent with published descriptions of injection site necrosis.”

The researchers identified 104 VAERS reports, but just 48 met their case definition, 43 of which were for skin necrosis. Of the remaining cases, two were necrosis of fascia, one was of fat and fascia, one was muscle and one was fat, fascia and muscle. Half of the cases were in the United States. The median age for patients with skin necrosis was 67 years; 12 patients were immunocompromised; and most — 36 — were women.

Fewer than half of cases (n = 23) had serious reactions, including one fatality that was unrelated to vaccination. Also, 26 patients required surgical intervention — most commonly debridement — and 17 patients required hospitalization. Eight underwent more than one surgical procedure, and three required a skin graft.

The researchers wrote that there were too few cases of muscle, fat and fascia necrosis to draw any meaningful conclusions.

“The Pneumovax 23 US package insert has been updated to include injection site necrosis in section 6.2, PostMarketing Experience,” Day and colleagues concluded. “The overall benefit-risk balance for this vaccine remains favorable.”

perspective

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William Schaffner, MD

We have known for a long time – there’s pretty solid literature and it’s in the experience of many physicians – that some people do get when they receive pneumococcal polysaccharide vaccine, a substantial local reaction. This can be characterized by redness and swelling and can also have some associated tenderness and even fever. It is thought to occur because these are people who either have been previously vaccinated or they’ve had previous experience with at least some of the pneumococcal types that are represented in the vaccine.

This paper advances this knowledge a step further because it indicates that sometimes — rarely, fortunately — these local reactions can be even more severe, and the redness and swelling can be further inflamed so that you actually get tissue injury at that site and develop necrosis. In other words, some of the local tissue at the injection site is disrupted and you get a sore at that local place. This, according to the data here, sometimes leads to hospitalization, and there may be a little surgical intervention that’s necessary to clean out the tissue and make sure that you get some healing. Depending on the size of the problem, there may also have to be a small tissue, skin graft put over the site. Fortunately, this is very, very rare.

The vaccine in question here is the pneumococcal vaccine that has been in longest use in the US But given that there are newer pneumococcal vaccines now available, the CDC advisory committee has made some recommendations about how these vaccines are to be used. There still will continue to be an option for using this vaccine, the pneumococcal polysaccharide vaccine. But my prediction is now that there are newer vaccines that are as effective or more effective, the use of this very vaccine that we’re concerned about here is going to wane over time. In other words, practitioners and their patients will be making the decision to use these newer vaccines. So, I actually anticipate this problem — already rare — is going to wane even further.

William Schaffner, MD

Professor of preventive medicine and infectious diseases, Vanderbilt University Medical Center

Medical director, National Foundation for Infectious Diseases

Member, Infectious Disease News Editorial Board

Disclosures: Schaffner reports no relevant financial disclosures.

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