Pneumococcal vaccine label adds injection-site risk MedTwitter
A US Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.
Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population. The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System , which relies on people who get the vaccines to report adverse events.After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.
The US package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.
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