COVID-19 mRNA vaccines are registered for intramuscular (IM) injection, however the standard 25mm needle length is insufficient to ensure deltoid muscle delivery in up to 45% of adults with obesity. The current vaccination guidelines provide non-specific advice for needle length selection, and only 2% of COVID-19 vaccine doses in Aotearoa New Zealand (A/NZ) are actually administered with a needle longer 25 mm.
It is currently unknown whether regulatory-mandated IM delivery of COVID-19 vaccines is essential to achieve full therapeutic effects and whether inadvertent subcutaneous (SC) delivery could lead to increased reactogenicity and local adverse events following vaccination.
This study is a randomised controlled trial of 486 adults conducted at community pharmacies across A/NZ. Study participants will be randomised to receive a booster dose of Pfizer bi-valent COVID-19 vaccine by IM or SC injection. This study will compare immunogenicity and reactogenicity following vaccination by IM or SC route.
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