The effect of needle length and skin to deltoid muscle distance in adults receiving an mRNA COVID-19 vaccine. Hills, T., Paterson, A., Woodward, R., Middleton, F., Carlton, L. H., McGregor, R., Barfoot, S., Ramiah, C., Whitcombe, A. L., Zimbron, V. M., Mahuika, D., Brown, J., Palmer-Neels, K., Manning, B., Jani, D., Reeves, B., Whitta, G. T., Morpeth, S., Beasley, R., Weatherall, M., Jordan, A., McIntyre, P., Moreland, N. J., & Mirjalili, S. A. Vaccine, 40(33):4827–4834, August, 2022. doi abstract bibtex BACKGROUND: The mRNA COVID vaccines are only licensed for intramuscular injection but it is unclear whether successful intramuscular administration is required for immunogenicity. METHODS: In this observational study, eligible adults receiving their first ComirnatyTM/BNT162b2 dose had their skin to deltoid muscle distance (SDMD) measured by ultrasound. The relationship between SDMD and height, weight, body mass index, and arm circumference was assessed. Three needle length groups were identified: 'clearly sufficient' (needle exceeding SDMD by \textgreater5 mm), 'probably sufficient' (needle exceeding SDMD by ≤ 5 mm), and 'insufficient' (needle length ≤ SDMD). Baseline and follow-up finger prick blood samples were collected and the primary outcome variable was mean spike antibody levels in the three needle length groups. RESULTS: Participants (n = 402) had a mean age of 34.7 years, BMI 29.1 kg/m2, arm circumference 37.5 cm, and SDMD 13.3 mm. The SDMD was \textgreater25 mm in 23/402 (5.7%) and \textgreater20 mm in 61/402 (15.2%) participants. Both arm circumference (≥40 cm) and BMI (≥33 kg/m2) were able to identify those with a SDMD of \textgreater25 mm, the length of a standard injection needle, with a sensitivity of 100% and specificities of 71.2 and 79.9%, respectively. Of 249/402 (62%) participants with paired blood samples, there was no significant difference in spike antibody titres between needle length groups. The mean (SD) spike BAU/mL was 464.5 (677.1) in 'clearly sufficient needle length' (n = 217) compared with 506.4 (265.1) in 'probably sufficient' (n = 21, p = 0.09), and 489.4 (452.3) in 'insufficient needle length' (n = 11, p = 0.65). CONCLUSIONS: A 25 mm needle length is likely to be inadequate to ensure vaccine deposition within the deltoid muscle in a small proportion of adults. Vaccine-induced spike antibody titres were comparable in those vaccinated with a needle of sufficient versus insufficient length suggesting deltoid muscle deposition may not be required for an adequate antibody response to mRNA vaccines.
@article{hills_effect_2022,
title = {The effect of needle length and skin to deltoid muscle distance in adults receiving an {mRNA} {COVID}-19 vaccine},
volume = {40},
issn = {1873-2518},
doi = {10.1016/j.vaccine.2022.06.070},
abstract = {BACKGROUND: The mRNA COVID vaccines are only licensed for intramuscular injection but it is unclear whether successful intramuscular administration is required for immunogenicity.
METHODS: In this observational study, eligible adults receiving their first ComirnatyTM/BNT162b2 dose had their skin to deltoid muscle distance (SDMD) measured by ultrasound. The relationship between SDMD and height, weight, body mass index, and arm circumference was assessed. Three needle length groups were identified: 'clearly sufficient' (needle exceeding SDMD by {\textgreater}5 mm), 'probably sufficient' (needle exceeding SDMD by ≤ 5 mm), and 'insufficient' (needle length ≤ SDMD). Baseline and follow-up finger prick blood samples were collected and the primary outcome variable was mean spike antibody levels in the three needle length groups.
RESULTS: Participants (n = 402) had a mean age of 34.7 years, BMI 29.1 kg/m2, arm circumference 37.5 cm, and SDMD 13.3 mm. The SDMD was {\textgreater}25 mm in 23/402 (5.7\%) and {\textgreater}20 mm in 61/402 (15.2\%) participants. Both arm circumference (≥40 cm) and BMI (≥33 kg/m2) were able to identify those with a SDMD of {\textgreater}25 mm, the length of a standard injection needle, with a sensitivity of 100\% and specificities of 71.2 and 79.9\%, respectively. Of 249/402 (62\%) participants with paired blood samples, there was no significant difference in spike antibody titres between needle length groups. The mean (SD) spike BAU/mL was 464.5 (677.1) in 'clearly sufficient needle length' (n = 217) compared with 506.4 (265.1) in 'probably sufficient' (n = 21, p = 0.09), and 489.4 (452.3) in 'insufficient needle length' (n = 11, p = 0.65).
CONCLUSIONS: A 25 mm needle length is likely to be inadequate to ensure vaccine deposition within the deltoid muscle in a small proportion of adults. Vaccine-induced spike antibody titres were comparable in those vaccinated with a needle of sufficient versus insufficient length suggesting deltoid muscle deposition may not be required for an adequate antibody response to mRNA vaccines.},
language = {eng},
number = {33},
journal = {Vaccine},
author = {Hills, Thomas and Paterson, Aimee and Woodward, Rebecca and Middleton, Francis and Carlton, Lauren H. and McGregor, Reuben and Barfoot, Sebastien and Ramiah, Ciara and Whitcombe, Alana L. and Zimbron, Victor M. and Mahuika, David and Brown, Joshua and Palmer-Neels, Kate and Manning, Brittany and Jani, Devanshi and Reeves, Brooke and Whitta, Georgia T. and Morpeth, Susan and Beasley, Richard and Weatherall, Mark and Jordan, Anthony and McIntyre, Peter and Moreland, Nicole J. and Mirjalili, S. Ali},
month = aug,
year = {2022},
pmid = {35792021},
pmcid = {PMC9239984},
keywords = {Adult, Antibodies, Viral, BNT162 Vaccine, COVID-19, COVID-19 Vaccines, Deltoid Muscle, Deltoid muscle, Humans, Immunisation, Immunogenicity, Vaccine, Intramuscular injection, Needle length, RNA, Messenger, Vaccination, Vaccines},
pages = {4827--4834},
}
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{"_id":"6dRKLiThn6GCtyQfF","bibbaseid":"hills-paterson-woodward-middleton-carlton-mcgregor-barfoot-ramiah-etal-theeffectofneedlelengthandskintodeltoidmuscledistanceinadultsreceivinganmrnacovid19vaccine-2022","author_short":["Hills, T.","Paterson, A.","Woodward, R.","Middleton, F.","Carlton, L. H.","McGregor, R.","Barfoot, S.","Ramiah, C.","Whitcombe, A. L.","Zimbron, V. M.","Mahuika, D.","Brown, J.","Palmer-Neels, K.","Manning, B.","Jani, D.","Reeves, B.","Whitta, G. T.","Morpeth, S.","Beasley, R.","Weatherall, M.","Jordan, A.","McIntyre, P.","Moreland, N. J.","Mirjalili, S. A."],"bibdata":{"bibtype":"article","type":"article","title":"The effect of needle length and skin to deltoid muscle distance in adults receiving an mRNA COVID-19 vaccine","volume":"40","issn":"1873-2518","doi":"10.1016/j.vaccine.2022.06.070","abstract":"BACKGROUND: The mRNA COVID vaccines are only licensed for intramuscular injection but it is unclear whether successful intramuscular administration is required for immunogenicity. METHODS: In this observational study, eligible adults receiving their first ComirnatyTM/BNT162b2 dose had their skin to deltoid muscle distance (SDMD) measured by ultrasound. The relationship between SDMD and height, weight, body mass index, and arm circumference was assessed. Three needle length groups were identified: 'clearly sufficient' (needle exceeding SDMD by \\textgreater5 mm), 'probably sufficient' (needle exceeding SDMD by ≤ 5 mm), and 'insufficient' (needle length ≤ SDMD). Baseline and follow-up finger prick blood samples were collected and the primary outcome variable was mean spike antibody levels in the three needle length groups. RESULTS: Participants (n = 402) had a mean age of 34.7 years, BMI 29.1 kg/m2, arm circumference 37.5 cm, and SDMD 13.3 mm. The SDMD was \\textgreater25 mm in 23/402 (5.7%) and \\textgreater20 mm in 61/402 (15.2%) participants. Both arm circumference (≥40 cm) and BMI (≥33 kg/m2) were able to identify those with a SDMD of \\textgreater25 mm, the length of a standard injection needle, with a sensitivity of 100% and specificities of 71.2 and 79.9%, respectively. Of 249/402 (62%) participants with paired blood samples, there was no significant difference in spike antibody titres between needle length groups. The mean (SD) spike BAU/mL was 464.5 (677.1) in 'clearly sufficient needle length' (n = 217) compared with 506.4 (265.1) in 'probably sufficient' (n = 21, p = 0.09), and 489.4 (452.3) in 'insufficient needle length' (n = 11, p = 0.65). CONCLUSIONS: A 25 mm needle length is likely to be inadequate to ensure vaccine deposition within the deltoid muscle in a small proportion of adults. Vaccine-induced spike antibody titres were comparable in those vaccinated with a needle of sufficient versus insufficient length suggesting deltoid muscle deposition may not be required for an adequate antibody response to mRNA vaccines.","language":"eng","number":"33","journal":"Vaccine","author":[{"propositions":[],"lastnames":["Hills"],"firstnames":["Thomas"],"suffixes":[]},{"propositions":[],"lastnames":["Paterson"],"firstnames":["Aimee"],"suffixes":[]},{"propositions":[],"lastnames":["Woodward"],"firstnames":["Rebecca"],"suffixes":[]},{"propositions":[],"lastnames":["Middleton"],"firstnames":["Francis"],"suffixes":[]},{"propositions":[],"lastnames":["Carlton"],"firstnames":["Lauren","H."],"suffixes":[]},{"propositions":[],"lastnames":["McGregor"],"firstnames":["Reuben"],"suffixes":[]},{"propositions":[],"lastnames":["Barfoot"],"firstnames":["Sebastien"],"suffixes":[]},{"propositions":[],"lastnames":["Ramiah"],"firstnames":["Ciara"],"suffixes":[]},{"propositions":[],"lastnames":["Whitcombe"],"firstnames":["Alana","L."],"suffixes":[]},{"propositions":[],"lastnames":["Zimbron"],"firstnames":["Victor","M."],"suffixes":[]},{"propositions":[],"lastnames":["Mahuika"],"firstnames":["David"],"suffixes":[]},{"propositions":[],"lastnames":["Brown"],"firstnames":["Joshua"],"suffixes":[]},{"propositions":[],"lastnames":["Palmer-Neels"],"firstnames":["Kate"],"suffixes":[]},{"propositions":[],"lastnames":["Manning"],"firstnames":["Brittany"],"suffixes":[]},{"propositions":[],"lastnames":["Jani"],"firstnames":["Devanshi"],"suffixes":[]},{"propositions":[],"lastnames":["Reeves"],"firstnames":["Brooke"],"suffixes":[]},{"propositions":[],"lastnames":["Whitta"],"firstnames":["Georgia","T."],"suffixes":[]},{"propositions":[],"lastnames":["Morpeth"],"firstnames":["Susan"],"suffixes":[]},{"propositions":[],"lastnames":["Beasley"],"firstnames":["Richard"],"suffixes":[]},{"propositions":[],"lastnames":["Weatherall"],"firstnames":["Mark"],"suffixes":[]},{"propositions":[],"lastnames":["Jordan"],"firstnames":["Anthony"],"suffixes":[]},{"propositions":[],"lastnames":["McIntyre"],"firstnames":["Peter"],"suffixes":[]},{"propositions":[],"lastnames":["Moreland"],"firstnames":["Nicole","J."],"suffixes":[]},{"propositions":[],"lastnames":["Mirjalili"],"firstnames":["S.","Ali"],"suffixes":[]}],"month":"August","year":"2022","pmid":"35792021","pmcid":"PMC9239984","keywords":"Adult, Antibodies, Viral, BNT162 Vaccine, COVID-19, COVID-19 Vaccines, Deltoid Muscle, Deltoid muscle, Humans, Immunisation, Immunogenicity, Vaccine, Intramuscular injection, Needle length, RNA, Messenger, Vaccination, Vaccines","pages":"4827–4834","bibtex":"@article{hills_effect_2022,\n\ttitle = {The effect of needle length and skin to deltoid muscle distance in adults receiving an {mRNA} {COVID}-19 vaccine},\n\tvolume = {40},\n\tissn = {1873-2518},\n\tdoi = {10.1016/j.vaccine.2022.06.070},\n\tabstract = {BACKGROUND: The mRNA COVID vaccines are only licensed for intramuscular injection but it is unclear whether successful intramuscular administration is required for immunogenicity.\nMETHODS: In this observational study, eligible adults receiving their first ComirnatyTM/BNT162b2 dose had their skin to deltoid muscle distance (SDMD) measured by ultrasound. The relationship between SDMD and height, weight, body mass index, and arm circumference was assessed. Three needle length groups were identified: 'clearly sufficient' (needle exceeding SDMD by {\\textgreater}5 mm), 'probably sufficient' (needle exceeding SDMD by ≤ 5 mm), and 'insufficient' (needle length ≤ SDMD). Baseline and follow-up finger prick blood samples were collected and the primary outcome variable was mean spike antibody levels in the three needle length groups.\nRESULTS: Participants (n = 402) had a mean age of 34.7 years, BMI 29.1 kg/m2, arm circumference 37.5 cm, and SDMD 13.3 mm. The SDMD was {\\textgreater}25 mm in 23/402 (5.7\\%) and {\\textgreater}20 mm in 61/402 (15.2\\%) participants. Both arm circumference (≥40 cm) and BMI (≥33 kg/m2) were able to identify those with a SDMD of {\\textgreater}25 mm, the length of a standard injection needle, with a sensitivity of 100\\% and specificities of 71.2 and 79.9\\%, respectively. Of 249/402 (62\\%) participants with paired blood samples, there was no significant difference in spike antibody titres between needle length groups. The mean (SD) spike BAU/mL was 464.5 (677.1) in 'clearly sufficient needle length' (n = 217) compared with 506.4 (265.1) in 'probably sufficient' (n = 21, p = 0.09), and 489.4 (452.3) in 'insufficient needle length' (n = 11, p = 0.65).\nCONCLUSIONS: A 25 mm needle length is likely to be inadequate to ensure vaccine deposition within the deltoid muscle in a small proportion of adults. Vaccine-induced spike antibody titres were comparable in those vaccinated with a needle of sufficient versus insufficient length suggesting deltoid muscle deposition may not be required for an adequate antibody response to mRNA vaccines.},\n\tlanguage = {eng},\n\tnumber = {33},\n\tjournal = {Vaccine},\n\tauthor = {Hills, Thomas and Paterson, Aimee and Woodward, Rebecca and Middleton, Francis and Carlton, Lauren H. and McGregor, Reuben and Barfoot, Sebastien and Ramiah, Ciara and Whitcombe, Alana L. and Zimbron, Victor M. and Mahuika, David and Brown, Joshua and Palmer-Neels, Kate and Manning, Brittany and Jani, Devanshi and Reeves, Brooke and Whitta, Georgia T. and Morpeth, Susan and Beasley, Richard and Weatherall, Mark and Jordan, Anthony and McIntyre, Peter and Moreland, Nicole J. and Mirjalili, S. Ali},\n\tmonth = aug,\n\tyear = {2022},\n\tpmid = {35792021},\n\tpmcid = {PMC9239984},\n\tkeywords = {Adult, Antibodies, Viral, BNT162 Vaccine, COVID-19, COVID-19 Vaccines, Deltoid Muscle, Deltoid muscle, Humans, Immunisation, Immunogenicity, Vaccine, Intramuscular injection, Needle length, RNA, Messenger, Vaccination, Vaccines},\n\tpages = {4827--4834},\n}\n\n","author_short":["Hills, T.","Paterson, A.","Woodward, R.","Middleton, F.","Carlton, L. H.","McGregor, R.","Barfoot, S.","Ramiah, C.","Whitcombe, A. L.","Zimbron, V. M.","Mahuika, D.","Brown, J.","Palmer-Neels, K.","Manning, B.","Jani, D.","Reeves, B.","Whitta, G. T.","Morpeth, S.","Beasley, R.","Weatherall, M.","Jordan, A.","McIntyre, P.","Moreland, N. J.","Mirjalili, S. A."],"key":"hills_effect_2022","id":"hills_effect_2022","bibbaseid":"hills-paterson-woodward-middleton-carlton-mcgregor-barfoot-ramiah-etal-theeffectofneedlelengthandskintodeltoidmuscledistanceinadultsreceivinganmrnacovid19vaccine-2022","role":"author","urls":{},"keyword":["Adult","Antibodies","Viral","BNT162 Vaccine","COVID-19","COVID-19 Vaccines","Deltoid Muscle","Deltoid muscle","Humans","Immunisation","Immunogenicity","Vaccine","Intramuscular injection","Needle length","RNA","Messenger","Vaccination","Vaccines"],"metadata":{"authorlinks":{}}},"bibtype":"article","biburl":"https://api.zotero.org/users/6607533/collections/VKGURBGN/items?key=hSjrOPQRRHHWY81SKs6CEz45&format=bibtex&limit=100","dataSources":["upP78A3qvEd6tbHFm","zpWcq5jS35za3AmLx"],"keywords":["adult","antibodies","viral","bnt162 vaccine","covid-19","covid-19 vaccines","deltoid muscle","deltoid muscle","humans","immunisation","immunogenicity","vaccine","intramuscular injection","needle length","rna","messenger","vaccination","vaccines"],"search_terms":["effect","needle","length","skin","deltoid","muscle","distance","adults","receiving","mrna","covid","vaccine","hills","paterson","woodward","middleton","carlton","mcgregor","barfoot","ramiah","whitcombe","zimbron","mahuika","brown","palmer-neels","manning","jani","reeves","whitta","morpeth","beasley","weatherall","jordan","mcintyre","moreland","mirjalili"],"title":"The effect of needle length and skin to deltoid muscle distance in adults receiving an mRNA COVID-19 vaccine","year":2022}