tetano
Editor, Senior Moderator
J Infect Chemother
. 2022 Sep 21;S1341-321X(22)00272-0.
doi: 10.1016/j.jiac.2022.09.013. Online ahead of print.
Safety of and antibody response to the BNT162b2 COVID-19 vaccine in adolescents and young adults with underlying disease
Kensuke Shoji[SUP] 1 [/SUP], Takanori Funaki[SUP] 2 [/SUP], Masaki Yamada[SUP] 3 [/SUP], Masashi Mikami[SUP] 4 [/SUP], Kozue Miyake[SUP] 5 [/SUP], Saki Ueno[SUP] 5 [/SUP], Chiaki Tao[SUP] 2 [/SUP], Shota Myojin[SUP] 2 [/SUP], Hiroyuki Aiba[SUP] 2 [/SUP], Toshihiro Matsui[SUP] 6 [/SUP], Chikara Ogimi[SUP] 2 [/SUP], Hitoshi Kato[SUP] 7 [/SUP], Isao Miyairi[SUP] 8 [/SUP]
Affiliations
Abstract
Background: Data are limited regarding the safety of and antibody response to the BNT162b2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid vaccine in adolescents and young adults with underlying disease.
Methods: This prospective observational study enrolled patients age 12-25 years with chronic underlying disease who received 2 doses of BNT162b2. A 19-item questionnaire was used to assess adverse events within 7 days post-vaccination, and data regarding severe adverse events were collected from electronic medical records. An antibody titer for the receptor-binding domain of the spike protein in SARS-CoV-2 was used to assess antibody response after the second vaccine dose.
Results: Study participants were 429 patients (241 [56%] age 12-15 years; 188 [43.8%] age 16-25 years). The most common underlying diseases were genetic or chromosomal abnormalities and/or congenital anomalies, followed by endocrine or metabolic diseases; 33% of participants were immunocompromised. Severe adverse events were observed after the second dose in 1 (0.4%) patient age 12-15 years and in 2 (1.1%) patients age 16-25 years; all patients recovered. Seropositivity after the second vaccine dose was 99.0%. The geometric mean antibody titer was higher in patients age 12-15 years versus 16-25 years (1603.3 [1321.8-1944.7] U/mL vs. 949.4 [744.2-1211.0] U/mL). Compared with immunocompetent patients, immunocompromised patients had a lower antibody titer (2106.8 [1917.5-2314.7] U/mL vs. 467.9 [324.4-674.8] U/mL).
Conclusions: Vaccination with BNT162b2 was acceptably safe and immunogenic for adolescents and young adults with underlying disease.
Keywords: Immunization; SARS-CoV-2; mRNA.
. 2022 Sep 21;S1341-321X(22)00272-0.
doi: 10.1016/j.jiac.2022.09.013. Online ahead of print.
Safety of and antibody response to the BNT162b2 COVID-19 vaccine in adolescents and young adults with underlying disease
Kensuke Shoji[SUP] 1 [/SUP], Takanori Funaki[SUP] 2 [/SUP], Masaki Yamada[SUP] 3 [/SUP], Masashi Mikami[SUP] 4 [/SUP], Kozue Miyake[SUP] 5 [/SUP], Saki Ueno[SUP] 5 [/SUP], Chiaki Tao[SUP] 2 [/SUP], Shota Myojin[SUP] 2 [/SUP], Hiroyuki Aiba[SUP] 2 [/SUP], Toshihiro Matsui[SUP] 6 [/SUP], Chikara Ogimi[SUP] 2 [/SUP], Hitoshi Kato[SUP] 7 [/SUP], Isao Miyairi[SUP] 8 [/SUP]
Affiliations
- PMID: 36152928
- PMCID: PMC9490955
- DOI: 10.1016/j.jiac.2022.09.013
Abstract
Background: Data are limited regarding the safety of and antibody response to the BNT162b2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid vaccine in adolescents and young adults with underlying disease.
Methods: This prospective observational study enrolled patients age 12-25 years with chronic underlying disease who received 2 doses of BNT162b2. A 19-item questionnaire was used to assess adverse events within 7 days post-vaccination, and data regarding severe adverse events were collected from electronic medical records. An antibody titer for the receptor-binding domain of the spike protein in SARS-CoV-2 was used to assess antibody response after the second vaccine dose.
Results: Study participants were 429 patients (241 [56%] age 12-15 years; 188 [43.8%] age 16-25 years). The most common underlying diseases were genetic or chromosomal abnormalities and/or congenital anomalies, followed by endocrine or metabolic diseases; 33% of participants were immunocompromised. Severe adverse events were observed after the second dose in 1 (0.4%) patient age 12-15 years and in 2 (1.1%) patients age 16-25 years; all patients recovered. Seropositivity after the second vaccine dose was 99.0%. The geometric mean antibody titer was higher in patients age 12-15 years versus 16-25 years (1603.3 [1321.8-1944.7] U/mL vs. 949.4 [744.2-1211.0] U/mL). Compared with immunocompetent patients, immunocompromised patients had a lower antibody titer (2106.8 [1917.5-2314.7] U/mL vs. 467.9 [324.4-674.8] U/mL).
Conclusions: Vaccination with BNT162b2 was acceptably safe and immunogenic for adolescents and young adults with underlying disease.
Keywords: Immunization; SARS-CoV-2; mRNA.