Endocrine Unit and Diabetes Center, Department of Clinical Therapeutics, Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Faculty of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece.
Front Endocrinol (Lausanne). 2022 Feb 22;13:840668. doi: 10.3389/fendo.2022.840668. eCollection 2022.
This is the first study, that aimed: a) to compare immune response, namely the kinetics of neutralizing antibodies (Nabs), after vaccination with BNT162b2 mRNA vaccine (Comirnaty, Pfizer/BioNTech) between patients with autoimmune thyroiditis and controls, and b) to investigate changes in thyroid function in healthy subjects with no history of thyroid dysfunction before and after vaccination with BNT162b2 mRNA vaccine (Comirnaty, Pfizer/BioNTech).
The entire study consisted of two sub-studies. In the first sub-study, NAbs levels after BNT162b2 mRNA vaccination were compared between 56 patients with autoimmune thyroiditis and 56 age and gender-matched healthy controls from the day of the first dose until a period of up to three months after the second dose. In the second sub-study, thyroid hormones (T3, T4, TSH) and thyroid auto-antibodies levels (anti-TG, anti-TPO) of 72 healthy subjects with no history of thyroid disease were examined before (D1) and one month after completion of the second dose (D50).
Among patients with autoimmune thyroiditis, the median neutralizing inhibition on D22, immediately before second dose, was 62.5%. One month later (D50), values increased to 96.7%, while three months after the second dose NAbs titers remained almost the same (94.5%). In the healthy group, median NAbs levels at D22 were 53.6%. On D50 the median inhibition values increased to 95.1%, while after three months they were 89.2%. The statistical analysis did not show significant differences between two groups (p-values 0.164, 0.390, 0.105 for D22, D50 and three months). Regarding changes in thyroid function, the mean value for T4 before vaccination was 89.797 nmol/L and one month after the second dose was 89.11 nmol/L (p-value=0.649). On D1 the mean T3 value was 1.464 nmol/L, which dropped to 1.389 nmol/L on D50 (p-value = 0.004). For TSH, mean levels were 2.064 mIU/ml on D1 and fell to 1.840 mIU/ml one month after the second dose (p-value=0.037). Despite decrease, all thyroid hormone levels remained within the normal range. No changes were found for anti-TPO or anti-TG.
This study provided evidence that patients with autoimmune thyroiditis present similar immunological response to COVID-19 BNT162b2 mRNA vaccine (Comirnaty, Pfizer/BioNTech) with healthy subjects, while vaccination may affect thyroid function.
本研究旨在：a）比较接种 BNT162b2 mRNA 疫苗（辉瑞/BioNTech 的 Comirnaty）后自身免疫性甲状腺炎患者与对照组之间的免疫反应，即中和抗体（Nabs）的动力学；b）研究接种 BNT162b2 mRNA 疫苗（辉瑞/BioNTech 的 Comirnaty）前后无甲状腺功能障碍史的健康受试者甲状腺功能的变化。
整个研究由两项子研究组成。在第一项子研究中，比较了 56 名自身免疫性甲状腺炎患者和 56 名年龄和性别匹配的健康对照组在第一剂后至第二剂后长达三个月的时间内接种 BNT162b2 mRNA 疫苗后的 Nabs 水平。在第二项子研究中，72 名无甲状腺疾病史的健康受试者在接种第二剂前（D1）和第二剂后一个月（D50）检查甲状腺激素（T3、T4、TSH）和甲状腺自身抗体水平（抗 TG、抗 TPO）。
在自身免疫性甲状腺炎患者中，第二剂前（D22）的中位数中和抑制率为 62.5%。一个月后（D50），数值增加到 96.7%，而第二剂后三个月时 NAbs 滴度几乎相同（94.5%）。在健康组中，D22 时的中位数 NAbs 水平为 53.6%。D50 时的中位数抑制值增加到 95.1%，而三个月后则为 89.2%。统计学分析未显示两组之间存在显著差异（D22、D50 和三个月时的 p 值分别为 0.164、0.390 和 0.105）。关于甲状腺功能的变化，接种前 T4 的平均值为 89.797nmol/L，第二剂后一个月为 89.11nmol/L（p 值=0.649）。D1 时 T3 的平均值为 1.464nmol/L，D50 时降至 1.389nmol/L（p 值=0.004）。对于 TSH，D1 的平均水平为 2.064mIU/ml，第二剂后一个月降至 1.840mIU/ml（p 值=0.037）。尽管有所下降，但所有甲状腺激素水平仍在正常范围内。抗 TPO 或抗 TG 无变化。
本研究表明，自身免疫性甲状腺炎患者对 COVID-19 BNT162b2 mRNA 疫苗（辉瑞/BioNTech 的 Comirnaty）的免疫反应与健康受试者相似，而接种疫苗可能会影响甲状腺功能。
