98-110年度DTP類疫苗檢驗放行趨勢分析   全文下載

Trends in Batch Release of DTP Vaccines in Taiwan from 2009 to 2021

白喉、破傷風、百日咳類疫苗（Diphtheria vaccine, tetanus vaccine and pertussis vaccine，以下簡稱DTP類疫苗）係嬰幼兒／學童預防接種重要疫苗，曾歷經多次疫苗改良沿革及公衛政策，本研究統計分析98-110年度經衛生福利部食品藥物管理署（下稱食藥署）檢驗合格放行之DTP類疫苗，並研析相關政策歷程情形，以瞭解國人使用該類疫苗之整體概況。分析結果顯示「破傷風疫苗（TT）」及「白喉破傷風混合疫苗（Td）」，過去雖以國產品為主，惟歷經藥廠生產策略改變，現則多仰賴國外已有上市核准惟國內無許可證之專案進口產品。自98年起放行最後一批「白喉破傷風全細胞性百日咳混合疫苗（DTwP）」，後續DTP類疫苗均改以非細胞性百日咳疫苗取代不良反應高之全細胞型百日咳疫苗，且「減量破傷風白喉非細胞性百日咳混合疫苗（Tdap）」、「五合一疫苗（白喉破傷風非細胞性百日咳、b型嗜血桿菌及不活化小兒麻痺混合疫苗）（DTaP-Hib-IPV）」、「減量破傷風白喉非細胞性百日咳及不活化小兒麻痺混合疫苗（TdaP-IPV）」、「六合一疫苗（白喉破傷風非細胞性百日咳、不活化小兒麻痺、b型嗜血桿菌及B型肝炎混合疫苗）（DTaP-IPV-Hib-Hep B）」依序分別於98年、99年、102年、106年有放行劑量增加之情形，均可對應疫苗發展沿革及公衛政策時間軸，顯示食藥署檢驗封緘放行作業與政策息息相關，未來食藥署持續為疫苗安全嚴謹把關，並因應公衛政策等需求，協助加速生物藥品放行以順應供貨，保障國人用藥安全與權益。

DTP vaccines are crucial vaccines for public health policies regarding infants/children vaccination. Considering the improvement of vaccine components and public health policy implementation, trends in released batches of DTP vaccines in Taiwan from 2009 to 2021 were analyzed in this report. Based on the records, tetanus vaccines (TT) were mainly domestic products before 2018, while currently imported ones. Due to the high incidence of adverse effects of diphtheria and tetanus vaccines with whole cell pertussis vaccine (DTwP), the final batch was released in 2009. Since then, DTP vaccines released were composed of acellular, rather than whole cell, pertussis vaccine. Gradually increased doses of “tetanus vaccine, reduced diphtheria vaccine and acellular pertussis vaccine (Tdap)”, “5 in 1 (diphtheria tetanus acellular pertussis, inactivated polio and Haemophilus influenzae type b conjugate vaccines; DTaP-Hib-IPV)”, “Tetanus vaccine, reduced diphtheria vaccine, acellular pertussis and inactivated polio vaccine (Tdap- IPV)” and ”6 in 1 (diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccine; DTaP-IPV-Hib-Hep B) were released in 2009, 2011, 2013 and 2017, respectively. These cases corresponded to the history of public health policy, indicating that the vaccines batch release executed by Taiwan Food and Drug Administration (TFDA) was closely connected to public health policies. TFDA will keep ensuring the vaccine safety and cooperate with government policies to meet public needs.