臨床試驗是多餘？

豬流感其實再無任何值得關心嘅新消息，不過最近發現原來即使疫苗未完全通過臨床試驗，政府也可能認可其使用。換句話說，認可與否跟臨床試驗可以無甚關係。以下兩段報導為証。

節錄自 ScienceInsider：

... vaccine may be ready and approved by the Food and Drug Administration before clinical trials that test different doses of the vaccine are completed ...

第二篇報導來自 The Lancet，由於需要註冊方可見全文（雖是免費），以下全文照錄（粗體由我加）：

Last week, Australia and the USA announced that they would begin trials of an H1N1 vaccine. Vaccination against H1N1 will be an important development in controlling the impact of the pandemic. However, several thorny issues exist around vaccine manufacture and approval.

All countries will require the vaccine but current global manufacturing capacity will not be able to meet this demand. Additionally, experts think that individuals might need two doses of the vaccine instead of one, reducing capacity further. Vaccine manufacturers are also struggling to produce good vaccine yields with the H1N1 seed virus.

One way to ease these supply problems is the use of adjuvants in a vaccine. On July 7, WHO's Strategic Advisory Group of Experts on Immunization recommended that vaccine formulated with oil-in-water adjuvants and live-attenuated influenza vaccines should be promoted to help increase the global supply of a vaccine and because they are better at protecting against strain variations. Yet there are signs that the USA might not follow this recommendation. "Adjuvant use would be contingent upon showing that it was needed or clearly beneficial", Jesse Goodman, acting chief scientist and deputy commissioner of the Food and Drug Administration told a press briefing on July 17. The USA must support the use of dose-sparing strategies to avoid depletion of an already short vaccine supply.

As well as availability, safety of an H1N1 vaccine is a concern. Many national regulatory agencies have set-up fast-track approval processes for the H1N1 vaccine, which means that a vaccine might be licensed without the usual safety and efficacy data requirements. Vaccine safety will therefore have to be monitored through post-marketing surveillance. But some fear a repeat of the 1976 H1N1 outbreak in the USA, where mass vaccination was associated with complications, which stopped the campaign and led to the withdrawal of the vaccine.

Countries need to assess carefully the risks and benefits of rapid approval of an H1N1 vaccine, especially since the disease has so far been mild with most patients making a full recovery. They must also ensure that they have strong post-marketing surveillance in place before rolling out a vaccine.

最後一段說得好，其實感冒洗乜打針。這兩段報導的「教訓」，政府認可不代表什麼。到時如果香港政府容許外國認可、但未完成臨床試驗的疫苗在香港使用，不知議員會否抓著這一點繼續咒罵？