Dear Civil Aviation Authority,

A vaccine must go through several phases of clinical trials before it can be licensed. Before a vaccine enters clinical trials, it undergoes pre-clinical assessment, where the target antigen is identified & the vaccine safety & efficacy are tested in laboratory & animal models.

In phase I clinical trials, dozens of participants are recruited. In this phase, the vaccine dose level & safety are tested. It takes at least 1 year for a phase I clinical trial to be complete.

In phase II clinical trials, using hundreds of participants, the immunogenicity & safety of the vaccine are tested. It is important to ensure that the candidate vaccine stimulates both humoral and cellular antibody responses against the target antigen. Very few candidate vaccines will have satisfactory phase II clinical trial results & move on to phase III trials.

In phase III clinical trials, the safety and efficacy of the vaccine are tested. The virus must be circulating during Phase III trials, which take a few years to complete.

After collecting data, regulatory bodies assess vaccine safety & effectiveness before the vaccine is licensed. The whole process of vaccine development to licensure takes around 10 years (refer to Figure 1).

The Federal Aviation Authority will not permit a commercial pilot to fly using any medical product that is not at least 12 months post license marketing phase.

With regards to all the above;

1/ What amendments (if any) were made by the CAA to allow commercial pilots to fly after taking medical products such as Covid vaccines while they were/are not yet out of emergency or trial phase, nor fully licensed for commercial use?

2/ Has the CAA held any meetings whatsover (formal or informal) to discuss the emergency use of vaccines by pilots in relation to insurance companies & potential civil liability suit/cases, if a covid vaccinated pilot is taken ill or commits an error while piloting a commercial airliner?

Yours faithfully,

Laurence de Mello