Question: 1. Why are we deliberately avoiding the word “trial”, but saying, it is “piloting”? 2. Which of the vaccines in the EPI was ever “piloted” in Ghana?
Some answers:
1. We have
i. Pre-clinical trial: using the product in animals
ii. Phase I clinical trial: the first time the product is introduced in human. Usually using from 1 to 10 people. It must be done in the country of origin. This has most of the time been in WHITES. The focus is to check if it is safe to be used in human. Is it also tolerable and not toxic? Are some questions you want answers to. In the case of the malaria vaccine, it was done among US Soldiers in the 70s.
iii. Phase II clinical trial: This will use a maximum of 50 people after the product is found to be safe from Phase I. Here too, safety, toxicity and efficacy are looked for. Strict monitoring just as in Phase I. In Ghana, Kintampo and Agogo did this phase of the vaccine in 2004/2007.
iv. Phase III clinical trial: In this phase of the trial, a large number of people are used to check the efficacy and all other parameters to enable regulatory authorities to get the information to register the product when found to be good.
With the case of the malaria vaccine (RTSS), it was done with about 16000 children from 7 African countries where malaria is endemic. Eleven (11) research centres were used for the clinical trial including Kintampo and Agogo recruiting about 1200 children each in 2006/2010.
v. Phase IV clinical trial: Post-marketing monitoring. At this stage, the documents with all information about all the stages of the trial needed by regulators are ready and discussed for the product to be rejected or approved for use in a larger population. So the malaria vaccine has gone through all these and approved by the EMA, WMA, WHO, FDA for use as indicated.
You will not routinely use TRIAL because just like every drug or vaccine in routine use, there is pharmacovigilance surveillance on them but we do not say we are trying paracetamol, diclofenac, etc whenever we use. This is the same case with the vaccine.
Because of some of these issues, it will be introduced only in THREE regions and later spread across. Still post-marketing surveillance.
NOTE: Anytime you take any drug or vaccine and get a reaction, you MUST report to the FDA within 24hrs. It is the same monitoring that will be going on while looking for what the 16000 children could not reveal.
Using TRIAL might denote clinical trial in early phases and no wonder, the ignorance has been expressed by many videos and audios
2. Please, ROTAVIRUS VACCINE, PANDEMRIX (H1N1) VACCINE were all pilot before full-scale introduction
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