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Do we know what goes into vaccine development? Or I should leave this one here?
So here is the long and short of it. Based on what I learnt, my knowledge working in a clinical trial setting and medical research in general. Vaccine development is one of the longest and most expensive processes in medical research. https://twitter.com/the_laxa/status/1285881507207421953?s=21 https://twitter.com/the_laxa/status/1285881507207421953
Typically yes, it will start in a research laboratory in a Uni, medical center or biotech/pharma companies most of which are often funded by grants from the govt or private institutions. Funds of which are pretty non-existent in Malawi.
Firstly, pre-clinical development: involves discovering relevant antigens, evaluation of efficacy invivo and In vitro. Testing in animal models. This is to largely inform cellular responses and safe starting doses. Takes 2-4 years.
Infact as far as I understand, most of the companies developing the vaccine now are using the gene sequence that was released a few months ago from China. It is known to cut in development time https://www.nature.com/articles/d41573-020-00073-5
The vaccine design process largely involves growing the virus, inactivation, blending the vaccine,filing etc depending on the disease all of which require specific equipment, technology, that can be specific to the proposed vaccine. Majority of which we simply do not have in Mw
And this is not ‘basic technology’...
I am more familiar with the next stage, the clinical development stage
If the vaccines progresses to this stage, majority of which do not, an application to proceed into human trials has to be made to a drug admin agency either FDA in US or EMA in Europe. The application has to be approved before the vaccine can go into human clinical trials phase
Enter phase I of clinical trials, aim is to test for safety, in humans. Tested in a very small number of people, healthy people in this case. Takes ~2 years. If successful,it goes on to phase II to understand and confirm the immune response, efficacy and safety. Another 2-5 yrs
On average it is estimated that the process from discovery to phase II costs about $31-68 million, the range is $8-$350 million https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(18)30346-2/fulltext
Enter phase III. This is where the vaccine is tested in as many people as possible to assess if the vaccine really protects against the disease. Takes about 5-10 years and completion upto this phase, assuming availability of funds is estimated at a *minimum* of $2.8-3.7 billion.
Phase III is the pivotal stage which will dictate whether the vaccine will go on to market approval and mass production. The entire time results have to be submitted to the drug admin agencies for monitoring and approval. Statisticians love this part.
Throughout these stages the vaccine needs to demonstrate that it is safe, has a strong immune response and provides protection against the virus. It passes through a battery of regulatory scrutiny
If along the way the vaccine does not demonstrate any ot this, the researchers have to go back to discovery and preclinical stage. Spending millions of dollars again. Is it already clear why Malawi is nowhere near any such type of discoveries?
So in an outbreak like this, the vaccine production has been expedited for centers that have the technology, expertise and the money to develop them but it will still take roughly 12-18 months before we know any of the vaccines work at all.
The Oxford trial is going into phase III which SA is taking part in and looks promising. There is no evidence yet that it can protect against Covid-19 though a good immunological response and no safety concerns have been observed https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext
Oxford received a £84 million grant from the UK govt to help in the vaccine development. Oxford has stressed that if the vaccine doesn’t work they will stop the program. https://www.ox.ac.uk/news/2020-07-20-new-study-reveals-oxford-coronavirus-vaccine-produces-strong-immune-response
Then there are phase IV trials, which are post approval/marketing surveillance studies and are equally involving but on the regulatory side. So every drug that is on the market now has more or less gone through this process.
Oh and in general vaccines/drugs on average have 94% chance of failure. For example, if transmission rates start declining, that will mean slow recruitment, slow numbers to mantain statistical power, all of which can affect the rate at which efficacy can be demonstrated.
So why are Malawians not developing a vaccine you say? We do not have the capacity, funds, resources, expertise. Simples. Countries could pool resources if Africa wants to be a player in the vaccine devt landscape but going at it alone is a non-starter.
I know I could have just said this and saved y’all a thread but where is the fun in that? 
