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No. Phase 3 is for to demonstrate effectiveness. Safety: phase 1 - animals and phase 2 - humans. What "safety" they can test for vector what is tested and used more than 6 years already in Russian vaccines against Ebola and SARS?
>>>>>>>Except it's also for sale
It isn't Putin's business. It is Moscow governor (mayor) Sobianin. As New-York city in US Moscow is "city-state" - governor here is quite independent from state and president. Moscow city's yearly budget is bigger than budget of Philippines or Qatar or Pakistan.
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The vector is MODIFIED. So the modification could modify the results. Even if there is some hypothesis that suggests the modification is harmless, the hypothesis could be wrong.
So it's normal to prove it with a large trial to prove both the effectiveness AND the safety. Or that's how I interpret it from reading about various vaccines, including the Oxford one which is also a vector vaccine, using a modified adenovirus.
In most safety critical technical fields, unless there is 100% certainty in the theory, you test. I'm NOT claiming any medical expertise, but I do have experience of safety critical product development.
No. It is the same vector. Modification is in attachment: instead of small part of RNA Ebola or SARS viruses now small part of RNA of COVID-19 is attached. Such attachments are safe, any problem are limited to allergy only, because such small cuts from RNA are harmless. It is why vector method is going to be more and more popular in medicine.
Yes about Oxford. The difference of Sputnik V and Oxford is: Gamaleya already had ready modified and tested (5+ years for sure) adenovirus at time when they started to make vaccine, Oxford made vector "from the scratch" and have to prove its safety.
Gamaleya's problem now is to prove what they made correct cut from RNA and this part of RNA exists in all mutations of COVID-19, because vaccine will be effective only against mutations where such sample exists in RNA code. Also they need proof what in all cases level of antibodies generated by our immune system as a responce to vaccination will be high enough for to protect us from real virus, and also they need proof what such level will be high enough at least 1-2 years.
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