Recent update.
India has given approval to the Oxford vaccine, known in India as Covishield.
They have also given approval to an Indian developed killed vaccine. This vaccine (Covivax) has only completed phase 1 an II clinical trials. They seem to be intent on using early roll out as there phase III trial, and study all those that receive it. I suppose if you have a high transmission rate, you would see a significant reduction in cases in the vaccinated compared to those who have not received the vaccine yet.
Now this pandemic is taking such a serious turn, it does present an ethical dilemma for phase III trials of new vaccines not yet approved. You now have to ask the question, if it is ethical to do a placebo controlled trial, when there are known effective vaccines. So from now on the arms I feel are going to have to be new vaccine versus and known effective vaccine. I suspect this may be part of the thinking of the Indian regulator.
For Covaxin, however, the regulator granted an approval “in clinical trial mode.”
["Experts appeared surprised by this qualifier. When asked what the phrase means, Gagandeep Kang, a microbiology professor at Christian Medical College in the southern city of Vellore,
told The Times of India, “I have no clue. I have never seen anything like this before.”
Health minister Vardhan has explained that the “clinical trial mode” would mean that all vaccine recipients will be tracked as if they’re in a trial, and that the approval would add another tool to India’s arsenal against the coronavirus. But given that all vaccine recipients must register with the government, it’s unclear how tracking for Covaxin will differ or be more robust than that for the Covishield vaccine."]
Of concern, Sir John Bell, Regius Professor of Medicine at Oxford University, has raised serious concerns as to whether the current vaccines will be effective against the new South African mutation. According to him genome studies in Oxford, show more significant changes to the virus resulting in changes to the S-spike protein
This strain is even more infectious than the Kent strain. This is a big problem. Professor Bell thinks the new vaccines may well need to be edited. He feels this could be done for the Oxford vaccine in a six to eight week time frame
This is something that will have to be kept under constant review.
Unfortunately this highlights that we may now be over optimistic that this pandemic will end this year. One thing is clear to me that travel needs to be severely limited until this is sorted out. Clearly there needs to be enormous effort given to control the spread of this latest variant until more is known about it.
