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Originally Posted by Gsynch ICMR study on Covaxin shows a comparable neutralization activity of the vaccinated individuals against UK-variant strain. |
Looks like ICMR is jumping the gun (yet again)!
Bharat Biotech had submitted data compiled from the Phase 1 and Phase 2 trials to medrXiv, a pre-print NON-PEER reviewed research repository, in December 2020. The newly published peer-reviewed paper in "The Lancet" adds technical details to the preprint paper, of the same phase 1 trial of BBV152, that was previously available online. By way of a broad summary, to quote directly from the paper: “BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted.”
ICMR, being a partner in development of this vaccine (based on a SARS-CoV-2 strain isolated by NIV, Pune) faces a serious conflict of interest as also acting as a govt authority to certify anything (positive or negative) related to this vaccine.
After going on record to publish the need for further efficacy trials, the same author/s are assuming hypothesised results against multiple strains which they themselves have not factored in their own study! Remember, no neutralisation studies were ever published before running to get the restricted EUA (in strict clinical trial mode) for Covaxin.
The sole premise of the theory of its POSSIBLE efficacy against other mutant strains (other than the one isolated, on which it is based) is that it contains the complete virus genome (which has mutated in mutant strains) rather than only subunits (spike protein or receptor binding domains). Hence, ICMR (& BB) theorise that Covaxin can generate antibodies against multiple proteins instead of spikes alone which in theory suggests that it MIGHT have a better chance against the mutated variants.
A senior official at the ICMR was quoted saying “To check whether that happens, we will use the vaccine using the culture of virus variants, cell lines and the vaccine." Perhaps, going back to studies on why viruses do not satisfy all of (Robert) Koch's postulates would have stopped them in their tracks before making such claims.
Independent and unbiased experts expressed their apprehensions that such an experiment can only be in-vitro neutralisation data — comparing between the UK or South Africa strain and the Covid-19 strains that have remained dominant so far. Simply put, this means that in vitro results achieved in viral cultures CANNOT BE assumed to be the same in-vivo (human body).
"What is needed, at least, is to use say sera from RBD vaccine immunised individuals and whole virus vaccine immunised individuals and see if the former group is extremely poor in blocking the variant viruses,” said a virologist from a government institution who did not wish to be named.
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Originally Posted by carboy How have so many people in this thread already got vaccinated? All you are all healthcare professionals? Or have they already started vaccinating people who aren't aren't healthcare professionals?
Any idea when it will trickle down to common folk? |
HCW → sanitation workers → those above 50 WITH co morbidities → general population - is govt's vaccine rollout plan, as of now. But considering the govt's penchant to politicize anything & everything, I wouldn't be surprised if that changed overnight.
I am a "HCW", but have not registered myself for vaccination simply based on my personal assessment of lack of significant additional benefit it might confer in this waning stage, standard precautions we take - Irrespective of the degree of efficacy and safety of the vaccines.