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This is a limited point about availability of efficacy data for vaccines under development in the context of the approval for CovidShield and Covaxin in India.
There have been many so-called experts on the idiotbox opining about apparent availability of P III data which 1/n
2/n apparently the SEC had access to based on which it "supposedly" approved Covaxin. Another argument that is prevalent is other regulators (US FDA and MHRA) also approved vaccines based on P II data alone. Let me give you a few facts so that you can make your own decision.
3/n The protocols for both mRNA vaccines are publicly available. You can check. Both protocols *define* when the interim analysis will be done. This is not subjective. They clearly define how many infections need to be documented before the Data Safety Monitoring Board meets.
4/n Find the protocols for the bridging study for CovidShield and Covaxin and look for a similar milestone.
Here is one set of efficacy data post the interim analysis of a mRNA vaccine.
Source: https://t.co/BAPnP3PxEb
5/n This data was analyzed post the interim analysis where the blind was broken by the DSMB. Now ask yourself this question:
How does the SEC, or the sponsor of these studies, or the experts who are offering their opinion liberally on the idiotbox know what the efficacy is
There have been many so-called experts on the idiotbox opining about apparent availability of P III data which 1/n
2/n apparently the SEC had access to based on which it "supposedly" approved Covaxin. Another argument that is prevalent is other regulators (US FDA and MHRA) also approved vaccines based on P II data alone. Let me give you a few facts so that you can make your own decision.
3/n The protocols for both mRNA vaccines are publicly available. You can check. Both protocols *define* when the interim analysis will be done. This is not subjective. They clearly define how many infections need to be documented before the Data Safety Monitoring Board meets.
4/n Find the protocols for the bridging study for CovidShield and Covaxin and look for a similar milestone.
Here is one set of efficacy data post the interim analysis of a mRNA vaccine.
Source: https://t.co/BAPnP3PxEb
5/n This data was analyzed post the interim analysis where the blind was broken by the DSMB. Now ask yourself this question:
How does the SEC, or the sponsor of these studies, or the experts who are offering their opinion liberally on the idiotbox know what the efficacy is
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https://t.co/6cRR2B3jBE
Viruses and other pathogens are often studied as stand-alone entities, despite that, in nature, they mostly live in multispecies associations called biofilms—both externally and within the host.
https://t.co/FBfXhUrH5d
Microorganisms in biofilms are enclosed by an extracellular matrix that confers protection and improves survival. Previous studies have shown that viruses can secondarily colonize preexisting biofilms, and viral biofilms have also been described.
...we raise the perspective that CoVs can persistently infect bats due to their association with biofilm structures. This phenomenon potentially provides an optimal environment for nonpathogenic & well-adapted viruses to interact with the host, as well as for viral recombination.
Biofilms can also enhance virion viability in extracellular environments, such as on fomites and in aquatic sediments, allowing viral persistence and dissemination.
Viruses and other pathogens are often studied as stand-alone entities, despite that, in nature, they mostly live in multispecies associations called biofilms—both externally and within the host.
https://t.co/FBfXhUrH5d
Microorganisms in biofilms are enclosed by an extracellular matrix that confers protection and improves survival. Previous studies have shown that viruses can secondarily colonize preexisting biofilms, and viral biofilms have also been described.
...we raise the perspective that CoVs can persistently infect bats due to their association with biofilm structures. This phenomenon potentially provides an optimal environment for nonpathogenic & well-adapted viruses to interact with the host, as well as for viral recombination.
Biofilms can also enhance virion viability in extracellular environments, such as on fomites and in aquatic sediments, allowing viral persistence and dissemination.