c933103 wrote:par13del wrote:c933103 wrote:A question
Given the increasing prominence of strains featuring E484K mutation, and given the reportedly relative ease for mRNA vaccine makers to adopt their vaccine according to newly mutated strains, and the reportedly short time span needed for such adaptation, given that E484K mutation have already been known to reduce effectiveness of immunity established from other strains, why haven't vaccine makers start making vaccine variants that would work against E484K?
The question I would ask is how long would it take the authorities to certify the change, paperwork may be the largest hold up, not the science.
Based on what is taking place, the authorities require a test group of significant size and demographics. Existing production facilities are not meeting stated output but modification must be made to accommodate the new variant, not an easy task with existing certified facilities. Proper documentation of the test group and equipment changes must be maintained and submitted for inspection and approval.
As has been seen, the public support the authority of the regulators whether scientific or otherwise, the easy thing may be to suspend production while switching, but the risk there is too great. One, the current vaccines work and are 100 times better than nothing, two, you have to be sure there will be no complications from the new version before taking the leap.
I suspect they are working on the new version but due to the scale of the pandemic the resources are the limiting factor, not the science.
I thought that wouldn't be required, in the same way annual flu shot wouldn't need to be recertified every year?
Well you just seen this week that the USA still had issues with data AZ submitted even though millions of doses have already been administered in other nations, why would the certification of other variant of the vaccine be any different? Each regulator has their own certification requirements.
The EU had issues with AZ vaccine produced in factory not yet certified because AZ did not submit the paperwork, claim is that was being used to hide doses, circumvent etc etc etc, such issues will continue.