With global HIV deaths in hundreds of thousands each year, but less evenly distributed and more stigmatized, will this vaccine be given emergency authorization as well, or is it likely to go through the full 10 year process?
Emergency Authorization is a regulatory matter, and thus isn't a global decision.
New Zealand did not use Emergency Authorization for the pandemic, because they had elimination so they were able to wait while their medicines agency performed full (but expedited) assessment for the Pfizer mRNA vaccine and gave a recommendation based on that assessment. As a result they didn't even begin vaccinating people until months after some other countries, but (because of elimination) they had zero deaths meanwhile.
So, in some countries regulators might decide an HIV vaccine is something that needs Emergency Authorization and in others not.
Another factor in what you're calling a "10 year process" is how long it takes to collect data from a Phase III trial. I think lots of people still do not appreciate why the Phase III trial for these coronavirus vaccines was so fast. The pandemic meant that huge numbers of people in your control group get infected. This is terrible news for them, some will die, but it means you get very rapid trial results.
So if you're confident that HIV has similar levels of spread, this is "good news" there too, the vaccine trials won't take very long to give results, regardless of whether you are intending to do Emergency Authorization or a normal process.
> So if you're confident that HIV has similar levels of spread
It does if you do phase III trials in the right countries. In South Africa, there's 15 million HIV cases give or take, and a million infections per year - so trials could yield results rather quickly...
It may even be 100 years for all we know. It's not a problem of legislation. It's a problem of not knowing how to do this. This really has to be emphasised: it will most likely be much harder to achieve anything here. The covid vaccine was exceptional not only in the overall time-to-market but also in that it just worked on the first try. I'd wager a working HIV vaccine will instantly attract a Nobel prize, if not more than one.
Everyone has heard of the covid strains and the anxiety around them (are the strains much worse? will there be cross strain immunity?). This is like child's play compared to HIV, where essentially every infected person has a separate HIV variant, evolutionally crafted to evade the specific host immune system as best as it can. I would call it "amazing" had it not been inappropriate to call "amazing" a deadly disease.
Read the full paper, they go in detail on how the vaccine would have to create a "portfolio immunity" against the parts of the virus that are known to be most important. For example in terms of the humoral immunity they call them broadly neutralizing antibodies (bnAbs). Those will have to cover a range of variants.
Just to make things a bit more interesting (and grim): every HIV patient has multiple variants at the same time. In this regard HIV is pretty much like cancer :(
> Nucleotide sequences of the hypervariable V3 region of HIV-1 obtained from different organs of one patient demonstrated distinct viral variants.
I think it's not just a question of the societal pressure. From the little I could understand in the paper, the HIV vaccine would be considerably more complicated than the Covid-19 ones, primarily do deal with all the immune escape issues. So it'd likely have a harder time getting authorized due the complexity of the mechanisms.
tialaramex|4 years ago
New Zealand did not use Emergency Authorization for the pandemic, because they had elimination so they were able to wait while their medicines agency performed full (but expedited) assessment for the Pfizer mRNA vaccine and gave a recommendation based on that assessment. As a result they didn't even begin vaccinating people until months after some other countries, but (because of elimination) they had zero deaths meanwhile.
So, in some countries regulators might decide an HIV vaccine is something that needs Emergency Authorization and in others not.
Another factor in what you're calling a "10 year process" is how long it takes to collect data from a Phase III trial. I think lots of people still do not appreciate why the Phase III trial for these coronavirus vaccines was so fast. The pandemic meant that huge numbers of people in your control group get infected. This is terrible news for them, some will die, but it means you get very rapid trial results.
So if you're confident that HIV has similar levels of spread, this is "good news" there too, the vaccine trials won't take very long to give results, regardless of whether you are intending to do Emergency Authorization or a normal process.
MagnumOpus|4 years ago
It does if you do phase III trials in the right countries. In South Africa, there's 15 million HIV cases give or take, and a million infections per year - so trials could yield results rather quickly...
H8crilA|4 years ago
Everyone has heard of the covid strains and the anxiety around them (are the strains much worse? will there be cross strain immunity?). This is like child's play compared to HIV, where essentially every infected person has a separate HIV variant, evolutionally crafted to evade the specific host immune system as best as it can. I would call it "amazing" had it not been inappropriate to call "amazing" a deadly disease.
Read the full paper, they go in detail on how the vaccine would have to create a "portfolio immunity" against the parts of the virus that are known to be most important. For example in terms of the humoral immunity they call them broadly neutralizing antibodies (bnAbs). Those will have to cover a range of variants.
pas|4 years ago
> Nucleotide sequences of the hypervariable V3 region of HIV-1 obtained from different organs of one patient demonstrated distinct viral variants.
https://pubmed.ncbi.nlm.nih.gov/8151287/
anarazel|4 years ago