Breaking: FDA authorizes Paxlovid, a pill, for preventing severe disease in COVID patients 12 & older who are at high risk due to comorbidities or advanced age. I welcome this.
Clearly they took some discretion with expanding beyond the phase 3 to include patients 12-18 with risk factors, although the specified a minimum weight. Good decision.
Also shows how much discretionary power they have. And they should be more liberal like this with approving rapid tests. @michaelmina_lab
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Why is this important? Spain is one of the best vaccinated countries in Europe: 80% fully vaccinated.
The US is only 60% fully vaccinated. UK is 70%.
It's a warning. 1/
The sharp rise in cases in Spain shows omicron can easily cause post vaccine breakthrough infections. Deaths are lower suggesting vaccines do protect against severe disease. 2/
Note that the lower deaths may be also partially due to a lag in cases and deaths. But there is no question omicron will stress out an already stressed out healthcare system.
People who need care for their illnesses won't get the care they need if hospitals are overwhelmed.
3/
When all is said and done, COVID vaccines have taken the sting out of COVID.
This is seen in cases versus deaths in UK: Deaths lower this time around even though cases skyrocket. Vaccines work.
Also seen in the US but not as striking as in the UK probably because a) heterogeneity: some states are doing like UK, some worse; b) we are not as well fully vaccinated (60% vs almost 70% UK); c) UK had a bigger death toll in January; d) they are ahead of us in the omicron wave.
This is even better illustrated in countries that are much more fully vaccinated than the US or UK. Note how deaths have stayed low with recent waves even as cases went up.
At this point, the US should have 4 times more immunity than SouthAfrica: 3 times more people have already had COVID in the US; our vaccination rate is more than double theirs.
But our current death rate is running 4 times higher. Why? 1/
I really don't know
3 possible reasons:
a) Differences in demographics & co-morbidities (although with prior waves, their deaths have tracked ours)
b)Inaccurate case ascertainment: they may have had far more people with prior Covid than has been reported
c) Different variants
2/
Many have pointed to the low death rate now in South Africa with the Omicron wave as an indication that Omicron is milder.
But I think our problem in the US is different: we are facing delta plus omicron. Not just omicron.
3/
In the global race to vaccinate against COVID, the US is lagging behind most developed countries. ig.ft.com/coronavirus-va…
In fact, countries which have lower vaccination rates than us are mainly those with inadequate access to vaccines.
Overall we are at #93 of about ~225 countries in %fully vaccinated. Excluding small countries with less than 200,000 population, we are at still >#60 in the race.
This is not due to limited vaccinate availability but vaccine hesitancy.
Vaccine hesitancy is not due to a uniform cause. There are many reasons. But mostly it is due to misinformation about Covid and Covid vaccines spread on media and social media.
Without leading a trial it's hard for you to realize how hard it is to do one and you may end up throwing stones at investigators trying to do their best. #ASH21
See this thread on how many people control the design of a trial. Most of this thread applies also to investigator initiated non randomized trials also. #ASH21
When you have this brilliant idea on how a trial should have been designed, in many cases the PI is also brilliant enough to know the same but they often had to make the hard choice of putting their foot down and not have a trial at all or compromise. #ASH21