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.

In trials, this drug reduced risk of deaths or hospitalization by almost 90%
washingtonpost.com/health/2021/12…
Treatment should start as soon as possible after onset of symptoms and within 5 days of symptom onset.

The trial studied adults 18 and older with a prespecified risk factor for progression to severe disease OR were 60 years and older.
Link to the FDA authorization. fda.gov/news-events/pr…
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

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Vincent Rajkumar

Vincent Rajkumar Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @VincentRK

22 Dec
Cases in Spain have now exceeded the US.

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/
Read 7 tweets
17 Dec
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.
Read 8 tweets
16 Dec
The Great South African Mystery.

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/
Read 5 tweets
15 Dec
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.
Read 5 tweets
14 Dec
We are back up to nearly 120,000 cases a day in the US.

A small % getting seriously ill out of a large number is a large number. #Omicron Image
Healthcare workers are tired and weary. Another big wave when we have the tools to prevent and to mitigate will be sad.

Get vaccinated if you haven't.
Get your booster if you haven't
Wear masks
Continue other precautions.
You can see what Omicron can do here.
Read 5 tweets
14 Dec
Clinical trials:

See one
Do one
Teach one

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
Read 8 tweets

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal

Or Donate anonymously using crypto!

Ethereum

0xfe58350B80634f60Fa6Dc149a72b4DFbc17D341E copy

Bitcoin

3ATGMxNzCUFzxpMCHL5sWSt4DVtS8UqXpi copy

Thank you for your support!

Follow Us on Twitter!

:(