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Vincent Rajkumar Profile picture
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22 Mar, 6 tweets, 3 min read
Nov 23: Astra Zeneca Vaccine shows 70% efficacy
Dec 30: UK approves AZ vaccine

We decided to wait for our own trial.

10 million: New cases YTD
180,000: New deaths YTD

US results out today: 79% efficacy.
~100% efficacy in preventing serious COVID. astrazeneca.com/media-centre/p…
I called it a blunder then.
Why because it didn't make sense as the right judgment call.

We were essentially saying no to a vaccine when we we had 200,000 new daily cases a day and 3000 new deaths a day.
Too many pundits criticized the initial Astra Zeneca trials. Overstating procedural problems double blind placebo controlled trials. Most of these pundits were purists who had never led a randomized trial themselves. Let alone in lightning speed.
We confused following the process as following the science.

It's kind of too late now. We have 3 approved vaccines and getting Astra Zeneca approved now will only take supplies away from the rest of the world which needs it much more than us at this time point.
I'm trying to look for news reports from early Jan on this risk benefit judgment call. One of the best write ups was this last month. @sallypipes @FortuneMagazine google.com/amp/s/fortune.…
Looks like minds were made up pretty early about the procedural problems and errors. However in this large double blind data set what was in doubt was margin of efficacy. Not whether the vaccine had efficacy. Or the certainty of that call. @RebeccaDRobbins google.com/amp/s/www.nyti…

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Vincent Rajkumar Profile picture
23 Mar
I would take a deep breath and wait for AZ to release primary efficacy results to see if there is any meaningful difference from the prespecified interim analysis reported yesterday. Usually there will be some differences. It happened with the other vaccines also.
It is quite extraordinary for a DSMB to express concern over release. Not sure if there was a misunderstanding when the DSMB asked AZ to release results, if it specifically told them to wait and release Primary Analysis or not.
Again unless the difference is meaningful not sure what to make of this other than it's pretty strange. Never happened to me in any of the trials that I have been involved with.
Read 5 tweets
Vincent Rajkumar Profile picture
20 Mar
Real world data from Israel on Pfizer BNT COVID vaccine.
Population of 1.6 million with 1.2 million vaccinated.

Per test model:
-91.2% efficacy in preventing all infections.
-99.3% efficacy in preventing symptomatic infections.

#GetVaccinated medrxiv.org/content/10.110…
There was a decrease in efficacy noted in people with advanced age (80+), Type 2 diabetes, COPD, and immunosuppression.

However, efficacy was still very good in these groups. And the best way to protect them is for everyone around them to also get vaccinated.
This is incredibly good data. In medicine real world studies seldom give results as good as the randomized trials.

With 99.3 overall protection against symptomatic COVID, it doesn't get any better.
Read 6 tweets
Vincent Rajkumar Profile picture
19 Mar
Astra Zeneca COVID vaccine update.

1/ Out of ~20 million people who received this vaccine, 16 have developed cerebral venous sinus thrombosis in EU/UK. @EMA_News

Germany 7
Italy 3
Norway 2
Spain 1
UK 3

In addition, 2 cases were reported from India.
2/ There were also 7 cases of DIC.

3/ All of the EU /UK events were in people less than 55.

4/ 9 deaths.

ema.europa.eu/en/news/covid-…
5/ The rate of DIC and cerebral venous thrombosis appear higher than expected baseline.

6/ Since these adverse events are very rare, the risks of COVID high, & the high efficacy of the vaccine, the @EMA_News recommended that the benefits of the vaccine outweighed the risks.
Read 4 tweets
Vincent Rajkumar Profile picture
19 Mar
In May 2020, we would have been happy with any vaccine by 2022

By fall 2020, we were going to be happy if any vaccine was 50% effective.

By Feb 2021, we have vaccines with 95% efficacy but we worry about why it's not 100% effective, & if it prevents transmission or long COVID.
What we can control: Try and vaccinate as many people as possible, globally, so that there are less immunologically unprepared hosts for the virus to multiply in.

What we cannot control: The innate ability of the virus to mutate.
What we can do: Take precautions till a significant proportion of the population you live in has been vaccinated.

What we can't do: Create new vaccines in a month. It's going to take time for boosters that improve on the protection offered by current vaccines to arrive.
Read 4 tweets
Vincent Rajkumar Profile picture
19 Mar
Paradigm shifts in multiple myeloma.

1/ Change in diagnostic criteria. MDE not CRAB. @TheLancetOncol
2/ Treatment of high risk SMM. Early preventive therapy with Len or Len/dex significantly delays end organ damage in high risk SMM. @SagarLonialMD @mvmateos
3/ Role of Transplant.
Early versus Delayed Transplant. Similar overall survival at 8 years means selected patients with standard risk myeloma can opt to delay transplant if feasible.
Read 5 tweets
Vincent Rajkumar Profile picture
18 Mar
COVID and thrombosis.

There's concern about 11 people who developed central venous thrombosis following COVID vaccine.

But what about COVID itself?
A brief summary:

1/ COVID has been associated with central venous sinus thrombosis. Singapore 2 cases. ncbi.nlm.nih.gov/pmc/articles/P…
2/ France 2 cases. pubmed.ncbi.nlm.nih.gov/33725828/
3/ Egypt 2 cases. pubmed.ncbi.nlm.nih.gov/33520667/
Read 5 tweets

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