All this quarrel was over whether Astra Zeneca vaccine is 79% effective or 76% effective.

Pundits/Experts: Don't let irritation with how the company managed the trial supersede the fact that this is a great vaccine that saves lives.

Don't become a reason for vaccine hesitancy
Your wanting to sounding wise may lead to more vaccine hesitancy.

Be clear on how unbelievably good the vaccine is. That's the truth. Analyze the data & present the efficacy and safety results.

Hold your thoughts on how the company could have better publicized the results.
There is just too much bashing of a vaccine over process and details and too much missing the big picture.

There is no evidence that the integrity of the randomization was compromised. The vaccine works. Really well.
This bashing is mostly coming from US pundits/experts, when our country doesn't need this vaccine anymore.

This is the only realistic vaccine for a large proportion of the world. It will save countless lives. There is no doubt about it.
Here is the press release of the updated primary efficacy analysis. astrazeneca.com/content/astraz…
You know the big mistake was? It was not that Astra Zeneca put out a press release with 79% efficacy instead of 76% — probably in their excitement to get good news out early.

It's that we didn't approve a highly effective vaccine in December. We lost 180,000 lives since Jan 1

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More from @VincentRK

25 Mar
For the public to know about Data Safety Monitoring Boards (DSMBs).

Ive been on DSMBs for trials led by colleagues. Those colleagues have been on DSMBs for trials led by me. People in DSMBs don't necessarily have some special superior skills to the study team. And vice versa.
DSMBs in randomized trials get to see data ahead of the study team investigators and decide if any safety concerns and to decide when to stop the trial/release results either because the endpoint was met or there was futility or a safety issue.
The DSMB is independent of the study team and does what is in the best interest of the trial participants and the public.

Their advantage comes from access to data early and without the bias that a study team may have.
Read 5 tweets
25 Mar
Updated progress towards herd immunity in USA:
~30 million have had COVID
~85 million have received at least 1 dose of vaccine
(~70 million are children)

~100 million to go to get 80% of eligible population immune —an overestimate coz it excludes people who had undiagnosed COVID
I'm excluding people who have had COVID by seroprevalence because 1) it's hard to get a good idea of the % for the whole country; 2) the immunity from mild COVID may not be as robust; 3) Im excluding children so it compensates on the other end; 4) meant to be worst case scenario
At the rate we are vaccinating we are within 1-2 months of where we need to be. Which is good news.

I've said for months that we are closer to herd immunity than we think we are. Because of other factors. But that was a soft call. This time with vaccines I'm more confident.
Read 5 tweets
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
22 Mar
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.
Read 6 tweets
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
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

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