1/ This is a truly excellent and important outcome. Greater than 90% efficacy at preventing disease, with 94 COVID-19 cases to evaluate, is an excellent outcome! It would be good to see more of the data, but those are very convincing numbers.
2/ It is also encouraging that the 90% efficacy is for all cases, not just a subset of cases. Finally, I find it very encouraging for the other COVID-19 candidate vaccines also!
3/ Multiple candidate vaccines had similar immunogenicity profiles in humans, and multiple candidate vaccines had efficacy in pre-clinical models, so there is not specific reason not to expect multiple other candidate vaccines to do well in humans nows.
4/ The Pfizer vaccine results are consistent with the pre-clinical data and what we have learned about COVID-19 immunology and immunity, but there’s nothing like Phase 3 vaccine trial data for a definitive outcome.
5/ I got a number of questions yesterday related to COVID-19 vaccines, vaccines in general, and the Pfizer clinical trial interim results, so I will answer several of the big ones here:
6/ Can vaccines really be 90% effective?
Yes, definitely! That’s one big reason vaccines are so awesome! Many of them are close to 100% effective. Smallpox, polio, measles, Diphtheria, and more! Image
7/ Is the Pfizer vaccine safe?
There is an independent safety board tracking the clinical trial. The information is not all publicly available, but the vaccine has been into over 20,000 people, with two doses (so, > 40,000 immunizations), and the statement was:
8/ “The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.”
That is consistent with the safety of the Phase 1/2 vaccine trials, which have been published and were safe.
9/ Why were there only 94 COVID-19 cases?
The short answer is that it is because the trial has been short so far. There hasn’t been much time for people to get infected after they enrolled in the trial. Based on some quick estimates, that number of cases matches expectations....
10/ Ok, let’s break it down:
That would be, in guesstimated terms: 100 cases per 20,000 people per 1.5 months = 33 cases per 10k per month.
Epidemiologists put it as per 100k, so, 330 cases per 100k per month. Image
11/ One should also assume that people who enroll in vaccine trials tend to be safety conscious; wear masks and social distance etc. So their case rate could easily be less than the average population, even though the clinical trials try to enroll higher risk individuals.
12/ The USA average for August was 27.5 cases per 10k per month (275 cases per 100k), from the CDC.
I don’t have the CDC October cases #s in front of me, but those numbers appear to be ~400 cases per 100k per month. USAfacts.org. bit.ly/3ki9ELJ Image
13/ So, ~330 cases per 100k per month in the placebo group seems very similar to the ~400 cases per 100k per month in the USA for October.
14/ Why is the report of symptomatic cases, not coronavirus infections?

This was decided well in advance by most of the vaccine trials. Preventing systemic disease is the #1 goal of COVID-19 vaccines. In addition, ...
15/ it is extraordinarily challenging to test 40,000 people for infections continuously, spread out around the country. So, instead this clinical trial (and others) have people report symptoms, and then anyone with symptoms gets a SARS2 viral test. Those are the confirmed cases.
16/ What important things have not been shown in the initial clinical trials results?

The bigs one are:
Does the vaccine prevent severe cases?
Does it work in the elderly?
How durable is the protection?
Does the vaccine prevent transmission?

But, you know, day-by-day.
17/ It is a phenomenal accomplishment, for the world, to go from nothing to a vaccine with a 90% efficacy signal in ~10 months.
18/ To comment on age: The vaccine has been tested already in the older people to measure immune responses, and the results were encouraging. Antibody responses were similar in both age groups (T cell data were not reported) nejm.org/doi/10.1056/NE…
19/ That is also true for multiple other COVID-19 vaccines in phase 3 now, or going into phase 3 trial soon.

• • •

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

Keep Current with Shane Crotty

Shane Crotty 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 @profshanecrotty

6 Oct
1/ Our new perspective piece on “Crossreactive memory T cells and herd immunity to SARS-CoV-2”is out now.
@mlipsitch @yonatan @SetteLab @ljiresearch @NatRevImmunol

nature.com/articles/s4157… Image
2/ Given the amount of discussion in scientific, public, and political spheres, it is useful to undertake a thought experiment examining crossreactive T cell effects on COVID-19 disease severity and herd immunity, should crossreactive memory T cells confer some form of protection
3/ We consider immunological and epidemiological aspects and implications of pre-existing crossreactive immune memory to SARS-CoV-2, largely originating from previous exposure to circulating common cold coronaviruses.
Read 7 tweets
24 Sep
1/ There are several major aspects of what Scott Atlas is saying that are wrong.
2) There is no direct evidence that pre-existing T cell immunity affects COVID-19 infections. LJI researchers and other have proven that such T cells exist, but neither we nor anyone else have shown that the pre-existing T cells make COVID-19 better, worse, or no difference.
3) To say it another way, There is no direct evidence that crossreactive memory T cells to common cold viruses affects COVID-19.
Read 8 tweets
21 Sep
Crotty lab member of the week is Carolyn Rydyznski Moderbacher, PhD!
1. Carolyn is the lead author of our new COVID-19 immunology paper studying T cell and antibody responses in acute COVID-19 cases.
cell.com/cell/fulltext/…
@ljiresearch Image
2. Carolyn wasn’t planning on working on COVID-19, but she had developed excellent multi parameter flow cytometry panels for other human T cell studies, and AIM assays, and I needed her to take the lead on COVID-19 T cell work,
3. so she dropped her other project and has worked full time on COVID-19 for the past 6 months, trying to understand immunity to COVID-19. Culminating in the new paper. Image
Read 5 tweets
16 Sep
1/ Our newest COVID-19 immunology work is online today at Cell! @ljiresearch cell.com/cell/fulltext/…
2/ We aimed to better understand hospitalized COVID-19 cases by examining virus-specific immune responses all in the same people. SARS2-specific Helper T cells, killer T cells, and neutralizing antibodies.
3/ (I.e., measure the adaptive immune response in acute COVID-19 cases with virus-specific tools.)
Read 11 tweets
16 Sep
Our newest COVID-19 immunology work is online today at Cell! bit.ly/3mugShW
We aimed to better understand hospitalized COVID-19 cases by examining virus-specific immune responses all in the same people. SARS2-specific Helper T cells, killer T cells, and neutralizing antibodies.
(I.e., measure the adaptive immune response in acute COVID-19 cases with virus-specific tools.)
Read 10 tweets
8 Sep
1/ Crotty Lab member of the week: Yu (Alex) Kato
Alex led the work just published in @ImmunityCP on the multifaceted ways antigen valency affects B cell responses in vivo. That study is important for vaccine immunology, connecting vaccine designs to immunological rules. Image
2/ He used two photo intravital microscopy, custom engineered proteins, a variety of in vivo models manipulating antigen-specific B cells and CD4 T cells, and all kinds of flow cytometry to figure out this interesting and important puzzle. All told, it was almost 4 years of work!
3/ Alex has also been deeply involved in fantastically successful collaborations with Darrell Irvine's lab at MIT, including a novel vaccine delivery / adjuvant study in @NatureMedicine this year.
Read 4 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 Become our Patreon

Thank you for your support!

Follow Us on Twitter!