Pretty striking now with 6 Phase 3 vaccine trials, adding Sputnik today:
Not a single death or hospitalization in the vaccine arms due to covid-19 in over 75,000 participants
Updating my table
For Sputnik, "moderate to severe" endpoints were 20 in the placebo group, 0 in the vaccine arm (100% reduction); not broken down by severe only
One more pretty important point to emphasize:
The zero deaths or hospitalizations in the vaccine groups includes the J&J trial in South Africa (~11,000, 25% of all participants) with 95% B.1.351 (501Y.V2) AND the 4,400 participants in the @Novavax viral conducted in South Africa.
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From serology studies it is estimated that 80 to 100 million Americans have had covid-19 infections. New data from @florian_krammer and colleagues suggests that, with + antibody testing, 1 dose of vaccine may be a viable strategy to achieve protection medrxiv.org/content/10.110…
Which is why many people getting their 1st dose of the mRNA vaccines have the expected side-effect profile of the 2nd dose. In the mRNA vaccine trials, only 2-3% of the participants were determined to be seropositive after enrollment.
I've been advocating the use of rapid, quantitative antibody testing to promote the optimal use of our vaccine supply, limited in the short term, while assuring maximal protection:
For evaluating the vaccine trials (and any trials), it's important to look at the number of endpoints and their severity.
The J&J trial has the same number of endpoints as @Pfizer/ @BioNTech_Group, @moderna_tx and @Novavax (1st interim) combined /1
The total number of participants was nearly the same for J&J and Pfizer trials, but the number of events was 2.75X higher for the former. While the J&J trial had 25% of participants in South Africa (w/ 95% B.1.351 variant) that doesn't account for this difference /2
The vaccine elimination of deaths and hospitalizations in the J&J trial (including South Africa) is noteworthy since there were so few of these events in the other 3 trials. Most (~90%) of the events in all the trials are mild to moderate infections /3
Back in September, we wrote a @nytopinion on the need to focus on severe infection events prevented by Covid-19 vaccines nytimes.com/2020/09/22/opi…
Yesterday JNJ presented their Phase 3 data stressing that benefit. I spoke w/ them today & have much more confidence that it's real /1
My first question is why didn't they give actual data points and confidence intervals?
Answer: The FDA guided them not to do that. Interesting that the other companies (@Pfizer, @moderna_tx, @Novavax) did provide their data with their press releases /2
Then we reviewed the outstanding finding in their data set.
There were approximately 40-60 hospitalizations and deaths in the whole trial. All in the placebo group. Period. Even those occurring in South Africa. That is *great news* /3
Big news: The JNJ vaccine results of 44,000 Phase 3 trial, a single dose. Overall 66% efficacy, with the contrast of 72% in US but 57% in South Africa, confirming immune escape/resistance of B.1.351 variant seen by Novavax
This news is certainly welcome, clearly fulfills FDA threshold and adds to the vaccine tool chest. It is a clear drop down from the 2-dose mRNA efficacy statnews.com/2021/01/29/jj-…@matthewherper@statnews
I have to revise the #SARSCoV2 Variant table with latest information from past 12 hours
South African trial of >4,000 participants
49.4% efficacy
Of 44 participants with infection events, sequencing of their virus showed B.1.351 in 25 samples
@novavax slide via @kakape shows differences in participants with or without HIV and different denominator for sequencing than above.
--25/27 infection events were B.1.351
1. A year ago the first person with asymptomatic covid was documented. My colleague @danieloran culled the data from 61 studies, 1.8 million people to determine how often this occurs. Just published @AnnalsofIM acpjournals.org/doi/10.7326/M2…
2. First a definition:
"The asymptomatic fraction of infection is the proportion of infected persons who never develop, perceive, and report symptoms"
In contrast to "presymptomatic" individuals who ultimately develop symptoms.
Both groups can transmit infections.
3. Here are the 14 longitudinal studies where symptom status was assessed over time