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14 Oct, 4 tweets, 3 min read
The benefit of the Pfizer boosters across all age groups (vs infections in 16+, vs severe disease 40+), presented @US_FDA today as background for consideration of other vaccine boosters
fda.gov/media/153086/d…
In July, many maintained there was no attrition of vaccine effectiveness (VE) vs symptomatic infections or severe disease. Denial of Israeli data.
That continued for months.
In October, all vaccines are getting approvals for boosters to prevent VE attrition in people at high risk
Beyond the mRNAs (Pfizer and Moderna), Astra Zeneca, and J&J, the Chinese vaccines, Sinopharm and Coronavac, are also following suit
nature.com/articles/d4158… @Nature
Calling out this concern of VE decline, intended to amp up protection in vaccinees, was met with major backlash

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More from @EricTopol

Eric Topol Profile picture
16 Oct
Yesterday the FDA Advisory committee recommended that the 15 million Americans who have had J&J vaccines, more than 2 months out, get a 2nd shot.
There are some significant issues with this that could have been prevented /1 Image
By May 1, there were over 8 million people 5.5 months out
By June 1, the number rose to nearly 11 million people 4.5 months out
Yet data have consistently been showing attrition of protection vs infections for this vaccine, this week in 620,000 US Veterans /2 Image
This is the only Covid vaccine that was positioned as "one and done." J&J is the largest healthcare company in the world, yet research to back that up was undone until recently.
Single dose: 70% protection vs symptomatic infection
2-dose: 94% protection /3
fda.gov/media/153129/d… Image
Read 7 tweets
Eric Topol Profile picture
13 Oct
A big mix and match vaccine report in 458 participants with Pfizer, Moderna, J&J, then getting another vaccine 12 weeks later: markedly increased neutralizing antibody response by mixing (up to 76-fold) w/ these 9 combinations (Figure)
medrxiv.org/content/10.110… (not Delta strain)
The big takeaway from this dataset is the response to J&J vaccine with a Moderna or Pfizer booster, taking that vaccine with low levels of neutralizing antibodies to close to parity with the mRNAs
(also worked in reverse, J&J boost to mRNA, middle panel)
A few add’l points:
1. 100 μg dose of Moderna booster used here is not (2X) 50 μg proposed by their EUA for FDA tomorrow
2. In prior reports, Astra Zeneca 1st, then mRNA had superior levels of nAbs over mRNA 2 doses, not seen here w/ J&J
3. Assessments were w/ D614G, not Delta
Read 5 tweets
Eric Topol Profile picture
12 Oct
What data does @moderna_tx have to support its 50 ug booster dose? @US_FDA briefing documents provide immune response data across age groups but no evidence of restoration of clinical effectiveness fda.gov/media/152953/d…
The same amended criteria given for Pfizer's emergency authorization are what Moderna is requesting. This will be an interesting VRBPAC meeting that essentially leverages effectiveness data from another vaccine (which I support) vs purists who will claim clinicaldata are lacking
The unusual FDA reviewer staff response
wsj.com/articles/fda-s… @felschwartz and @Loftus
Read 4 tweets
Eric Topol Profile picture
10 Oct
New data have shed light on breakthrough infections across all age groups and multiple vaccines
1. The Israel data on restoration of protection vs severe illness with Pfizer booster shots among 4.6 million people
medrxiv.org/content/10.110…
2. The New York State data for decline in protection from confirmed infections in all age groups for Pfizer, Moderna and J&J vaccines among 8.8 million people
medrxiv.org/content/10.110…
3. Summary of recent reports for decline (from >90%) in vaccine effectiveness vs symptomatic infections for Pfizer, Moderna, and AZ vaccines
Read 7 tweets
Eric Topol Profile picture
7 Oct
Covid vaccines are essential and have had a profoundly positive impact.
There's controversy as to whether boosters will be useful for age <60.
New data highlights significantly less protection vs symptomatic infections and, to a lesser extent, hospitalizations /1
Summary of the recent data for vaccine effectiveness vs symptomatic infections. At 2 months, this was well over 90% for mRNA vaccines, but by 4-6+ months has declined to between 44-70%.
All ages.
Data for Pfizer, Moderna, and AZ /2
The Qatar data were just published @NEJM

Here are the ICATT data (age <65), presented at the recent CDC ACIP meeting /3
Read 6 tweets
Eric Topol Profile picture
1 Oct
This could turn out to be one of the most important advances to counter Covid. Molnupiravir, a pill for 5 days (I'll nickname "M-pack") to markedly reduce hospitalization. Await details beyond press release, including safety
statnews.com/2021/10/01/mer… by @matthewherper @statnews
Molnupiravir is a broad spectrum anti-viral that achieves "lethal mutagenesis" of #SARSCoV2. Unlike remdesivir, it's a pill, it's not repurposed, had solid data from a Phase 2 trial supporting potency + safety vs Covid nature.com/articles/s4159… @nature The mechanism of action 👇
The fact that the new clinical trial was stopped by the Data and Safety Monitoring Board early because of overwhelming efficacy, deeming it unethical to proceed, would be considered a Eureka moment in the fight against Covid
Read 6 tweets

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