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12 Oct, 4 tweets, 3 min read
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
The J&J booster data for FDA review this week, like Moderna, has evidence for the immune response but without clinical effectiveness
fda.gov/media/152954/d…

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More from @EricTopol

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
Eric Topol Profile picture
28 Sep
Why are symptomatic post-vaccination covid infections, without hospitalization (H), important?
—they can be severe, on the brink of H
—they can result in #LongCovid
—they can transmit to others
—they were the primary endpoint of the vaccine clinical trials for efficacy
Inconvenient truth #1
The waning of vaccine effectiveness vs symptomatic infections for both Pfizer and Moderna across all age 20+ groups, presented at @CDCgov Advisory meeting last week
cdc.gov/vaccines/acip/… Image
Inconvenient truth #2
Transmission among fully vaccinated health care workers, with some asymptomatic individuals with higher viral loads than those with symptoms
papers.ssrn.com/sol3/papers.cf…
(not common, but it can occur) Image
Read 4 tweets
Eric Topol Profile picture
25 Sep
The waning of Pfizer and Moderna vaccine protection vs *symptomatic infections* over time in all age groups, slide presented at ACIP @CDCgov meeting by Sara Oliver MD cdc.gov/vaccines/acip/…
(this was the primary endpoint for the pivotal trials to approve these vaccines)
Red=Delta (Green=pre-Delta)
It's still early into the period of waning, w/ frequency of exposures increasing over time.
Recall the UK (and other countries) decision to provide 3rd shots irrespective of vaccine to all age 50+ is at odds with FDA/CDC (Pfizer only, age 65+)
Meanwhile we have left the people who got a J&J vaccine stranded with comparatively very low antibody levels 2-6 weeks after dosing, while we've learned such levels are tied to protection
cdc.gov/mmwr/volumes/7…
I think that's now ill-considered.
Read 4 tweets
Eric Topol Profile picture
22 Sep
New reports @NEJM today support higher vaccine effectiveness (VE) of Moderna over Pfizer, with both providing strong level of protection
1. vs Symptomatic infection in health care personnel
96.3 vs 88.8% (see Table for 95% CI, slight overlap)
nejm.org/doi/full/10.10…
2. ~6-Month Follow-Up of Moderna pivotal trial
nejm.org/doi/full/10.10…
VE 98.2% vs severe disease (here VE = vaccine efficacy, with a placebo control)
Difference between protection, VE for symptomatic infections during extended follow-up of Pfizer and Moderna
Pfizer data nejm.org/doi/full/10.10…
Read 4 tweets

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