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
Here are data for neutralization with AZ, then Pfizer, showing that was superior vs 2 AZ or 2 Pfizer doses for Alpha & Beta variants thelancet.com/journals/lanre…
Preprint today: look at neutralization not binding Abs; yes Moderna -> more boost than Pfizer to J&J, but w/ 100 μg dose
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
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
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
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
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
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/…
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)