Young children, age 5/6-11, and vaccination dose of mRNA
Pfizer used 10 μg in their trial of 2,270 children w/ 90.7% efficacy vs symptomatic infections
Moderna used 50 μg in their trial of 4,753 children
Wondering about this 5X mRNA dose; both trials small for v rare side effects
Another issue:
We have learned that vaccine dose spacing 8-12 weeks induces a better immune response than short (3-4 week spacing). Why hasn't this been incorporated in the new trials and roll out?
The event curve for symptomatic infections in the age 5-11 Pfizer trial presented at FDA today (2 doses given, 3 weeks apart) fda.gov/media/153513/d…
Just in: Vote of the advisory panel 17-0 in favor of approval of Pfizer vaccine for ages 5-11
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A new, rigorous and important study of Covid transmission—with or without prior vaccination—in 621 people with mild infections
Just published @TheLancetInfDis thelancet.com/lancet/article…
Vaccination reduced spread, but it still occurred in household contacts (unvaxx 38%, vaxx 25%)
Viral load was assessed from 8145 respiratory tract samples for up to 20 days, irrespective of symptoms
The peak load (Delta variant) was similar for unvaccinated vs vaccinated cases, but faster clearance in the latter
All breakthrough cases were mild
From the accompanying editorial thelancet.com/pb-assets/Lanc…
“This study unfortunately also highlights that the vaccine effect on reducing transmission is minimal in the context of Delta variant circulation”
The 1st randomized trial of a booster (3rd) shot in 10,000 people, placebo-controlled, shows 95.6% efficacy, with 5 cases (Pfizer vaccine) vs 109 in placebo group, Delta variant, broad benefit across age groups ft.com/content/d4e58d…
Until now there were only vaccine effectiveness reports without randomization, without a placebo control group, and multiple potential confounding factors. That’s what makes this trial report significant proof of benefit of booster shots, at least for this vaccine regimen.
Current booster recommendations. They are going to need to be revised.
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
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
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…
Why does the UK currently have 6-fold hospital admissions and a 3-fold higher death rate compared with Europe? ft.com/content/345825…@FT@mroliverbarnes@jburnmurdoch@danieldombey
Among possible explanations, two that stand out are less use of mitigation measures /1
And less vaccination of kids, age 12-17
More reliance on Astra Zeneca vaccines offered as another possible contributing factor
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
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