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Monica Gandhi MD, MPH Profile picture
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20 Sep, 5 tweets, 2 min read
BREAKING NEWS: Pfizer releases results of 5-11 year old trial for its vaccine. 2-dose 10 microgram regimen (Pfizer uses 30 mcg for 12 and up) administered 21 days apart (sigh, we now know we need longer duration between doses for better effectiveness)
pfizer.com/news/press-rel…
4500 person trial of 6 months-11 years (FDA asked Pfizer to enroll more) & this data is for 2,268 participants aged 5 to 11. This phase 2/3 study looked at safety & immune reactions only (antibodies not T cells) - no endpoints of symptomatic disease. Found safety same as 12 & up
and antibody titers high (didn't give breakdown of those with and without prior SARS-CoV-2 infection; both groups enrolled in this phase 2/3 study). This will lead to filling of EUA for 5-11 & suggest further detail on safety, any effectiveness data?, continuing follow-up
Good interview by the very measured @DrPaulOffit on the status of boosters and this preliminary data on the 5-11 vaccine for children
c-span.org/video/?514731-…
Well-aware other countries with higher adult vax rates than we (keeps children safe) allowing transition to endemicity & normal life for children without vax <12 years. US had rocky course with vax/adult acceptance/delta & "normal" in many US places won't occur without child vax.

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More from @MonicaGandhi9

Monica Gandhi MD, MPH Profile picture
21 Sep
JOHNSON & JOHNSON TWO DOSE DATA TODAY: First, want to remind us how J&J vaccine works. More "traditional vaccines" are proteins of the vaccine combined with an adjuvant (see thread on Novavax). J&J and mRNA vaccines novel in that they put genetic material of the spike protein
into a lipid container (mRNA vaccines) or into a benign cold virus (DNA inside an adenovirus vector with J&J) and then YOU as the host take that genetic material and code it into the spike protein to which you raise immune response (mRNA or DNA & spike protein degrade right away)
So, what did J&J press release show today? That even ONE dose conferred long-lasting protection against hospitalizations/death (81% protection against hospitalizations median 4 months in study) and that is because of yes, cellular immunity. Effectiveness
jnj.com/johnson-johnso…
Read 6 tweets
Monica Gandhi MD, MPH Profile picture
20 Sep
Interesting paper from July: "Clinical evidence that the pandemic from 1889 to 1891 commonly called the Russian flu might have been an earlier coronavirus pandemic". Genetic detective work in the study suggests that a common cold coronavirus, HCoV-OC43,
sfamjournals.onlinelibrary.wiley.com/doi/full/10.11…
which NOW only causes mild upper respiratory tract infections, may in fact have caused a major pandemic (1889-1891) about 30 years before the 1918 (H1N1) influenza pandemic. A few tentative lessons: 1) it ended on its own, without a vaccine; 2) it did not go away completely
(i.e., we have probably all had it); 3) as it became entrenched ("endemic"), became milder; it became a cold - this was a possible future for COVID-19 and now with vaccines, the virus can be defanged. Vaccines limit further mutations of COVID-19 seen here
medrxiv.org/content/10.110…
Read 5 tweets
Monica Gandhi MD, MPH Profile picture
17 Sep
BOOSTERS: Dr. Jonathan Sterne's slide from VRBPAC on how 2-dose vaccines provide persistent protection from severe disease in studies where delta variant is circulating. For me, the debate on boosters can be divided into 2 lines of research: immunologic & epidemiologic
IMMUNOLOGIC: From an immunology standpoint, no evidence that a 3rd shot needed. Antibodies waning is a normal part of the immune system; you have the blueprint (memory B cells) to make more with T cells helping. Saying "HepB, HPV are 3 shot series" belies
leaps.org/how-long-do-co…
fact that we have NEVER done this amount of research on a vaccine or the immune response before. We have robust studies showing strong memory B cells formed in response to the vaccine in lymph nodes after 2 shots.
EPIDEMIOLOGIC: However, we didn't tamp down transmission enough
Read 7 tweets
Monica Gandhi MD, MPH Profile picture
15 Sep
This is likely study (just got released) pushing booster conversation in US for >60 (of note, booster discussion most relevant to places with high circulating virus due to low vax rates, not urgent in EU now). Data from Israel -not an RCT-
nejm.org/doi/full/10.10…
but decision made in Israel to boost those >60 whose 2nd shot >5 months ago on June 30. This is data from July 30-August 31, 2021, from Israeli Ministry of Health database comparing those who had 3rd shot >=12 days before to those who had not. No matching on co-morbidities etc.
>= 12 days after booster, rate of confirmed infection lower (factor 11.3) in booster group than in nonbooster group as was rate of severe illness (factor of 19.5) . Better protection later on. Likely to push US to boost >60 while cases will circulating with our low vax rate
Read 4 tweets
Monica Gandhi MD, MPH Profile picture
15 Sep
Don't have time to analyze this now but publicly-available documents that the FDA will review for their decision on boosters on Friday are now available here if you want to take a look
fda.gov/media/152176/d…
FDA seems unconvinced so far but we need to go through it bit-by-bit and make a clean decision by Friday so will analyze the studies for you later today
endpts.com/as-booster-sho…
However, this India study showing declining antibodies after vaccination is not really showing anything but how the immune system works. Antibodies wane to avoid your blood becoming the consistency of a milkshake but memory cells make more
reuters.com/world/india/in…
Read 5 tweets
Monica Gandhi MD, MPH Profile picture
14 Sep
Discussing balance, nuance, risk factors for COVID (before vax or even after vax, including heart disease, obesity, etc.) is important. Episode with @DrTomRifai & @DrDavidKatz about balance, collateral damage of pandemic (ok to say that word) and 1918 pandemic
For instance, even fetal stress in 1918 due to health, lower attainment of adulthood income, and occupational fulfillment led to shorter lifespans. Similar to discussions of long-acting impacts of our prolonged school closures in US last year (balance)
read.dukeupress.edu/demography/art…
Cohorts born during 1918 pandemic and in its aftermath exposed to stress, which leads to inflammation which has long-term health effects (on cancer, cardiovascular disease, etc.)
ajph.aphapublications.org/doi/10.2105/AJ…
Read 6 tweets

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