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…
against any infection 79% even with circulation of delta in the US. Booster at 2 months (56 days) - did not report what % increased protection against any infection (symptomatic or asymptomatic); said 100% protection against hospitalization but that is only data at 14 days after
2nd dose. 94% protection against symptomatic infection in US (75% elsewhere). Bottom line? Think vaccine principles. We have circulating virus in US > other places due to low vax, so 2nd dose for J&J seems prudent. Only yellow fever vax is a 1 dose for life & even there we say
get another shot if travel to high incidence region with high risk exposure so between data from CDC MMWR last Fri of J&J lower protection against hospitalization in current time, would give 2nd shot of J&J. Still think cellular memory from J&J 1-shot good
When public health officials do not provide "off ramps", clear metrics of taking off and on restrictions, a city will be parodied. Europe did this cleanly (Denmark when 74% vax'd- no restrictions). CDC trying to do here: cdc.gov/mmwr/volumes/7… sfgate.com/sf-culture/art…
France looked at COVID transmission rates in a region to decide when to remove masks for children. These are clean metrics, earns trust of the people, we are not doing this in US even as we admit the virus will be endemic thelocal.fr/20210922/franc…
Decide on metrics to remove restrictions, relay cleanly, have public health officials say same thing or US will have deepening distrust. Denmark & so many places had high acceptance of vax because trusted public health. Ideas of school metrics here: nytimes.com/2021/06/08/opi…
ENDEMICITY. "Perspective | We won’t eradicate covid. The pandemic will still end"- my piece in @washingtonpost that explains what endemicity will look like with COVID. The virus has features that make it unlikely to be eradicated but we can achieve control washingtonpost.com/outlook/2021/0…
Here, I explain the definitions of containment in the field of infectious diseases (control, eradication, elimination, extinction); definition of endemicity (doesn't cause undue burden of disease); emerging normalcy in countries with high vax rates (fervently hope for US too)
Didn't realize it was paywalled- here is the article to explain principles of ID
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
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…
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
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