Great article! We keep seeing these amazing descriptions of the real-world effectiveness of vaccines. This one from 62,138 individuals from Mayo Clinics (Arizona, Florida, Minnesota, Wisconsin between 12/1/20-2/8/21. Compared 31,069 with (at least 1 dose) medrxiv.org/content/10.110…
versus without vaccine propensity matched. 8,041 received two doses. Administration of two COVID-19 vaccine doses was 88.7% effective in preventing SARS-CoV-2 infection with onset at least 36 days after the first dose. Crazy. 88.7% similar to 94% in the trial.
And then here is a safety after vaccine data by same group as some offered vaccines want to wait for real-world safety data. Now remember, the adverse effects in clinical trials are "solicited" - people asked if they have injection site reactions medrxiv.org/content/10.110…
Same 31069 individuals with and without vaccine. Bottom line: incidence rates of all surveyed adverse effects were similar or lower in vaccinated individuals compared to unvaccinated individuals after either dose. Most frequently documented adverse effects
within 7 days of each vax dose were all mainly <1% and were fatigue, nausea, myalgia, diarrhea, arthralgia, erythema, vomiting & and fever. All very low rates and hugely lower than "solicited" reactions in clinical trials. Should give people confidence of safety of these vaccines
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Let's put data on why vaccines reduce transmission all in 1 place: Beyond sheer biological plausibility that vaccine-mediated immune responses block viral replication in nose, through which you are most likely to spread the virus, as effectively as blocks elsewhere, data here:
Lancet preprint showed that health-care workers in UK swabbed every two weeks after vaccination had an 86% reduction in asymptomatic infection compared with unvaccinated individuals: papers.ssrn.com/sol3/papers.cf…
Other data in Lancet - health care workers vaccinated had 85% reduction in infection (asymptomatic & symptomatic) 15-28 days after 2nd dose thelancet.com/journals/lance…
UK today records lowest case in 5 months! I am sorry, the U.S. is not vaccinating fast enough. We are in a race of cases vs vaccines. UK had its own variant (B117) with likely increase in transmissibility & they could have lost their race but they didn't independent.co.uk/news/health/co…
They didn't lose because they approved 3 vaccines- one adenovirus/DNA vaccine (AztraZeneca) + 2 mRNA vaccines (Pfizer/Moderna) & went crazy with roll-out: 1 dose to all first (2nd in 12 weeks). And remember, AztraZeneca is the one with less efficacy for mild disease with variants
but doesn't matter. Why? Because herd immunity means that you win race. You turn more sheep pink (two white not next to each other to pass) & virus slows down. We are not slowing our virus fast enough. We didn't approve a 3rd vaccine until today (J&J authorized today by the way)
Here is full Johnson & Johnson dataset provided to FDA. Remember, this is one-dose vaccine and is an adenovirus vector with DNA inside your body will use to code for the full spike protein + receptor binding domain. We had press release data now have more fda.gov/media/146217/d…
ENSEMBLE- Phase 3 randomized, double-blind, placebo-controlled trial of a single
dose (5x10^10 vp) of Ad26.COV2.S in ~40K participants
for pro-protocol analysis. Results 14 & 28 days after the one-dose (28 days likely best indicator given immunogenicity data that shows Ab titers
keep on going up in phase I/II data). Let’s start with worse outcomes & move backwards. . Deaths: 7 COVID-19 related deaths in placebo group and none in vaccine group so 100% protection against death. 29 hospitalizations in placebo group from COVID-19 and 2 in vaccine group so
Some of this discussion after this article came out yesterday which shows that asymptomatic infection (transmission thereby) will reduce after vaccination reminded me how wed some are to continuing a narrative of fear. Remember how we used to say that "the clinical trials
designed to tell you if asymptomatic infection was reduced because post-vaccination regular asymptomatic screening was not done?" Well, here you have this done among HCWs after vaccination - swabbing just to make sure there is no virus in the nose & 86% of the time (these
are EXPOSED health care workers, they are around others), there was NO virus in that nose. Okay, what about the remaining 14%? Take these two papers please- tweeted details before so please read those. medrxiv.org/content/10.110… medrxiv.org/content/10.110…
UK (rolling out better than any other large country) on efficacy of Pfizer& AZ vaccines on reducing hospitalizations and transmission in real-world. By 4th week, Pfizer & AZ 1st dose reduce risk of hospitalization from Covid-19 by 85% & 94%, respectively ed.ac.uk/news/2021/scot…
okay that's 1 dose. 1 dose. If you blocked death by 94%, we would have 30,000 deaths from COVID-19 this year in the US instead of 500,000. Spectacular efficacy. So, like UK let's do 4 things: 1) 1 dose to all first; 2) 12 weeks between; 3) Approve more vaccines; 4) mix if have to
Also, we have never had time in history while we are rolling out vaccine in the throes of a pandemic. Means that we must do everything in our power to save lives in US - improve vaccine roll-out by these same procedures as UK ed.ac.uk/usher/eave-ii/…
Helpful to understand more about the Sinopharm vaccine & UAE roll-out. 4 vaccines approved in the UAE: Sinopharm, Pfizer-BioNTech, Sputnik V and Oxford-AstraZeneca. As of Feb 20, 2021, UAE has already vaccinated 56% of its population, 2nd highest in world gulfnews.com/special-report…
Sinopharm is an inactivated virus vaccine developed in China (but phase 3 trial elsewhere as cases too low in China). We like to look at the phase I/II trial data first which was published in Lancet. Two-dose with 4 μg vaccine 3-4 weeks apart thelancet.com/journals/lanin…
We are now used to seeing T-cell responses being measured in the safety/immunogenicity phase but not measured in Lancet paper; neutralizing Ab titers went up with time out to measured 42 days. Pain/fever most common AEs. Next -phase 2 results in JAMA jamanetwork.com/journals/jama/…