💡[Whisper]… there is actually a proven vaccine for kids age 2-4 that is *CURRENTLY UNDER REVIEW* at the @US_FDA with an EUA app submitted on November 5th—but FDA has not moved yet on approval meeting. ➡️Why is the media not talking about this? #COVAXINir.ocugen.com/news-releases/…
2) COVAXIN™ (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.
3) The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.
4) Even the recent NIH director has mentioned #COVAXIN — with randomized trial published in Lancet. But it was done in India 🇮🇳. Meanwhile, Moderna, Pfizer, J&J was done in the US (among other places).
5) COVAXIN notably is not mRNA based nor vector based with an adenovirus like J&J or AstraZeneca or Sputnik. #COVAXIN is an inactivated (dead) virus vaccine that presents the WHOLE (dead) virus to the body for it to learn how to develop immune response. It’s classic old tech.
6) overall, #Covaxin had 77.8% efficacy against symptomatic #COVID19 (usual metric reported by other vaccines) in India 🇮🇳. And much of the cases came in the middle of the #DeltaVariant deadly wave in India. Efficacy against severe was 93.4% — decent. thelancet.com/journals/lance…
7) here is the Kaplan-Meier plot for #Covaxin’s efficacy against symptomatic confirmed #COVID19 showing the 77.8% difference. And quite remarkable given the epically large #DeltaVariant crush that hit India hard in the spring during mid trial.
8) FYI - for parents with kids under 5 who can’t wait, the UAE 🇦🇪 has been vaccinating kids as young as 3 years old since August, using Sinopharm, a WHO approved classic inactivated vaccine akin to COVAXIN. reuters.com/world/middle-e…
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📍NEW RECORD holder: Denmark🇩🇰 has now surpassed UK🇬🇧 in #Omicron growth rate—🇩🇰 now doubling every **1.6 days**, while 🇬🇧 doubling every 1.7 days. Meanwhile, 🇿🇦 is doubling every 3 days—still fast. But we may have to revise how fast Omicron truly is.
2) To be clear, Denmark & UK are world leaders in genome 🧬 sequencing to confirm #Omicron. Hence their rates stand above the rest of the 🌍 in Omicron tracking. But their number numbers are indeed more accurate because of high sequencing—thus gives true Omicron speed. Forecast—
3) KEEP IN MIND— Speed of spread is >> importance than severity in a pandemic—a lower severity won’t prevent mass hospitalization deaths if the virus is more contagious / evasive against past immunity. Exponential math will catch up ultimately much faster in the end. See 🧵 below
NEW—“Omicron is producing hospitalizations & sadly at least 1 patient has now died with #Omicron. The idea that this is somehow a milder version of virus—we need to set [aside] & recognize the sheer pace at which it accelerates.” @BorisJohnson#COVID19
3) U.K. Health Secretary Sajid Javid said the number of Omicron infections “is doubling every two to three days,” and warned, “we’re in a new race, whether we like it or not, between the virus and the vaccine.”
⚠️OMICRON “EVADES” NEUTRALIZATION—1st ever #Omicron variant study of blood from Moderna, Oxford-AstraZeneca, Pfizer vaccinated, vs survivors of Alpha, Beta, Delta variants. Omicron #B11529 evasive—but 2x Pfizer/mixed stronger>> convalescent; 3x hit best.🧵 medrxiv.org/content/10.110…
2) “We found that sera from vaccinated individuals neutralized the B.1.1.529 variant to a much lesser extent than any other variant analyzed. Neutralization capacity against #Omicron was maintained best against sera of “infected + 2x vaccinated” or “2x vaccinated + infected”
3) it’s clear vaccine neutralization of #Omicron is much harder than any other variants tested - Alpha, Beta, or Delta. Though 2 doses of Pfizer or Pfizer+AstraZeneca mixed vaccination had somewhat better performance against #Omicron. But 2x AstraZeneca not good enough.
Doctors & nurses in UK 🇬🇧 are too traumatized and refusing to be redeployed to #COVID19 hospital wards with the looming #Omicron surge approaching. If & when the hospitalizations rise… I pray everyone listening is #vaccinated & #boosted, or else the 🏥 may not have enough beds.
2) it’s not a matter of “if” hospitalizations for #Omicron will rise, it’s a matter of “when” and how much…
3) don’t forget, it’s the more contagious transmission of a virus that will ultimately kill more people than the individual severity of a virus. The hospitalizations will inevitably go up, albeit slower at first if mild (not proven yet), but catch up with a vengeance later. 👇
📍NOTA BENE—a “mild but faster” virus will often kill & harm more people than a virus that is slower & more severe. Even if just 2x more transmissible & 1/10 less deadly! ➡️Folks who call #Omicron “nature’s vaccine” need to stop the public endangerment. Figure by @GosiaGasperoPhD
2) And we believe #Omicron is not just 2x more contagious but likely 3-4.5x by some estimates.
NEW—The UK is facing a substantial wave of #Omicron infections in January without further restrictions, according to scientists. The researchers said tougher restrictions may be needed to prevent Omicron overwhelming hospitals. #covid19bbc.co.uk/news/uk-596210…
2) Dr Nick Davies, one of the researchers, said Omicron was spreading "very fast" and was "quite concerning" and was likely to be the dominant form of the virus in England by the end of the year.
3) The report says the number of people infected is currently doubling every 2.4 days in England despite the country having high levels of vaccination. That is faster than the original form of the virus spread when nobody had protection.