Getting❓about how #COVID #vaccines were tested & granted EUAs so quickly? I sure am, esp from folks "on the fence" or taking the "wait & see" approach.
👇Here's an infographic you can use to explain the #clinicaltrials process.
#epitwitter #MedTwitter #vaccinehesitancy
👇Here's an infographic you can use to explain the #clinicaltrials process.
#epitwitter #MedTwitter #vaccinehesitancy
2/Pre-clinical research:
Decades of groundwork prepared the scientific community for this moment:
🦠6 other human coronaviruses
💉mRNA & viral vector vaccine technologies
Decades of groundwork prepared the scientific community for this moment:
🦠6 other human coronaviruses
💉mRNA & viral vector vaccine technologies
3/Clinical trials:
No #clinicaltrials phases were skipped. The scientific community was 'all hands on deck' w/many layers of red tape removed.
🐌In 'normal' times @NIH may require 1yr PLANNING grant b4 eligible to submit Phase 3 trial grant (>2yrs b4 full grant MIGHT get funded)
No #clinicaltrials phases were skipped. The scientific community was 'all hands on deck' w/many layers of red tape removed.
🐌In 'normal' times @NIH may require 1yr PLANNING grant b4 eligible to submit Phase 3 trial grant (>2yrs b4 full grant MIGHT get funded)
4/🌎Pandemic nature of #SARSCoV2 = relatively easy to enroll tens of thousands of participants & accrue enough #COVID cases in trials to detect vaccine effects (adequate statistical power). It might take several yrs for less common diseases.
📣#ShoutOut to ALL trial volunteers❤️
📣#ShoutOut to ALL trial volunteers❤️
5/@US_FDA & @CDCgov completed thorough reviews of safety & efficacy data.
For #COVID #vaccine trials, 60+ days of follow-up after last dose was required for at least 1/2 of participants (to monitor for non-acute effects; 30-45d likely sufficient to detect long-term vax effects).
For #COVID #vaccine trials, 60+ days of follow-up after last dose was required for at least 1/2 of participants (to monitor for non-acute effects; 30-45d likely sufficient to detect long-term vax effects).
6/Phase 4: monitoring of "real world" safety & effectiveness data continues after EUA, including via VAERS & V-safe systems in 🇺🇸
cdc.gov/coronavirus/20…
cdc.gov/coronavirus/20…
7/The @JNJNews💉pause this week is example of Phase 4 monitoring of real world data in action.
⭐️Our systems are working when rare (even 1 in a million) safety signals are detected & investigated⭐️
See @JesseOSheaMD🧵for context about CVST risk:
⭐️Our systems are working when rare (even 1 in a million) safety signals are detected & investigated⭐️
See @JesseOSheaMD🧵for context about CVST risk:
https://twitter.com/JesseOSheaMD/status/1382015600831172611
8/Nearly 80 million persons in 🇺🇸 have been fully vaccinated for #COVID19. Nearly 200 million doses have been administered. The full clinical trials process was implemented & rigorous safety monitoring continues.
💉#ThisIsOurShot
covid.cdc.gov/covid-data-tra…
💉#ThisIsOurShot
covid.cdc.gov/covid-data-tra…
9/9 It was wonderful to work with local graphics designer LisAurel Winfree on the clinical trials infographic❗️
lisaurel.com
#Michigan #shopsmallbiz
lisaurel.com
#Michigan #shopsmallbiz
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