Read on Twitter
We interviewed @SteveFDA and Peter Marks @US_FDA about the new vaccines
https://www.webmd.com/coronavirus-in-context/video/whyte-topol-hahn-marks w/ @drjohnwhyte @WebMD @Medscape
Key points that we covered:
1. The EUA tightening that got the trials to full efficacy completion and better read on safety
https://www.webmd.com/coronavirus-in-context/video/whyte-topol-hahn-marks w/ @drjohnwhyte @WebMD @Medscape
Key points that we covered:
1. The EUA tightening that got the trials to full efficacy completion and better read on safety
2. Operation/Project Warp Speed was invented by Peter Marks (a star trekkie) to streamline and accelerate the path to a successful vaccine
More on that here https://www.washingtonpost.com/health/coronavirus-vaccine-approval-decider/2020/08/11/7c6fb7a0-d8f1-11ea-930e-d88518c57dcc_story.html by @lauriemcginley2
More on that here https://www.washingtonpost.com/health/coronavirus-vaccine-approval-decider/2020/08/11/7c6fb7a0-d8f1-11ea-930e-d88518c57dcc_story.html by @lauriemcginley2
3. Why didn't the vaccine trials study transmission (mucosal impact/ sterilization immunity)?
The requirement of the participants for daily nasopharyngeal swabs would have been cumbersome and slowed down the trial's critical question of preventing illness
The requirement of the participants for daily nasopharyngeal swabs would have been cumbersome and slowed down the trial's critical question of preventing illness
4. Why did the UK wind up approving a vaccine first, ~10 days earlier?
"We did not see this as a competition"
The need to do it right, fully transparent, fully vetted before rolling it out to millions of Americans. It took <3 wks for each of the vaccines to go thru this process.
"We did not see this as a competition"
The need to do it right, fully transparent, fully vetted before rolling it out to millions of Americans. It took <3 wks for each of the vaccines to go thru this process.
5. What about single-dose of the vaccines since there was a sign of some efficacy after ~10 days?
"I understand the temptation.... But...We did really good science." Don't throw it out.
"One [dose] could be worse than none."
"Good to study but don't do it."
"Not responsible."
"I understand the temptation.... But...We did really good science." Don't throw it out.
"One [dose] could be worse than none."
"Good to study but don't do it."
"Not responsible."
6. What about the new variant (B.1.1.7) w/ its 23 mutations? And N501Y?
Do we need do to big clinical trials again for tweaking the mRNA vaccines (booster shots)?
"Starting to look like son of flu or father of flu" w/r to evolution
Just needs small trials for immune response
Do we need do to big clinical trials again for tweaking the mRNA vaccines (booster shots)?
"Starting to look like son of flu or father of flu" w/r to evolution
Just needs small trials for immune response
7. What is the culprit for extremely rare allergic reactions?
Could be IgE antibodies to the polyethylene glycol but don't know yet, incidence may be ~1 in 100,000.
Could be IgE antibodies to the polyethylene glycol but don't know yet, incidence may be ~1 in 100,000.
8. What about the the people in the trials who actually had prior covid-19?
—No evidence of antibody-dependent enhancement
—Wait 90 days after covid-19 infection or after receiving antibodies
—The look of superior protection by vaccine than via natural infection
—No evidence of antibody-dependent enhancement
—Wait 90 days after covid-19 infection or after receiving antibodies
—The look of superior protection by vaccine than via natural infection
9. What are the major unsettled vaccine questions or ones that keep you up at night?
—Do the vaccines stop asymptomatic transmission?
—How long does the protection last?
—How will they handle the drift/mutation changes in the virus?
—Do the vaccines stop asymptomatic transmission?
—How long does the protection last?
—How will they handle the drift/mutation changes in the virus?
