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The impact of the first companies getting #FDA emergency use authorization & unblinding studies expected to be among the topics debated over at today's #FDA #VRBPAC
My Oct 20 story: https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/us-fda-wants-expert-input-on-covid-19-vaccines-but-keeps-mum-on-range-of-advice-60823662
Questions posted Oct. 21: https://www.fda.gov/media/143153/download #COVID19 #vaccines https://twitter.com/DonnaYoungDC/status/1319245207792160768
My Oct 20 story: https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/us-fda-wants-expert-input-on-covid-19-vaccines-but-keeps-mum-on-range-of-advice-60823662
Questions posted Oct. 21: https://www.fda.gov/media/143153/download #COVID19 #vaccines https://twitter.com/DonnaYoungDC/status/1319245207792160768
#FDA #VRBPAC page here: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement
Video access here:
#COVID19 #vaccines #pharma #biotech
Video access here:
#COVID19 #vaccines #pharma #biotech
. @cspan also carrying #FDA's #VRBPAC today on #COVID19 #vaccines https://www.c-span.org/video/?476804-1/fda-advisory-committee-holds-covid-19-meeting
Here's the @YouTube link again:
#pharma #biotech
Here's the @YouTube link again:
#pharma #biotech
Live now:
#FDA #VRBPAC acting chair @UMich Arnold Monto starts out noting he just rotated off the committee last January.
And he's back for #COVID19 #vaccines
Or
https://www.c-span.org/video/?476804-1/fda-advisory-committee-holds-covid-19-meeting&live
#FDA #VRBPAC acting chair @UMich Arnold Monto starts out noting he just rotated off the committee last January.
And he's back for #COVID19 #vaccines
Or
https://www.c-span.org/video/?476804-1/fda-advisory-committee-holds-covid-19-meeting&live
Ha, already some glitches at #VRBPAC today.
#FDA #VRBPAC acting chair @UMich Arnold Monto notes he's been working for abut 30 years on & off on coronaviruses & was in Beijing during the #SARS outbreak.
#COVID19 #vaccines
#COVID19 #vaccines
#FDA Marion Gruber notes NO specific #pharma #biotech applications discussed today.
"Facilitating the development of safe & effective #COVID19 #vaccines is highest priority"
#VRBPAC
"Facilitating the development of safe & effective #COVID19 #vaccines is highest priority"
#VRBPAC
Agenda here: https://www.fda.gov/media/143127/download
Discussion questions here:
https://www.fda.gov/media/143153/download
#FDA Marion Gruber notes the #VRBPAC committee is not asked to vote on any of the questions about #COVID19 #vaccines.
Discussion questions here:
https://www.fda.gov/media/143153/download
#FDA Marion Gruber notes the #VRBPAC committee is not asked to vote on any of the questions about #COVID19 #vaccines.
This is likely the largest audience any #FDA adcomm has ever had with @cspan & @YouTube both broadcasting #VRBPAC today.
#COVID19 #vaccines
#COVID19 #vaccines
#CDC's Cliff McDonald displays photo of #SARSCoV2, calling it the "Star of the show" today.
#COVID19 #vaccines #VRBPAC #FDA
#COVID19 #vaccines #VRBPAC #FDA
#CDC's Cliff McDonald: 2% increase in #COVID19 deaths in past 7 days & 50,000 to 60,000 new infections per day.
Plenty of work ahead & cannot let our guard down.
#vaccines #VRBPAC #FDA
Plenty of work ahead & cannot let our guard down.
#vaccines #VRBPAC #FDA
And @cspan seems to be back up again for #VRBPAC: https://www.c-span.org/video/?476804-1/fda-advisory-committee-holds-covid-19-meeting
Again, @YouTube is here:
#COVID19 #FDA #vaccines
Again, @YouTube is here:
#COVID19 #FDA #vaccines
#CDC's Cliff McDonald: There have been a handful of well-documented reinfections #COVID19.
Frequency still uncertain, however, appear quite infrequently.
Reinfection should not be surprising.
Have appeared after 3 months/90 days.
#vaccines #VRBPAC #FDA
Frequency still uncertain, however, appear quite infrequently.
Reinfection should not be surprising.
Have appeared after 3 months/90 days.
#vaccines #VRBPAC #FDA
#CDC's Cliff McDonald notes #COVID19 goes up with age.
Case fatality rate of COVID-19 is 10 to 13 times of that of #influenza.
#vaccines #VRBPAC #FDA
Case fatality rate of COVID-19 is 10 to 13 times of that of #influenza.
#vaccines #VRBPAC #FDA
And @sciencecohen's article "Chinese researchers reveal draft genome of virus implicated in Wuhan pneumonia outbreak" gets highlighted at #VRBPAC https://www.sciencemag.org/news/2020/01/chinese-researchers-reveal-draft-genome-virus-implicated-wuhan-pneumonia-outbreak #FDA #COVID19 #vaccines
#NIAID Hilary Marston notes $MRNA / NIH #COVID19 vaccine was enabled by long-term investment taxpayer investment in basic research.
[ @BarackOBama admin had long invested in mRNA R&D. This all started long before Trump, who was unaware start of MRNA/NIH vax]
#VRBPAC #FDA
[ @BarackOBama admin had long invested in mRNA R&D. This all started long before Trump, who was unaware start of MRNA/NIH vax]
#VRBPAC #FDA
Some background on #NIH #COVID19 Network https://www.nih.gov/news-events/news-releases/nih-launches-clinical-trials-network-test-covid-19-vaccines-other-prevention-tools
and COVID-19 Prevention Network
https://www.coronaviruspreventionnetwork.org/
#VRBPAC #FDA #vaccines
and COVID-19 Prevention Network
https://www.coronaviruspreventionnetwork.org/
#VRBPAC #FDA #vaccines
#NIAID Hilary Marston: We are finding these adverse events because we are specifically looking for them & finding them according to tried & true processes. There are multiple layers of safety oversight.
$AZN $JNJ holds signs system is working.
#COVID19 #vaccines #VRBPAC #FDA
$AZN $JNJ holds signs system is working.
#COVID19 #vaccines #VRBPAC #FDA
#NIAID Hilary Marston says diversity in #COVID19 #vaccines trials been a priority at highest #NIH level & have been working on community engagement.
Know it's going to be essential for future acceptability of vaccines
#VRBPAC #FDA
Know it's going to be essential for future acceptability of vaccines
#VRBPAC #FDA
#FDA #VRBPAC acting chair @UMich Arnold Monto asks why #NIH is using 60% efficacy standard when #FDA uses 50% in #vaccines guidance?
#NIAID Hilary Marston: We set a slightly higher bar than #FDA guidance. Want to make sure it has greatest impact as possible on #COVID19 outbreak.
#NIAID Hilary Marston: We set a slightly higher bar than #FDA guidance. Want to make sure it has greatest impact as possible on #COVID19 outbreak.
#BARDA Robert Johnson on #COVID19 #vaccines manufacturing:
A vaccine is only as good as being able to produce it in numbers where it will have an impact.
#VRBPAC #FDA
A vaccine is only as good as being able to produce it in numbers where it will have an impact.
#VRBPAC #FDA
#BARDA Robert Johnson notes work on for SARS in 2002 [Bush admin] & MERS in 2012 [Obama admin] played critical role in moving forward for work done now for #COVID19 #vaccines.
Also the work on #Zika in mRNA [ again, @BarackObama administration]
#VRBPAC #FDA
Also the work on #Zika in mRNA [ again, @BarackObama administration]
#VRBPAC #FDA
#VRBPAC Michael Kurilla: #WarpSpeed 2-dose vaccines versus 1 dose?
#BARDA Robert Johnson: #OWS portfolio is not set. Always looking for candidates.
[ $JNJ is single dose]
#FDA #COVID19 #vaccines
#BARDA Robert Johnson: #OWS portfolio is not set. Always looking for candidates.
[ $JNJ is single dose]
#FDA #COVID19 #vaccines
#VRBPAC #NIAID Luigi Notarangelo: Manufacturing facilities & inspections?
#BARDA Robert Johnson: Mitigation always key for us. Trying to do everything to ensure multiple facilities.
Quality always paramount.
#COVID19 #vaccines #FDA
#BARDA Robert Johnson: Mitigation always key for us. Trying to do everything to ensure multiple facilities.
Quality always paramount.
#COVID19 #vaccines #FDA
#VRBPAC #NIAID Luigi Notarangelo: Number of #vaccines manufacturing facilities & inspection in #FDA EUA guidelines?
#BARDA Robert Johnson: Mitigation always key for us. Trying to do everything to ensure multiple facilities.
Quality always paramount.
#COVID19
#BARDA Robert Johnson: Mitigation always key for us. Trying to do everything to ensure multiple facilities.
Quality always paramount.
#COVID19
#VRBPAC Archana Chatterjee: Populations diversity & children?
#BARDA Robert Johnson: Diversity of enrollment is a key criteria for us.
$PFE is only #pharma testing in children as young as 12 years.
Lots of discussion ongoing younger population w/ #FDA.
#COVID19 #vaccines
#BARDA Robert Johnson: Diversity of enrollment is a key criteria for us.
$PFE is only #pharma testing in children as young as 12 years.
Lots of discussion ongoing younger population w/ #FDA.
#COVID19 #vaccines
#VRBPAC back with #FDA CBER Director Peter Marks, who simply does a lot of thank yous to everyone.
#COVID19 #vaccines
#COVID19 #vaccines
#CDC's Stephanie Schrag: An EUA may limit efficacy information available.
Many secondary endpoints requires longer time than primary to accrue events.
#COVID19 #vaccines #VRBPAC #FDA
Many secondary endpoints requires longer time than primary to accrue events.
#COVID19 #vaccines #VRBPAC #FDA
#CDC's Schrag: Need for post-authorization or licensure vaccine efficacy estimates: More important than usual if EUA issued before trial completed.
Limited efficacy info for 2nd endpoint
Limited insight into duration of protection
#VRBPAC #FDA #COVID19 #vaccines
Limited efficacy info for 2nd endpoint
Limited insight into duration of protection
#VRBPAC #FDA #COVID19 #vaccines
#CDC's Schrag: Also needed for usual reasons: real-world protection may differ from efficacy under trial conditions
Most #COVID19 #vaccines require 2-dose & varying cold-chain conditions: challenging to implement.
#VRBPAC $PFE #FDA
Most #COVID19 #vaccines require 2-dose & varying cold-chain conditions: challenging to implement.
#VRBPAC $PFE #FDA
#FDA's Steven Anderson: Many times EHRs provide richer source of data than claims data.
#COVID19 #vaccines #VRBPAC
#COVID19 #vaccines #VRBPAC
#FDA's Steven Anderson: Not all claims & EHR systems can be used.
To address vaccine safety/effectiveness regulatory question
Each data system has its limitation.
#COVID19 #vaccines #VRBPAC
To address vaccine safety/effectiveness regulatory question
Each data system has its limitation.
#COVID19 #vaccines #VRBPAC
#FDA's Steven Anderson: FDA plans to monitor 10 to 20 safety outcomes of interest to be determined for #COVID19 #vaccines
FDA will coordinate with other federal partners, like #CDC.
#VRBPAC
FDA will coordinate with other federal partners, like #CDC.
#VRBPAC
#FDA's Anderson reiterates "there may be limited information on effectiveness" at time of #COVID19 #vaccines licensure/EUA.
So manufacturers may conduct certain effectiveness post -licensure studies.
FDA may conduct its own studies/will coordinate w/ #CDC
#VRBPAC
So manufacturers may conduct certain effectiveness post -licensure studies.
FDA may conduct its own studies/will coordinate w/ #CDC
#VRBPAC
#VRBPAC Hayley Altman-Gans asks about keeping data mining agnostic & are systems used in children's hospitals?
#FDA's Steven Anderson: Goal is to use as many data systems.
Right now in consolidation phase.
Engaged pediatrics network.
#COVID19 #vaccines
#FDA's Steven Anderson: Goal is to use as many data systems.
Right now in consolidation phase.
Engaged pediatrics network.
#COVID19 #vaccines
#FDA's Steven Anderson: We have preferred access to CMS data/live insurance data stream.
Lag is a challenge. EHR quicker.
#COVID19 #vaccines #VRBPAC
Lag is a challenge. EHR quicker.
#COVID19 #vaccines #VRBPAC
#CDC's Janell Routh: Roll out of #COVID19 #vaccines undoubtedly a phased approach.
First weeks of limited doses: Intent to get vaccine out to groups for early access, like health care providers.
Will eventually reach a point where supply outweighs demand.
#VRBPAC #FDA
First weeks of limited doses: Intent to get vaccine out to groups for early access, like health care providers.
Will eventually reach a point where supply outweighs demand.
#VRBPAC #FDA
#CDC Routh: Not recommending at this time for hospitals purchase their own ultra-cold equipment. If ultra-cold product is granted authorization to administer, it will come in its own shipping container able to maintain that cold chain for a period of time.
#VRBPAC #FDA $PFE
#VRBPAC #FDA $PFE
More details on the #OWS "Tiberius" system #CDC's Routh just talked about here from @WSJ https://www.wsj.com/articles/palantir-to-help-u-s-track-covid-19-vaccines-11603367276 #VRBPAC #WarpSpeed #COVID19 #vaccines
#CDC's Janell Routh notes there will be systems to track/ensure people get second dose. There will be a vaccine card about information on #COVID19 #vaccines to ensure they get the appropriate second dose.
#VRBPAC #FDA
#VRBPAC #FDA
#VRBPAC Chatterjee asks about mandating #COVID19 #vaccines for health care professionals/emergency personnel? #PPE measures?
#CDC's Janell Routh: Not discussed mandating. It's hard. Hospitals hard time even #flu shots. Instead should build trust/confidence.
Encourage PPE for now.
#CDC's Janell Routh: Not discussed mandating. It's hard. Hospitals hard time even #flu shots. Instead should build trust/confidence.
Encourage PPE for now.
#VRBPAC Jeannette Lee: Reminders for second dose?
#CDC's Janell Routh: Will have electronic & texting reminder systems.
#COVID19 #vaccines #FDA
#CDC's Janell Routh: Will have electronic & texting reminder systems.
#COVID19 #vaccines #FDA
#VRBPAC Michael Kurilla: How will messaging go so people aren't waiting for the perfect vaccine?
#CDC's Janell Routh: I think we are really going to lean forward into the promotion of the vaccines available & get them out as quickly as possible.
#COVID19 #vaccines #FDA
#CDC's Janell Routh: I think we are really going to lean forward into the promotion of the vaccines available & get them out as quickly as possible.
#COVID19 #vaccines #FDA
#VRBPAC Consumer Rep Toubman: Prioritization of people living/working in congregate settings for #COVID19 #vaccines?
#CDC's Janell Routh: @theNASEM made recommendations & CDC #ACIP will be doing its deliberations.
#FDA
#CDC's Janell Routh: @theNASEM made recommendations & CDC #ACIP will be doing its deliberations.
#FDA
#CDC's Amanda Cohn clarifies: Federal government cannot mandate vaccines & will not for #COVID19 #vaccines
Hospitals other organizations have capability to asking workers to get vaccinated.
But in setting of EUA, people will have right to refuse
#VRBPAC #FDA
Hospitals other organizations have capability to asking workers to get vaccinated.
But in setting of EUA, people will have right to refuse
#VRBPAC #FDA
. @reaganudall . @SusanWinckler: 8 listening sessions have been powerful, illuminating & sobering.
#COVID19 #vaccines #VRBPAC #FDA
#COVID19 #vaccines #VRBPAC #FDA
. @reaganudall Chris Wilks reads listening session quotes:
The speed is appreciated but are questions.
I would not be first in line & would want to see data.
For them to try to do it in a year is pretty absurd.
Who can we trust? That's the million-dollar question.
#VRBPAC
The speed is appreciated but are questions.
I would not be first in line & would want to see data.
For them to try to do it in a year is pretty absurd.
Who can we trust? That's the million-dollar question.
#VRBPAC
Another listening session quote from . @reaganudall Chris Wilks: A lot of people don't trust the people who are making the vaccine, because they're politically motivated and we are all a bunch of guinea pigs.
#VRBPAC #COVID19 #vaccines #FDA #WarpSpeed
#VRBPAC #COVID19 #vaccines #FDA #WarpSpeed
After . @reaganudall Chris Wilks read this quote "The more they study me, the more they know how to get rid of me," there was an audible whistle, that went from high pitch to low. 
#VRBPAC #FDA #COVID19 #vaccines
#VRBPAC #FDA #COVID19 #vaccines
#FDA Doran Fink: Widespread deployment of a weakly effective COVID-19 vaccine could result in more harm than good by providing a false sense of security that interferes with measures to reduce #SARSCoV2 transmission.
#VRBPAC #COVID19 #vaccines
#VRBPAC #COVID19 #vaccines
#FDA Doran Fink: Without sufficiently stringent effectiveness criteria, the risk of deploying a weakly #COVID19 vaccine increases as the number of vaccines being evaluated in phase 3 trials increases.
#VRBPAC #vaccines
#VRBPAC #vaccines
Here's the June 30 #FDA #COVID19 #vaccines guidelines:
https://www.fda.gov/media/139638/download
Oct. 6 EUA guidelines:
https://www.fda.gov/media/142749/download
#VRBPAC #pharma #biotech
https://www.fda.gov/media/139638/download
Oct. 6 EUA guidelines:
https://www.fda.gov/media/142749/download
#VRBPAC #pharma #biotech
#FDA's Fink: CBER doesn't consider issuance of EUA for a #COVID19 vaccine in & of itself grounds to unblind ongoing clinical trials & offer vaccine to placebo recipients.
#VRBPAC #vaccines $PFE $JNJ
#VRBPAC #vaccines $PFE $JNJ
#FDA's Fink: "Once a decision is made to unblind an ongoing placebo-controlled trial, that that decision cannot be walked back and that controlled follow-up is lost forever."
#VRBPAC #COVID19 #vaccines $PFE $JNJ
#VRBPAC #COVID19 #vaccines $PFE $JNJ
#VRBPAC Luigi Notarangelo: Strategies to keep people enrolled & not withdraw after another company gets EUA?
#FDA Fink: We do share concern about dropouts. Don't have specific remedies to offer. Asked #pharma & gov agencies to think carefully about how they would ensure retention
#FDA Fink: We do share concern about dropouts. Don't have specific remedies to offer. Asked #pharma & gov agencies to think carefully about how they would ensure retention
#VRBPAC . @DrPaulOffit: We have a language problem. For EUA, people hear a permitted product, which is a very low bar. Still 30k to 60k in studies.
Need to make that clear.
#FDA Fink: Some differences subtle but some not.
Evaluation criteria stringent but access sooner.
Need to make that clear.
#FDA Fink: Some differences subtle but some not.
Evaluation criteria stringent but access sooner.
#VRBPAC Cody Meissner: Need a solid database about vaccine in older adults before start studying in children.
#FDA Fink: We do take pediatric concerns very seriously. What sort of safety data do you think necessary for younger age groups.
#COVID19 #vaccines
#FDA Fink: We do take pediatric concerns very seriously. What sort of safety data do you think necessary for younger age groups.
#COVID19 #vaccines
HEY, #FDA, why is your public comments website down just as #VRBPAC about to hear from the PUBLIC?
What's up?
https://beta.regulations.gov/document/FDA-2020-N-1898-0001/comment
#COVID19 #vaccines
What's up?
https://beta.regulations.gov/document/FDA-2020-N-1898-0001/comment
#COVID19 #vaccines
Seems odd timing for #FDA to have problems with its public comment docket at this very moment #VRBPAC about to hear from the public on #COVID19 #vaccines.
So, all that transparency FDA keeps promising.
So, all that transparency FDA keeps promising.
I'm going through my chocolate much too fast today.
Speaker 1: $PFE Kathrin Jansen: Hope mRNA vaccines become one of the tools to fight #COVID19.
[Pfizer said if its vaccine gains EUA, it would propose amending its ongoing study to allow cross-over of eligible placebo pts to active vaccine arm if they wish to do so]
#VRBPAC
[Pfizer said if its vaccine gains EUA, it would propose amending its ongoing study to allow cross-over of eligible placebo pts to active vaccine arm if they wish to do so]
#VRBPAC
Speaker 2: $MRNA Jacqueline Miller notes her company was first to post its full phase three study protocol.
She says Moderna study represents U.S. demography.
#VRBPAC #COVID19 #vaccines
She says Moderna study represents U.S. demography.
#VRBPAC #COVID19 #vaccines
Speaker 3: Oncord David Essayan raises concerns bout mutation rate of #COVID19 & risk of "escape mutants that may render spike protein-specific vaccines ineffective."
#VRBPAC #vaccines
#VRBPAC #vaccines
Speaker 4: UCLA's Annabelle De St. Maurice urges disproportionately affected populations/chronic conditions should be prioritized in clinical trials. This will help ensure public trust/confidence. We need to get this right to maintain vaccine confidence.
#VRBPAC #FDA #COVID19
#VRBPAC #FDA #COVID19
Speaker 5: Univ. Maryland Peter Doshi: We need trials to find out which vaccines can save lives
FDA's severe COVID-19 endpoint needs revising.
#VRBPAC #FDA #COVID19
FDA's severe COVID-19 endpoint needs revising.
#VRBPAC #FDA #COVID19
Speaker 6: Stanford Robert Kaplan: Stanford/YouGov survey: Only 35% very likely & 29% somewhat likely to take #COVID19 vaccine. 20% very unlikely under any circumstances. 36% endorse "it is definitely or probably true vaccine harmful effects are not being disclosed."
#VRBPAC
#VRBPAC
Speaker 7: Kermit Kubitz: I need to know if a vaccine is 65% effective, is it working for me?
#VRBPAC #COVID19 #vaccines
#VRBPAC #COVID19 #vaccines
Speaker 8: HIVMA/Univ. of Utah: Andrew Pavia: We strongly recommend that a vote of support by #FDA's #VRBPAC be required before FDA consider an authorization or a formal approval to #COVID19 vaccine.
#vaccines
#vaccines
And the public docket for this #FDA #VRBPAC meeting still down https://beta.regulations.gov/document/FDA-2020-N-1898-0001/comment
#COVID19 #vaccines
#COVID19 #vaccines
Speaker 9: ECRI Marcus Schabacker wants 6 months of follow up before EUA granted.
6 months necessary to understand the risks of inadequate exposure & waning immunity.
#VRBPAC #COVID19 #vaccines
6 months necessary to understand the risks of inadequate exposure & waning immunity.
#VRBPAC #COVID19 #vaccines
Speaker 10: @Public_Citizen Sidney Wolfe says #FDA standards for EUA for #COVID19 #vaccines are "grossly inadequate."
[It wouldn't be an adcomm without Sidney Wolfe]
#VRBPAC
[It wouldn't be an adcomm without Sidney Wolfe]
#VRBPAC
Speaker 11: NCHR Diana Zuckerman: Vaccine trials have serious design flaws.
Vaccines OK'd won't achieve public/policymakers expect. Will only be proven to reduce risk of mild #COVID19 but not proven reduce hospitalization/death.
Once vax on market, placebo will switch
#VRBPAC
Vaccines OK'd won't achieve public/policymakers expect. Will only be proven to reduce risk of mild #COVID19 but not proven reduce hospitalization/death.
Once vax on market, placebo will switch
#VRBPAC
Speaker 12: @IDSAinfo U of Wash Jeff Duchin: Vote of support by #VRBPAC be required before EUA or licensure.
Transparency critical. Urge FDA to share trial data w/ ACIP as soon as available. ACIP is the trusted authority to provide guidance vaccines. Facilities must be inspected.
Transparency critical. Urge FDA to share trial data w/ ACIP as soon as available. ACIP is the trusted authority to provide guidance vaccines. Facilities must be inspected.
Speaker 13: @HealthyWomen Elizabeth Battaglino: Vaccines save millions of lives every year but only if access & willing to get vaccinated.
People worried #COVID19 #vaccines approval being driven by politics not science.
Must address misinformation/mistrust/politicization
#VRBPAC
People worried #COVID19 #vaccines approval being driven by politics not science.
Must address misinformation/mistrust/politicization
#VRBPAC
Unfortunately, Speaker 14 @ArthurCaplan wasn't able to stay on line for #FDA #VRBPAC comments.
Speaker 15: NWHN Sarah Christopherson: Trump promoted unproven "miracle" cures. FDA has made serious missteps this year.
Much damage already been done to public trust.
#COVID19
Speaker 15: NWHN Sarah Christopherson: Trump promoted unproven "miracle" cures. FDA has made serious missteps this year.
Much damage already been done to public trust.
#COVID19
Speaker 16: AIDS Action Baltimore Lynda Dee urges more stringent EUA guidelines b/c if not, could do more harm than good.
Must ensure diversity in trials. Adequate funds for advisory boards w/ #COVID19 survivors.
Tuskegee is foremost in minds of African-Americans.
#VRBPAC
Must ensure diversity in trials. Adequate funds for advisory boards w/ #COVID19 survivors.
Tuskegee is foremost in minds of African-Americans.
#VRBPAC
Speaker 17: AIM Claire Hannan: People will only show up if we establish trust in confidence in vaccine.
Trust must be established early.
#FDA guidance helpful. Reassuring #VRBPAC will meet. But transparency critically important.
Praises FDA for making today meeting accessible.
Trust must be established early.
#FDA guidance helpful. Reassuring #VRBPAC will meet. But transparency critically important.
Praises FDA for making today meeting accessible.
Speaker 18: Treatment Action Group Elizabeth Lovinger: Unprecedented missteps for #hydroxycholoriquine & #convalescentplasma.
Must remove staff who have been involved in perpetrating political interference [So that #FDA staffer who helped Trump promote unapproved drug?]
#VRBPAC
Must remove staff who have been involved in perpetrating political interference [So that #FDA staffer who helped Trump promote unapproved drug?]
#VRBPAC
Speaker 19: @CSPI Peter Lurie: #COVID19 #vaccines has been inappropriately politicized with an eye on the election calendar. Now is the time for a reset. #VRBPAC has an opportunity to set a new tone. Ensure transparency
Must ensure FDA honors its commitment.
Must ensure FDA honors its commitment.
Speaker 20: @UMich Emily Martin: EUA should only be applied in limited situations.
Standards must be high & only allowed for those with high levels of exposure, like health care workers/first responders.
#VRBPAC #FDA #COVID19 #vaccines
Standards must be high & only allowed for those with high levels of exposure, like health care workers/first responders.
#VRBPAC #FDA #COVID19 #vaccines
Speaker 21: @Aging_Research Susan Peschin: Hard to comprehend mass deaths 65 years & older.
#Flu vaccines specifically designed for older adults. Unfortunately, ACIP avoided recommending.
Critical to understand geriatric immune for #COVID19 #vaccines & safety/efficacy
#VRBPAC
#Flu vaccines specifically designed for older adults. Unfortunately, ACIP avoided recommending.
Critical to understand geriatric immune for #COVID19 #vaccines & safety/efficacy
#VRBPAC
Speaker 22: MedShadow Foundation Suzanne Robotti: A faulty #COVID19 vaccine more dangerous to population health than COVID-19 itself.
One chance to introduce a COVID-19 vaccine.
If that goes badly, going to be a long time before get another.
#VRBPAC #FDA #vaccines
One chance to introduce a COVID-19 vaccine.
If that goes badly, going to be a long time before get another.
#VRBPAC #FDA #vaccines
Speaker 23 Dorit Rubinstein Reiss absent.
Speaker 24: NCL Nissa Shaffi: We depend on vaccines as life-saving medical interventions.
#VRBPAC #COVID19
Speaker 24: NCL Nissa Shaffi: We depend on vaccines as life-saving medical interventions.
#VRBPAC #COVID19
Speaker 25: AVAC/CAAB Mitchell Warren: Support #FDA guidances but should be viewed as absolute minimum requirements.
What happens coming days/weeks/months will enable/inhibit ability to translate trial results into public impact/instill confidence in vaccines/reg process
#VRBPAC
What happens coming days/weeks/months will enable/inhibit ability to translate trial results into public impact/instill confidence in vaccines/reg process
#VRBPAC
Speaker 26: Woody Matters Kim Witczak: Perception is #vaccines will help get our lives back to normal.
Reality is trials were not designed to test if reduces the risk of severe #COVID19 or hospitalization/ICU.
Transparency crucial.
Public ultimately pay the price.
#VRBPAC #FDA
Reality is trials were not designed to test if reduces the risk of severe #COVID19 or hospitalization/ICU.
Transparency crucial.
Public ultimately pay the price.
#VRBPAC #FDA
That's that for #FDA #VRBPAC open public hearing.
Now on with the rest of the show ... discussion of #COVID19 #vaccines in general. A two hour discussion of FDA questions. https://www.fda.gov/media/143153/download
Now on with the rest of the show ... discussion of #COVID19 #vaccines in general. A two hour discussion of FDA questions. https://www.fda.gov/media/143153/download
#FDA Marion Gruber: Did we strike the right balance on guidance documents?
Are there areas in data needs that you think are too strict or not strict enough?
Broad disagreement/agreement in guidance documents?
#VRBPAC #COVID19 #vaccines
Are there areas in data needs that you think are too strict or not strict enough?
Broad disagreement/agreement in guidance documents?
#VRBPAC #COVID19 #vaccines
#FDA Marion Gruber puts expanded access on the table after asking are there other considerations?
Complexities for national EA program.
We're concerned about risk EUA would interfere w/ long-term safety/efficacy in ongoing trials & even jeopardize approvals.
#VRBPAC #COVID19
Complexities for national EA program.
We're concerned about risk EUA would interfere w/ long-term safety/efficacy in ongoing trials & even jeopardize approvals.
#VRBPAC #COVID19
#VRBPAC Consumer Rep Toubman: Concerned endpoint on EUA didn't require serious disease. Could have vaccine does well in mild but little to address what we really care about: Serious disease/death.
Why not 50% for serious disease #FDA?
NIAID said 60%.
Why only 2 months follow up.
Why not 50% for serious disease #FDA?
NIAID said 60%.
Why only 2 months follow up.
#FDA Fink: We really to try to strike a balance between getting info on most clinically significant outcomes & how a vaccine might prevent vs. making impact on the pandemic in reasonable amount of time based on good data.
More severe disease going to be less common.
#VRBPAC
More severe disease going to be less common.
#VRBPAC
#FDA Fink: We make our recommendations based on efficacy standards impact on pandemic & would not argue with any study that aims to go higher [than 50%].
2 months follow up versus longer was a consideration of balance.
#VRBPAC
2 months follow up versus longer was a consideration of balance.
#VRBPAC
#VRBPAC Michael Kurilla: Some scientific discussion of non-COVID19 vaccines having potential role in reducing severity of disease. How would #FDA handle that?
FDA Fink: Guidelines don't specify what vaccine components need to be. Can't divulge any studies underway under IND.
FDA Fink: Guidelines don't specify what vaccine components need to be. Can't divulge any studies underway under IND.
#FDA #VRBPAC acting chair @UMich Arnold Monto warning need to move on to the more general discussion.
He doesn't want this panel getting bogged down in a lot of questions outside of its charge today.
#COVID19 #vaccines
He doesn't want this panel getting bogged down in a lot of questions outside of its charge today.
#COVID19 #vaccines
#VRBPAC Steven Pergam: No specification for racial breakdown in EUA requirements. Concerned adequate enrollment might be seen in negative light?
#FDA Fink: Never had demographic requirement for licensure of #vaccines, it would be difficult to outline for EUA.
#COVID19
#FDA Fink: Never had demographic requirement for licensure of #vaccines, it would be difficult to outline for EUA.
#COVID19
#VRBPAC Nelson: If not enough data in certain groups, will they be excluded for EUA?
#FDA Fink: Will look carefully at demographics & OK for populations for which data support. May be circumstances when data less data, but in & of itself, won't result in restriction.
#COVID19
#FDA Fink: Will look carefully at demographics & OK for populations for which data support. May be circumstances when data less data, but in & of itself, won't result in restriction.
#COVID19
#VRBPAC Gans: How public health measures for #COVID19 may impact 50% standard. Also don't see uniqueness of virus & immune responses & thrombotic events.
#FDA Fink: Concerns theoretical but well founded. We mentioned enhanced respiratory disease in guidance but won't be end-all.
#FDA Fink: Concerns theoretical but well founded. We mentioned enhanced respiratory disease in guidance but won't be end-all.
#VRBPAC Holmes: This is a giant experiment that is being done with many vaccines & possibly have a great deal of data that could inform a lot of information about this disease & this virus & future COVID-like diseases.
But haven't heard much about measure infection not just mild
But haven't heard much about measure infection not just mild
#VRBPAC CDC's David Wentworth: Longer premarket follow up for unique platforms?
#FDA Fink: 6 mos BLA, 2 mos EUA, which is somewhat benefit/risk calculation but not that different when talking about millions of people.
Regulate vaccines all different tech/same set of regs for all.
#FDA Fink: 6 mos BLA, 2 mos EUA, which is somewhat benefit/risk calculation but not that different when talking about millions of people.
Regulate vaccines all different tech/same set of regs for all.
#VRBPAC Meissner: #FDA licenses vaccine based on data presented to FDA. It doesn't make recommendations about how it should be used. That's responsibility of ACIP.
@UMich Monto: You're absolutely right
FDA Fink agrees & FDA doesn't have authority to mandate demographics in trials
@UMich Monto: You're absolutely right
FDA Fink agrees & FDA doesn't have authority to mandate demographics in trials
#VRBPAC #NIAID Luigi Notarangelo: I have a problem with the standard of efficacy. Measures are skewed to mild & that's concern. Mild disease doesn't mean much.
Also, most measures are really subjective. Ver few objective. That's a major concern.
#COVID19 #vaccines
Also, most measures are really subjective. Ver few objective. That's a major concern.
#COVID19 #vaccines
#VRBPAC Chatterjee: We are being asked to build this plane as flying.
While would like to see data/rigor, have to weigh those 2 things. Comments very clear public has significant concerns about safety.
1st/foremost safe, then get to efficacy [what's point if not effective?]
While would like to see data/rigor, have to weigh those 2 things. Comments very clear public has significant concerns about safety.
1st/foremost safe, then get to efficacy [what's point if not effective?]
#VRBPAC Gans: They haven't gone far enough w/ safety outline, efficacy as well. Need to think about this differently. Some ways affect people/immunogenicity data. No immune markers. Public suggested probably not going to have an appetite for anything short of rigorous process.
[From earlier that didn't get tweeted]
#VRBPAC Hildreth: Severe disease/death highest among minorities & if put a vaccine out that doesn't address, going to perpetuate perception that population/segment doesn't matter.
On FDA mandating demographics: "Taxpayers paying for this"
#VRBPAC Hildreth: Severe disease/death highest among minorities & if put a vaccine out that doesn't address, going to perpetuate perception that population/segment doesn't matter.
On FDA mandating demographics: "Taxpayers paying for this"
#VRBPAC Cohn: I'm less concerned about adverse events in 30,000 in trials after 2 months follow up as more rare adverse events. Prolonging EUA won't change that.
That's why safety surveillance system needs to be strong.
Worry VE estimates for mild over estimated 2 mos.
#COVID19
That's why safety surveillance system needs to be strong.
Worry VE estimates for mild over estimated 2 mos.
#COVID19
#VRBPAC industry rep $MRK Paula Annunziato says she thinks #FDA #COVID19 #Vaccines guidance has struck balance & should be supported.
#VRBPAC Consumer Rep Toubman: EUA shouldn't be used. #COVID19 #vaccines.
Perception speed/political pressure. Anything sounds like emergency use authorization sounds like rushed.
Even if EUA like BLA, doesn't sound alike. If EUA, people bail from trials. Lots of problems.
Perception speed/political pressure. Anything sounds like emergency use authorization sounds like rushed.
Even if EUA like BLA, doesn't sound alike. If EUA, people bail from trials. Lots of problems.
#VRBPAC Consumer Rep Toubman: Only got one chance to do this & if we do it wrong, we're done for.
We won't be able to dig out of it.
#COVID19 #vaccines #FDA
We won't be able to dig out of it.
#COVID19 #vaccines #FDA
#FDA Philip Krause: EUA also does in fact represent an investigational product. It hasn't yet met standards for licensure.
Although EUA standards high for #COVID19 #vaccines, not as high for BLA licensure.
EUA is not a guarantee of BLA. Hope they qualify.
Commit #VRBPAC review.
Although EUA standards high for #COVID19 #vaccines, not as high for BLA licensure.
EUA is not a guarantee of BLA. Hope they qualify.
Commit #VRBPAC review.
#VRBPAC Stanley Perlman: Want to prolong EUA's2 months follow up to few more months.
If do a few more months, may have a chance to pick up problems might not see at two months.
#COVID19 #vaccines #FDA
If do a few more months, may have a chance to pick up problems might not see at two months.
#COVID19 #vaccines #FDA
#FDA #VRBPAC chair Monto: There is some concern about period of 2 mos being somewhat arbitrary but recognition study still going on if randomization can be continued for those after EUA.
Want to ensure minorities represented.
Concern about immuno-bridging to children.
#COVID19
Want to ensure minorities represented.
Concern about immuno-bridging to children.
#COVID19
#FDA #VRBPAC Question 2:
https://www.fda.gov/media/143153/download
Please discuss considerations for continuation of blinded Phase 3 clinical trials if an EUA has been issued for an investigational #COVID19 vaccine.
https://www.fda.gov/media/143153/download
Please discuss considerations for continuation of blinded Phase 3 clinical trials if an EUA has been issued for an investigational #COVID19 vaccine.
#VRBPAC Meissner: Can't imagine informed consent didn't address unblinding/withdrawal if EUA granted.
#FDA Krause: Isn't promise for cross-over to available EUA vaccine. Continue them on placebo wouldn't break a deal. Also, placebo volunteers not 1st in line for EUA vaccine.
#FDA Krause: Isn't promise for cross-over to available EUA vaccine. Continue them on placebo wouldn't break a deal. Also, placebo volunteers not 1st in line for EUA vaccine.
#VRBPAC Steven Pergam: Not sure how much #COVID19 #vaccines going to be available. EUA doesn't dictate a ton of vaccine available. So what's our goal here?
Health workers 1st in line makes sense.
Heard about @reaganudall comments. But curious how health workers felt?
Health workers 1st in line makes sense.
Heard about @reaganudall comments. But curious how health workers felt?
#VRBPAC Notarangelo: If issue EUA, at that point, next step prioritization which groups.
Health care workers might not be right population.
But nursing homes would be. That would help gain time to accumulate data required. EUA not necessarily initiate unblinding
#COVID19
Health care workers might not be right population.
But nursing homes would be. That would help gain time to accumulate data required. EUA not necessarily initiate unblinding
#COVID19
#VRBPAC Archana Chatterjee: Who will get it & how quickly? Losing people from trials is less likely to happen
There will be lag while data still accumulated.
#COVID19 #vaccines
There will be lag while data still accumulated.
#COVID19 #vaccines
#VRBPAC Consumer Rep Toubman apparently didn't see comments from $PFE that the company said it would propose amending its ongoing study to allow cross-over of eligible placebo participants to the active vaccine arm if they wish to do so at any time.
#COVID19 #vaccines #FDA
#COVID19 #vaccines #FDA
#FDA #VRBPAC acting chair @UMich Arnold Monto: "Unblinding destroys the whole purpose of a randomized trial." He notes complexity of the issue.
But says can worry about $PFE's #COVID19 vaccine if/when it comes before the committee for review/debate.
But says can worry about $PFE's #COVID19 vaccine if/when it comes before the committee for review/debate.
#VRBPAC Michael Kurilla: EUA won't be for specific population but based on the available data in the trial protocol.
Just b/c EUA issued for under 65 doesn't mean everybody gets it – not enough in first place. Don't think issue for ongoing phase 3.
Just b/c EUA issued for under 65 doesn't mean everybody gets it – not enough in first place. Don't think issue for ongoing phase 3.
#FDA #VRBPAC acting chair Monto: We all wish continue blinded collection of data but realize may be some problems.
But if can't, move into follow-up studies in observational setting.
#COVID19 #vaccines
But if can't, move into follow-up studies in observational setting.
#COVID19 #vaccines
#FDA #VRBPAC #3: Please discuss studies following licensure and/or issuance
of an EUA for #COVID19 #vaccines to:
a. Further evaluate safety, effectiveness and immune
markers of protection
b. Evaluate the safety and effectiveness in specific
populations
of an EUA for #COVID19 #vaccines to:
a. Further evaluate safety, effectiveness and immune
markers of protection
b. Evaluate the safety and effectiveness in specific
populations
#VRBPAC Hayley Altman-Gans says markers she's particularly interested in are pro-imflammatory & prothrombotic.
#COVID19 #vaccines #FDA
#COVID19 #vaccines #FDA
#FDA Gruber: #pharma need to submit pediatric studies plan.
We will be getting data on subject population.
#VRBPAC Cody Meissner: Pediatrics need to be evaluated as a distinct group.
Pattern of #COVID19 disease quite different w/ children. Lumping w/ adults cause me discomfort.
We will be getting data on subject population.
#VRBPAC Cody Meissner: Pediatrics need to be evaluated as a distinct group.
Pattern of #COVID19 disease quite different w/ children. Lumping w/ adults cause me discomfort.
#VRBPAC Michael Kurilla: We need to recognize there's a lot of new platforms utilized. So rather than traditional vaccine by vaccine need long-term effects on platforms or novel adjuvants.
#FDA #COVID19 #vaccines
#FDA #COVID19 #vaccines
So, anybody know where @DrPaulOffit went? Did I miss when he left #VRBPAC today [sorry, I've been paying very close attention but not sure when he left & haven't heard from him most of the day].
#FDA #COVID19 #vaccines
#FDA #COVID19 #vaccines
#FDA #VRBPAC acting chair @UMich Monto: Postmarketing studies are absolutely necessary for duration of immunity, safety b/c using new platforms, look not just by product but by platforms b/c commonalities of effects based on platforms, must have population-specific data.
#FDA Gruber says heard: Guidance/approaches for safety/effectiveness principles/standards "right on the money." Some concern ensure minorities included. Also endpoints.
We hear you on bridging peds pop. Concern 2 mos follow may be shorter.
BUT #VRBPAC Monto questions about 2 mos
We hear you on bridging peds pop. Concern 2 mos follow may be shorter.
BUT #VRBPAC Monto questions about 2 mos
Where in the HELL did #FDA's Gruber get the idea that #VRBPAC wanted the 2 months for EUA to be shorter?
What was she talking about? Please. Anybody?
Gruber said she heard concern 2 months "may be not short enough" for EUA from some panelists?
Who?
#COVID19 #vaccines
What was she talking about? Please. Anybody?
Gruber said she heard concern 2 months "may be not short enough" for EUA from some panelists?
Who?
#COVID19 #vaccines
