FDA Vaccines and Related Biological Products Advisory Committee Meeting September 17, 2021

 

Vaccines and Related Biological Products Advisory Committee Meeting, September 17, 2021 

Dr. Peter Marks - 21:00 - encourages all participating in this meeting to be able to speak without censure - realizes there will be a lot of differing opinions.  Dr. Marion Gruber - 24:00 - this will be her last meeting as she is retiring in October. - It is not known if there will be a risk of blood clots after the booster.  Important to know if booster will work against Delta.Dr. Ramachandra Naik - 31:00 - Does the safety and effectiveness data from the clinical trial CR591001 support approval of a CORMIRNATY booster dose administered at least 6 months of the completion of the primary series for use in individuals 16 years of age and older?  (36:00) Dr. Sara Oliver - 37:00 - Delta Variant Breakthroughs Identified (39:00)  More unvaccinated hospitalized than vaccinated according to this data. - effectiveness overall is waning over time  - not known if this is in general or against Delta.  VE for the elderly has fallen to just over 50% against Delta (50:00) Summary COVID vaccine continues to maintain high protection against severe disease, hospitalization and death.  Protection against infection is lower.  (51:00) 
Dr. Johnathan Sterne (UK) (1:00:00) Real World Effect of Vaccines - Randomized trials are extremely important, but these trials were completed before the Delta Variant. So far reaching policy decisions need to be made without trial data. White people were vaccinated faster and those with learning disabilities slower.  (1:10:00)
Dr. Sharon Price and Prof. Ron Milo (1:26:00) Booster Protection Against Confirmed Infections (Israel) (1:32:00) Fourth wave started when over 85% fully vaccinated.  (1:52:00) following 3rd dose cases decrease. (1:57:00)  Only 19 serious reports of effects following the third dose.  
Donna Boyce (2:23:00) Global Regularly Affairs Pfizer - Vaccine Efficacy wanes over time (6 to 8 months following 2nd dose). 
Dr. William Gruber  (2:33:00) Discusses safety of the 3 shot - (2:39:00) drops to 40% 4 months out after 2nd dose in older population (2:42:00) Vaccine effectiveness wanes over time irrespective to variant.(2:56:00)In the test group it appears that the 3rd dose offers better protection than the 2nd dose.  Indicating that 3 doses are necessary to offer best protection according to Dr. William Gruber. Dr. Joohee Lee (FDA) (3:14:00) This is regarding a booster of CORMIRNATY 6 months after the first two.  (3:17:00) talks about adverse effects including death being followed for up to 2 years. (3:27:00) Immunology results 1 month after dose 2 and 1 month after booster. 

Public Group 

Dr. Gupta (4:03:00) Booster Doses may generate escape mutants Benjamin Newton (4:08:00) Vaccines have to have 50% efficacy against symptomatic disease 
*Dr. Jessica Rose (4:09:00) Discusses VAERS Deaths - over 1000% increase in adverse effects in 2021
Dr. Retsef Levi (4:13:00) Discusses the vaccination program in Israel 
Dr. Joseph Fraiman (14:17:00) wants to reduce vaccine hesitancy by more trials
*Steve Kirsch (4:19:00) The Elephant in the Room - Early Treatment - Trial by Psizer was gamed*David Wiseman (4:24:00) primary reason for approving CORMIRNATY was to overcome hesitation 
Kermit Kubitz (4:27:00)Wants boosters yesterday 
*Dr. Peter Doshi (4:30:00)Dr. Michael Carome (4:33:00) Wants to vaccinate the entire world
*Kim Witczak (4:36:00) Politics and Vaccines - We are part of the largest human experiment
Lynda Dee  (4:39:00) 
Dr. Meg Seymour (4:44:00) Data should be taken on all segments of the population not just extrapolated from other data.
Kathleen Cameron (4:47:00)
Beth Battaglino (4:50:00) Heathy Women 
Brian Hujdich (4:52:00) HealthHIV Wants busters 
Dr. Paul Alexander (4:55:00) VAERS need proper safety boards - vaccine accumulation in testes, ovaries and spleen 
At the 5 hour point it starts open Q & A