Coronavirus Vaccine Update From the FDA – October 5, 2020

Peter Marks, MD, PhD directs the US FDA's Center for Biologics Evaluation and Research (CBER) and will "call the balls and strikes" on any COVID-19 vaccine, according to FDA Commissioner Stephen Hahn, MD. He joins JAMA editor Howard Bauchner, MD for an update on vaccine progress-to-date and prospects for pre-election political interference in the FDA approval process. Recorded October 5, 2020.

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Topics discussed in this interview:
0:00 Introduction
1:02 Background on CBER
2:03 Vaccine application process and EUAs
4:22 Primary data vs. summary tables
5:52 Do you get the playbook from vaccine companies?
7:53 How do you go through the data in these applications?
10:28 Vaccine safety
13:23 Mandating additional safety data
15:18 Data Monitoring Safety Board (DMSB)
16:50 FDA Advisory Committees
20:09 Do these committees weigh in before approval?
21:18 Advisory Committee on Immunization Practices (ACIP)
22:20 When does ACIP weigh in?
23:04 How long do EUAs and BLAs take?
24:17 Preventing DMSBs from prematurely terminating studies
25:35 FDA review meetings
27:42 Requesting additional information before FDA regulatory decisions
28:47 Does the FDA Advisory take a formal vote?
29:16 Career scientists at the FDA
31:34 What has this been like for you personally?
33:11 When will we see the first vaccine application?
34:28 EUA applications before the 2 month followup period

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[JAMANetwork]

Topics discussed in this interview:
0:00 Introduction
1:02 Background on CBER
2:03 Vaccine application process and EUAs
4:22 Primary data vs. summary tables
5:52 Do you get the playbook from vaccine companies?
7:53 How do you go through the data in these applications?
10:28 Vaccine safety
13:23 Mandating additional safety data
15:18 Data Monitoring Safety Board (DMSB)
16:50 FDA Advisory Committees
20:09 Do these committees weigh in before approval?
21:18 Advisory Committee on Immunization Practices (ACIP)
22:20 When does ACIP weigh in?
23:04 How long do EUAs and BLAs take?
24:17 Preventing DMSBs from prematurely terminating studies
25:35 FDA review meetings
27:42 Requesting additional information before FDA regulatory decisions
28:47 Does the FDA Advisory take a formal vote?
29:16 Career scientists at the FDA
31:34 What has this been like for you personally?
33:11 When will we see the first vaccine application?
34:28 EUA applications before the 2 month followup period

[rmholt]

Omg Dr Bauchner thanks for addressing the conflict between the FDA & powerful pressure on them to not do their jobs

[fredmaxfield]

I have known Peter Marks for more than 30 years. He is and always has been a careful and analytical scientist. I am very relieved that we have such a thoroughly rigorous and ethical person in his position right now. My only concern is whether he may be forced out. I am very confident in his ability to resist political pressure.

[jenniewilliamsmural]

I am thankful for this fantastic interview. I liked your nuts and bolts questions and Dr Marks' commitment to safety, addressing the political pressure.
I have a much better understanding of the process of reviewing Emergency Use Authorization after watching your video.
Your videos are priceless. Thank you Dr Bachner.
Warm regards
Jennie

[pellagra]

Terrific interview. I hope that Dr Marks and his team have the fortitude to resist the political pressure that is shocking those of us interested in vaccines and evidence-based regulation.

[sevans]

Absolutely excellent. Certainly a great team at CEBER that the US can rely on

[nsgksvh]

This guy is helping to restore public confidence in scientists. Maybe they haven't all fallen into a state of corruption.

[anjelkeya]

In addition to approving a drug to meet standards, FDA procedures need to quickly identify the best drug if there is more than one qualified. Otherwise, we may get a suboptimal drug for our people. The FDA can indeed hold a drug candidate for the right reason, but in doing so for too long the country will suffer. In this Corona pandemic, I believe we should have a special committee to make sure we don’t miss any good drug candidates regardless of whether the drug comes from a big or small pharmaceutical company. We, as taxpayers, deserve the best.

[sunshine]

Dr. Hana El Shaly had a huge improper conflict of interest involving Moderna Covid 19 vaccine. Why isn't the FDA discussing this???

[abekawser]

what's about long term rare side-effect of vaccine? what's about antibody dependent enhancement and covid-19 vaccine??

[sunshine]

What is the role of corticosteroids (such as dexamethasone) in the treatment of coronavirus disease 2019 (COVID-19)?

Updated: Oct 02, 2020

[abekawser]

Only 2 months follow up data before emergency use??

[TBBrd]

Thanks for your videos. Do you think it might be possible to make them without insulting every Republican who might be tuning in? Thanks very much.

[valereehansen]

Wow. Hmmm...
Peter W. Marks, MD, PhD uses the word "try" way too much. Considering the critical nature of this Emergency Use Authorization, and that Dr. Marks heads the 250 member team in-charge, "try" is not a very comforting word.
I am not left with the warm-fuzzies I expected from this interview.

[erthamishina]

I have known Peter Marks for more than 30 years. He is and always has been a careful and analytical scientist. I am very relieved that we have such a thoroughly rigorous and ethical person in his position right now. My only concern is whether he may be forced out. I am very confident in his ability to resist political pressure.

[nguyentrieu]

Topics discussed in this interview:
0:00 Introduction
1:02 Background on CBER
2:03 Vaccine application process and EUAs
4:22 Primary data vs. summary tables
5:52 Do you get the playbook from vaccine companies?
7:53 How do you go through the data in these applications?
10:28 Vaccine safety
13:23 Mandating additional safety data
15:18 Data Monitoring Safety Board (DMSB)
16:50 FDA Advisory Committees
20:09 Do these committees weigh in before approval?
21:18 Advisory Committee on Immunization Practices (ACIP)
22:20 When does ACIP weigh in?
23:04 How long do EUAs and BLAs take?
24:17 Preventing DMSBs from prematurely terminating studies
25:35 FDA review meetings
27:42 Requesting additional information before FDA regulatory decisions
28:47 Does the FDA Advisory take a formal vote?
29:16 Career scientists at the FDA
31:34 What has this been like for you personally?
33:11 When will we see the first vaccine application?
34:28 EUA applications before the 2 month followup period

[HoangTran-nbyv]

In addition to approving a drug to meet standards, FDA procedures need to quickly identify the best drug if there is more than one qualified. Otherwise, we may get a suboptimal drug for our people. The FDA can indeed hold a drug candidate for the right reason, but in doing so for too long the country will suffer. In this Corona pandemic, I believe we should have a special committee to make sure we don’t miss any good drug candidates regardless of whether the drug comes from a big or small pharmaceutical company. We, as taxpayers, deserve the best.

[nomad]

This guy is helping to restore public confidence in scientists. Maybe they haven't all fallen into a state of corruption.