Coronavirus Vaccine Development

Coronavirus Q&A: Paul Offit, MD of the Children's Hospital of Philadelphia discusses principles and progress-to-date in COVID-19 vaccine development. Recorded on June 1, 2020.

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Topics discussed in this interview:
0:00 Background on Dr Offit
1:26 Paul, what are the traditional phases, of vaccine development?
3:50 How many coronavirus vaccines are there in development, and how far along are some of them?
5:49 So there appears to be four different types of vaccines being developed. Do companies bet on one type, or do they develop more than one type?
6:41 How large are phase two trials in comparison to phase three trials?
7:16 What committees do you sit on?
8:05 Human challenge trials
9:07 Does that approval of human challenge trials rest with the FDA?
9:41 Are there any robust, larger phase two trials ongoing? What is the timeline for those trials?
10:44 What happens if there's little disease over the summer? How does that impact these trials?
11:25 When do you begin to accrue meaningful data from that these studies?
11:56 Will there be a distribution of ages in terms of people who are vaccinated for these studies?13:17 So over the summer, we begin to accrue more information, but how valuable that information is will depend upon how much disease is in the area where people have been vaccinated. Is that an accurate statement?
13:30 Do they just add more and more numbers to the initial phase three trial if there's simply not enough disease?
14:23 Will a vaccine be 100% effective?
15:55 What is Operation Warp Speed?
17:04 Mass producing the vaccine while coronavirus trials are ongoing.
18:36 Does America's investment in a vaccine then entitle the US to "own" that vaccine or some portion of that vaccine?
19:24 Do you have any sense of how the issue of equity will play out in the US and other countries?
20:56 With Operation Warp Speed, do you anticipate that a successful phase three trial will lead to 300 million doses a few months later?
21:27 Vaccine-hesitancy
23:44 Political pressure on the FDA to approve a vaccine
25:07 What will be the mechanism that will lead to FDA approval of a vaccine?
25:49 Hydroxychloroquine and chloroquine are examples of why we need randomized clinical trials for COVID-19 treatments.
27:08 Why are we optimistic about a vaccine that's 1) a first-of-a-kind mRNA vaccine and 2) a first-of-a-kind coronavirus vaccine?
28:33 Which vaccine will be made under Operation Warp Speed?
29:15 For the phase three trials to start in July, are there plans to recruit enhanced numbers of Latinx and African Americans - who are known to have higher infectious rates for whatever reason?
30:14 Are persons with conditions that might put them at greater risk from a vaccine - autoimmune conditions, pregnant women - will they be excluded from the safety testing?
30:44 The Sweden experiment
31:55 What would a second wave without a vaccine look like in the fall?
35:30 Closing comments about vaccines and COVID-19?

Editors' Notes:

At 14:00 the video shows a vial of parenteral rotavirus vaccine. That image is inaccurate - rotavirus vaccine is oral only. We cannot edit out the brief image without deleting the entire video, and judging the benefits of the conversation to outweigh the harms of the image we are leaving it intact, and regret the error.

[JAMANetwork]

Topics discussed in this interview:
0:02 Background on Dr Offit
1:26 Paul, what are the traditional phases, of vaccine development?
3:50 How many coronavirus vaccines are there in development, and how far along are some of them?
5:49 So there appears to be four different types of vaccines being developed. Do companies bet on one type, or do they develop more than one type?
6:41 How large are phase two trials in comparison to phase three trials?
7:16 What committees do you sit on?
8:05 Human challenge trials
9:07 Does that approval of human challenge trials rest with the FDA?
9:41 Are there any robust, larger phase two trials ongoing? What is the timeline for those trials?
10:44 What happens if there's little disease over the summer? How does that impact these trials?
11:25 When do you begin to accrue meaningful data from that these studies?
11:56 Will there be a distribution of ages in terms of people who are vaccinated for these studies?13:17 So over the summer, we begin to accrue more information, but how valuable that information is will depend upon how much disease is in the area where people have been vaccinated. Is that an accurate statement?
13:30 Do they just add more and more numbers to the initial phase three trial if there's simply not enough disease?
14:23 Will a vaccine be 100% effective?
15:55 What is Operation Warp Speed?
17:04 Mass producing the vaccine while coronavirus trials are ongoing.
18:36 Does America's investment in a vaccine then entitle the US to "own" that vaccine or some portion of that vaccine?
19:24 Do you have any sense of how the issue of equity will play out in the US and other countries?
20:56 With Operation Warp Speed, do you anticipate that a successful phase three trial will lead to 300 million doses a few months later?
21:27 Vaccine-hesitancy
23:44 Political pressure on the FDA to approve a vaccine
25:07 What will be the mechanism that will lead to FDA approval of a vaccine?
25:49 Hydroxychloroquine and chloroquine are examples of why we need randomized clinical trials for COVID-19 treatments.
27:08 Why are we optimistic about a vaccine that's 1) a first-of-a-kind mRNA vaccine and 2) a first-of-a-kind coronavirus vaccine?
28:33 Which vaccine will be made under Operation Warp Speed?
29:15 For the phase three trials to start in July, are there plans to recruit enhanced numbers of Latinx and African Americans - who are known to have higher infectious rates for whatever reason?
30:14 Are persons with conditions that might put them at greater risk from a vaccine - autoimmune conditions, pregnant women - will they be excluded from the safety testing?
30:44 The Sweden experiment
31:55 What would a second wave without a vaccine look like in the fall?
35:30 Closing comments about vaccines and COVID-19?

[JAMANetwork]

At 14:00 the video shows a vial of parenteral rotavirus vaccine. That image is inaccurate - rotavirus vaccine is oral only. We cannot edit out the brief image without deleting the entire video, and judging the benefits of the conversation to outweigh the harms of the image we are leaving it intact, and regret the error.

[IoannisHodgesMameletzis]

Greetings from Greece, these JAMA updates are incredibly informative.

[MrTahsine]

Thanks for this extensive elaborate explanation of the ongoing vaccine making. Hope that experiments will lead to success early so that world can benefit from it in fighting against this pandemic

[GinnyD]

Randomized clinical trials do not have to be with placebo. They can be a trial randomized to the two best options.

[dsmj]

You guys should figure out how to be more popular on YouTube. Your information is very helpful.

[kathychavez]

I would like to know how one becomes a part of the vaccine trial patient. I am a 61 year old female. No commodities . I am a pediatric nurse. I am also Latina.

[charleseggerstedt]

Thank you fir providing important information scientifically and not by “hunch.”

[suzannelooms]

You didn't mention black and ethnic minority people in your risk groups. Why not?

[dillonwood]

I hope the vaccines are ready for the world