WASHINGTON ANALYSIS

Moderator: Ira Loss

07-22-20/2:00 p.m. ET
Confirmation # 2698121
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Conference Call: Outlook for COVID Vaccine

Speaker: Dr. Rob Robinson, Former Director, Biomedical Advanced Research and
Development Authority (BARDA)

Hosts: Ira Loss, Beth Steindecker, & John Leppard, Washington Analysis

Date: Wednesday, July 22

Time: 2:00 PM ET

OPERATOR: This is Conference #: 2698121.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the
“Outlook for a COVID-19 Vaccine” conference call. At this time, all
participants are in a listen-only mode. After the speaker’s presentation, there
will be a question-and-answer session. To ask a question during the session,
you will need to press “star,” “1” on your telephone.

If you require further assistance, please press “star,” “0”. I would now like to
hand the conference over to your speaker today, Mr. Ira Loss, vice president
of Washington Analysis. Thank you. Please go ahead, sir.

Ira Loss: Thank you, (Chris). Thanks, everyone, for joining Beth Steindecker, John
Leppard and me this afternoon. Given the recent clinical trial results reported
on several COVID-19 vaccines and their impact on the financial markets, we
thought it would be a good time to bring back Dr. Robin Robinson to discuss
the results and get an update on this thinking about these results and their
impact on the timing for approval of one or more of these vaccines since he
last shared his views with us two months ago.
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Dr. Robinson is a leading authority on the development of breakthrough

biomedical technologies working across the lines of government, private
industry and academia. He was the founding director of HHS’ Biomedical
Advanced Research and Development Authority, known as BARDA, starting
in 2008.

During his eight-year tenure as the head of BARDA, the organization

supported the advanced development and acquisition of more than 240 drugs,
vaccines, diagnostics and medical devices from man-made biodefense threats,
pandemic influenza and emerging infectious diseases including Ebola and
Zika viruses.

Before we start, I just need to remind everyone that Washington Analysis

provides research to investors that any information provided today may be
used for investment purposes, and no person should discuss, disclose or solicit
any confidential or material non-public information during this call. This call
is for Washington Analysis clients only and is not for attribution.

With that – with that out of the way, we’ll be starting off with some questions
and answers with Dr. Robertson and, then, we wanted to open up the line for
questions. Please feel free to reach out to any of us via email or just hit Reply
on the flyer sent out this morning.

First question, Dr. Robinson. Just to kind of put you on the spot from the
start, the last time we spoke, you discussed your optimism that there could be
sufficient doses for vulnerable populations – nursing homes, health care
workers – by the first quarter of ’21, but the doses numbering in the hundreds
of millions for everyone else would likely need to wait until the second half of
2021. Do you still think that that’s a realistic timeframe, or could we move
either of those estimates backward or forward?

Robin Robinson: No. I’d stick with that. You are – you are not going to have this vaccine
approved by FDA under emergency use authorization because they will have
not met the six-month timeframe that the FDA has provided in its guidance by
election. So, you can (view that with what you want to). And nor will it be
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by the – in December. It’s going to be probably, in the earliest, sometime in

the middle of the first quarter.

Now, why do I say that? The reason is because the pivotal phase-three phase
has got to last at six months to show durability of immunity and show the
efficacious and safety that’s necessary for these vaccines to be used under
emergency use authorization.

Again, emergency use authorization does not mean it is a licensed vaccine that
could be marketed in this country. All right? It can only be used during the
pandemic as long as the pandemic declaration is in effect.

If you say – if you – if the pivotal studies start August 1 at the earlier – and if
you’ve been reading and reading between the lines, you will see that the
optimism and the naïveté and the sure (inaudible) that some of the companies
have actually been announcing they would be in the July and everything, well,
that’s just not going to happen. OK? When you actually are going to get
enrollment – that’s going to be in August at the earliest.

If you start looking at that timeline, (then it walks) you six months, then you
are already in January when you have your data available – the final data
available for the actual six months. Then, you actually have to collect your
six-month samples of the blood samples, and you also have to interview all –
everyone in six months. So, that’s already pushing February.

Then, you have to actually analyze it and see what you actually have and,
then, the data has to be provided to the FDA, which I’m sure will be done as
quickly as humanly possible or faster, OK, so that your – sometime in
February – at the earliest, you will probably see in February or March as the
likelihood of the earliest vaccines that have been – gone through the pivotal
clinical trials and actually have data that actually meet the expectations of the
FDA with the bar set at 50-percent efficacy level.

If there are such vaccines that are available at that time, those would be
prioritized to the high-risk individuals, including the health care workers,
elderly, immuno-compromised individuals and those with comorbidities and
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pregnant women. In the past, with the H1N1 pandemic, when I led the
vaccine efforts there, we also had children. I will say that probably children
(aren’t) going to be the highest priority at this time.

There will be multiple vaccines that will be probably available for review by
the FDA in this timeframe from about February through March or April. And,
then, there will be some more that will start coming through next summer.
And, so, the idea that the second half of next year is when you are going to see
multiple vaccines being available in the tens to hundreds of millions of doses
is still the same – second half of 2020.

And that coincides with what my other colleagues have said, including Dr.
Fauci. And Tony has said this over and over again. So, there is nothing to say
that has trampled that timeline to say it’s going to be – the first doses are
going to be available in the latter half of 2021. But, there is nothing to say
that there is going to be anything that is going to be sooner than the first
quarter of next year either.

Ira Loss: OK. Can I ask one (inaudible) follow on that, Dr. Robinson? It’s you
mentioned I think in passing that the EUA – emergency use authorization –
approved drugs can, of course, only be used during the – as long as the public
health emergency remains in effect. I just want to clarify that I heard that
correctly, just given some of the press that’s been out there that President
Trump has been toying with lifting that declaration. I mean that would just
seem to shoot that right (inaudible).

Robin Robinson: The EUA (inaudible) could – first, the pandemic declaration can always be
extended. And it doesn’t have to be the president. It could be the – Alex Azar
or the HHS secretary can issue that.

The second thing is none of the vaccines are going to have their BLAs
submitted to the FDA in time for it to be licensed. Normally, they have the
time to do so. And that’s going to be the post 2021. And realistic people and
not the cheerleaders for the vaccine companies will tell you that that’s true,
too, and that there is a lot more work to be done before you actually get a
vaccine licensed. So …
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Ira Loss: OK (inaudible).

Robin Robinson: … I think the – I think the EUA is there for a purpose and that it will help you
get the vaccine available to people who need it next year.

Ira Loss: OK. Then this brings up the question of distribution and equitable access,
which the National Academy of Sciences are going to be discussing this
Friday. Is it – is it at this point safe to assume that it will be the government
that’s in charge of prioritization rather than just market demand, meaning that
you will have to wait your demographic or geographic region is up in the
queue?

Robin Robinson: So, history teaches us that the wiser heads have always prevailed. And
certainly those – that talk at National Academy – that almost (identical to the
time) that we talked with the National Academy in 2009 over the H1N1
pandemic.

And that is that if you want equitable availability and distribution of the
vaccines – and the way to do that is to have the U.S. government purchase all
the vaccines and, then, through the CDC and using the states as the
information device to actually say where should the vaccine go within each
state and what are the programs.

Now, that’s just not just (inventing) this off the fly. OK? Since 2008, the
states have been required to actually provide to HHS their pandemic planning
– their plans. And they have to be approved or they don’t get any (money).
So, they have been really good about that (inaudible) there is money attached
to it.

So, those plans are they identify what entities or their school (inaudible)
immunization campaigns, big box pharmacies, health care, hospitals and other
venues for the vaccine to be distributed to and for the vaccine to the
administered. And both – and, then, the National Academy of Science is part
of the playbook.

It has always been there as a means to discuss this publicly to say what is the
best ways to do this. And we certainly went through that in 2009. And in
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2020, they are doing the same thing, which is a smart thing to do. And they
will go forward with a recommendation that what was used before should be
what’s going forward.

(Inaudible) that should be the states decide where it’s going to go in the local
municipalities and that then the vaccine is distributed when it’s available on a
weekly basis and that the means to distribute it to the local sites within states
should be through a wholesale distribution system with wholesale vaccine
carriers such as McKesson, Cardinal Health, Henry Schein and others, which
was done in 2009.

It worked as opposed to having a government agency that has never delivered

vaccine into this country and when they have done it outside of this country,
they made a mess of it in Haiti and trying to help in West Africa in the most
recent incidence. So, that would be the preferred way (inaudible) actually
(been reports and interviews of saying that).

And that’s what we did in 2009 and I’m sure – (this is what we brought) up to
the National Academy. That recommendation will be probably to do what
works as opposed to what is politically advantageous or (inaudible)
confidence. So, I hope that answers your question.

Ira Loss: OK. Next, we – I wanted to ask about the pricing. BARDA has announced
two contracts, one with AstraZeneca, which works out to about $4 a dose, and
another one today with Pfizer and BioNTech, which – it includes 600 doses
with – 600 million would be about $3.25 a dose.

Yet, Moderna and Merck yesterday at a hearing – congressional hearing said

they are not willing to supply their vaccine at cost. How is all these going to
work out? $4 a dose seems mighty inexpensive to me. Is that – is that what it
costs to make dose of vaccine? Or don’t we know?

Robin Robinson: No. We know how (exactly it costs). But – do you have the U.S.
government’s contract from BARDA that actually says that they are getting
500 million doses for $1.95 billion? If you do, you and I probably need to talk
and I need to provide some legal services or information to you because you
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just are probably in serious trouble. The answer is, of course not, you don’t
have the contract in front of you.

What it – (inaudible) no one – no one (technically have that. What you did
actually have access) was the file (inaudible) contract. I know that – you
shouldn’t have those. But, what it said is for – specifically – in the
announcement – and this has been (shot) with the HHS to say that the
announcement was (inaudible).

It said that the first 100 million doses would be – would be at 1.9 million –
$1.95 million and that the – which is the base of that contact. So, that would
mean $19.50 a dose and that they had an option on the contract to buy 500
million more. And what – the price of that was not disclosed.

That is pretty consistent with what is normally done. And that says that
around $20 a dose is about what recombinant vaccines cost. That (inaudible)
(not only retail) but for government purchase.

And the amount that you cited before with AstraZeneca saying that the $1.25
billion was for (inaudible) you – since you don’t have the contract there, you
would – you would know that that was not actually for the purchase or
procurement of actual vaccines, that the options on that contract would allow
them to buy vaccines from AstraZeneca and Oxford University at a price
which was not disclosed publicly and nor was it disclosed publicly on any
other contracts because, as it said in the press release, the U.S. government –
this is the first of the U.S. government procurement contracts – not the
development or the manufacturer – any other activities.

So, the money (that’s been announced) and (inaudible) (thus far) for
development, manufacturing infrastructure and regulatory submissions. So,
(inaudible) this is not a new thing. I went through this in 2009, 2014 and ’15
et cetera multiple times in which people see these numbers (inaudible)
companies and other news services saying this is what the contract is and is
therefore must be the price per dose. They are not. OK?

This is the first one and this is the only one. It is only one portion, the base of
that contract, that they actually (inaudible). Three months ago when I was
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asked the same question, what did I think the price of these vaccines, I said
they will probably be somewhere between $15 and $20 a dose. And that’s for
recombinant vaccines.

The vaccines that we paid for in the H1N1 pandemic were less than this. But,
that was using the technology that was very old and very well-known (with
the cost of goods and so forth are) and what the – and what we paid for –
based off of seasonal influenza vaccines versus the pandemic influenza
vaccine.

So, is this less than what they will be – probably be in the retail market?
Probably so because if you look at the recombinant vaccines, the HPV
vaccines, Gardasil or (inaudible) or you look at the recombinant influenza
vaccines that were allowed – that were out there, you saw a price that was
much more than the conventional vaccines and they were closer to $50 a dose.

So, $20 is probably about – again, I would say $15 to $20 is probably going to
be what the cost is. The cost of goods – the CEO under waterboarding and
other types of torture will never disclose that. Otherwise, they won’t be the
CEO. That’s CEO 101 management (by training).

Ira Loss: If I could follow up on that. I guess, if I understand you correctly, we

probably shouldn’t place too much emphasize on either of those numbers,
whether it’d be $4 for AstraZeneca or $20 for Pfizer. (Inaudible)
understanding, of course …

Robin Robinson: (Inaudible) the $20 for the first 100 million is absolutely right.

Ira Loss: Got you.

Robin Robinson: The contract (inaudible) it’s the first one and, therefore, is going to be the
benchmark in which you start seeing other procurement contracts come forth.
And I will tell you this is – this is something that most larger vaccine
companies are very careful about wording and very careful about even
disclosing because many of them – actually, when you look at the price of a
dose of vaccine, especially under a non-commercial setting, (it as to be a)
trade secret.
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So, this is – this is one of the few times in a pandemic that you see this. And
in 2009, the manufacturers were not willing to disclose that. And only under
testimony before Congress did I disclose that.

Ira Loss: I understand. I guess I was kind of thinking about it in terms of any – if there
is any (delta) to be had between, say, AstraZeneca versus Pfizer, could be
gleam anything in terms of the government’s confidence in its ability to
produce a viable vaccine?

Robin Robinson: No. (They already made their) – they already made their list, OK, and they
have already amended it once and they will do it probably again. They had
13. They went up five and then they amended it to six and they are probably
going to amend it again to seven. And, so, that’s pretty much – that’s
(inaudible) U.S. government through Operation Warp Speed (I’m thinking
so).

Ira Loss: And next question. The FDA said the vaccine guidance set a 50-percent
efficacy standard for approval of the vaccine. Isn’t that a low bar in the realm
of vaccine efficacy? And could we expect to see any pricing differential
based on performance?

Robin Robinson: No. This is a standard – this is the standard which they would have to meet.
And that’s only one of the standards. It’s – but, also, it’s not only 50 percent
but also is over at least six months. Is it a low bar? No. If you compare this –
I mean we see sometimes seasonal influenza to be much less than this. And
those are licensed vaccines.

With a new virus that we have never seen before with a new vaccine that we
never have had before, that’s a very reasonable amount. It certainly can be –
over a long period of time be very helpful in containment of the pandemic,
which is what this is ultimately about. And, again, this is why they put not
only 50-percent efficacy but also at least six months because you don’t want
every three months going back for a booster even if a booster will help. And
there are other problems that you will start realizing when you do that.
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But, will we see vaccines that have at least 50-percent efficacy? Probably
there would be multiple ones. I agree that it’s low compared to what we
would like. We would love 100 percent, OK, because that’s the ideal and
that’s what we pay our money to do. It’s to get perfect every time. But, this
is not – that’s not the real world. That’s just what we expect it to be.

We do know there are some other platform technologies that have – as

recently as four or five years ago when they were used the first time gave
efficacies greater than 90 percent. Some of these are actually vaccines that
have been used and licensed products already. There are some that have not
been used as licensed products.

All the mRNA and DNA vaccine candidates have never gone past the phase
one for mRNA and never gone past phase three with DNA. With the viral
vectors, specifically the adenovirus vectors, there are – there’s only one that
actually just got approved by the EMA just this week. That was the Ebola one
from J&J (inaudible) and that was an adenovirus vaccine – vaccine candidate
for Ebola.

Similarly, the vaccine candidate for Ebola is being approved by the FDA very
soon. We are using the VSV vector platform. And that’s – that was the one
that I referred to that have an efficacy of 95 percent or more. And that is a
very strong immunogenic vaccine candidate that we’ve seen before. This is
not as far long in the clinical development as the darlings of the stock world
being Moderna and others but certainly will be one – will be one that will
probably have higher-than-50-percent efficacy.

If history tells us anything, in the recombinant vaccines, the recombinant

protein vaccines with the adjuvants are likely to give more than 50 percent
and give you durable immune response greater than six months. So, we’ve
still got a long way to go. But, it – but, to answer your question, do I think the
bar is too low, no, I think the bar is too high.

Well, if it were – if we were be using that same – and we have used that same
bar for HIV and we don’t have an HIV licensed vaccine at this point. So,
saying it’s too low is – if you were an HIV, (you would love) to be 50 percent.
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But, they don’t even (give that). So, same thing for other (pharmaceuticals).
But, yes, compared to measles or something like that, yes. But, that’s a 60-
year-old vaccine, too.

Ira Loss: OK. A recent poll conducted by the Associated press shows that just 49
percent of Americans plan to get vaccinated with 31 percent saying they
weren’t sure and 20 percent saying “Absolutely not.” This is not a good
result. What should the administration be doing to counteract some of the
skepticism out there? And will a 50-percent efficacy bar make the sales job
more difficult?

Robin Robinson: Well, first of all, you may not have 50 percent. You may have more than that.
So, the second is that the communication (inaudible) plan the communication
spokesperson that is – that can be trusted and be there to (inaudible) as to be
the (point that – there’s be) someone that should be appointed (inaudible)
during the H1N1 pandemic. And we saw similar numbers back in the summer
of 2009 and we ended up immunizing close to 100 million people. So, when
it really comes to the end when you – people do change their minds.

But, communication from here on out especially once vaccine – we know

vaccines will become available and people will have to have someone they
can trust. It’s not any of the people that they’ve actually had up there talking.
The person I’m talking about that did this so well was Anne Schuchat.

Anne Schuchat is a physician who is just a long-time CDC epidemiologist and

health care expert. She is the principal deputy director at CDC. She was there
certainly with Redfield and also previously with Frieden. And I worked with
her very, very well, as many others did, during 2009 but also during other
epidemics – the (inaudible), Ebola and others.

And she is a comm head. She knows what she is talking about. And as long
as she is not (inaudible), she will do a great job and I would – I have
recommended her to do that, to come back again and be that common voice of
assurance. And she does this every year. She runs the vaccine program for
the country for children’s vaccines and influenza. So, she is used to this and
could handle it.
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So, you’re right. Communication is really important here. And the polls – not
too different from what we’ve seen in the past. But, they can – they will
change as we you the right people communicating and educating the
American public.

Ira Loss: OK. Switching, if we could, to some of the more specific vaccine candidates
out there. The reported conclusion from Moderna’s 45-patient, open-label,
phase-one of its two-dose vaccination schedule was that it produced a rapid
and strong response. Do you agree with that?

Robin Robinson: It did – it gave a rapid response. Strong – I wouldn’t agree with that. It was a
modest – and all of the vaccines that have been tested and published and at
least announced – they have given modest results.

If you compare those with other contemporary vaccine candidates for other
viral disease (inaudible) even five years, you would say that these numbers
that they have seen – and these are only from phase-one studies – are modest
compared to what you saw is good or excellent. OK? So, I would say they
are a solid C on the F being terrible and forget it to A being excellent. So,
they are not bad, but they are not – they are not great either.

Ira Loss: OK. Now, Moderna has an RNA vaccine that – there has never been an RNA
vaccine approved I don’t think anywhere. Do you think the bar has to be
higher for an RNA vaccine?

Robin Robinson: I think it has to at least clear what – no – I think it has to clear the hurdle or
the threshold that the FDA had set – all the vaccine candidates – for them to
be considered and to be allowed to be used under emergency use
authorization. They have to meet that bar.

And that’s – this is not an unreasonable bar. It is not the first time we’ve ever
had this. This is very similar to what we see with other epidemics and
pandemics and new vaccines that have been introduced. So, this is – the
database that they – the safety database that they will be generating in their
large clinical studies will be important.
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None of the recombinant vaccines have been reported and their studies have
been given a severe adverse event and that there never was going to be an
issue about the safety. And this is somewhat one reason why 35 years ago
recombinant vaccines was thought about and we developed them during the
1990s and through today.

And it’s partly to get away from some of the safety challenges that we had
with conventional vaccines that were using the whole virus or the subunit
virus or – and then the speed in which recombinant vaccines can be developed
and manufactured going forward. So, no – so, I don’t think that they should
have a – it should be held to a higher bar. I think that they just have to have –
at least make the standards that the FDA is requiring all the vaccines.

Ira Loss: OK. On Monday this week, The Lancet published the results from the
AstraZeneca-Oxford University phase-one/phase-two trial that involved
approximately 1,000 patients. The results indicated that two shots were
necessary to get 100-percent effectiveness, and they reported good antibody
and T cell responses. Do you think that AstraZeneca and Oxford have the
lead on the others?

Robin Robinson: No. I think they are all about the same.

Ira Loss: OK.

Robin Robinson: And the reason for that is that they are getting decent antibody – neutralizing
antibody responses. And I want to correct something that was in the question.
And that – it’s that what they reported was in their phase-one study that was
done in south England, 4,000. But, they only reported for the immunity data
from 40 – 35 patients with one dose and another 10 with – that got two doses.

So, it was – they reported much larger numbers for the safety because they
had already done – that was easier to do. They haven’t done all of the assays
on the (sero) from the (vaccinees) from the (inaudible) study. So, they were
just reporting this quickly as they could.

And one of the things that they did report is – and you saw the many different
assays that they used – is that there is – needs to be harmonization because
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they were having problems with doing that. The (inaudible) in the past and
are performing the validated antibody response – antibody assays for
Moderna, for J&J and AstraZeneca because they were having problems with
it.

Pfizer, Merck and Sanofi have already been cleared by the FDA because they
have validated their assays. And, so, they don’t need help. And that points
out that the large vaccine companies really do, as usual, know what they are
doing and that companies that are not large vaccine companies or even can be
considered a vaccine company usually have problems. And that’s what you
would expect. And they have.

So – but, to say that they have – their vaccine is shown to be better than
anybody else, no. I do think – and (this is what I said before) when we saw
the (inaudible) in China with their adenovirus vector that the adenovirus
vectors may have an issue about durability of immunity.

And the reason I said it then and again is because when this approach was
taken with the Ebola epidemic with the GSK vaccine where they give the first
dose with an adenovirus vector and then the second dose with the same
adenovirus vector, I saw a good immune response, but it was not durable.
After three months, it dropped precipitously and that program was abandoned.

The one that did work for Ebola was one that used the adenovirus vector for
the primary dose and the secondary dose was with (inaudible), which is what
we call heterologous immunization. The number of vaccine scientists,
including myself, have asked point blank why Janssen thinks that it can go
with just an adenovirus vector.

And they said, “Oh, well, we think that we only need one dose.” It was like,
“Good luck,” OK, because, clearly, the one dose was not enough to get a high
enough immune response that was at least modest or a good C plus from
AstraZeneca and Oxford. So, I don’t – so, they are not cooking it any
differently than they did before.

They are not using a different vector. So, (luckily) (inaudible) (maybe the
problem) (inaudible). So, the problem that we’re going to have to be
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concerned about – and that’s why the FDA said we want at least six months of
data to show that your immune responses still are decent level.

Ira Loss: OK. Last question from me is, well, I understand there are good intentions
behind the creating of Operation Warp Speed. It has created a clear conflict
of interest by having FDA Commissioner Hahn continue to serve as a
member. Doesn’t this make it more difficult to convince the public that there
– that there isn’t political pressure behind an approval decision?

Robin Robinson: He won’t make the decision. A commissioner doesn’t make the decision.
That has to be approved by the office within the Division of CBER. And
since it’s CBER, that person is Marion Gruber. She has been the head of
vaccines now for about 10 years. Excellent, excellent, excellent scientist and
excellent regulator. She is very fair, very tough. And they would have to
actually execute her if she said your – get her to (decide) something that is not
true. So, I don’t – I don’t have a problem with that.

You should know, though, that the commissioner of the FDA in 2009 was
Peggy Hamburg. And Peggy Hamburg watched – attended all the meetings.
And we had a – we didn’t call it Operation Warp Speed because we – I guess
we weren’t for Hollywood, I guess. OK? But, (we could say) we were just
doing our jobs.

And she was there, but she never voted or anything. And the final decision
always rested with the secretary and it has to be executed by – the
procurement of vaccines by me. And, so, we actually came – always came to
the conclusion and we actually sat in the White House with the president.
And there wasn’t a real fight there. We didn’t have an issue.

But, we never – we (inaudible) going to shortcut the safety and efficacy of the
vaccines being put into healthy individuals in the level of hundreds of millions
of people. And we did – and the Bush Administration didn’t do that, the
Obama Administration didn’t that. And I think as you get – well, by the time
we get a vaccine, that may be a different administration anyway. So, it may
be a moot point.
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Ira Loss: OK. Now, I have – several questions have been emailed in to me. The first
one is this.

John Leppard: (Inaudible) Ira. Just one second. Hey, (Chris), could we open it up to the line
as well? And, then, maybe we could ask Dr. Robin some of the questions we
have gotten over email.

Ira Loss: Sure.

Operator: OK. As a reminder, to ask a question, you will need to press “star,” “1” on
your telephone. To withdraw your question, press the “pound” key. Again,
press “star,” then the number “1” on your telephone keypad. Please stand by
while we compile the Q&A roster.

John Leppard: Sorry, Ira. Go ahead.

Ira Loss: The first question I got by email was, “Is the six-month bar a hard-and-fast
standard even under an EUA? What about the Moderna comments about
interim analysis after 100 to 150 events and then submission soon thereafter?
Why has Warp Speed said they are going to purchase 100 million doses
before the year ends, even October? Do they buy these doses before approval
and then have them sitting there waiting for February?”

Robin Robinson: No. They are not making (them now). But, put in perspective, six months is
the – is the least amount of time. You’d actually love it to be longer than that.
But, six months is – for a pandemic is a reasonable period of time in which we
can expect to see this and that you – that way you don’t have to go back and
(inaudible) vaccine every two months, three months.

Moderna, remember, is not a vaccine company. So, they don’t really

understand the intricacies of vaccination nor of the ability to mount an
immune response as well as some of the other longstanding and trusted
vaccine companies and organizations. So, their – it is true they will have the
interim analysis.

There is a – but, will that allow you, then, to – say, you have six-month data
and (inaudible) no because no matter how much money you have, you are not
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going to change one thing. That (inaudible) is still going to (know) the same
way it did yesterday and 1,000 years ago and 4 billion years ago and 4 billion
– well, (inaudible) (not be long) but at least for another six months, (they still
don’t) work the same way.

Six months is still going to take six months. And there is – (nothing is going
to change that). And they will be lucky if they can get enough data to do this.
So, God bless them and I hope they do well. (Bless them). You don’t see any
of the others (chirping) about this. And, so, that is just – take it for what it is.
It’s inexperience. So …

Ira Loss: So – OK. You would be – you would – you would kind of view it as a – or
some of the posturing from, for instance, yesterday’s hearing in front of
Congress that this could be ready for the FDA by October, fourth quarter as –
I guess you could call it optimistic or ambitious.

Robin Robinson: These are – these are senior leaders at companies that, in some ways, are
trying to keep their jobs because they are producing at risk. Some companies
like (Merck) can do that because they have much more than just vaccines.
They can afford to do that the same way with Pfizer.

And, so, they can produce what they think because they only have one
candidate and they are moving forward with that in a very measured,
methodical way. That is the way that has always worked and has been
successful for them to become multi-billion-dollar companies that sells every
year many, many things.

And, then, you have companies that have never sold anything. So, it is what it
is. And you’ve got companies that have already – their CEOs have already
backtracked on what they said. They are not really a vaccine company. They
may have one vaccine that they bought 10 years ago and that’s to claim to be
in the vaccine business. OK? So, you have to be very careful about that.
And, again, that’s a lot of political posturing by some leaders at some of the
companies.

I do want to answer part of your question about pressures that they think that
they can put on FDA. And that is they have to be very careful because that’s a
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double-edged sword. If you say, “Oh, yes, we are going to have this all
ready” and everything and the FDA goes in and does the inspections and you
are not ready, well, then, not only is your vaccine maybe not make great
efficacy and safety (lines) but they can – (inaudible) not let it go (out) because
it doesn’t meet all the quality standards.

So, this is why we’ve always said – (inaudible) have said that it’s a really
tough road and the money the government has been spending on development
and manufacturing infrastructure is out toward that so that you don’t have
issues about (inaudible) (and produce) huge amounts of vaccine. And that – I
hope they are going to secure that part of the deal. But, enough said on that.

Ira Loss: OK. Here is another question from the emails. “What is the probability that
none of these first-generation iterations of the vaccine meet the FDA’s
efficacy requirements in seniors with pre-existing conditions or not deemed
sufficiently safe in seniors with pre-existing conditions to allow for
licensure?”

Robin Robinson: As far as the safety, I think that the probability of not being safe in any
population – in the seniors, too – is probably very, very unlikely that that these
are all going to be probably very safe. Whether they are going to be
efficacious – I think there will be some that will be more efficacious than
others and certainly in certain populations.

I think the recombinant protein vaccines with adjuvants are likely to be very
effective in older populations and those with comorbidities and immuno-
compromising diseases. We have seen this already over the past 20 years with
using the newer adjuvants with vaccines, specifically recombinant vaccines,
and they worked very, very well.

I mean, in fact, that’s one of the things that Sanofi and Novavax are using
with their recombinant protein vaccines or using adjuvants that have either
been shown to work in influenza vaccines over the last 20 years or have
recently been shown in the last year to be – in the pivotal phase-three trials to
be a big advantage in elderly populations.
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So, I think that there is a lot of hope for the elderly population with
diminished immune systems to be enhanced with these recombinant protein
vaccine adjuvants and similarly with the live attenuated (inaudible) vaccine
candidate from Merck, that that was – has been shown – that platform has
been shown to work to stimulate both normal healthy individuals but also
older individuals, too.

Ira Loss: OK. Here is another question. “How does 50 percent – a 50-percent positive
vaccine at six months compare to seasonal flu? And would 50 percent at six
months allow substantial relaxation of social distancing?”

Robin Robinson: The first part of that is how does this compare with seasonal influenza. I don’t
think you could compare it with seasonal influenza. I think that’s a wrong
comparison. I think what you’d say is compared to a pandemic influenza.
And let’s compare it to those individuals that do not have a previous
experience with influenza. And that’s because these – we don’t have
experience with this virus before in our immune systems. That’s the proper
one.

And what do you see? What you see is the influenza vaccines, especially with
adjuvants (that would) give you 75-percent efficacy and you saw with
adjuvants greater than 83 to 85 percent. And these were in children. And,
similarly, I would expect something very similar with some of these vaccines,
whether using adjuvants or very potent platform technologies like the live
attenuated VSV platform. Could you repeat the second part of your question
again, please?

Ira Loss: Yes. The second part was what does this – how does this – what does this do
for social distancing …

Robin Robinson: OK.

Ira Loss: … if you have a 50-percent effective vaccine?

Robin Robinson: So, if it were only at 50 percent, it would say that – so, herd immunity is
(derived) and you probably should (inaudible) mask and at least you maintain
a six-foot distance, which the rest of the world except the United States has
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been able to do. But, our – the way that we are wired – hot-wired is not
(inaudible) everyone in the country to be adherent to that nor will they be
adherent because of their – the way that they are wired. It wouldn’t matter if
it’s 100 percent. It won’t matter.

Ira Loss: Right. OK. Here is another (inaudible).

John Leppard: If I could – if could just follow up on that real quick. Would you be – just
given the time that it would take to reach herd immunity, what’s the level
efficacy/inoculation kind of duration when …

Robin Robinson: Now, you’re at – now, you’re at – that’s the right question. So, what you
would like to see is that you see upwards of 70 percent – say, 70-percent
efficacy and you see at least two-thirds to 80 percent of the population be
vaccinated. And so, then, you can start saying and start (inaudible) herd
immunity was contributed both by natural infection of those that have already
been infected or will be infected and was not immunized plus those that are
vaccinated.

Then you can start to see in the 2021 would be the time when we could
actually get that herd immunity up. And if it’s 50 percent, it’s just going to
take longer. That’s really what it amounts to.

John Leppard: Got it.

Ira Loss: Next question from the – from the emails. “Since AstraZeneca said that they
began phase-three trials abroad earlier this year, could they meet the six-
month safety observation requirement from FDA sooner than February and
March?”

Robin Robinson: No. Because they haven’t started those trials in the United States, and that’s
where those studies are – pivotal studies can use patients from other portions
of the world, but their pivotal study protocol wasn’t approved until July of this
year and it’s not going to start until August. And that’s when the clock starts
ticking. Good try, though. Good try.
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Ira Loss: OK. “How do you square what the CEO said that these vaccine companies
testifying before Congress yesterday suggesting the vaccines would be ready
for FDA approval by October if things go according to plan? Was this under
an EUA only?”

Robin Robinson: Now, it certainly has to be under EUA. But, that’s not what is going to
happen because the FDA has already said it’s going to take six months. So, if
you start trials in August that you (ride in to) the end of January – so, there is
– we haven’t – we haven’t been able to change compression of time with our
present technology. So, there is no – it’s not going to happen. Sorry.

Ira Loss: OK.

Robin Robinson: And (inaudible) WHO said it’s not – WHO didn’t say anything about that. So
…

Ira Loss: All right. “And do you anticipate a large portion of the population being
inoculated under an EUA per the CDC pandemic guidelines from 2018?”

Robin Robinson: Yes. The answer is yes, I do. I think when a vaccine is available and we –
and it has been communicated properly in January and February of next year,
then I think people will step up to the plate. And I think that we may actually
have wiser heads not only in our leadership but also in communities to say –
peer pressure is going to say, “Have you had your vaccine yet?”

And since moms are the primary caregivers in families, they are certainly
going to get their children vaccinated because they wanted to take care of their
children. And as far as their spouse, who cares? They don’t care because
they won’t – they won’t listen to them anyway. But, they will make sure that
their – the people they know and they have influence on – and as far as males,
all you’ve got to say is, “Boy, you really look good and healthy and
everything” but, yet, males have a hard time with this infection than females.
And it does kill people, too.

So – and not all males are really forthcoming with their true – their true health
or even know about it. So, their immortality, actually, may play really against
them – at least a perspective on that. So, ultimately, I think there will be
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preponderance and, hopefully, we are seeing more responsible people step up

to the plate. And I think that that will happen provided that we communicate
the importance of vaccines and the safety of these vaccines.

Ira Loss: OK.

John Leppard: (Inaudible) Dr. Robinson, about how many people might be in that first
tranche for which this would be initially prioritized? And would the second
component have to be – have to wait until the BLA is approved?

Robin Robinson: No. They won’t have to wait for the BLA (inaudible). No. It will still be
under the EUA. We are going to be under a pandemic declaration for a while
because we won’t have the disease contained. I mean people have that
(inaudible) in terms of just a mild thing that’s happening. No.

This is – this is the same time that (1980 and 1990) occurred with the
influenza pandemic (inaudible) the United States (saw). And, so, it’s a
pandemic. It’s like, “Wake up,” (what drugs have you been taking) – not to
think this as important because it – you (are responsible) (inaudible).

But, the second – the first part of that is do I think that the vaccines will be –
what number of people will be in that first group of high-risk individuals.
When we estimated it back in 2009, it was between 22 million and 27 million
people. And I think that’s probably grown just a little bit more.

So, you may see as many as 30 million people in that high-priority category.
And that’s a reasonable amount to get those first doses of vaccine out to –
through those – go to the nursing homes for the elderly and to other elderly
individuals and to people that are – have comorbidities and/or immuno-
compromised and the pregnant women, too.

I mean one of the benefits of the 2009 H1N1 pandemic is that, for the first
time, obstetricians and gynecologists (inaudible) pregnant women could be –
their lives could be improved by actually having influenza vaccination. And
certainly, we know that this would be true for this COVID-19 vaccine
campaign also.
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John Leppard: So, if I understand you correctly, that first tranche is for roughly 10 percent of
the population, at which point we’d be kind of – the other 90 percent is
(going) to be stretched out over – ideally into the second half of 2021 and
potentially beyond, if I understand you correctly.

Robin Robinson: Well, it’s not like the vaccines are going to be rolling out on July 1 of 2021.
(Inaudible) coming out week by week. And that’s what’s going to happen, as
you are going to see. The first – the first week is going to be 5 million doses.
OK? That’s going to be then distributed among the states to – and those are
going to be directed towards seniors. And the next week, there will be
whatever amount.

So, as you go progressively more, you’re going to have more vaccines and a
number of different (inaudible) vaccines available and (quantity-approved)
vaccines increase also so that probably the second half of next year you are
going to see there may be 25 million to 30 million doses going out that week.
And that’s not unusual.

That’s what we saw in 2009. By the time we were really rolling with it at the
end of 2009, we were seeing upwards of 30 million doses available per week.
And we expect with more candidates, that will be – that will be working and
big companies like Merck and everything being able to provide – and Pfizer
and Sanofi – I mean they are going to be rolling out tens of millions of doses a
week when these things really (inaudible).

But, some of those are not – they are not all going to be ready to be used at the
same time. They are going to be – there are going to be staggered as to when
(they are – have been approved) by the FDA under EUA to be used. So – and
that was – and that’s a little bit of what happened in 2009 when those vaccines
were available. If you remember, the first doses were available (inaudible),
the ones that were given children. Those were the ones that were available
first.

John Leppard: I see.

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Ira Loss: Dr. Robinson, we have used up our time. And I wanted to thank you on
behalf of Washington Analysis and our clients for all of your insights. You’ve
been very helpful once again. Thanks a lot.

Robin Robinson: (Inaudible).

Ira Loss: This concludes our call. Thanks to everyone for dialing in today.

Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for
participating. You may now disconnect.

END