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Last week, Pfizer in collaboration with German firm BioNtech
announced results of early trials of its messenger RNA Covid-19 vaccine. The
company announced to the press—but not yet through peer-review journals—a 90
percent effective rate for the vaccine, which was far beyond industry
expectations. The vaccine has limitations in the way it is produced and that it
must be stored at extreme subzero temperatures. Cambridge, Mass.-based drug
company Moderna on Monday announced similar efficacy rates for its own mRNA type
Covid-19 vaccine. The company also announced results to the press, and neither
Pfizer nor Moderna has made holistic data available to review. However, two
trials with similar efficacy results bodes well for paving a pathway out of the
Covid-19 pandemic. BTN editorial director Elizabeth West separately spoke with three
senior medical officers at travel risk, safety and security firms Global
Guardian, Healix International and International SOS to get their reactions.
Only the Pfizer vaccine trials had been announced at the time of the discussions,
but some executives also spoke of upcoming drugs from Moderna and other
BTN: What is your first-blush reaction to Pfizer's
early results from its Covid-19 vaccine trials?
Global Guardian medical director Dr. Shelly Weisenfeld: I heard about it first, much like everyone else did, via a CNN newsflash.
Initially with the 90 percent success rate, there was immediate cynicism. I'm
still in academia. It really matters what the data shows. Recognizing it wasn't
peer-reviewed seemed like a false advertising. I need to see the data, and it's
not substantiated until it's reviewed by folks dissecting the data to see if
its real and valid and reproduceable. It goes into biostatistics: What was the
patient population, and what was the exclusion, and how can we take the data
and extrapolate to the community at large? They didn't disclose that in the
Healix International chief medical officer Dr. Adrian
Hyzler: I do feel we've been given a snippet of news that is remarkable,
and we've heard the [Pfizer] CEO talk with amazing jubilance. Whatever anyone
says, the company that got there first will have that badge and will always have
that badge. I think that is one of the reasons why this has its limitations: It
has to be stored at a temperature colder than the North Pole, and the vials
contain just under 1,000 doses in a bottle. Anywhere that is going to
distribute this vaccine [will] have to be prepared to give that out. Once you
take it out of the ultra-cold storage, [there's] five days to distribute the
thousand doses. They've forgotten about the individual little vials that would
slow down production enormously [and took a pass on] getting a more stable
lipid around the mRNA that would make it more transportable. They've just gone,
'Listen, let's just get this out.' I believe the Moderna vaccine can be stored
at warmer, more accessible temperatures. [Editor's note: Pfizer's must be
stored at -94 degrees Fahrenheit. Moderna's, now announced, must be stored at -4
degrees Fahrenheit]. It's the same kind of vaccine. Great that Pfizer got it
out there; literally, amazing results. But there are still things to think
International SOS SVP & global medical director Dr.
Robert L. Quigley: I was thrilled. Like everyone else, I can see pandemic
fatigue in my own life. We need a catalyst to get us back to normal commerce
and normal life. I was a little surprised; I'm a doctor of immunology. I was
surprised to see efficacy up in the 90 percent range. I'm not alone in that.
Other colleagues have the same reaction. Almost unprecedented it's that high.
But I'll take it. If the trial at Phase 3 that's coming to completion [in
several weeks] continues to indicate that efficacy, I'll take it. It will boost
confidence of those who want to travel but also get us to herd immunity. I'm
very optimistic about that, but also realistic about the next steps.
BTN: Everyone's excited about this particular
vaccine, but others are coming up. What are your expectations?
Weisenfeld: To a certain degree [the Pfizer vaccine]
may be dead in the water: First, it's two doses. One-third of the population
wouldn't even get the first vaccine for a variety of reasons, much less
capturing a population to take the second one. Second, the bigger logistical
barrier is the temperature thing. It's paramount because we cannot safely
transport that vaccine under its own quality maneuvers. The refrigerator to
take it down to that degree—not even all academic facilities would have that
refrigeration. Certainly, community-based facilities [wouldn't have that]. This
is an RNA vaccine, which means it's easy to produce, and it hit that Phase 2 and 3 clinicals quicker
than some of the others. I think the other vaccines will catch up. From
the pragmatic standpoint, I believe we are going to look at a traditional
vaccine like we had with H1N1 [as opposed to an RNA-type vaccine].
Hyzler: The fact that it's an mRNA vaccine is hugely
significant. [Editor's note: The Moderna version also is an mRNA-type vaccine.
No mRNA-type vaccines have ever won approval for use by a federal
administration.] We have a snip of genetic material that tells the muscle cells
in the body to make the [Covid-19] spike protein. You are not putting the live
virus in the body. Some vaccines are attenuated live viruses. Some are bits of
dead virus. This is not. The real amazing thing about this is that it can be
made quickly and in huge amounts, and we don't know of any safety issues yet. Also,
if you get a mutation, it's easy to tweak the RNA to incorporate that mutation
and you won't need to go through the clinical trials again. This is a proof of
concept. Assuming it all goes through, it will be amazing for other diseases
Quigley: Operation Warp Speed [in the United States]
and Covax, a global initiative, are working in parallel. We have a lot of
European and American pharmaceutical companies pushing to get their products
out. Pfizer's announcement was well-received and may encourage other
competitors to come forward. Warp Speed and Covax have to decide which vaccines
to use and how to make that decision. The more efficacious the vaccine, the
more we will want to invest in that, but are these companies capable of
producing the quantities required? I'm going to speculate that other vaccines
will be utilized. Because I don't think the capabilities of production [of the
Pfizer vaccine] are such that we could get the hundreds of millions of vials in
the timeframe that we like. So there will have to be other types of vaccines
that are prepared differently. Of course, we are hoping the efficacy will be
competitive with Pfizer.
BTN: To stop a pandemic, everyone needs access,
though, not just wealthy countries. How does this work?
Weisenheld: In the geopolitical context, [we have to
ask] how can we provide this ethically, how can we allow [access for] other
countries that may not have the economic resources to buy and distribute the
vaccine when they are more limited in their infrastructure. The whole equality
thing is emerging in this wake—and this is great. It needs to be addressed.
That will require more cooperation and an aerial view of health, global policy
and public health. Operation Warp Speed, at least domestically, had some
foresight. Companies are spinning up manufacturing just waiting for the switch
to be flipped. But then you have to decide who gets the vaccination first.
There are a few models out there. Whether it's tiered or phasing, the front
lines will get the vaccine first. I think most people would understand this is
reasonable. Then they'll tier out to the most vulnerable: institutions, nursing
homes, prisons. They'll immunize room to room in the hospital setting because
those patients may be at risk.
BTN: Is there any chance that a company would be able
to get it for their workers? Like a flu shot day at the office or manufacturing
Hyzler: We've had a number of organizations contact
us to say, 'Hey, listen, can I get this vaccination for our company?' It would
be too sensitive if Pfizer were to give vaccines to some multinational
corporation. I don't think it's possible in the early stages when everyone is
keying up to give to vulnerable people and trying to save lives. Selling to
companies to try and promote business—I don't think there will be a private
market auction at this stage. A number of organizations—Pfizer for sure—have
said this is not for profit, just recouping their costs.
Quigley: I never cease to be amazed by the human
species. But ISOS has always been very respectful of regulations, guidelines
and mandates. The bottom line is that we cannot intervene or jeopardize
whatever the government has in place.
Weisenfeld: I don't see that happening. It will be
several months after the vaccine is released and manufactured to scale before
it would even become available to the business travel population at large. When
you take that perspective, it's a lot longer than current messaging would lead
you to believe.
BTN: How will we see vaccinations impact business
travel and freedom of movement across borders?
Quigley: We'll see an evolution of what we have
already seen. We'll see airlines or destinations require certain documentation
before you get there. A demonstration of vaccination might be your passport to
enter. I can see that happening in what I've seen countries trying to control. …
It will take some time to get to the point, but it might be your requirement to
have this to cross borders. Domestically, I don’t know. It would behoove most
people to get the documentation.
Weisenheld: Internationally, we will have something
like a passport with immunization—something to show that you've had the
vaccine. I hope that we are all agreed on the same vaccine and efficacy so we
can have the same language on it. I sense that will take a lot of time to work
out. I think it will happen within two years.
Hyzler: It will be a while before the vaccine can
feed through to reduce quarantine times. Some vaccines may not be accepted by
certain governments [as effective enough]. We'll have to see standards and
agreements on those solutions as well. In terms of stimulating business, I
could see vaccinations playing out at the country level—[for those] able to
vaccinate en masse. Say a country like Finland, a real leading light in how
they have handled the pandemic. They are in an incredibly good situation and
keeping a lot of the country working. As a country of 5 million, could they get
enough vaccinations to two-thirds of their people, which is what is needed,
including vulnerable people? If so, they could then say, 'We're open. Come to
Finland.' From a country point of view, we get to see a difference. Rather than
a large tranche of businesspeople saying, 'Look at my app; I'm vaccinated.' Some
countries will be in a better position on this than others, and it could
benefit them economically.
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