Government AffairsReality check: travel medical experts caution against taking data of vaccine manufacturers at face value.

Vaccines promising, but temper your enthusiasm

By
|
Experts believe it will take months after the vaccine is released and manufactured to scale before it would even become available to the business travel population at large.
Experts believe it will take months after the vaccine is released and manufactured to scale before it would even become available to the business travel population at large. Photo Credit: Getty Images/nevodka

Pfizer in collaboration with German firm BioNtech recently 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% 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 also 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 pharmaceutical companies.

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% success rate, there was immediate cynicism. I'm still in academia. It really matters what the data shows. Recognising 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 media release.

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 about.

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% 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 manoeuvres. 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 too.

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 utilised. 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 immunise 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 plant?

Hyzler: We've had a number of organisations 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 organisations—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 jeopardise 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 immunisation—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.

Source: Business Travel News

JDS Travel News JDS Viewpoints JDS Africa/MI