January 20, 2021

Drug Topics®: Hi, I'm Gabrielle Ientile with Drug Topics®. Today I'm speaking with Naomi Lopez, director of healthcare policy at the Goldwater Institute.

Naomi is discussing the rollout of coronavirus disease 2019 (COVID-19) vaccines, expediting the authorization of vaccines already being administered in other countries, and the importance of allowing pharmacists to practice at the top of their license.

Naomi, you are director of healthcare policy at the Goldwater Institute, and you have expertise in a diverse range of health care issues, so I'd like to start with your professional background. And if you would, your work as director at the institute as well.

Lopez: Yes, so I've been involved in federal and state health care policy for about 25 years, and organizations in Washington, DC, and around the country at the state level as well. I've been with the Goldwater Institute for more than 5 years where I've focused on FDA issues such as off-label communication and right to try, as well as state level supply side healthcare issues.

Drug Topics®: Great, thank you for that background. So, our topic today is the US rollout of COVID-19 vaccine.

The federal government's Operation Warp Speed (OWS) has recently changed its recommendations, telling states to expand vaccination to all people 65 and older and those with comorbidities. And then according to the CDC, the total number of administered doses is estimated at 12.2 million.

And you recently wrote a piece about private industry being able to improve vaccination rates. So to dive in here, how is the current model of administering vaccine to Americans falling short?

Lopez: Well, keep in mind that this is the first time that an effort of this scale has been attempted. And it certainly is a large undertaking with a lot of logistical complications, so I do want to say that I think overall, we've seen some stumbles, but I don't think that they were totally unexpected given the magnitude of what is being attempted here.

But I do think that there is plenty of room for improvement. For example, pharmacists are educated and trained to administer vaccines, and there are some steps that states can take in order to allow their pharmacists to administer the COVID-19 vaccine. Unfortunately, at the state level, some states only allow for pharmacists to vaccinate for FDA approved vaccines. And as we know, the COVID-19 vaccines are under emergency authorization, which is not a full FDA approval.

So what I advocate is that states really unleash this workforce that's already educated and trained to do this very task in order to help assist in this effort much sooner. In addition, there are some other steps that can be taken. For example, while it is recommended that both doses be taken in about 3 or 4 weeks’ time, there is some reason to believe that the US federal government should not hold back a second dose and allow the complete supply of vaccines to be administered, because the evidence shows that there is some protection given with even a single dose. Now that's not a that's not a medical recommendation that I'm making. That is one that is established and available in the documents that the FDA evaluated from the clinical trials from both the Pfizer and the Moderna vaccines.

In addition, that we also know that there are a couple of vaccines that are waiting for emergency approval that already been used in other countries. There's really no reason why we should have to wait weeks, in order to evaluate and grant emergency authorization for additional vaccines that have already gone through the value clinical evaluation process. They likely meet the standard for emergency authorization. And that can end these meetings to establish and approve should be done taken immediately. The amount of time that it takes to evaluate the evidence should not take this long.

As we can see from other international examples where the data is evaluated on a rolling basis, as soon as the data comes in, the governments are evaluating the data. They don't wait until the end to do it.

There really are some areas where we really can continue to speed up the vaccination of Americans, which is becoming tremendously important now that there's a variant of COVID-19 that seems to be even more contagious.

Another step that can be taken is we're hearing, very disturbingly, that because of this recommendation, that certain populations are prioritized, which, it's understandable. You want your frontline workers, your physicians and hospitals and the elderly to be vaccinated first, of course, there's people who are at higher risk.

But the idea that if you have some vaccines sitting around, they need to be used. There's a timeframe that they have to be used. They should be used on any one who’s willing to get the vaccine, as long as it's reasonable medically for them to do so instead of having to follow this understandable list of priority prioritization list, if there simply isn't any one available that's on that list, anyone should be able to do take vaccine as well.

So there are some important steps, I think that we can continue to add to the protection of the of the US population as we move forward.

Drug Topics®: I just wanted to follow up real quickly on one thing that you said with throwing away of vaccines. I'm just interested, are there numbers that people are putting out on the amount of vaccine that is not being used?

Lopez: Yes, so there are reports coming out from several states that have had incidents where the vaccines were actually pitched, because these ones, you have to use them within a certain amount of time. And there weren't people that were in the what are called the A1 or AB list of priority, that were still wanting the vaccine or available to get the vaccine at that time. And so those vaccines went to waste.

And there are also anecdotes, which I think are very positive, where people made the decision that look, these are going to go to waste, so we're just going to vaccinate anyone that's able and willing to take the vaccine now. So you've got both examples out there.

But I think the example of providing if you don't have someone in the top tier group that's available to take the vaccine and you absolutely use the vaccine, don't let it go to waste.

Drug Topics®: So you mentioned expanding pharmacy scope of practice. Some jurisdictions in the United States have noted pharmacy as a real asset amid the pandemic and have expanded their scope of practice. What have some of these changes been and what are we seeing? Are they showing that expanding pharmacists’ scope of practice is really working?


Lopez: Oh, absolutely. A lot of governors followed the federal flexibilities that were provided early on in the pandemic, as soon as there was a public health emergency declared on January, I believe, January of last year by the secretary of Health and Human Services (HHS). The department created federal flexibilities and pharmacy was one of them, it was one of those areas where the federal government said that they would reimburse for Medicare, Medicaid, and in the State Children's Health Insurance Program. Patients for things like COVID testing for pharmacists to do those.

And so what a lot of states did is they followed that recommendation. And under, usually, under executive order, governors also followed that as well for the entire population. And so they expanded pharmacist scope of practice so that they could be allowed to do things like COVID testing, and for some states flu testing as well.

In addition to that, a lot of states also allowed pharmacists who are in good standing to come into their state, and also provide those pharmacy services. And as we know, the demand for skilled healthcare workers was changing very dramatically, where there are hotspots, they were in desperate need of more healthcare workers. And so that really worked out very well for a lot of states that did expand that scope.

I argued that because pharmacists are educated and trained in this area, this is part of pharmacy training, that they should be allowed to do this all the time, not just during an emergency. What's good policy and emergency is good policy all the time.

And we know that the demand for vaccines is not going to go away as soon as the pandemic ends. The reason is that a lot of people have not been keeping current with their vaccines, because they've been avoiding going into healthcare settings. They've been avoiding going and in keeping up with their routine health care in some cases, and so we're already seeing declines and other vaccine areas. And we've really got to, I think reexamine why there's limits were imposed, and why is that good policy to allow healthcare professionals to practice at the top of their education and training?

Drug Topics®: Absolutely. I also wanted to follow up with these declines in vaccination rates that you talked about overall, and also a noticeable lack of public confidence in vaccines. So how would expanding of scope of practice for pharmacy, how are pharmacists equipped to tackle these critical issues and then going forward beyond the pandemic as well?

Lopez: So we knew from Gallup surveys, that there is an enormous amount of trust that people have in their pharmacists and their community pharmacists and their neighborhood pharmacists. And so I think that there is an important role for pharmacists to play in the educational effort of vaccines.

With the COVID-19 vaccine, unfortunately, so much of this has been politicized. And that's been a real detriment that we're now seeing where the message that the FDA was not cutting corners, they were not skipping steps. And unfortunately, OWS was, I think it has a very unfortunate name as well. And but the reality is that there were a lot of time delays that were eliminated that a normal vaccine would normally go through.

In addition to that, the trials were being run, in some cases, concurrently. Phase 1 is basic safety, phase 2 is safety and efficacy. And then phase 3 is, because the FDA continue to monitor safety, of course, and even after approval, you want to continue to monitor safety. But phase 3 is much larger scale. And some of these phases were being run concurrently. So that also cut down on the amount of time that was needed in order to reach the emergency authorization.

As we know, this is not a full approval, but there is a lot of skepticism and with this particular vaccine, and unfortunately, like I said, this has been so politicized on both sides of the aisle that I think we're really seeing the detrimental result, especially when you have workers in nursing home settings that are declining the vaccine, workers in hospital settings that are declining. These are the people on the frontline, caring for the most vulnerable. It's unfortunate to see that but that's the reality that we now face

Drug Topics®: Wrapping up here. Do you have any biggest takeaways that you want our audience to take out of this discussion?

Lopez: I think the really big news is that we're actually administering a vaccine in less than a year. That is historic, it's never been done that quickly. And these are both incredibly effective vaccines based on the preliminary information upon which emergency authorization was based.

FDA officials will talk about they were hoping for 50% efficacy, we're talking about efficacy so far in our 2 vaccines that exceed 90%, we're looking about 95% efficacious rates.

And so we really are looking at 2, just extraordinarily effective and fast vaccines that, there were there were a lot of doubters that this can even be done. I will like I would like to mention that Pfizer, at the very beginning of the pandemic, opened up their platform for other scientists and researchers to collaborate. This was part of the story that we will, I think we will be telling in years to come and looking at as a model for future medical innovations.

I think that we've got to keep in mind that this is a tremendous operation with a lot of moving parts, very complicated logistics. And the idea that there have been stumbles should not be unexpected.

But I do think that we're seeing dramatic and rapid improvements in the deployment and administration of vaccines across the country. This is getting better, it's getting better much faster. And the next way to help make it become even more effective is to not delay the emergency approval of additional vaccines, particularly those that are waiting for emergency authorization that don't require cold temperatures that don't require multiple doses.

The biggest one is the vaccine that's now being used in the UK that was developed by Oxford University and pharmaceutical partners. That one is already being dosed in the UK and has been, I believe, for at least a couple of weeks now. It is on the schedule to be evaluated by an emergency authorization by the FDA. But you still got to wait a couple of weeks.

And the idea that you’ve got a vaccine that has been used for weeks, where in another country they've been evaluating the evidence on a rolling basis, really, I think is a model that we need to adopt here. There's no reason why in an emergency, there should be these long timelines, especially considering that the technology to create the vaccine is much faster than it used to be.

The next fastest vaccine that was ever approved took 4 years, we're looking at a vaccine that's actually being administered in less than 1 year. A lot of the reason that it's happened too fast is because the development is actually much faster. We have new technology that really wasn't even available a decade or 2 ago. For example, the Modrena vaccine was actually created in a weekend before the first confirmed case in the United States. There's no safety or efficacy established at that point, but think about what it would have made if the Moderna vaccine could have been trialed much faster and could have, say, gotten emergency authorization in the summer.

We really do have to go, once this is all over once we're past the crisis, we need to really take a look back and really acknowledge the fact that twenty-first century medicine has evolved well beyond the regulatory evaluation system that's currently being used. We have better tools, better technology, better information, and we should use our most advanced capabilities in these cases.

Drug Topics®: Naomi, thank you so much for taking the time to speak with me today. I really appreciate it.

Lopez: It's my pleasure. Thank you.

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