Monkeypox Vaccines: Current Options, Considerations for Patient Education

Michael Ganio, PharmD, MS, senior director of pharmacy practice and quality, American Society of Health-System Pharmacists, discusses measures being taken to address the rise in monkeypox cases in the United States and reviews the efficacy of two vaccines.

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Welcome back to PopHealth Perspectives, a conversation with the Population Health Learning Network where we combine expert commentary and exclusive insight into key issues in population health management and more.

Hi, I'm Michael Ganio. I'm senior director of pharmacy practice and quality with the American Society of Health-System Pharmacists.

My job responsibilities primarily include things related to practice of pharmacy, so drug shortages, drug supply chain issues, sterile and non-sterile compounding, hazardous drug safety. A lot of those things come together when you think about operationalizing mass vaccination sites or deploying treatments to different areas. The pandemic response for COVID-19 and preparing for monkeypox have been within my wheelhouse and the team that I work with at AHSP.

How might the rising number of monkeypox cases impact pharmacies, manufacturers, or health systems more generally?

Currently, the rising numbers have been located in specific metropolitan areas, so the pharmacists in those areas may be impacted. There are immunization efforts happening across the country, but so far we're not anywhere near what we were experiencing with COVID-19.

As these numbers rise, more pharmacists are going to have to be familiar with the presentation of the disease because they're a very accessible health care provider and a lot of patients may come to them with questions. They may not be as directly engaged with immunization or treatment efforts initially, as one, the numbers are remaining relatively low, and two, supplies are relatively low.

There's been a recent emergency use authorization for the vaccines that will expand the number of doses available from the current vaccine supply, but we know there's more vaccine on the way. Since pharmacists have been on the front lines of the COVID-19 immunization effort, there's a potential for them to be involved in this effort as well.

In October, we are expecting a larger supply of vaccine, and that's when pharmacists could be more on the front lines of this, depending on how things go with the cases between now and then.

You mentioned this a little bit, but can you review the actions that are already being taken to distribute the vaccines and treatments?

As I mentioned, the government is ordering more of these vaccines. There are two vaccines available, and the one that is highly preferred is the JYNNEO vaccine. It comes with a significantly lower risk of side effects. Under the new emergency use authorization, one vial can now immunize up to five people, so the supply should extend even further than what was initially expected with one dose per vial.

The other vaccine is an option. It's not specifically approved for use to prevent monkeypox—it's a smallpox vaccine. But it does come with increased risk of side effects. It actually can shed virus. So for anyone who's living with someone who's immunocompromised or could expose the shedding virus to someone who's immunocompromised, it wouldn't be the best option. We're really looking at the JYNNEO vaccine as the preferred vaccine.

In addition to the procurement of more vaccine, as I noted, the emergency use authorization extends that supply up to five-fold. By giving 20% of the dose intradermally, there's a study from 2015 that showed similar immunogenicity, meaning that the antibody response was similar to a full subcutaneous dose.

Not every vial will get five doses, depending on the equipment we're using. We saw this with COVID-19. If we have loaded space volume syringes and needles, we should be able to get all five of those doses out. But it's also worth noting that for pediatric patients, the recommendation is to stick to the full 0.5 mL subcutaneous dose that's approved vs the 0.1 mL intradermal dose.

We obviously saw some big supply chain disruptions during the pandemic. The pandemic was more wide scale than monkeypox is right now, but given the lessons we learned there, how do you think the industry should approach monkeypox differently to avoid those problems?

There's a couple responses there. One is I would not anticipate anywhere near the supply chain challenges that we faced in the early phases of the COVID-19 pandemic. What we saw there was a very unique shortage situation that was the result of increased demand.

Normally, when we see drug shortages, it's a supply issue. There's some quality in manufacturing or something else that has affected the ability of the market to supply a pretty steady demand. What we saw during the beginning of the pandemic was a substantial increase in patients requiring mechanical ventilation. We were still learning how to treat these patients, so they were all being heavily sedated, a lot of neuromuscular blockade. We were intubating and putting them on ventilators much more quickly than we did later on in the pandemic. All that resulted in a huge increase in the use of intensive care unit drugs that are used for sedation and paralyzing patients.

That's not going to happen with monkeypox. It's largely treated outpatient. There are some cases where the patients are admitted, and that's usually for pain control more than anything else. To date, there have been no fatalities with monkeypox in the United States, though there have been a couple internationally. But it's not going to overwhelm the health care system. I wouldn't expect that huge surge in demand for any of these supportive care drugs.

The other thing we saw with COVID-19 was regional shutdowns around the world, and that was in response to the pandemic, to try to prevent the spread. Again, monkeypox is not spread the same way. It's intimate skin-to-skin contact. It could be through respiratory droplets with sustained face-to-face contact, but it's not going to be spread in the workplace. It's not going to shut down businesses and trade routes. We would not expect any further upstream disruptions to our drug supply chain.

That said, we clearly have a shortage of vaccine vs demand. I haven’t heard of any shortage of the primary treatment, tecovirimat or TPOXX. As the vaccine supply builds up, we should be in a situation where we're meeting the demand of the immunization and treatment effort.

The other thing to think about is the advancement in therapeutics that we saw with COVID-19 and how rapidly we're able to use relatively novel treatments like monoclonal antibodies. The monoclonal antibodies as a drug class have been around for several decades, but to use them in an infectious disease type of mass scale during a pandemic, this was absolutely breakthrough medicine. Could there be a role for something like that in monkeypox? We'll see. With the rapid development of therapeutics and the emergency use authorization process, perhaps there is a novel therapeutic that will come along that can be used to treat monkeypox.

Tecovirimat is currently not approved for monkeypox. It's a smallpox treatment. It is available through expanded access, the investigational new drug process through the Centers for Disease Control and Prevention. That does expedite the procurement of the drug, but it's still not as easily accessible as an emergency use authorization (EUA). The reason for that is normally when there's an EUA filed, there's some data backing the use of the product.

All of the companies that developed COVID-19 therapeutics or vaccines did reasonably large studies in the disease population. We really haven't had that opportunity yet for monkeypox. While an EUA for tecovirimat would streamline access, it would really limit the ability to collect data on how effective the treatment is and what kind of side effects are we looking for.

One of the other actions that the government has taken that I didn't really mention—trying to streamline that process as much as possible. The government has pre-positioned some supply and coordination with state and local health departments, at different pharmacies or health systems, so that it eliminates that last mile delivery to the patient. There's still paperwork that has to be filed to enroll a patient in the expanded access study, but at least the drug is pre-positioned in some of these jurisdictions that are most affected by cases so far.

You already mentioned a little bit about how pharmacists are going to have to approach practice differently in places where cases are currently spiking. What advice would you give them, regarding how best to approach patients about receiving vaccines?

The vaccine has mostly been available through health departments and not necessarily through your community pharmacies. That doesn't mean that a health department could not reach out to a health system or community pharmacy in the area to ask them to help in the immunization effort. But the vaccine is not being sent wide scale directly to providers or immunizers. At this point, if pharmacists are involved in the process, it's because they're at a health department, or a health system or pharmacy that's been engaged with a health department.

Because of the expanding vaccine supply we're expecting later this fall, pharmacists may become part of that immunization effort. They should become familiar with the vaccine. Even though their pharmacy's not stocking the vaccine and not administering it, they may get questions of, “Am I eligible?” or “What should I know about the vaccine?” It's a good idea to be familiar with both of the vaccines in case pharmacists get questions about both of them.

It's also a good idea to recognize that this is a novel administration technique that many pharmacists likely don't know. That doesn't mean we can't learn it alongside most of the other immunization workforce. Nurses and others who are administering vaccines are used to giving vaccines a traditional way. This is a novel technique that they'll have to learn as well. There's no reason any pharmacist can't learn this technique right alongside some of those other providers.

Is there anything else that you feel we missed today that you wanted to add?

I just think it's important for the public to know how critical the pharmacy workforce has been in the COVID-19 pandemic. It's a very accessible way to ask these questions and to understand the latest public health emergency. If patients have questions, the pharmacy is there.

The one thing that can be challenging for most of the pharmacies these days is the amount of strain on the workforce. We know that flu vaccines are coming, and we have a booster for COVID-19 shots coming that will include one of the new variants. The pharmacies are going to be a little busy, so just have some patience. If you're going into the pharmacy, recognize that they may not have the resources available, and just be patient.

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