Exploring Current Response and Unmet Needs for Monkeypox: A Q&A With David E. Koren, PharmD, MPH, BCPS, AAHIVP, FIDSA

Monkeypox was declared a public health emergency on August 4, 2022, with response efforts made by HHS since then aimed at increasing the availability of vaccines and treatments, such as tecovirimat (Tpoxx), for the disease.

The outbreak in Europe and the United States has slowed in recent weeks, but several needs remain unmet regarding accessibility of these preventive therapeutics; in addition, misconceptions persist on which individuals are at risk, noted David E. Koren, PharmD, MPH, BCPS, AAHIVP, FIDSA, infectious disease clinical pharmacist at Temple University Hospital.

Having spoken with The American Journal of Managed Care^® (AJMC^®) recently on at-risk populations and educational efforts needed to address the outbreak, Koren spoke with us again to give an update on current preventive efforts being made in the United States and what further steps are needed to protect those most at risk.

AJMC^®: Can you provide a general update on the current response to the US monkeypox public health emergency?

Koren: There has been a tremendous effort from the federal government to educate the public about monkeypox. As soon as it was declared a public health emergency, we’ve seen increased messaging, the establishment of a White House coordinator for monkeypox response, and directed campaigns to people most at risk.

It is of note, however, that while men who have sex with men (MSM) may be the most affected  (statistically) now, they are not the only ones at risk. I think that while there were directed messaging campaigns to begin with—and I think those have been quite effective—there are still communication disparities to reach remaining at-risk persons that we need to address. We need to make sure that we get vaccines into the arms of the people who need it the most and who may not be as well accessed by the existing health care system.

AJMC^®: Can you discuss access of monkeypox vaccines to at-risk MSM populations and barriers observed here?

Koren: I think what's interesting is that we've seen huge amounts of disparities in terms of different locales. In New York, there was a tremendous effort very early on in getting vaccine supply, but that wasn’t the same everywhere. Now, we’ve reached the point of vaccine implementation. Public health departments are getting vaccines into interesting nontraditional spaces, though we're not necessarily getting enough vaccine to at-risk persons.

To clarify, we're reaching people who are well connected to health care, e-mail, internet, etc, but we may not be reaching the most vulnerable of our society.

AJMC^®: What are some of the creative approaches you’ve observed in improving accessibility to monkeypox vaccines?

Koren: Chicago, very publicly, had a mass vaccine event in a gay men's bathhouse, a known area where there is transmission risk. By making things accessible, we meet people where they are and perhaps access those who wouldn't have received directed messaging otherwise.

In my home city of Philadelphia, while we haven't been that unorthodox, we’ve partnered with various community groups and spaces. In doing so, we're sharing responsibility so that different people can access vaccines in different ways.

That being said, while there still isn't enough vaccine to go around, the total amount has increased because of studies done by the CDC changing delivery from a subcutaneous to an intradermal injection, exponentially increasing the reach of existing vaccines.

There’s good and bad news here: good, because we can significantly increase the amount of existing vaccine doses because only one-fifth of the existing vial is needed; however, this may be bad because an intradermal vaccine administration generally causes a visible bump on the skin, which, while self-limiting and will subside with time, may be stigmatizing.

We have to then ask, would anyone be averse to receiving vaccine because of this reaction? Especially when there’s stigma surrounding monkeypox as a whole. Although some patients may be unaffected by the reaction, others may not.

AJMC^®: How has Tpoxx had an impact on our treatment of monkeypox?

Koren: Tpoxx is a medication that has been in development for known activity against smallpox, a related virus. Recently, we have seen a mass mobilization of Tpoxx, and with all due credit to the CDC, the process for accessing this medication has been tremendously streamlined.

During this public health emergency, we need to continue to ensure mass/rapid availability while still monitoring for safety and efficacy. As of September 2022, there is still CDC paperwork required for each patient—for epidemiologic, safety, and efficacy reasons—but direct access is conducted through a local or state public health department.

In my home city of Philadelphia, we now have prepositioned supply in local hospitals. While appropriate CDC paperwork is still conducted, we can get medication into the hands of people faster, for better effect.

AJMC^®: As HHS seeks to improve the availability of the Jynneos vaccine and Tpoxx nationwide, what issues continue to impede access?

Koren: This is really a problem of supply and demand. There just isn't enough of the Jynneos vaccine nor Tpoxx. While production has increased, these things take time. At least with Jynneos, we took the evidenced-based step of switching from the subcutaneous to intradermal delivery, which extends the available supply given the lower needed dose.

Tpoxx is a little bit more difficult because we want to urgently get affected persons medication before significant complications develop. That being said, once medication is dispensed, we, as pharmacists, can’t take it back if a diagnostic test comes negative per se. We, as a health care community, are doing our best to get medication into the hands of the most at-risk for complications, such as those with immunocompromising conditions (such as persons who've undergone transplants, people living with HIV, pregnant women, etc)—not in a rationing capacity—but recognizing that certain persons may have a worse course of the disease due to a comorbidity.

AJMC^®: With announcements on vaccine accessibility being relayed over social media and online, what efforts are being made to reach individuals who don’t have access to these technology platforms?

Koren: Efforts to reach those without technological access is unfortunately haphazard across the country, simply due to funding capacity. What we need to ultimately see is significant investment in and empowerment of our overall public health infrastructure, which is a lesson we should have learned during the COVID-19 pandemic. Through these actions, we will be able to deliver public health in an equitable fashion across the country.