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Monkeypox: The Virus & Vaccines
Monkeypox has increasingly become a public health concern as cases in the United States have grown rapidly in recent weeks and months. While the disease in most cases is not deadly, it still poses a serious risk to the population and the FDA is working to scale up an already existing vaccine for the most at-risk populations.
This week the FDA released a statement regarding its response to the virus: ““The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D. “We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test. The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available. We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate.”
Monkeypox is a virus from the same family of viruses that cause smallpox known as orthopoxviruses. While the virus in most cases is not deadly, it can be extremely painful and can cause complications that require hospitalization. Currently there is only one FDA-cleared monkeypox test that require a swab taken directly from a lesion.
The good news is there is already an FDA approved vaccine for monkeypox known as JYNNEOS, which is a live non-replicating vaccine using Modified Vaccinia Ankara (MVA). The vaccine is administered as a subcutaneous injection in two doses, 28 days apart. The FDA considers the vaccine safe and effective, even for people with immunocompromising conditions. The FDA has also recently approved close to 800,000 additional doses of the JYNNEOS vaccine to expedite available across the country. There is another vaccine known as ACAM2000 that could be viable and is readily available, however because it is a live replicating vaccine, it has far more complications including the potential to spread to other people.
While pharmacists are not permitted to administer the JYNNEOS vaccine at this time, it is possible or even likely that authorization could come. In the meantime, it’s a good idea to stay up to date on the signs and symptoms of monkeypox so you can counsel your patients effectively and provide the best resources for those who might be infected. You can find out more information about monkeypox and the effort to fight it from the FDA right here.