The United States Food and Drug Administration (FDA) has issued an emergency use authorization that will change how the Jynneos monkeypox vaccine is administered in an attempt to stretch out supply amid high demand.
The decision made on Tuesday will allow the vaccine to be given to high-risk adults intradermally, which means between the layers of the skin, rather than subcutaneously, or under the skin. This would allow providers to get five doses out of a standard one-dose vial to increase "supply."
Monkeypox Vaccine Authorization
The new authorization will also allow subcutaneous vaccination in people under 18 years old who are at high risk of infection with monkeypox. The decision could increase the number of vaccine doses in the national stockpile from 441,000 to more than 2.2 million, said officials.
However, the EUA is not going to be a panacea as the monkeypox outbreak continues to grow and vaccine demand remains high. The Centers for Disease Control and Prevention (CDC) has estimated that at least 1.5 million Americans are eligible for the two-dose vaccine, as per CNN.
The White House's assistant national response coordinator, Dr. Demetre Daskalakis, on Tuesday said, "I think we're going to see that we will likely still run out of vaccines before we run out of arms."
In a report, the CDC revealed that 9,492 probably or confirmed monkeypox cases were reported in 49 states, Puerto Rico, and the District of Columbia as of Tuesday evening. FDA Commissioner Dr. Robert Califf said that in recent weeks, the monkeypox virus has continued to spread at an alarming rate.
According to CNBC, the Jynneos vaccine is the only FDA-approved monkeypox vaccine available in the United States. Typically, the shots are administered in two separate doses, 28 days apart.
Spreading Outbreak
Califf added that there was no data on how well the vaccine prevents disease because there were no smallpox cases and monkeypox outbreaks have been small in the past. The director of the CDC, Dr. Rochelle Walensky, added that the public health agency is launching various studies to collect real-world effectiveness data as the shots roll out across the country.
People in the U.S. have struggled to get appointments for monkeypox vaccine shots with long lines outside of clinics across the nation. The recent outbreak is the largest in the world and forced Health and Human Services Secretary Xavier Becerra to declare the outbreak a public health emergency last week.
While monkeypox is rarely fatal and no deaths have been reported in the U.S., it can cause lesions that can be very painful for the victims. Some patients even require hospitalization to manage the pain they feel from the infection.
The situation comes after protesters demanded swifter actions from the government to address the monkeypox outbreak and the lack of vaccines available to people across the country. Demonstrators gathered on Monday afternoon outside San Francisco's Federal Building.
They chatted and carried signs that read "vaccine access now" and "TPOXX now" and were organized by groups including the HIV Action Network and the Harvey Milk LGBTQ Democratic Club. The protest was meant to raise community awareness regarding the outbreak, CBS News reported.
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