Biden Admin Making $3.9 Billion Gamble on Vaccine for Monkeypox

The Biden administration is hoping — potentially to the tune of $3.9 billion — that a vaccine designed to prevent smallpox can work to save lives against the monkeypox outbreak, sending it out without human trials.

Some experts say this unprecedented push equates to saying, "Take this vaccine for monkeypox, so we can see if it works."

"Do we think that this vaccine is safe? Yes," UCLA epidemiology professor Anne Rimoin told Politico. "Do we think that this vaccine will provide some protection, in particular against severe disease and death? Absolutely.

"Is it going to provide protection against infection and transmission? That we don't know."

There have been studies done by the vaccine's Danish manufacturer to show it works against monkeypox in animals, but there have been no human trials now, according to the report.

"The Jynneos vaccine was approved by the FDA with very, very little data compared to other vaccines, and absolutely no clinical efficacy data," Johns Hopkins' International Vaccine Access Center Executive Director William Moss told Politico. "This is a very unusual circumstance."

There are "outstanding questions" regarding the efficacy in humans for the two available vaccines — ACAM2000 and Jynneos — Emory University professor Boghuma Kabisen Titanji told a recent American Public Health Association briefing.

"How effective are these vaccines against monkeypox?" Titanji's slide read, Politico reported. "How durable is the immunity they confer? Will boosters be needed? If yes, how soon?"

The fact the monkeypox is still a rare disease makes it even tougher to clinically study, and the Centers for Disease Control & Prevention noted uncertainty for the future of the U.S. outbreak.

"There hasn't been enough disease to know at what point you are at risk again," National Institute of Allergy and Infectious Diseases Associated Director John Beigel, who will be designing clinical trials, told Politico. "We don't know the duration of protection."

Monkeypox can cause flu-like symptoms, a painful rash and scarring. More than 19,400 Americans have been infected. And the World Health Organization has noted "breakthrough" infections in vaccinated people in Europe, according to the report.

"We don't know exactly how effective this vaccine is in the real world," Stanford University Dr. Abraar Karan told Politico. "How well does it work? What does it do? What doesn't it do? How well does it stop viral shedding versus severe disease versus risk of getting infected at all?"

The White House asked Congress for $3.9 billion in emergency funding for the monkeypox outbreak, which includes studying vaccine efficacy.

• US Monkeypox Cases Are Declining
• US Govt to Provide $11 Million for Production of Monkeypox Vaccine