FDA Will Reportedly Change Dose Of Monkeypox Vaccine To Stretch Supplies

Topline

The Biden administration plans to issue an emergency declaration as soon as Tuesday afternoon to allow healthcare workers to extract five vaccines from a one-dose Jynneos monkeypox vaccine vial by changing the method of administration, according to multiple outlets, in a move the White House hopes will help the U.S. combat a limited supply of vaccines as monkeypox cases climb.

Key Facts

The Department of Health and Human Services will issue the declaration to allow the Food and Drug Administration to authorize the new method, the New York Times reported, which involves injecting one-fifth of the vaccine intradermally—or into the skin—instead of the full dose subcutaneously, or underneath the skin into the fat.

The FDA first announced last week that it was considering the strategy—which it referred to as “dose sparing”—and said it would make a decision on whether to adopt the method in the coming days.

FDA Commissioner Robert Califf noted last week the new method—which is used for several other vaccines including tuberculosis—is not “highly unusual,” and called it a “promising approach” as the U.S. struggles with vaccine shortages.

The new method will not sacrifice the “safety and efficacy” of the vaccine, Califf said last week, and the Times reported officials have consulted with outside infectious disease groups about the move, though some experts raised concerns to the outlet the decision was based too strongly on one single 2015 study funded by the National Institutes of Health.

The change in methods comes after Biden officials have faced criticism for what some critics view as a sluggish rollout of the vaccine.

News Peg

As of last Monday, the U.S. had 8,934 confirmed cases of monkeypox and orthopoxvirus—the class of viruses that monkeypox belongs to—across every state except Wyoming, according to the Centers for Disease Control. That’s a jump of more than 1,000 cases from the week prior.

Key Background

The White House declared monkeypox a public health emergency last week in an effort to streamline resources to tackle the outbreak. The Biden administration has shipped more than 602,000 monkeypox vaccines to date and has about 1.1 million available, though that’s only one-third of the amount needed for the estimated population at highest risk in the current global outbreak: men who have sex with men, and in particular, those with multiple sexual partners. The U.S. is reliant on a small Danish biotechnology company, Bavarian Nordic, for the Jynneos two-dose regimen vaccine, the only shot approved by the FDA for monkeypox. The Biden administration has faced a backlash for taking too long to place orders from the company as the outbreak emerged and for letting its Strategic National Stockpile of the Jynneos vaccines dwindle. As a result, local jurisdictions have taken matters into their own hands, declaring public health emergencies and delaying the second dose of the vaccine to ensure more people can access the first shot as supplies are stretched thin.

What To Watch For

Some 150,000 doses of Jynneos are set to be released from the Strategic National Stockpile in September, health officials said last week. After that, more vaccines aren’t expected until October, according to reports.

Further Reading

U.S. Moves to Stretch Out Monkeypox Vaccine Supply (New York Times)

Limited monkeypox vaccine supply would be stretched under FDA plan (Washington Post)

Monkeypox Vaccines: Here’s How Many Have Been Shipped And Where As White House Declares Public Health Emergency (Forbes)