US declares monkeypox a national health emergency, as new drugmakers consider entering vaccine race
Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.
The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.
Stephen Hoge, head of R&D efforts at Moderna, said in the company’s Q2 call that the company has kicked off a research program and is tracking that effort closely.
“Obviously given the recent public health announcements and increasing concern about the availability of vaccine supply, we are beginning to look at what it would take for us to use our platform to provide a monkeypox vaccine,” Hoge said on the call, adding that the program is still in preclinical development.
Meanwhile, Tonix Pharmaceuticals, which has been researching a monkeypox vaccine for nearly a decade, will “look at expediting” its US development plans “in light of the HHS declaration,” CEO Seth Lederman told Endpoints News shortly after the US declared a public health emergency.
Last week, the biotech said it would test its live virus vaccine in collaboration with Kenya Medical Research Institute in a clinical trial in the first half of 2023.
While the biotech could ramp up its timeline for testing in the US, Lederman cautioned that he doesn’t see an emergency use authorization pathway for Tonix since Jynneos was already approved for monkeypox in 2019.
Bavarian Nordic said earlier this year that it has seen “overwhelming” interest in its vaccine Jynneos, including an expanded deal with the US and most recently, a new contract with an undisclosed Asia-Pacific country for 350,000 doses.
“While governments and health authorities around the world are busy fighting the current monkeypox outbreak we applaud those governments thinking beyond the current situation and building stockpiles to secure future preparedness and we are proud to assist our customers in both efforts,” Bavarian Nordic CEO Paul Chaplin said in a statement on Wednesday.
Emergent is also looking to step up its response, telling Endpoints in an email that it has received inquiries from governments and public health organizations around its smallpox vaccine ACAM2000.
“We are also aware that some governments and public health organizations have stated that our smallpox vaccine could be used to combat the current monkeypox outbreak. This is information governments and public health organizations are sharing based on the scientific data they have available,” the company said, adding that ACAM2000 isn’t specifically approved for monkeypox in the US or anywhere else.
However, HHS has previously noted that ACAM2000 isn’t recommended for everyone “due to significant side effects.” NIAID director Anthony Fauci told Newsweek that ACAM can’t be tolerated by people with certain conditions, including kids with eczema and those who are immunocompromised.
“By their very nature, medical countermeasures are most useful when produced and made readily available before they are needed. For our part, we will continue to support public health preparedness plans by reliably supplying ACAM2000 and other medical countermeasures to the U.S. and allied governments to combat a wide range of public health threats,” Emergent said.
“According to recent statements from government officials, more than 100 million doses of ACAM2000 are currently in the Strategic National Stockpile. We have the capacity to produce more than 18 million doses of ACAM2000 per year and could increase production to nearly 40 million doses per year if needed,” the company added.