BIO: Moderna to test mpox vaccine in humans this summer

Back in January, Moderna set a planned mpox vaccine on the back burner as the immediate outbreak waned, but now the shot has slid into the priority lane, with entry to the clinic likely a “month or so” away, according to a top vaccine developer and strategist at the company.

Moderna is set to launch a phase 1/2 trial of the shot this summer, Hamilton Bennett, senior director of vaccine access and partnerships at Moderna, said in an interview at the the BIO International Convention. The company had previously teased launching human trials sometime this year. 

Bennett said the goal is to build a preclinical data package that shows efficacy across orthopoxviruses, which include mpox and smallpox, and then generate "robust" phase 1/2 data to inform dose selection and eventually licensure. She added that the company has met with the U.S. mpox response team a couple of times to say, “this is where we are, these are the barriers that we're seeing.” 

“They've been incredibly helpful in helping us get access to samples and people and information,” she said. 

Moderna CEO Stéphane Bancel told Fierce Biotech in January that developing a mpox vaccine was not a high priority as development pressed ahead on more than a dozen unique assets beyond the COVID vaccine that helped make the company a household name. Bennett clarified that he was speaking relative to Moderna’s urgency to develop a COVID-19 vaccine during the pandemic. 

“I think when Stéphane says it's not a priority, it is not a COVID-like priority,” she said. 

The upcoming trials are just the latest example of the swiftness of Moderna's mRNA platform. The company announced in May 2022 that preclinical work would begin on an mpox vaccine. But no update had been made on the progress prior to Bancel's comments at the beginning of the year. 

For Bennett, the development of the shot means more than just the potential for a new product; it’s an opportunity to flex her muscles leading the company’s public health portfolio, a position she’s pivoted to since helping lead development and dissemination of the COVID shot. That new role broadly puts her in charge of coordinating with developing nations to help scale up vaccine-related economic infrastructure and ensuring that Moderna is accountable and its products are available to those nations. 

Bennett said that mpox is a “perfect example” of some of the barriers the company will face as it develops these products, in part because, as of now, funding for an mpox vaccine is really for a smallpox vaccine. At a grander level, mpox represents a virus that only gained national attention when people outside of Africa began to be infected. Bennett doesn’t want Moderna to be caught on its back foot when addressing diseases of significance, even if they aren’t affecting high-income countries. 

“Our portfolio in global health is designed to allow those associations to happen because they're not something where we can pick up the phone when the clock starts,” she said. “We need to build those relationships now.”