Sanofi's Dengvaxia faces even more restrictions in U.S. after FDA panel vote

Sanofi’s dengue ambitions are all but dashed in the Philippines, but the company still hopes its Dengvaxia vaccine can deliver the goods elsewhere. Those hopes took another hit, though, with a lukewarm reception from the FDA's expert advisers.

The shot won backing only in kids younger than 17, and the panel's assessment was based on restricted use, too. The committee only considered Dengvaxia for people who have contracted dengue before, as confirmed by a laboratory, and who live in a region where the mosquito-borne disease is endemic.

In the U.S., cases are mostly limited to territories, including Puerto Rico, the U.S. Virgin Islands and Guam, the CDC says.

For a broad age range that included adults, the vaccine won only middling support. The committee voted 6-7 against Dengvaxia’s efficacy in people aged 9 to 45 with one abstention, according to SAC Tracker. The panel’s vote on safety came in tied at 7-7. 

The committee's positive vote for Dengvaxia covered children and adolescents aged 9 to less than 17. Panelists favored Dengvaxia's efficacy for the group by a 13-1 vote, and on safety, the vote came in at 10-4 in favor, SAC Tracker reports.  

RELATED: Sanofi's dengue shot Dengvaxia wins FDA priority review despite controversial past 

If the FDA follows the panel’s recommendations, it will mean an even smaller label for a vaccine that’s been a disappointment since its 2015 launch. Before its rollout, the shot carried blockbuster expectations.

In 2017, Sanofi’s vaccine famously came under controversy in the Philippines after the drugmaker reported that the shot can cause more serious dengue cases if given to people who haven’t had a prior infection. The disclosure sparked a quick backlash, because the country had already kicked off a mass immunization campaign. Officials stopped vaccinations, demanded refunds and started investigations. 

Last week, prosecutors in the Philippines said they’ve established probable cause to indict six Sanofi managers and numerous other government officials. The government says certain officials broke regulations and hastily rolled out the vaccine, which led to the deaths of 10 children. 

RELATED: Philippine prosecutors prepare to indict Sanofi officials in Dengvaxia disaster 

Despite the controversy, the company has pledged to push forward with Dengvaxia in other regions, and the shot recently won European approval.

Challenges remain, though. The World Health Organization said an on-site dengue diagnostic should be used with Dengvaxia, one doesn’t yet exist. The company has said it’s working with partners on a diagnostic test. 

Meanwhile, Takeda is advancing a potential competitor and recently disclosed its candidate hit its efficacy endpoint in a large phase 3 trial.