Takeda introduced Tuesday that it has voluntarily withdrawn its software to the Meals and Drug Administration for its dengue vaccine, making it unclear when or if the vaccine can be licensed on this nation.
The corporate mentioned in a press launch that it’ll evaluation whether or not to proceed with making an attempt to carry the vaccine to the U.S. market. The vaccine has already been accredited within the European Union, the UK, Brazil, Argentina, Indonesia, and Thailand.
“The pressing international must fight the rising burden of dengue stays, and we are going to proceed to progress regulatory opinions and supply entry for folks dwelling in and touring to dengue-endemic areas whereas we work to find out subsequent steps within the U.S.,” Gary Dubin, president of Takeda’s international vaccines enterprise unit, mentioned in an announcement.
At present there is just one dengue vaccine licensed within the U.S., GSK’s Dengvaxia. However it is just licensed to be used in kids and youths aged 6 to 16 dwelling in dengue-endemic areas — principally Puerto Rico — who’ve beforehand had a laboratory-confirmed case of dengue. It can’t be used as a journey vaccine, for folks dwelling on the U.S. mainland who’re touring to areas of the world the place dengue spreads.
Dengue has been a difficult virus to develop a vaccine in opposition to, due to a peculiarity of the virus. There are 4 serotypes of dengue, numbered 1 by 4. An infection with one doesn’t defend in opposition to an infection by one other. And, the truth is, in some instances a earlier publicity to dengue — by an infection or vaccination — can result in extra severe illness on the second or subsequent infections.
The Takeda press launch said that the corporate’s determination was primarily based on the truth that the FDA requested for added knowledge that weren’t captured by the medical trial for the vaccine. It additional mentioned that the company had beforehand reviewed and accepted the trial protocol.
Takeda declined STAT’s request for an interview and didn’t specify what extra info the FDA was searching for.
Dengue is nicknamed breakbone fever, due to the painful an infection it triggers. Transmitted by Aedes aegypti mosquitoes, it’s estimated that almost 100 million to 400 million folks a 12 months are contaminated with dengue, which is present in a lot of Asia, Africa, and Latin America.
A small portion of people that contract the illness develop a extreme type — dengue hemorrhagic fever — which could be deadly. It’s estimated that about 500,000 folks develop extreme dengue annually and about 22,000 die.
In a lot of the United States, dengue will not be ceaselessly identified. Within the first 5 months of this 12 months, there have been 129 dengue instances reported, solely three of which had been thought to have been regionally acquired. In Puerto Rico, the place dengue is endemic, 256 instances had been reported from the beginning of the 12 months by June 1.
The virus is discovered in additional than 100 nations across the globe, based on the World Well being Group.
There have been some considerations concerning the efficiency of Takeda’s vaccine, which is a two-dose vaccine with pictures spaced three months aside. The Part 3 medical trial discovered an absence of efficacy in opposition to dengue 3 in kids who had been sero-negative — those that had by no means beforehand been contaminated with dengue. And there have been too few instances of dengue 4 to find out if the vaccine was efficient in opposition to it.
A spokesperson mentioned Takeda will not be involved that the choice to withdraw the appliance from the FDA will damage the repute of the vaccine or have an effect on its probabilities of being accredited elsewhere.
“Takeda’s determination to withdraw the appliance for TAK-003 within the U.S. will not be anticipated to have a fabric influence on the total 12 months consolidated reported forecast for the fiscal 12 months ending March 31, 2024,” the spokesperson mentioned by way of e mail.
“Extra broadly, the withdrawal can have no influence on the label in nations which have accredited the vaccine, nor will it change the indication that we search. We’ll proceed to progress regulatory filings in dengue-endemic and non-endemic nations globally.”
The medical trial to assist the licensure software enrolled 20,000 folks from eight dengue-endemic areas in Latin America and Asia.