FDA News

FDA gives fast-track designation to Takeda’s Zika vaccine candidate

The FDA has granted fast-track status to Takeda’s Zika virus vaccine candidate, the company announced today in a news release.

The designation is meant to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, according to the FDA.

Takeda said the inactivated vaccine candidate TAK-426 is currently being evaluated in a phase 1 trial in the continental United States and U.S. territories.

Laurence De Moerlooze, PhD, Takeda’s global program lead for Zika, noted the importance of receiving financial support from HHS’s Biomedical Advanced Research and Development Authority (BARDA). In September, Sanofi Pasteur canceled work on a similar vaccine after BARDA pulled funding for the project.

“With fast-track designation, the ongoing support of BARDA and the abilities of our organization, we are confident that we will continue to make expedient progress,” De Moerlooze said in the release. “We look forward to continuing to work closely with the FDA and BARDA, as well as other health authorities across the world, on the development of this important vaccine candidate.”

Vaccines can take a decade or longer to develop, but there has been a push to get one on the market quickly for Zika, which can cause serious birth defects like microcephaly in babies born to mothers who were infected during pregnancy. Last year, WHO said a vaccine may not be available until 2020.

Disclosures: De Moerlooze works for Takeda.

The FDA has granted fast-track status to Takeda’s Zika virus vaccine candidate, the company announced today in a news release.

The designation is meant to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, according to the FDA.

Takeda said the inactivated vaccine candidate TAK-426 is currently being evaluated in a phase 1 trial in the continental United States and U.S. territories.

Laurence De Moerlooze, PhD, Takeda’s global program lead for Zika, noted the importance of receiving financial support from HHS’s Biomedical Advanced Research and Development Authority (BARDA). In September, Sanofi Pasteur canceled work on a similar vaccine after BARDA pulled funding for the project.

“With fast-track designation, the ongoing support of BARDA and the abilities of our organization, we are confident that we will continue to make expedient progress,” De Moerlooze said in the release. “We look forward to continuing to work closely with the FDA and BARDA, as well as other health authorities across the world, on the development of this important vaccine candidate.”

Vaccines can take a decade or longer to develop, but there has been a push to get one on the market quickly for Zika, which can cause serious birth defects like microcephaly in babies born to mothers who were infected during pregnancy. Last year, WHO said a vaccine may not be available until 2020.

Disclosures: De Moerlooze works for Takeda.

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