Push Admin

Sanofi wins US approval to sell dengue vaccine but with major restrictions

Article (news)

Julie Steenhuysen, Reuters

CHICAGO - The US Food and Drug Administration on Wednesday gave Sanofi SA&#x27;s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.The FDA says the drug may only be given to people aged 9 through 16 who have laboratory-confirmation of a previous dengue infection and live in areas where the disease is prevalent, such as Puerto Rico, the U.S. Virgin Islands and American Samoa.Sanofi had sought a much broader approval that would have included people aged 9 to 45, but an FDA advisory panel in March recommended the narrower age range, excluding its use in adults.In late 2017, Sanofi disclosed that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, triggering a government investigation in the Philippines where 800,000 school-age children had already been vaccinated.In March, the Philippine Justice Department said it found probable cause to indict Sanofi officials and former Philippine health officials over 10 deaths it said were linked to the dengue vaccine. Sanofi has said it strongly disagrees with those findings.The FDA stipulated that Dengvaxia is not approved for individuals who have not previously been infected by one of the four types of the virus, which is spread by mosquitoes. (<a href="http://bit.ly/2IQav7S">bit.ly/2IQav7S</a>)Dengue is the world&#x27;s fastest-growing infectious disease, afflicting hundreds of millions of people worldwide. It causes half a million life-threatening infections and kills about 20,000 people, mostly children, annually.After reviewing the safety risks, the World Health Organization last spring said Sanofi&#x27;s vaccine should only be used on individuals with proven prior dengue exposure, significantly reducing the potential market for Dengvaxia, the world&#x27;s first dengue vaccine which had been seen as a potential $1 billion a year product.In December, Dengvaxia won European approval for people aged 9 to 45 living in endemic areas who have a documented prior infection.&quot;Today&#x27;s FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue, particularly among children, in U.S. dengue endemic areas,&quot; Dr. David Greenberg, Sanofi&#x27;s regional medical head for North America, said in a statement.

CHICAGO - The US Food and Drug Administration on Wednesday gave Sanofi SA's dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.

CHICAGO - The US Food and Drug Administration on Wednesday gave Sanofi SA's dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.

Sanofi wins US approval to sell dengue vaccine but with major restrictions

News

Entertainment

Lifestyle

Sports

Metro.Style

More

Sudoku

Word of the Day

Lotto

Horoscope

Overseas

Sanofi wins US approval to sell dengue vaccine but with major restrictions

Julie Steenhuysen,

Reuters

Published May 02, 2019 02:57 PM PHT

|

Updated May 02, 2019 03:02 PM PHT

Read More:

Dengvaxia

Dengue

Sanofi

ABS-CBN Newsletter

Your go-to source for the latest news, entertainment highlights, exclusive interviews, and updates on your favorite Kapamilya stars.

ABS-CBN Newsletter

Your go-to source for the latest news, entertainment highlights, exclusive interviews, and updates on your favorite Kapamilya stars.

Sign Up

I have read and agree to the Terms and Privacy Policy.

ABS-CBN is the leading media and entertainment company in the Philippines, offering quality content across TV, radio, digital, and film. Committed to public service and promoting Filipino values, ABS-CBN continues to inspire and connect audiences worldwide.

Corporate

Investors

Governance

International Distribution

Corporate

Governance

Investors

International Distribution

NPC Seal of Registration

Privacy Policy

AI Policy

Terms of Service

Advertise with Us

© 2026 ABS-CBN Corporation. All Rights Reserved.

NPC Seal of Registration

Privacy Policy

Terms of Service

AI Policy

Advertise with Us

© 2026 ABS-CBN Corporation. All Rights Reserved.

NPC Seal of Registration

Privacy Policy

Terms of Service

AI Policy

Advertise with Us

© 2026 ABS-CBN Corporation. All Rights Reserved.