FDA NewsPerspective

FDA grants Sanofi Pasteur’s dengue vaccine priority review

Sanofi Pasteur said its controversial dengue vaccine, known in other countries as Dengvaxia, has been granted priority review by the FDA. A decision on approval is expected by May 1, 2019.

If approved, it would be the first vaccine against dengue available in the United States, including Puerto Rico and the U.S. Virgin Islands, where the disease is endemic.

In a statement, Sanofi’s David Greenberg, MD, said the company is "committed to reducing the global burden of dengue,” which is thought to infect as many as 400 million people each year, according to the CDC.

"The vaccine has been evaluated in studies involving more than 40,000 people from 15 countries around the world with up to 6 years of follow-up data from large-scale investigations that included Puerto Rico as a study site,” Greenberg said.

Dengue is a challenging virus to protect against. Patients infected with one of the four serotypes develop a lifelong immunity to that serotype but are then at an increased risk for severe dengue if they are infected with one of the other three. An effective vaccine must prevent infection from all four serotypes.

Dengvaxia — the world’s only approved dengue vaccine — is already licensed in many countries, including the Philippines, where controversy erupted and a nationwide vaccination campaign was suspended late last year after Sanofi Pasteur announced that the vaccine raises the risk for severe dengue and hospitalization in people with no prior exposure to the virus. More than 830,000 children received at least one dose of the vaccine before the campaign was halted.

Earlier his year, an expert committee that advises WHO on global immunization policy recommended that only people in dengue-endemic countries with confirmation of prior dengue infection receive Dengvaxia, and full findings from a study supported by Sanofi Pasteur confirmed that the vaccine is potentially harmful in people with no prior exposure to dengue.

Disclosure: Greenberg is an employee of Sanofi Pasteur.

Sanofi Pasteur said its controversial dengue vaccine, known in other countries as Dengvaxia, has been granted priority review by the FDA. A decision on approval is expected by May 1, 2019.

If approved, it would be the first vaccine against dengue available in the United States, including Puerto Rico and the U.S. Virgin Islands, where the disease is endemic.

In a statement, Sanofi’s David Greenberg, MD, said the company is "committed to reducing the global burden of dengue,” which is thought to infect as many as 400 million people each year, according to the CDC.

"The vaccine has been evaluated in studies involving more than 40,000 people from 15 countries around the world with up to 6 years of follow-up data from large-scale investigations that included Puerto Rico as a study site,” Greenberg said.

Dengue is a challenging virus to protect against. Patients infected with one of the four serotypes develop a lifelong immunity to that serotype but are then at an increased risk for severe dengue if they are infected with one of the other three. An effective vaccine must prevent infection from all four serotypes.

Dengvaxia — the world’s only approved dengue vaccine — is already licensed in many countries, including the Philippines, where controversy erupted and a nationwide vaccination campaign was suspended late last year after Sanofi Pasteur announced that the vaccine raises the risk for severe dengue and hospitalization in people with no prior exposure to the virus. More than 830,000 children received at least one dose of the vaccine before the campaign was halted.

Earlier his year, an expert committee that advises WHO on global immunization policy recommended that only people in dengue-endemic countries with confirmation of prior dengue infection receive Dengvaxia, and full findings from a study supported by Sanofi Pasteur confirmed that the vaccine is potentially harmful in people with no prior exposure to dengue.

Disclosure: Greenberg is an employee of Sanofi Pasteur.

    Perspective
    Amesh Adalja

    Amesh Adalja

    Dengue is a major public health burden in many parts of the world and there is a desperate need for countermeasures to combat this virus. The Sanofi vaccine is one such countermeasure that has unfortunately been limited because of safety concerns in certain populations. However, the vaccine has a niche use and is effective in those who have had prior dengue infections, and in this context, the vaccine is a success. What will be needed is a means to identify those who are candidates for the vaccine through an accurate, and hopefully rapid, serological test. Viewed from this vantage point, the Sanofi vaccine is an example of precision medicine where a tool can be precisely targeted to those whom it will benefit. While the hope is for a better dengue vaccine, it is important to recognize the value represented by Dengvaxia.

    • Amesh Adalja, MD
    • Senior scholar Johns Hopkins Center for Health Security

    Disclosures: Adalja reports no relevant financial disclosures.