Sanofi may seek U.S. approval for Dengvaxia

PARIS - Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines, a senior executive said on Wednesday.

David Loew, head of Sanofi Pasteur, the French drugmaker's vaccines division, said his teams had complied with all regulations regarding Dengvaxia and had no regrets about the way the product had been developed.

The Philippines, where more than 800,000 school-age children were vaccinated in 2016, suspended a vast public immunisation programme last year because of safety concerns.

Sanofi warned in November that the use of Dengvaxia was to be limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection.

In February, a Philippine government agency filed a lawsuit against Sanofi, demanding compensation for the parents of a 10-year-old girl who the agency said had died as a result of receiving Dengvaxia.

Sanofi has repeatedly said it knew of no deaths resulting from the vaccine. While some experts have said the company and regulators might have ignored warnings about how the vaccine was developed, executives at Sanofi deny any wrongdoing.

"On the whole path of development, we always worked with the World Health Organisation (WHO) and experts in the dengue community. We were always transparent," Loew told Reuters in an interview, referring to the WHO and other regulators.

"You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say no, we would not have done anything differently."

Mosquito-borne dengue is the world's fastest-growing infectious disease, afflicting up to 100 million people worldwide. It causes half a million life-threatening infections and kills about 20,000 people, mostly children, each year.

Loew said the company would decide within two months whether to make a regulatory filing for Dengvaxia with the U.S. Food and Drug Administration.

He also said Sanofi was holding discussions with external partners and universities to come up with a test which would be applicable before vaccination. Such a test would take at least two years to bring to the market.

"We operate in environments where the temperature is 30-40 degrees Celsius so you want to be sure that the tests resist (...) If you have a vaccination campaign taking place in a school for example, you want to make sure it is 'implementable,'" he said.

Dengvaxia has been approved and registered in 19 countries so far, mostly in the developing world. It is currently under review by the European Medicines Agency.

Sanofi booked an impairment charge of 87 million euros ($108 million) related to Dengvaxia in its fourth-quarter results.

Loew said the prospect of another financial charge this year was "extremely low."

source: news.abs-cbn.com

Brazil approves dengue vaccine

Brazil became the first South American country Monday to authorize the world's first-ever dengue fever vaccine, which its French manufacturer says has the potential to save hundreds of lives here.

The tropical disease, a flu-like illness carried by mosquitoes, killed 839 people this year in Brazil and infected more than 1.5 million.

The sprawling South American country's decision to allow the new vaccine, called Dengvaxia, is a coup for French pharmaceutical giant Sanofi, which has now gotten the green light from regulators in three countries.

Mexico became the first country to allow the vaccine on December 9, and the Philippines followed suit last week.

Sanofi has requested regulatory approval in 20 countries across Asia and Latin America.

The vaccine is a potential "blockbuster" drug for the company, which estimates it could generate more than $1 billion a year in revenue.

The Brazilian government said regulators must still set a price per dose, a process that takes about three months on average.

A separate review would have to be carried out for the vaccine to be incorporated in the national vaccination plan, a health ministry official told AFP.

Scientists have long been stumped by dengue, which has four separate strains.

Clinical tests -- carried out on 40,000 people from 15 countries -- have found Dengvaxia can immunize two-thirds of people aged nine years and older, rising to 93 percent for the more severe form of the disease, dengue hemorrhagic fever.

Dengue infects as many as 400 million people per year, and the deadliest form kills 22,000 per year, says the World Health Organization.

It was once considered a disease of the tropics, endemic in only nine countries.

But globalization, urbanization, climate change and air travel are helping it to move into more temperate zones. It is now endemic in more than 100 countries.

The WHO says cases have risen 30-fold over the last 50 years, with more than half the world's population potentially at risk.

The 20 countries where Sanofi Pasteur hopes for regulatory approval have a total population of two billion people -- 200 million of them in Brazil.

source: www.abs-cbnnews.com

Dengue fever spreads around the world

PARIS - Dengue fever, the world's fastest growing mosquito-borne disease, has spread its wings from being a tropical disease, endemic in just nine countries, to a worldwide threat.

Globalization, urbanization, climate change and jet travel have enabled it to move into more temperate zones.

Following are some basic facts:

- What is dengue fever ? -Dengue fever is a flu-like infection, caused by the flavivirus in the same family as yellow fever.

Dengue fever has four separate strains -- DEN-1, DEN-2, DEN-3 and DEN-4. Once cured, the patient is protected for life but only against the strain he was stricken by.

- How is the virus transmitted ? -Dengue is transmitted by several species of mosquito within the Aedes aegypti, which originate in Africa but which are now present in all tropical and subtropical areas.

- The symptoms - Dengue can trigger a crippling fever along with headache, nausea, vomiting, muscle and joint pain, and skin rashes similar to measles.

- The most severe form -The most severe form of the disease, dengue haemorrhagic fever, accounts for one percent of cases, killing 22,000 people a year, the World Health Organisation (WHO) says. It results in bleeding and blood plasma leakage. It can be fatal, in particular among children.

- How many cases ? -The number of cases in the world has risen 30-fold over the last 50 years, according to the WHO, making it the world's fastest growing mosquito-borne disease and leaving more than half of the world's population potentially at risk.

The WHO says that half a million people are hospitalised by the illness every year, many of them children of which around 2.5 percent die.

- Treatment and vaccination -There is currently no specific treatment for dengue fever.

The world's first-ever dengue vaccine, Dengvaxia, manufactured by French pharmaceutical giant Sanofi, secured its first regulatory approval in Mexico on December 9.

The Philippines became the first Asian country on Tuesday to approve the sale of the vaccine.

Other pharmaceutical companies are developing dengue vaccines, including US firm Merck, Japan's Takeda and Britain's GlaxoSmithKline.

source: www.abs-cbnnews.com