Philippines is first Asian country to approve dengue vaccine

[rainymike 4,376]

Think I'm getting the entire family to the doc to get this when available. It is one of my greatest concerns living in this country.

 

http://news.yahoo.com/philippines-first-asian-country-approve-dengue-vaccine-175101513.html

 

 

 

Paris (AFP) - The Philippines became the first Asian country on Tuesday to approve the sale of the world's first-ever dengue vaccine.

 

Dengvaxia, manufactured by French pharmaceutical giant Sanofi, secured its first regulatory approval in Mexico a fortnight ago and is currently being reviewed by around 20 countries in Asia and Latin America.

 

It is hoped the drug could eventually help prevent millions of deaths from dengue, the world's fastest-growing mosquito-borne disease.

 

The World Health Organization says as many as 400 million people are infected worldwide every year, and two-thirds are in Asia.

 

"It's a major step in the prevention of dengue and for public health," Olivier Charmeil, head of Sanofi's vaccines division, said in a statement.

 

Scientists have long been stumped by dengue, which has four separate strains, forcing researchers to find a drug able to fight all of them at once.

 

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

 

It was also found to reduce the risk of hospitalisation by 80 percent.

 

Dengue can trigger a crippling fever, along with muscle and joint pain. There is no known cure, and children are at particular risk.

 

The deadliest form of the disease kills 22,000 people a year, the WHO says.

 

It was once considered a disease of the tropics, endemic in only nine countries, but globalisation, urbanisation, climate change and jet 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.

 

Several million doses of the vaccine are ready to ship, and Sanofi expects annual production to reach 100 million doses by 2017.

 

Sanofi's research and development work took 20 years, costing more than 1.5 billion euros ($1.6 billion).

 

But the vaccine could bring the company more than $1 billion annually starting in 2018 or 2019, analysts said.

 

Other pharmaceutical companies are developing dengue vaccines, including US firm Merck, Japan's Takeda and Britain's GlaxoSmithKline, but Sanofi is ahead of the competition.

Edited December 22, 2015 by rainymike

[Woolf 8,555]

Where is the link to that news article ?

[rainymike 4,376]

Where is the link to that news article ?

 

fixed

[Woolf 8,555]

  Anti-dengue vaccine sold in PH by year-end

 

http://newsinfo.inquirer.net/749665/anti-dengue-vaccine-sold-in-ph-by-year-end

 

03:15 AM December 23rd, 2015

THE WORLD’S first vaccine against dengue virus will be approved for use in the country by the end of the year, making the Philippines the second country to make it available in the market next to Mexico, according to the Department of Health (DOH).

Health Secretary Janette Garin disclosed that the Food and Drug Administration (FDA) was on the last phase of deliberations in approving the use of Dengvaxia, which was developed by French pharmaceutical company Sanofi.

“We had a meeting with FDA and they are wrapping up the review. After the approval, this means it will now be available for the private sector,” said Garin in a recent interview. “We are looking to issue the FDA approval before the end of the year,” she said.

Garin had expected the Philippines to be the first country to give the green light to the sale and use of the dengue vaccine.

But on Dec. 9, Mexico granted marketing authorization to the vaccine, which will curb the spread of the disease caused by all four dengue virus stereotypes in children and adults residing in endemic areas.

Dengue is endemic in the Philippines, where about 100,000 people get infected yearly and hundreds die due to the virus.

From January to October this year alone, the DOH has recorded 108,263 dengue cases nationwide, with 31.8 percent aged 5 to 14 years old. More than 300 deaths have also been reported during this period.

But with the vaccine, the DOH is hoping to significantly bring down the number of infections and deaths.

Garin said the FDA is in the process of completing the guidelines in relation to giving Sanofi the license to market the dengue vaccine.

“We are reviewing many literatures and the FDA is also looking at the effect of the vaccine on not only one but four strains of the virus,” said the health chief.

Once the FDA has issued its approval for the market and use of the Dengvaxia in the country, the DOH will need to seek World Health Organization pre-qualification of the vaccine and its guidelines and recommendations to proceed with procurement, she said.

Garin said the DOH is seriously considering making the dengue vaccine a Philippine Health Insurance Corp. benefit, making it available to members at “a very discounted price.”

Officials of the French drug-maker paid a courtesy call on President Aquino while he was in Paris for the 21st Conference of Parties for the United Nations Framework Convention on Climate Change early this month.

Garin was present during the meeting, along with Finance Secretary Cesar Purisima, Trade Secretary Gregory Domingo and Transportation Secretary Joseph Emilio Abaya.

During the meeting, Sanofi expressed its gratitude to the Philippines for its major contribution for the development of the vaccine for 20 years, said Garin.

“The Philippines was among the countries where the three phases of the clinical trials were conducted so our country is very vital to the success of the vaccine,” she said, noting that officials of Sanofi also commended the Research Institute for Tropical Medicine.

 

Edited December 22, 2015 by Woolf

[+to_dave007 6,839]

Mexico approved this drug less than a month ago.

 

Looks like it's only available (or SUPPOSED to be available) for patients from 9 to 45 years of age..  so not yet including those most at risk.  Still a big step in right direction.  Did not yet see anything about costs.

 

http://www.sanofipasteur.com/en/articles/dengvaxia-world-s-first-dengue-vaccine-approved-in-mexico.aspx

Edited December 23, 2015 by to_dave007

[MarinePride 626]

I do not trust any vaccines and no one in the family will be getting it.  The Gardisil vaccine and how it affected some the girls that took it are all the proof I need.  Do some research on vaccines, I believe there is a reasonable doubt to their safety.

[+RogerDuMond 15,675]

I do not trust any vaccines and no one in the family will be getting it.  The Gardisil vaccine and how it affected some the girls that took it are all the proof I need.  Do some research on vaccines, I believe there is a reasonable doubt to their safety.

 

This topic will not degenerate into an argument over whether or not vaccines are bad for you. Anyone doing that from this point forward will be warned and be banned from the topic. If you want to discuss that start your own topic.

Edited December 23, 2015 by RogerDuMond

[colemanlee 21,440]

 

 

Mexico approved this drug less than a month ago.  

 

While I have to agree this could be a great thing...We have personally known several kids here that almost died from Dengue. I have to wonder about the testing considering Mexico and the Philippines are so far the only two that have accepted it...

 

And considering the following....

In 2013, cases have occurred in Florida (United States of America) and Yunnan province of China. Dengue also continues to affect several South American countries, notably Costa Rica, Honduras and Mexico. In Asia, Singapore has reported an increase in cases after a lapse of several years and outbreaks have also been reported in Laos. In 2014, trends indicate increases in the number of cases in the People's Republic of China, the Cook Islands, Fiji, Malaysia and Vanuatu, with Dengue Type 3 (DEN 3) affecting the Pacific Island countries after a lapse of over 10 years. Dengue was also reported in Japan after a lapse of over 70 years. In 2015 an increase in the number of cases was reported in Brazil and several neighbouring countries. The Pacific island countries of Fiji, Tonga and French Polynesia 

 

http://www.who.int/mediacentre/factsheets/fs117/en/

 

I have to wonder why the world is not clammering at their door....however, if it proves out, it would indeed be a blessing...

[+to_dave007 6,839]

I have to wonder about the testing considering Mexico and the Philippines are so far the only two that have accepted it...

 

This is one of my concerns as well, and I'm guessing this is one reason why they say this is only for those 9 to 45 so far..  which is obviously not the age group we all worry about for dengue.  Personally, I would feel better if I knew this had been approved by the FDA.. or at least the drug approval of several "bribe free" countries.

[+RogerDuMond 15,675]

This is one of my concerns as well, and I'm guessing this is one reason why they say this is only for those 9 to 45 so far..  which is obviously not the age group we all worry about for dengue.  Personally, I would feel better if I knew this had been approved by the FDA.. or at least the drug approval of several "bribe free" countries.

 

 

This will be approved by the Philippine FDA before use and have WHO pre-qualification.

 

The efficacy of this vaccine is 56% which is not great, but there is good news even in that. When you break down the efficacy between the 4 major strains of the virus, the efficacy is less on the least serious of the strains and is 85% effective for the hemorrhagic strain of the virus.