Philippines suspends problematic drug from dengue after more than 730,000 were immunized – 3rdUpdate



[ad_1]

The Philippines suspended a vaccine against dengue fever that was given to thousands of children and launched an investigation, after the drug maker said that the new evidence showed that it could worsen the symptoms in some cases.

The tropical country became the first nation last year to widely distribute the vaccine, called Dengvaxia, after an accelerated approval process. The government says that more than 730,000 people, mostly children over the age of nine, received the vaccine, manufactured by the vaccine division of the French pharmaceutical giant Sanofi SA.

A person can be infected by dengue up to four times due to the existence of different strains. Subsequent infections are often more severe.

Sanofi said last week that the new data found that the vaccine was effective for people who had already had dengue, but for those who did not, "more cases of serious illness could occur after vaccination." The company said it had asked regulators to change the vaccine label to recommend that people not take the vaccine if they have not previously been infected.

Dengvaxia was recommended for use by the World Health Organization in April last year. It was the first of its kind, targeting a mosquito-borne disease that afflicts some of the poorest countries in the world.

However, a few months later, the WHO noted that the vaccine "may be ineffective or theoretically may increase the future risk of hospitalized or severe dengue disease" in those who have not had dengue at the time of vaccination.

Continue reading below

PUBLICITY

So far, no death or case of severe dengue has been definitively related to the vaccine in the Philippines. The government said on Monday it had a record of all children who had received the vaccine, which was approved by the previous administration, and would control them for five years to detect signs of the disease.

The case has quickly become political, as the allies of President Rodrigo Duterte ask for an investigation into the process of approval of the vaccine. Others called for swift action to advise and protect those at risk. "This is our most urgent task, laxity is not an option, we are competing against time," said opposition Senator Risa Hontiveros.

Philippine Health Secretary Francisco Duque III told local media on Monday that the government would evaluate the responsibility for the vaccine and consider the charges against its manufacturer.

Sanofi said he does not comment on legal issues, but noted that "the vast majority of those vaccinated to date live in highly endemic environments and, therefore, have had a previous dengue infection before vaccination" .

In a statement last week, Sanofi Pasteur, the company's vaccine division, said the new clinical data badysis highlights the complex nature of the dengue infection. "We are working with the health authorities to ensure that the prescribers, vaccinators and patients are fully informed about the new findings, with the aim of improving the impact of Dengvaxia in dengue endemic countries," said Su-Peing Ng, global chief medical officer of Dengvaxia. Sanofi Pasteur

Dengue infects about 390 million people a year worldwide, 96 million of whom require treatment, according to the WHO. Of them, about half a million enter the hospital, and 2.5% of all cases are lethal. The virus causes a severe illness similar to influenza marked by painful joints and extreme fatigue.

Write to Jake Maxwell Watts at [email protected]

Philippines suspended a vaccine against dengue fever that was given to thousands of children and launched an investigation, after the drug maker said that new evidence showed that it could worsen the symptoms in some cases.

The tropical country became the first nation last year to widely distribute the vaccine, called Dengvaxia, after an accelerated approval process. The government says that more than 730,000 people, mostly children over the age of nine, received the vaccine, manufactured by the vaccine division of the French pharmaceutical giant Sanofi SA.

A person can be infected by dengue up to four times due to the existence of different strains. Subsequent infections are often more severe.

Sanofi said last week that the new data found that the vaccine was effective for people who had already had dengue, but for those who did not, "more cases of severe disease could occur after vaccination." The company said it had asked regulators to change the vaccine label to recommend that people not take the vaccine if they have not previously been infected.

This is not the first time that warnings about the vaccine have emerged. In a July 2016 report, the World Health Organization noted that the vaccine "may be ineffective or theoretically may increase future risk of hospitalized or severe dengue disease" in those who have not had dengue at the time of vaccination .

The WHO Strategic Advisory Group of Experts will meet before the end of the year to review data on the Sanofi dengue vaccine, a WHO spokesperson said on Monday. The WHO reiterated its November 30 recommendation that "as a precautionary and interim measure", Dengvaxia will only be administered to people known to have already been infected with Dengue.

Philippine presidential spokesman Harry Roque said Sunday that Manila promised "not to leave stone unturned" by holding those responsible "responsible for this shameless public health scam."

On Monday, however, the government said it had a record of all the children who had received the vaccine and who would control them for five years to detect signs of the disease. The impact of the new findings was downplayed, noting that the threat of severe dengue contraction was a risk only for those who had not had dengue before, but had received the vaccine.

The government last week suspended its vaccination program. Although deaths or cases of severe dengue have not been definitively linked to the vaccine, some politicians have reported cases of children who have died since receiving it. "This is our most urgent task, laxity is not an option, we are competing against time," said opposition Senator Risa Hontiveros.

Philippine Health Secretary Francisco Duque III told local media on Monday that the government would evaluate the responsibility for the vaccine, which was approved under the previous administration, and will consider the charges against its manufacturer. The case has quickly become political, as the allies of President Rodrigo Duterte ask for an investigation into the process of approval of the vaccine.

In a response to a request for comments, Sanofi said he does not comment on legal issues, but noted that "the vast majority of those vaccinated to date live in high endemic environments and, therefore, have had a dengue infection before vaccination. " He said the company "had not seen any evidence of a higher incidence of severe dengue in people vaccinated in the actual experience with the vaccine."

In a statement last week, Sanofi Pasteur, the company's vaccine division, said the new clinical data badysis highlights the complex nature of the dengue infection. "We are working with the health authorities to ensure that the prescribers, vaccinators and patients are fully informed about the new findings, with the aim of improving the impact of Dengvaxia in dengue endemic countries," said Su-Peing Ng, global chief medical officer of Dengvaxia. Sanofi Pasteur

Sanofi said the vaccine had been launched in eleven countries: Brazil, Mexico, Costa Rica, Indonesia, Guatemala, Salvador, Peru, Singapore, Paraguay, Thailand and the Philippines.

Brazil's health regulator Anvisa said on November 29 that only people exposed to the virus should take the vaccine. He ordered an update of the medication instructions to users while more studies are being done, according to a statement.

It is not clear how many people have been vaccinated in Brazil. However, in the state of Paraná, about 300,000 people took at least two of three doses that comprise the complete vaccination cycle since the end of 2016, according to a spokeswoman for the local health department, adding that there have been no reports of side effects. serious.

Dengvaxia was recommended for use by the World Health Organization in April last year. It was the first of its kind, targeting a mosquito-borne disease that afflicts some of the poorest countries in the world.

Dengue infects about 390 million people a year worldwide, 96 million of whom require treatment, according to the WHO. Of them, about half a million enter the hospital, and 2.5% of all cases are lethal. The virus causes a severe illness similar to influenza marked by painful joints and extreme fatigue.

Paulo Trevisani and Noémie Bisserbe contributed to this article.

Write to Jake Maxwell Watts at [email protected]

(FINAL) Dow Jones Newswires

December 4, 2017 2:28 PM ET (19:28 GMT)

[ad_2]
Source link

Leave a Reply

Your email address will not be published.