WHO recommends testing before use of Sanofi’s dengue vaccine
by UNTV News | Posted on Friday, 20 April 2018 10:17 PM
FILE PHOTO: Boxes of anti-dengue vaccine Dengvaxia are placed inside a freezer for storage at the Manila Health Department in Sta Cruz, metro Manila, Philippines December 5, 2017. REUTERS/Romeo Ranoco
PARIS/CHICAGO (Reuters) – The World Health Organization (WHO) said on Thursday Sanofi’s vaccine against dengue should only be used after testing on individuals to assess whether they have ever been exposed to the infection.
After a two-day meeting in Geneva, Switzerland, experts at the U.N. agency recommended extra safety measures for the medicine, sold as Dengvaxia.
“We have now clear information that the vaccine needs to be dealt with in a much safer way by using it exclusively in people already infected with dengue before,” Alejandro Cravioto, Chair of the WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization, told reporters.
“It requires for the people to be tested through a system that is not currently available but that we feel will be developed in the next years,” he said.
Sanofi said in a statement: “We are confident in Dengvaxia’s safety and its proven potential to reduce dengue disease burden in endemic countries.”
Sanofi also said it would “continue to work with the international public health community and endemic countries, to ensure the best usage of the vaccine.”
The French drugmaker warned in November that Dengvaxia, first approved in late 2015, could increase the risk of severe dengue in some cases in people who had not been previously exposed to the disease.
Mosquito-borne dengue is the world’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.
Dengvaxia, the world’s sole licensed vaccine against dengue, is at the center of a health scare in the Philippines where the government suspended its use last year amid safety fears.
The company has repeatedly said it knows of no deaths resulting from the medicine.
Joachim Hombach, executive secretary of WHO’s SAGE group, said: “For us, the primary consideration is to assure our recommendation makes public health sense in terms of ensuring the use of vaccine will maximize public health benefit and minimize risk.”
“It is very important we signal ways in which this vaccine could be used,” he said, adding that it was up to the company to decide how to deal with this.
Hombach defended the WHO’s initial recommendation that the vaccine could be used in children aged 9 and older in places where 70 percent of the population had previously been exposed to the virus, and were likely to benefit from the vaccine.
He said the WHO pointed out a gap in data on the use of the vaccine in people who had never been exposed to the virus, and asked Sanofi to study the impact of the vaccine on children who had never been exposed to the virus.
That study resulted in Sanofi’s announcement last November.
Executives at Sanofi have denied any wrongdoing and insist on the benefits the medicine brings as a whole.
In a interview with Reuters last month, David Loew, head of Sanofi Pasteur, the group’s vaccines division, said Sanofi remained committed to Dengvaxia.
He added Sanofi was holding discussions with external partners and universities to come up with a test which would be applicable before vaccination. Such a test, however, would take at least two years to bring to the market, he said.
Dengvaxia has been approved and registered in 19 countries and is currently under review by the European Medicines Agency.
Japan’s Takeda Pharmaceutical, the United States National Institute of Health and Brazil’s Butantan Institute are developing rival products.
Initially seen as potential $1-billion-a-year-plus product, Dengvaxia net sales stood at 3 million euros ($3.71 million) in 2017 as Sanofi was forced to buy back unused doses. The company took a charge of 87 million euros in the fourth quarter.
by UNTV News and Rescue | Posted on Wednesday, 6 March 2019 12:59 PM
Member States of the World Health Organization (WHO) in 2016 agreed to reduce by 30% the global population’s intake of salt (sodium) by 2025.
In observance of the ‘Salt Awareness Week’ from March 4 to 10, the Pan American Health Organization/World Health Organization (PAHO/WHO) joins the international community in efforts to campaign salt-intake reduction in view of the risks that high salt intake may cause to human health.
WHO recommends just under a teaspoon or less than 5 grams of salt intake a day for adults while children are recommended to have less or adjusted amount based on their energy requirements.
The WHO recommends iodized or “fortified” with iodine, “essential for healthy brain development in the fetus and young child and optimizing people’s mental function in general”.
However, in many countries, salt comes in different, ‘unrecognizable’ forms.
According to a UK-based expert group World Action on Salt and Health (WASH), “salty sauces such as soy sauce are big contributors of salt to diets worldwide”.
Packaged food or ready meals and food served in restaurants, food chains and cafeterias are actually loaded with salt.
Health and wellness experts say that though salt is an essential part of our diet, it should come in small amounts as eating too much salt can have huge health impacts.
High sodium intake raises blood pressure that leads to stroke and heart diseases, the two biggest causes of death and disability worldwide, according to WHO.
In the Philippines, the Department of Health (DOH) reported that more than 170,000 individuals die each year from heart diseases, specifically hypertension.
A study from the US National Library of Medicine, National Institutes of Health added that too much salt intake may develop urinary tract infection (UTI); kidney stones; bone mineral loss in women; and hypercalciuria or increased calcium in the urine which may lead renal failure; and other disabilities.
PH’s Internet-based ‘Salt Calculator’
In 2015, the Food and Nutrition Research Institute – Department of Science and Technology (FNRI-DOST) together with Unilever Philippines launched an Internet-based tool that measures one’s salt intake.
The web-based tool presents main food sources of salt in Filipino diets and reveals an individual’s salt intake based on the result of the Sodium Intake Level Test provided.
Read product labels for salt content: Green is healthy
In Northern Ireland, the country’s Public Health Agency (PHA) issued high salt intake warning to remind the public of the dangers of eating too much salt.
Caroline Bloomfield, health and social well being improvement senior manager at PHA noted the importance of tasting the food first to know if adding salt is necessary than automatically adding salt to the food.
The agency also advises consumers to read product labels before buying any ready-to-eat food items.
These labels have indicators of the nutritional value a portion of food accounts for and will guide consumers if the product has high, medium or low amount of salt.
Red means high; amber means medium; and green means low which imply that the more greens you buy, the healthier are your choices.
Meanwhile, there are products that do not use the color codes but the amount of salt is indicated by grams.
A product is high in salt if it contains more than 1.5g of salt per 100g.
The product has medium amount if the salt content is between 0.3g and 1.5g while 0.3g of salt or less per 100g is considered low.
The WHO recommends discipline in eating and watch the salt content in food that we eat.
To date, WHO-member states are bound to adhere with the “Global Strategy on Diet, Physical Activity and Health” which calls on governments to take action to support healthy diets and physical activity at local, regional and global level. – Marje Pelayo
by admin | Posted on Tuesday, 19 February 2019 06:54 PM
The Food and Drug Administration has permanently revoked anti-dengue vaccine Dengvaxia’s certificates of product registration (CPR) due to the continued failure of manufacturer, Sanofi Pasteur Inc. to submit post-approval commitment documents.
FDA Director General Nela Charade Puno on Tuesday cited in a statement the French pharmaceutical firm’s disregard of the agency’s rules and regulations as reason for its CPRs’ cancellation.
“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” Puno said.
The revocation of the Dengvaxia’s CPR makes its importation, sale and distribution illegal in the Philippines, according to the FDA.
Dengvaxia’s CPR was initially suspended for a year since December 29, 2017 after Sanofi’s failure to comply with post-marketing requirements.
Prior to the lapse of the one-year suspension on December 17, 2018, Sanofi failed to comply with post-marketing authorization requirements. The company has since then suspended the sale and marketing of the vaccine. — Robie de Guzman
by UNTV News and Rescue | Posted on Wednesday, 6 February 2019 04:29 PM
QUEZON CITY, Philippines – The House Committee on Good Government and Public Accountability on Wednesday (February 6) recommended the filing of graft charges, technical malversation and grave misconduct against former president Benigno Aquino III for allowing the use of Dengvaxia in government immunization programs that allegedly caused the death of several children.
Also implicated were former Budget Secretary Florencio ‘Butch’ Abad and former health Secretary Janette Garin.
Based on the approved committee report, the three were among other government officials who conspired to procure the controversial anti-dengue vaccine despite lack of certificate of product registration and safety assurance from authorizing bodies.
House committee chair Rep. Xavier Romualdez argued that Aquino violated the law when he allowed the use of P3.5 billion in public funds to procure Dengvaxia vaccines in 2015.
Meanwhile, Dinagat Island Rep. Kaka Bag-Ao questioned the committee’s recommendation arguing that the House inquiry has not established proof that the said officials’ actions indeed violated the law.
But Romualdez stood by the House committee’s report.
Several congressmen proposed charges against the executives of Dengvaxia manufacturer Sanofi Pasteur as well as former health Secretary Paulyn Ubial.
The UNTV News Team has sought the statement of those involved such as Aquino, Garin and Abad but to no avail.
The Department of Justice (DOJ), meanwhile, is now probing the complaints filed by the Public Attorney’s Office (PAO) in relation to the deaths of 30 children being linked to the Dengvaxia immunization. – Marje Pelayo (with reports from Grace Casin)
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