Philippines orders probe into Sanofi dengue vaccine for 730,000 children

Concepcion Yusop, a national immunization program manager, shows an anti-dengue vaccine Dengvaxia inside a vaccine storage room in Sta. Cruz city, Metro Manila, Philippines December 4, 2017.

By Manolo Serapio Jr and Neil Jerome Morales

MANILA (Reuters) – The Philippines ordered an investigation on Monday into the immunization of more than 730,000 children with a vaccine for dengue that has been suspended following an announcement by French drug company Sanofi  that it could worsen the disease in some cases.

The World Health Organization said it hoped to conduct a full review by year-end of data on the vaccine, commercially known as Dengvaxia. In the meantime, the WHO recommended that it only be used in people who had a prior infection with dengue.

The government of Brazil, where dengue is a significant health challenge, confirmed it already had recommended restricted use of the vaccine but had not suspended it entirely.

Amid mounting public concern, Sanofi explained its “new findings” at a news conference in Manila but did not say why action was not taken after a WHO report in mid-2016 that identified the risk it was now flagging.

A non-governmental organization (NGO) said it had received information that three children who were vaccinated with Dengvaxia in the Philippines had died and a senator said he was aware of two cases.

However, Department of Health Undersecretary Gerardo Bayugo told Reuters the three referred to by the NGO died due to causes not related to the vaccine and Sanofi said no deaths had been reported as a result of the program.

“As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination,” said Ruby Dizon, medical director at Sanofi Pasteur Philippines.

Last week, the Philippines Department of Health halted the use of Dengvaxia after Sanofi said it must be strictly limited due to evidence it can worsen the disease in people not previously exposed to the infection.

In a statement, Sanofi said the long-term safety evaluation of the vaccines showed significantly fewer hospitalizations due to dengue in vaccinated people over 9 years old compared with those who had not been vaccinated.

Nearly 734,000 children aged 9 and over in the Philippines have received one dose of the vaccine as part of a program that cost 3.5 billion pesos ($69.54 million).

The Department of Justice on Monday ordered the National Bureau of Investigation to look into “the alleged danger to public health … and if evidence so warrants, to file appropriate charges thereon.”

There was no indication that Philippines health officials knew of any risks when they administered the vaccination.

However, the WHO said in a July 2016 research paper that “vaccination may be ineffective or may theoretically even increase the future risk of hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination regardless of age.”

Singapore’s Health Sciences Authority said last week that it flagged risks when Dengvaxia was approved there in October 2016, and was working with Sanofi to strengthen risk warnings on the drug’s packaging.

According to Sanofi in Manila, 19 licences were granted for Dengvaxia, and it was launched in 11 countries, two of which – the Philippines and Brazil – had public vaccination programs.

Brazil’s healthcare regulator Anvisa said in a statement that it now recommends that people who have never been infected with dengue not take the vaccine, which was approved for use in Brazil at the end of 2015.

It was not known whether many people have taken the vaccine, if it was part of any government immunization program or if any illnesses or deaths linked to the drug have been reported to the government.

Anvisa did not immediately respond to a request for comment, nor did the Health Ministry.

A spokesman for Sanofi in Paris was not immediately available for comment. “A SHAMELESS SCAM” A spokesman for Philippines President Rodrigo Duterte said on Sunday the government would hold to account those responsible for the program.

Former Health Secretary Janette Garin, who implemented the program under the administration of then-President Benigno Aquino, said she welcomed the investigation.

“In the event that there will be authorities who will point culpability to me, I am ready to face the consequences,” she told ANC TV. “We implemented it in accordance with WHO guidance and recommendations.”

Presidential spokesman Harry Roque said there had been no reported case of severe dengue infection since the vaccine was administered and urged the public “not to spread information that may cause undue alarm.”

Volunteers Against Crime and Corruption, an NGO, said it was checking a report that three children on the northern island of Luzon had died since being vaccinated in April 2016 but the Department of Health said the deaths were not due to Dengvaxia.

“When we evaluated the clinical records, it was not related to the dengue vaccination,” Bayugo said.

A prominent senator, Richard Gordon, told Reuters he was aware of two deaths – but gave no details – and said approval and procurement for the program was done with “undue haste.”

Dengue is a mosquito-borne tropical disease. Although it is not as serious as malaria, it is spreading rapidly in many parts of the world, killing about 20,000 people a year and infecting hundreds of millions.

While Sanofi’s Dengvaxia is the first-ever approved vaccine for dengue, scientists already recognized it was not perfect and did not protect equally against the four different types of the virus in clinical tests.

A new analysis from six years of clinical data showed Dengvaxia vaccine provides persistent protective benefit against dengue fever in those who had prior infection.

But for those not previously infected by the virus, more cases of severe disease could occur in the long term following vaccination, Sanofi said.

 

(Additional reporting by Karen Lema in Manila, John Geddie in Singapore and Brad Brooks in Sao Paulo and Anthony Boadle in Brasilia; Writing by John Chalmers; Editing by Raju Gopalakrishnan and Bill Trott)

 

Dengue outbreak kills 300 in Sri Lanka, hospitals at limit

A mosquito landing on a person. Courtesy of Pixabay

COLOMBO (Reuters) – An outbreak of dengue virus has killed around 300 people so far this year in Sri Lanka and hospitals are stretched to capacity, health officials said on Monday.

They blamed recent monsoon rains and floods that have left pools of stagnant water and rotting rain-soaked trash — ideal breeding sites for mosquitoes that carry the virus.

The International Federation of Red Cross and Red Crescent Societies is scaling up emergency assistance to Sri Lanka with the Sri Lanka Red Cross to help contain the outbreak.

“Dengue patients are streaming into overcrowded hospitals that are stretched beyond capacity and struggling to cope, particularly in the country’s hardest hit western province,” Red Cross/Red Crescent said in a statement.

According to the World Health Organization, dengue is one of the world’s fastest growing diseases, endemic in 100 countries, with as many as 390 million infections annually. Early detection and treatment save lives when infections are severe, particularly for young children.

The Sri Lankan government is struggling to control the virus, which causes flu-like symptoms and can develop into the deadly hemorrhagic dengue fever.

The ministry of health said the number of dengue infections has climbed above 100,000 since the start of 2017, with 296 deaths.

“Ongoing downpours and worsening sanitation conditions raise concerns the disease will continue to spread,” Red Cross/Red Crescent said.

Its assistance comes a week after Australia announced programs to help control dengue fever in Sri Lanka.

“Dengue is endemic here, but one reason for the dramatic rise in cases is that the virus currently spreading has evolved and people lack the immunity to fight off the new strain,” Novil Wijesekara, head of health at the Sri Lanka Red Cross said in a statement.

(Reporting by Ranga Sirilal and Shihar Aneez Editing by Jeremy Gaunt.)

Fijian islands still cut off after cyclone, fear of Zika and Dengue outbreaks

SYDNEY (Reuters) – Fiji sent boats on Tuesday carrying desperately needed aid to remote islands and coastal villages devastated by a powerful cyclone which killed at least 29 people, as aid workers warned of possible outbreaks of Zika and Dengue viruses.

There are fears the death toll could rise in the nation of 900,000 people when communication resumes with the smaller islands hit by Cyclone Winston on Saturday.

Aerial footage of outlying islands taken by the Royal New Zealand Air Force, and posted on the Fiji government’s official website, showed whole villages flattened and flooded after Winston’s destructive winds, up to 200 mph, tore through the archipelago of 300 islands. Thousands of Fijians live in tin or wooden shacks in low-lying coastal areas.

Authorities have warned of “catastrophic” damage to Koro Island, Fiji’s seventh-largest island, and more than 8,000 people continue to shelter in evacuation centers across the country.

Prime Minister Frank Bainimarama reassured Fijians that the government was doing all it could amid growing criticism of the slow emergency response in some parts of the country.

“We realize the desperate position that you are in,” Bainimarama said in a statement after visiting an evacuation center. “We will not rest until we have reached you and given you the helping hand you so badly need and deserve.”

“Unfortunately the recovery process will take time, perhaps a long time,” he added. “Almost no part of our nation has been left unscarred.”

Aid workers warned of potential outbreaks of the Zika and Dengue viruses, both carried by mosquitoes which will breed in the stagnant water left by the storm.

“The threat of dengue and Zika in the coming days in Fiji is real,” said Chris Hagarty, senior health program manager at Plan International Australia.

“The period immediately following a disaster of this scale can be a particularly dangerous one.”

The World Health Organization declared a Zika outbreak in South America an international health emergency on Feb. 1, citing a “strongly suspected” relationship between Zika infection in pregnancy and microcephaly, a condition marked by unusually small heads that can result in developmental problems.

Much remains unknown about Zika, including whether the virus actually causes microcephaly. Brazil has confirmed more than 500 cases of microcephaly, and considers most of them related to Zika infections in mothers. Brazil is investigating more than 3,900 additional suspected cases of microcephaly.

Fiji’s international airport at Nadi has reopened and an aeromedical evacuation team was being sent to outer islands on Tuesday to provide urgent support and supplies, including water and hygiene kits, medicines and access to shelter.

(Editing by Michael Perry)

Hawaii Reports Additional Cases of Dengue Fever

The number of people infected with dengue fever in Hawaii is climbing, officials said Monday.

The Hawaii Department of Health reported that it was investigating 167 total cases of the mosquito-borne illness, which can lead to fatal consequences in extreme cases. There were 122 confirmed dengue cases as of Dec. 2, signifying 45 additional infections in about three weeks.

State health officials said only three of the 167 cases are currently infectious. The other people got sick between Sept. 11 and Dec. 10, so they are no longer at risk of transmitting the disease.

The health department also reported there were 659 additional potential dengue infections that had been ruled out, either through test results or the illnesses failing to meet the case criteria.

Dengue isn’t endemic (regularly found) in Hawaii, though health officials said it can occasionally be brought in from travelers who got infected in endemic regions. But this latest outbreak on the Big Island is unique because it’s the first cluster of locally acquired cases since 2011, when Centers for Disease Control and Prevention (CDC) records indicate five people got sick in Oahu.

According to the World Health Organization (WHO), an arm of the United Nations, dengue is transmitted when an infected mosquito bites a human. The infection generates a flu-like illness — from which most people usually recover within a week — though it sometimes progresses to severe dengue. In those instances, people can suffer organ impairment and severe bleeding.

The WHO estimates severe dengue hospitalizes about 500,000 people per year, and about 2.5 percent of them die. Dengue is much more common, with some estimates indicating as many as 136 million people falling ill every year, but non-severe cases of the disease are rarely ever fatal. Symptoms can include severe headaches, swollen glands, joint and muscle pain and a high fever.

The Hawaii outbreak reflects a global trend in which dengue is spreading to new locales.

The WHO reports the disease was traditionally found in the tropics and subtropics, but it’s now endemic in more than 100 countries and about half the world’s population is at risk of infection. Still, early detection and access to good medical care keeps the mortality rate below 1 percent. Without those, the WHO says severe dengue can be fatal in more than 20 percent of cases.

Hawaii health officials say it’s still safe to visit the island. The department encourages travelers to use insect repellant and wear long sleeves and pants to help prevent mosquitos from biting.