Philippines says anti-dengue vaccine may be connected to three deaths

Dr. Rolando Enrique Domingo (R), Undersecretary of the Department of Health (DOH), with Dr. Gerardo Legaspi, Director of the Philippine General Hospital (PGH), answer questions during a news conference at the DOH headquarter in metro Manila, Philippines February 2, 2018.

By Manuel Mogato

MANILA (Reuters) – The Philippines said on Friday the anti-dengue vaccine Dengvaxia may be connected to three deaths in the country, according to a government-ordered inquiry, and that the drug is not ready for mass immunisation.

French drug maker Sanofi said in November that Dengvaxia – the world’s first dengue vaccine – might increase the risk of severe disease in people who had never been exposed to the virus.

The news prompted an uproar in the Philippines, where more than 800,000 school-age children had been vaccinated in 2016.

“We sympathise with all the families who have suffered the loss of a child. Sanofi Pasteur’s mission is to reduce or eliminate suffering for millions around the world through vaccination, including in the Philippines,” a spokesman for Sanofi said in an emailed statement.

“Dengue fever is one of the most pressing public health issues facing the Philippines today. Sanofi Pasteur remains committed to working with the Philippines government and all organisations to address this urgent public health challenge.”

The Philippine Health Ministry halted Dengvaxia immunisations in November. It formed a 10-member panel of experts to determine if the drug was directly connected to the deaths of 14 children after they were given the vaccine.

It found it may have been connected to the deaths of three.

“Three cases were found to have causal association. They died of dengue even (though) they were given Dengvaxia. Two of them may have died because of vaccine failure,” Health Undersecretary Enrique Domingo told a news conference.

“These findings strengthen the decision of the Department of Health to stop the vaccine. It has failed in some children. Dengvaxia is not ready for mass vaccinations and we would need three to five more years to watch and monitor if there would be other adverse reactions from the vaccine.”

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

Domingo said the panel’s findings would be shared with the justice department, which is considering cases against those responsible for the mass immunisation programme.

Paediatrician and panel member Juliet Sio-Aguilar, from the University of the Philippines-Philippine General Hospital, said the team was recommending further studies as it was difficult to directly connect the three deaths to Dengvaxia.

No vaccine has a 100 percent success rate, she said. The dengue death rate in the Philippines was 60 times higher than global rate, Sio-Aguilar said.

The Philippines spent 3.5 billion pesos ($68 million) on the Dengvaxia programme to reduce the 200,000 dengue cases reported every year.

The Philippines has already fined Sanofi a symbolic $2,000, citing violations in product registration and marketing.

(Additional reporting by Ben Hirshler in London, Matthias Blamont in Paris; Editing by Nick Macfie and David Evans)

CDC director urges flu vaccinations as pediatric deaths mount

Emergency room nurse Christine Bauer treats Joshua Lagade of Vista, California, for the flu as his girlfriend Mayra Mora looks on in the emergency room at Palomar Medical Center in Escondido, California, U.S., January 18, 2018.

By Julie Steenhuysen

CHICAGO (Reuters) – Of the 30 U.S. children who have died from the flu so far this season, some 85 percent had not been vaccinated, said Centers for Disease Control and Prevention Director Dr. Brenda Fitzgerald, who urged Americans to get flu shots amid one of the most severe flu seasons in years.

“My message is, if you haven’t gotten a vaccine, please get a vaccine. Also, please get your children vaccinated,” said Fitzgerald, who is urging citizens “to take every advantage that you can to protect yourself.”

The dominant strain during this flu season is an especially nasty type called influenza A (H3N2) that in seasons past has been linked with severe disease and death, especially in the elderly and young. This year’s seasonal flu epidemic is especially severe.

In its latest report, the CDC said the virus is present in every state, with 32 states reporting severe flu activity.

Although the vaccine is only estimated to be about 30 percent effective against the H3N2 strain, it has been shown in studies to reduce severity and duration if people do become infected, said Dr. Dan Jernigan, director of the influenza division at the Centers for Disease Control and Prevention.

Fitzgerald conceded in a telephone interview that reports that the flu vaccine in Australia was only 10 percent effective may have caused people to think the vaccine would not be worth the trouble.

Fitzgerald said the agency’s flu division has been on the job during the three-day federal government shutdown. Senators on Monday reached a deal to keep the government funded through Feb. 8.

Studies have shown that even a vaccine that has lower overall effectiveness can decrease the number of days spent in hospital, duration of the flu and the degree of symptoms.

“That helps support the point of getting a vaccine,” Jernigan said.

Fitzgerald said the flu vaccine and antiviral drugs used to fight the flu are widely available across the country, noting that people can go to the CDC website and enter their zip code to find the nearest flu clinics with vaccines.

Fitzgerald also recommended that people frequently wash their hands or use hand sanitizer, avoid those who are sick or coughing and carry disinfectant wipes.

The CDC does not have numbers for adult deaths from the flu because adult flu is not a reportable disease in all U.S. states. But she said North Carolina, which collects such data, has reported 42 adult flu deaths so far this season.

Official estimates from the CDC are expected at the end of the current season, based on a calculation from hospitals and states reporting data to the agency.

In the 2014/2015 flu season, in which the H3N2 strain was also the leading strain, there were an estimated 35.6 million cases, 710,000 hospitalizations and 56,000 deaths. At this point, it is not clear whether the current flu season will surpass those estimates, Jernigan said.

(Reporting by Julie Steenhuysen; Editing by Cynthia Osterman)

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

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

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 <SASY.PA> 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)

U.S. Zika vaccine begins second phase of testing

FILE PHOTO: A pair of Aedes albopictus mosquitoes are seen during a mating ritual while the female feeds on a blood meal in a 2003 image from the Centers for Disease Control (CDC). REUTERS/Centers for Disease Control/James Gathany/Handout via Reuters

By Julie Steenhuysen

CHICAGO (Reuters) – Researchers have begun the second phase of testing of a Zika vaccine developed by U.S. government scientists in a trial that could yield preliminary results as early as the end of 2017.

Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases (NIAID), said on Friday the $100 million trial has already been funded and will proceed, irrespective of the $7 billion in cuts to the National Institutes of Health (NIH) budget proposed by the Trump Administration over the next 18 months.

In a conference call with reporters, Fauci would not comment on the proposed cuts because it is not clear yet what the actual budget will be. Both Democratic and Republican lawmakers oppose cuts to the NIH, which funds 21 institutes, including NIAID.

NIH Director Dr. Francis Collins is scheduled to speak with President Donald Trump later on Friday. “I will certainly be talking to Francis Collins when he returns from the White House,” Fauci said.

Zika typically causes mild symptoms, but when the virus infects a pregnant women, she can pass it to her fetus, causing a variety of birth defects including microcephaly, in which the baby’s head is abnormally small.

Fauci said the current Zika vaccine candidate had cleared preliminary safety hurdles, and would now enter testing for efficacy, which would occur in two phases.

The first phase will continue testing for safety and evaluate the vaccine’s ability to stimulate the immune system to develop antibodies to fight Zika. It will also test different doses to see which works best.

The second phase, set to begin in June, will attempt to determine if the vaccine can actually prevent Zika infection.

Several companies are developing Zika vaccines, including Sanofi SA, GlaxoSmithKline Plc and Takeda Pharmaceuticals.

In the NIAID study, researchers aim to enroll at least 2,490 healthy volunteers in areas with confirmed or potential active transmission of Zika by mosquitoes. These include parts of the continental United States, Puerto Rico, Brazil, Peru, Costa Rica, Panama and Mexico. They will receive either the vaccine, or a placebo, and be followed for two years.

If enough people are exposed to the virus, Fauci said they could get an effectiveness signal as early as the end of this year. The trial is expected to be completed by 2019.

Fauci said the government is already in discussions with pharmaceutical companies that would share the costs of the final stage of testing and handle manufacturing.

Zika is primarily transmitted by mosquitoes, but it can also be transmitted sexually. According to Centers for Disease Control and Prevention, 5,182 people in the continental United States have been infected by Zika either locally or through travel to places where the virus is spreading. Another 38,303 cases have been reported in U.S. territories, including Puerto Rico.

(Reporting by Julie Steenhuysen; editing by Diane Craft)

China jails two over vaccine scandal

BEIJING (Reuters) – A court in China on Tuesday jailed two people for selling vaccines without a license, state media said, after a scandal last year that sparked public anger.

The case, involving possibly as much as $90 million of illegal trades of vaccines through a black market drugs ring, underscored regulatory weaknesses in the world’s second largest pharmaceuticals market.

The court in Jinan city sentenced Pang Hongwei to 15 years in prison for illegally purchasing vaccines, including rabies vaccines, which she stored in warehouses in Jinan and another city, before selling them around China, Xinhua news agency said.

Pang improperly stored the vaccines she bought, and earned nearly 75 million yuan ($10.93 million) from selling them, Xinhua added.

She was also given another six years for a previous accusation of illegally trading vaccines, and so will serve a total of 19 years, the news agency said.

Pang’s daughter, Sun Qi, was sentenced to six years in prison for assisting her mother, Xinhua added.

It was not possible to reach legal representatives of either of them for comment.

The vaccines, including ones against meningitis and other illnesses, are suspected of being sold in dozens of provinces around China since 2011.

The government has said it has not found any spike in abnormal reactions to inoculations and that the vaccines themselves were real, though traded illegally and improperly stored.

($1 = 6.8588 Chinese yuan renminbi)

(Reporting by Ben Blanchard; Editing by Robert Birsel)

U.S. government shifts $81 million to Zika vaccine research

Zika prevention kit for pregnant women

By Julie Steenhuysen and Toni Clarke

CHICAGO/WASHINGTON (Reuters) – The U.S. Department of Health and Human Services has shifted $81 million in funds from other projects to continue work on developing vaccines to fight Zika in the absence of any funding from U.S. lawmakers.

In a letter addressed to Nancy Pelosi, a Democrat and minority leader of the U.S. House of Representatives, HHS Secretary Sylvia Burwell said she was allocating $34 million in funding to the National Institutes of Health and $47 million to the Biomedical Advanced Research and Development Authority (BARDA) to work on Zika vaccines.

Burwell said the funding was intended to keep Zika vaccine research going despite the lack of funding from U.S. lawmakers, who left for summer recess before allocating any funding to Zika research and preparedness.

The mosquito-borne Zika virus has spread to more than 50 countries and territories since the outbreak began last year in Brazil. On Thursday, Governor Rick Scott said state health officials have identified three additional people in the affected area with locally transmitted Zika, bringing the total to 25.

The Obama administration in February requested $1.9 billion to fight Zika, but congressional lawmakers have been considering a much smaller sum. A bill providing $1.1 billion was blocked by Democrats after Republicans attached language to stop abortion-provider Planned Parenthood from using that government funding for healthcare services, mainly in U.S. territories like Puerto Rico.

The Republican legislation also would siphon off unused money under President Barack Obama’s signature 2010 healthcare law to combat Zika. In addition, Democrats balked at a Republican provision that they said would gut clean water protections.

The new bolus of funds from HHS comes on top of the $589 million in repurposed funds previously allocated for Ebola efforts. HHS has said these funds will run out at the end of August.

At a press briefing in Washington, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he needs $33 million to prepare to move the first potential Zika vaccine to the second phase of human clinical trials. The first phase of that testing is expected to end in late November or December.

Fauci said the health secretary has the authority to transfer 1 percent of NIH’s $33 billion budget per year from one Institute to the other. He said the director of the NIH, Dr. Francis Collins, will decide which existing programs the funds will be drawn from.

“He will probably do it on a prorated basis across the Institutes,” he said.

Fauci said the budget transfer will not fill the longer-term NIH funding needs to fight the virus and to develop a second or third potential vaccine candidate. Drugs frequently fail to realize the promise they show in early trials.

“We still need about $196 million more,” he said.

Fauci said the health secretary’s action was essentially one of desperation given the failure of Congress to authorize additional funding.

Taking money from other research programs “is extremely damaging to the biomedical research enterprise,” he said. “We’re taking money away from cancer, diabetes, all those things.”

Dr. LaMar Hasbrouck, executive director of the National Association of County and City Health Officials, said at the briefing that local health authorities are similarly siphoning off money from other programs.

“We’re robbing Peter to pay Paul,” he said.

In her letter, Burwell said the $47 million in funding for BARDA will allow the agency to enter into contracts with key partners to develop vaccines. But, she said BARDA will need an estimated $342 million in additional funding to continue its work with outside partners in the development of vaccines, diagnostics and pathogen inactivation technology used to protect the U.S. blood supply.

(Reporting by Julie Steenhuysen in Chicago and Toni Clarke in Washington; editing by Grant McCool and Bernard Orr)

Six innovations scientists hope will end Malaria

An Anopheles stephensi mosquito obtains a blood meal from a human host through its pointed proboscis in this handout photo

By Katy Migiro

ARUSHA, Tanzania (Thomson Reuters Foundation) – After being abandoned as too ambitious in 1969, global plans to eliminate malaria are back on the agenda, with financial backing from the world’s richest couple, Bill and Melinda Gates, and U.S. President Barack Obama.

The Gateses aim to eradicate malaria by 2040 by doubling funding over the next decade to support the roll out of new products to tackle rising drug resistance against the disease.

Their goal of permanently ending transmission of the disease between humans and mosquitoes is more ambitious than the Sustainable Development Goal of ending epidemic levels of malaria by 2030.

They are also supporting a push to create the world’s first vaccine against a parasite.

Six innovations scientists are working on are:

* New insecticides: Mosquitoes are becoming resistant to insecticides used to spray inside homes and in bed nets.

“There is no current insecticide that doesn’t show insect-resistance at the moment,” said Jed Stone, a spokesman for the UK-based Innovative Vector Control Consortium (IVCC).

Indoor spraying of walls with insecticide — which was used to wipe out malaria in the United States in the 1940s — has fallen by 40 percent since 2012 due to resistance to older products and the high cost of newer ones.

The IVCC is developing three new insecticides for use in indoor sprays and bed nets that kill insecticide-resistant mosquitoes.

“The insecticides are virtually ready but it will take about five years to finally develop them,” Stone said, adding that this largely involves registration with regulators.

* A single-dose cure: A pill that would wipe out all parasites in the body could be available by 2019, the Gates Foundation says.

Human trials of one candidate are planned following successful tests on mice, published in 2015.

Existing drugs have to be taken for three days with the risk that people do not finish their medication, contributing to the development of drug-resistant malaria.

They also only kill parasites at the asexual-stage where they cause fever but not at the sexual-stage where they are picked up by mosquitoes in blood.

* Insecticide-treated wall liners: Scientists hope insecticide-treated wall liners, which look like wallpaper, will be more effective than spraying people’s homes with insecticide every three to eight months. The wall liners kill mosquitoes that rest on them and can last for three years.

Tanzania’s National Institute for Medical Research is testing wall liners in 6,000 homes to see if they protect people from malaria. Results will be published in 2017.

* Insecticide-embedded clothing: American soldiers have been wearing combat uniforms treated with permethrin, a synthetic insecticide, since 2010 to protect them against insect-borne diseases.

The U.S. government’s Walter Reed Army Institute of Research will test the effectiveness of treated combat uniforms and repellent creams in July on Tanzanian soldiers who often catch malaria when working at night as peacekeepers.

* A vaccine: This is a big one, given vaccines success in eliminating smallpox, polio and measles in many countries.

More than 30 malaria vaccines are under development.

The Mosquirix vaccine, discovered in 1987, is a decade ahead of other candidates but, to date, it only halves the number of bouts of malaria young children suffer.

The World Health Organization is seeking funding for a pilot program to administer Mosquirix to 400,000 to 800,000 African children. The results will be used to make a decision on whether to use the vaccine more widely.

* GM mosquitoes: Scientists have genetically modified (GM) mosquitoes by adding genes that block the development of the malaria parasite inside the insect and prevent it from being transmitted to people.

Scientists have also genetically modified mosquitoes to make them infertile, so that they die out. But many are cautious about the unforeseen consequences of this.

“When people imagine a malaria end game scenario, GM mosquito technology would be incredibly powerful because it doesn’t rely on a robust health system in order to go in and disrupt transmission of the parasite,” said Martin Edlund, chief executive of Malaria No More, referring to war-torn countries like South Sudan.

The International Center for Journalists and Malaria No More provided a travel grant for this report

(Reporting by Katy Migiro; Editing by Katie Nguyen; Please credit the Thomson Reuters Foundation, the charitable arm of Thomson Reuters, that covers humanitarian news, women’s rights, trafficking, property rights and climate change. Visit http://news.trust.org to see more stories.)

Measles Outbreak At Disney Grows To 70 Patients

A measles outbreak traced to Disney theme parks in California continues to grow with 70 people sickened from the highly contagious disease.

The outbreak has now spread to five states and into Mexico with the majority reported in California.

State epidemiologist Gil Chavez told reporters that anyone who has not had the MMR (mumps/measles/rubella) vaccine should temporarily avoid Disney theme parks.  He also said highly crowded locations like airports or bus stations should also be avoided.

He said anyone who’s been vaccinated has nothing to fear.

State officials said cases range from 7 months to 70 years old.  About 25% of those infected had to be hospitalized and five of the sickened were Disney employees.

Chavez said California averages 4 to 60 measles cases a year, so 2015 is off “to a bad start.”  He said that it’s likely they won’t be able to find patient zero for this outbreak.

CDC: Too Late To Make Flu Vaccine

The Centers for Disease Control says that it’s too late in the flu season to create a vaccine to fight the predominant strain of flu virus in the United States.

The strain, influenza A (H3N2) has mutated since the current flu shots were created and the current shots are only partially effective in containing the virus.

CDC Director Dr. Thomas Frieden said it would take up to four months to create a new flu vaccine even if newer technologies are used in creation.

Doctors say that the H3N2 strain has been especially severe when dominant and that without good match in a vaccine the likelihood of increased hospitalizations and deaths significantly increases.

The CDC is still recommending a flu shot because they say it could provide partial protection against H3N2.  They also say that if someone comes seriously ill with the flu it’s vital they be taken to a hospital for treatment.

Study Links Autism To Vaccines Using Aborted Fetus Cells

A new study shows vaccines that come from human fetal cell lines can contribute to autism.

The study uses data from the U.S., U.K., Denmark and Australia.  It was complied by the Sound Choice Pharmaceutical Institute.

“Not only are the human fetal contaminated vaccines associated with autistic disorder throughout the world, but also with epidemic childhood leukemia and lymphomas,” said Dr. Theresa Deisher of SCPI.

The study showed that in most cases, the amount of fetal DNA in the vaccines was significantly above the levels considered safe.  No more than 10ng should be in a dose, yet in some cases the levels were as high at 2000ng per dose.

“There are a large number of publications about the presence of HERV (human endogenous retrovirus – the only re-activatable endogenous retrovirus) and its association with childhood lymphoma,” noted Dr Deisher. “The MMR II and chickenpox vaccines and indeed all vaccines that were propagated or manufactured using the fetal cell line WI-38 are contaminated with this retrovirus. And both parents and physicians have a right to know this!”

The report comes on the heels of a CDC report that was withheld showing an increase among African American boys and autism when vaccinated prior to 36 months.