WHO sounds Ebola alarm as risks intensify

A Congolese health worker administers ebola vaccine to a child at the Himbi Health Centre in Goma, Democratic Republic of Congo, July 17, 2019. REUTERS/Olivia Acland

By Tom Miles

GENEVA (Reuters) – The World Health Organization on Wednesday declared Congo’s Ebola outbreak an international health emergency, sounding a rarely used global alarm after the virus threatened to spread to a major city and into neighboring countries.

Despite a highly effective vaccine and a swift international response after it was declared 11 months ago, the outbreak has proved tenacious in an unstable region beset by violence, becoming Congo’s worst ever, with almost 1,700 dead.

A vast campaign of vigilance and vaccination, with almost 75 million screenings, has kept the highly infectious virus almost entirely confined to two provinces in northeastern Congo. The emergency committee of international health experts that advises WHO had thrice declined to declare an emergency.

But this month a pastor died after traveling to Goma, a city of 2 million and a gateway to other countries in the region. On Wednesday, the WHO reported a fisherwoman had died in Congo after four vomiting incidents at a market in Uganda, where 590 people may be sought for vaccination.

“The committee is concerned that a year into the outbreak, there are worrying signs of possible extension of the epidemic,” the committee’s report said.

The committee had been under pressure from many experts who felt the scale of the outbreak and the risks meant it had to be given the emergency status – only the fifth such disease outbreak since the WHO introduced such designations in 2005.

“It shows no sign of coming under control,” said Peter Piot, a member of the team that discovered Ebola and is now director of the London School of Hygiene & Tropical Medicine.

“I hope that today’s decision serves as a wake-up call to drive high-level political action, improved coordination, and greater funding to support DRC in their efforts to stop this devastating epidemic,” he said.

NO BORDER CLOSURES

The previous international emergencies, under a system introduced after the 2004 Asian SARS epidemic, were the 2013-2016 West African Ebola epidemic that killed over 11,300 people, the 2009 flu pandemic, polio in 2014 and the Zika virus that caused a spate of birth defects across Latin America.

The WHO committee’s chairman, Robert Steffen, tempered the outbreak’s designation as an emergency by saying it remained a regional, rather than a global threat, and stressed that no country should react to Ebola by closing borders or restricting trade.

The WHO has warned that the nearby countries of Rwanda, South Sudan, Burundi and Uganda are the most at risk, while Central African Republic, Angola, Tanzania, Republic of Congo and Zambia are in a second tier.

Earlier this week the WHO said hundreds of millions of dollars were needed immediately to prevent the outbreak billowing out of control and costing far more lives and money.

But WHO chief Tedros Adhanom Ghebreyesus, who convened the emergency committee after viewing the Goma case as a “potential gamechanger”, said the designation as an international emergency was not meant to suggest that some countries had been withholding funds and would now unlock them.

One priority was to accelerate the production of the vaccine, which is in short supply. It is produced by Merck and still unlicensed, which means it can only be used in a clinical trial overseen by Congo’s health ministry.

WHO has already begun using smaller doses to ration supplies and the committee recommended taking “all measures to increase supplies”, including contracting supply to other manufacturers and transferring Merck’s technology.

(Reporting by Tom Miles, Kate Kelland and Nairobi newsroom; Editing by Gareth Jones, John Stonestreet and Dan Grebler)

U.S. records 33 new measles cases, raising year’s total to 1,077

FILE PHOTO: A vial of the measles, mumps, and rubella (MMR) vaccine at the International Community Health Services clinic in Seattle, Washington, U.S., March 20, 2019. REUTERS/Lindsey Wasson

(Reuters) – The United States recorded 33 new measles cases last week, bringing the number of confirmed cases this year to 1,077 in the worst outbreak of the virus since 1992, federal health officials said on Monday.

The U.S. Centers for Disease Control and Prevention said the cases of the highly contagious and sometimes deadly disease rose 3% in the week ended June 20 from the prior week. The 2019 outbreak, which has spread to 28 states, is the worst since 1992, when 2,126 cases were recorded.

Health experts say the virus has spread among school-age children whose parents declined to give them the measles-mumps-rubella vaccine, which confers immunity to the disease. A vocal fringe of U.S. parents, some in New York’s ultra-Orthodox Jewish communities, cite concerns that the vaccine may cause autism, despite scientific studies that have debunked such claims.

The disease has mostly affected children who have not received the vaccine.

Measles was declared eliminated in the United States in 2000, meaning there was no continuous transmission of the disease for a year. Still, cases of the virus occur and spread via travelers coming from countries where measles is common.

CDC officials have warned that the country risks losing its measles elimination status if the ongoing outbreak, which began in October 2018 in New York, continues until October 2019.

The outbreak has escalated since 82 people in 2018 and more than 40 people in 2019 brought measles to the United States from other countries, most frequently Ukraine, Israel and the Philippines, federal officials said.

(Reporting by Gabriella Borter in New York and Ankur Banerjee in Bengaluru; Editing by Shailesh Kuber and Susan Thomas)

Measles outbreak spreads to Oklahoma as U.S. reports 41 new cases

FILE PHOTO: FILE PHOTO: FILE PHOTO: A vial of the measles, mumps, and rubella virus (MMR) vaccine is pictured at the International Community Health Services clinic in Seattle, Washington, U.S., March 20, 2019. REUTERS/Lindsey Wasson/File Photo/File Photo/File Photo

(Reuters) – The worst measles outbreak in the United States in 25 years has spread to Oklahoma, federal health officials said on Monday as they reported 41 new cases nationwide, raising the total number sickened this year to 880 people.

The U.S. Centers for Disease Control and Prevention reported a 4.9% increase in the number of measles cases from May 10 to May 17 in an outbreak that has now reached 24 states. The agency has been providing weekly updates every Monday.

The CDC said there had been one confirmed case in Oklahoma.

Most of the new cases were in New York, CDC spokesman Jason McDonald said, with 21 cases recorded in New York City and nine in Rockland County.

Health experts say the virus has spread among school-age children whose parents declined to give them the vaccine, which confers immunity to the disease. A vocal fringe of U.S. parents, some in New York’s ultra-Orthodox Jewish communities, cite concerns that the vaccine may cause autism, despite scientific studies that have debunked such claims.

Although the virus was eliminated from the country in 2000, meaning the disease was no longer a constant presence, outbreaks still happen via travelers coming from countries where measles is still common, according to the CDC.

Experts warn that the outbreak is not over as the number of cases approaches the 1994 total of 958. That was the highest number since 1992, when the CDC recorded 2,126 cases.

More than 40 people in 2019 brought measles to the United States from other countries, most frequently Ukraine, Israel and the Philippines, federal officials said.

(Reporting by Gabriella Borter in New York, Ankur Banerjee in Bengaluru; Editing by Scott Malone and Bill Berkrot)

U.S. measles outbreak raises questions about immunity in adults

FILE PHOTO: An illustration provides a 3D graphical representation of a spherical-shaped, measles virus particle studded with glycoprotein tubercles in this handout image obtained by Reuters April 9, 2019. Centers for Disease Control and Prevention (CDC)/Handout via REUTERS/File Photo

By Julie Steenhuysen

(Reuters) – Adults in the United States who were vaccinated against measles decades ago may need a new dose depending on when they received the shot and their exposure risk, according to public health experts battling the nation’s largest outbreak since the virus was deemed eliminated in 2000.

Up to 10 percent of the 695 confirmed measles cases in the current outbreak occurred in people who received one or two doses of the vaccine, according to the U.S. Centers for Disease Control and Prevention.

The figure illustrates what can happen when a large number of individuals, even those who have been vaccinated, are exposed to the measles. CDC recommends that people who are living in or traveling to outbreak areas should check their vaccination status and consider getting a new dose.

Dr. Allison Bartlett, an infectious disease expert at the University of Chicago Medicine, said the “continued vulnerability to infection” is why high-risk adults such as healthcare workers are routinely advised to get a second dose of the measles vaccine if they have not had one.

But knowing your vaccination status can be tricky, experts said.

“It’s complicated and often futile because it’s very difficult to resurrect those old records,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center.

People vaccinated in the United States since 1989 would most likely have received two doses of the combined measles, mumps and rubella (MMR) shot under federal guidelines, and that is still considered the standard for protection.

Anyone vaccinated between 1963 and 1989 would likely have received only one dose, with many people immunized in the earlier years receiving an inactivated version of the virus. Americans born before 1957 are considered immune as they would have been exposed to the virus directly in an outbreak.

Merck & Co Inc is the sole U.S. provider of the MMR vaccine. The company said in a statement that it has “taken steps to increase U.S. supply” of the vaccine due to the current outbreak.

HIGHLY CONTAGIOUS

The measles virus is highly contagious and can cause blindness, deafness, brain damage or death. It is currently spreading in outbreaks in many parts of the world.

According to the World Health Organization, 95 percent of a population needs to be vaccinated to provide “herd immunity,” a form of indirect protection that prevents infection in people too young or sick to be vaccinated. U.S. public health officials have blamed the current outbreak in part on rising rates of vaccine skepticism that have reduced measles immunity in certain communities.

For travelers to outbreak areas abroad, the CDC recommends adults consider getting another dose of MMR unless they have proof of receiving two prior doses, take a blood test showing immunity, or were born before 1957.

In general, the CDC says two doses of the measles vaccine should provide 97 percent protection; one dose should offer 93 percent protection. However, immunity can wane over time.

This has occurred even in adults with two documented doses of the vaccine, said Dr. Michael Phillips, chief epidemiologist at NYU Langone Health, which serves parts of New York City, a hot spot in the U.S. outbreak.

He said in kids, “the vaccine is really effective,” but in some adults, memory T-cells, which recognize and attack germs, do not fight the virus as effectively as they once did.

Rapid blood tests are available that can detect whether a person is immune based on the level of measles antibodies, but the tests are not 100 percent reliable.

Adults who have any doubt about their immunity should get another dose, Schaffner said: “It’s safe. There’s no downside risk. Just roll up your sleeve.”

(Reporting by Julie Steenhuysen in Chicago; Additional reporting by Mike Erman and Gabriella Borter in New York; Editing by Lisa Shumaker)

Ebola fight has new science but faces old hurdles in restive Congo

A doctor cares for a patient inside an isolate cube at The Alliance for International Medical Action (ALIMA) treatment center in Beni, North Kivu province of the Democratic Republic of Congo September 6, 2018. REUTERS/Fiston Mahamba

By Fiston Mahamba

BENI, Democratic Republic of Congo (Reuters) – When Esperance Nzavaki heard she was cured of Ebola after three weeks of cutting-edge care at a medical center in eastern Democratic Republic of Congo, she raised her arms to the sky with joy and praised the Lord.

Her recovery is testament to the effectiveness of a new treatment, which isolates patients in futuristic cube-shaped mobile units with transparent walls and gloved access, so health workers no longer need to don cumbersome protective gear.

“I started to feel sick, with a fever and pain all over my body. I thought it was typhoid. I took medicine but it didn’t work,” Nzavaki told Reuters in Beni, a city of several hundred thousand, where officials are racing to contain the virus.

“Then an ambulance came and brought me to hospital for Ebola treatment. Now I praise God I’m healed.”

The fight against Ebola has advanced more in recent years than in any since it was discovered near the Congo River in 1976. When the worst outbreak killed 11,300 people in West Africa in 2013-2016, there was no vaccine and treatment amounted to little more than keeping patients comfortable and hydrated.

Now there’s an experimental vaccine manufactured by Merck which already this year helped quash an earlier outbreak of this strain of the virus on the other side of the country in under three months. And there are the cube treatment centers, pioneered by the Senegalese medical charity, ALIMA.

“With this system … where there are not people donning masks, the patients feel reassured and perceive that there is life here,” said Claude Mahoudeau, the coordinator of ALIMA’s treatment center in Beni.

In addition, three experimental treatments have been rolled out for the first time, offering patients additional reason to hope that their diagnosis is not a death sentence.

Yet even the smartest science can do little about the marauding rebel groups and widespread fear and mistrust that could yet scupper efforts to contain Congo’s tenth outbreak of the deadly haemorrhagic fever.

The latest outbreak is so far believed to have killed 90 people since July and infected another 40.

The stakes are high, not just for health reasons. Ebola could complicate Congo’s first democratic change of power, the holding of a Dec. 23 election to replace President Joseph Kabila that is already two years late.

FILE PHOTO: Congolese officials and the World Health Organization officials wear protective suits as they participate in a training against the Ebola virus near the town of Beni in North Kivu province of the Democratic Republic of Congo, August 11, 2018. REUTERS/Samuel Mambo

FILE PHOTO: Congolese officials and the World Health Organization officials wear protective suits as they participate in a training against the Ebola virus near the town of Beni in North Kivu province of the Democratic Republic of Congo, August 11, 2018. REUTERS/Samuel Mambo

REBELLION, FEAR, MISTRUST

The affected North Kivu and Ituri provinces have been a tinder box of armed rebellion and ethnic killing since two civil wars in the late 1990s. Some areas near the epicenter require armed escorts to reach because of insecurity. Two South African peacekeepers there were wounded in a rebel ambush last week.

And last week, authorities confirmed the first death from Ebola in the major trading hub of Butembo, a city of almost a million near the border with Uganda, dampening hopes that the virus was being brought under control.

Insecurity aside, the biggest challenges the government faces could be panic and downright denial, as they were during the catastrophic West Africa outbreak.

“Ebola does not exist in Beni,” resident Tresor Malala said, shaking his head. “For a long time, people got sick with fever, diarrhea, vomiting and they healed. Now someone gets a fever, they get sent to the Ebola treatment center and then they die.”

Taxi driver Mosaste Kala was equally skeptical: “The only people dying are the ones going to the … treatment center.”

Tackling these perceptions will be crucial if authorities are to halt the epidemic.

At a news conference on Saturday, Health Minister Oly Ilunga Kalenga admitted that “community resistance is the first challenge to the response to the epidemic”.

In the district of Ndindi, in Beni, Ebola is spreading due to the community’s reluctance to cooperate with health workers, the ministry says. Some locals have hidden sick relatives or refused to be vaccinated.

The problem, says school teacher Alain Mulonda, many of whose pupils were being kept at home by anxious parents, is that locals have little understanding of Ebola.

“If the population of Beni continues to show this distrust,” he said, “this disease will consume the whole town.”

(Additional reporting by Amedee Mwarabu in Kinshasa and Aaron Ross in Dakar; Writing by Alessandra Prentice; Editing by Tim Cocks, David Evans and Peter Graff)

Miami among cities at risk from yellow fever spread : study

FILE PHOTO: The downtown skyline of Miami, Florida is seen on Nov 5, 2015. REUTERS/Joe Skipper/File Photo

GENEVA (Reuters) – Miami is at risk of a deadly yellow fever outbreak because the disease could thrive there but the city has no checks on travelers arriving from endemic zones, a study to be published by the World Health Organization showed.

Yellow fever is spread by the same mosquito that causes Zika virus, which spread through the Americas after being detected in Brazil in 2015 and has been reported in southern Florida and southern Texas.

The U.S. Centres for Disease Control advises that yellow fever is found in tropical and subtropical areas of Africa and South America, and is a very rare cause of illness in U.S. travelers.

But the study, “International travel and the urban spread of yellow fever”, showed that almost 2.8 million people flew to the United States from endemic yellow fever areas in 2016.

Unlike some countries, the United States does not require travelers from such places to show proof of yellow fever vaccination.

“At a time when global yellow fever vaccine supplies are diminished, an epidemic in a densely populated city could have substantial health and economic consequences,” the researchers based in Canada, the United States and Britain wrote in the study.

Around 9.5 million people live in U.S. urban areas such as Miami that are ecologically suitable for an outbreak, they wrote in the study, issued online ahead of its publication in the Bulletin of the World Health Organization.

They said climate change, mobility, urbanization and a vaccine shortage had increased the risk of yellow fever globally and they called for a review of vaccination policies.

The study found 472 cities suitable for an outbreak in 54 countries, but many, such as New Delhi, Mumbai, Karachi, Manila and Guangzhou, required vaccination certificates on arrival from endemic countries.

WHO spokeswoman Fadela Chaib said the need for vaccination certificates was at each country’s discretion.

The researchers said a substantial proportion of the world’s yellow fever vaccine stocks had been used up by recent epidemics in Africa and Brazil, and further depleted by manufacturing difficulties. Preventive campaigns could cause shortages.

“Should another urban epidemic occur in the near future, vaccine demand could easily exceed the available supply,” they said.

Yellow fever, which can be hard to diagnose, causes symptoms including muscle pain, nausea and vomiting, and about 15 percent of cases lead to a more toxic phase within 24 hours, potentially experiencing jaundice, abdominal pain, deteriorating kidney function and bleeding from the mouth, nose, eyes or stomach.

Half of severe sufferers die within a week or two, but the rest recover without significant organ damage, according to WHO.

(Reporting by Tom Miles; Editing by Hugh Lawson)

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)