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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)

Philippines’ Duterte ditches peace process with Maoist rebels

By Neil Jerome Morales

MANILA (Reuters) – Philippine President Rodrigo Duterte said on Friday he has terminated intermittent peace talks with Maoist-led rebels and would consider them “terrorists” because hostilities had continued during negotiations.

Ending the nearly half-century long conflict with the communists, in which more than 40,000 people have been killed, was among Duterte’s priorities when he took office in June last year.

Duterte said he would consider the political arm of the Maoists a “terrorist group” and was demanding that dozens of rebel leaders he freed last year in order to restart talks turn themselves in.

“I am ordering those I have released temporarily to surrender or face again punitive action,” Duterte in a speech to soldiers.

“Let it not be said that I did not try to reach out to them,” he said.

Duterte on Thursday signed a proclamation ending the peace talks, which started in August last year and were brokered by Norway. Talks have been intermittent since 1986.

“We find it unfortunate that their members have failed to show their sincerity and commitment in pursuing genuine and meaningful peaceful negotiations,” Duterte’s spokesman, Harry Roque, said in a statement late on Thursday.

In May, government negotiators canceled a round of formal talks with the Maoist-led rebels in the Netherlands as the guerrillas stepped up attacks in the countryside.

The rebels had no choice but to intensify guerrilla warfare in rural areas, Jose Maria Sison, chief political consultant of the National Democratic Front of the Philippines (NDF), said in a statement.

The NDF, the political arm of the Maoist guerrillas, said it regretted the unilateral cancellation of talks on such vital social and economic reforms.

Government troops were advised to stay alert on the movements of the estimated 3,800 leftist guerrillas, said military spokesman Major-General Restituto Padilla.

Government forces are also battling Islamist fighters in the south of the largely Christian country, some of whom recently occupied a town for several months in the biggest battle in the Philippines since World War Two.

(Reporting by Neil Jerome Morales; Editing by Simon Cameron-Moore, Robert Birsel)

Philippines’ Duterte threatens to close mines that support rebels

MANILA (Reuters) – Philippine President Rodrigo Duterte on Tuesday threatened to shut down any mine that supports Maoist rebels waging a protracted guerrilla war to overthrow the government.

The Philippines has been in on-again, off-again peace talks with the National Democratic Front (NDF), the political arm of the communist movement, since 1986 to end a rebellion that has killed more than 40,000 people and stunted growth in resource-rich rural areas.

In a speech honoring soldiers who fought pro-Islamic State militants for five months in the southern city of Marawi, Duterte said that attacks from the Maoist rebels had been on the rise, forcing him to end negotiations, and that he would declare the guerrilla group a terrorist organization.

“If I go against the communists, then everybody has to reconfigure their relationship with the New People’s Army,” he said, referring to the communists’ armed wing. “If you support them financially, I will close you down.”

Duterte said some mines were paying “revolutionary taxes” to the rebels in exchange for allowing their operations in remote areas to continue. He did not name any companies.

Mines in the Philippines, many with foreign partners, are digging for gold, nickel, copper, chromite and coal. The Mines and Geosciences Bureau said the country had estimated $840 billion worth of untapped mineral wealth as of 2012.

The rebels are also engaged in small-scale mining, like gold panning in the south.

Mining companies shared the president’s position, Ronald Recidoro, executive director at the Chamber of Mines of the Philippines, said.

“We do not condone any member supporting the New People’s Army through the payment of revolutionary taxes,” Recidoro told Reuters.

“This is clearly against the law and they really should be prosecuted if they are found to be supporting these organizations. And if closure is warranted, that is within the prerogative of the president.”

The Chamber of Mines groups 20 of the country’s 43 operating mines. Recidoro said some mining firm members had experienced some of their equipment being burned by the NPA because of their refusal to pay the taxes.

“I am fighting a rebellion… I have to build a strong army,” Duterte said, adding the military would next year acquire 23 attack helicopters to boost counter-insurgency capability.

Military spokesman Major-General Restituto Padilla said the Philippines already had approval for the purchase of attack helicopters but had not decided what type or where to source them.

($1 = 50.6 pesos)

(Reporting by Manuel Mogato and Manolo Serapio; Editing by Nick Macfie)

Amnesty urges independent probe into atrocities, bombings in battle for Philippines Marawi city

MANILA (Reuters) – The war in the Philippine city of Marawi saw Islamist insurgents execute civilians or use them as human shields, while military air strikes killed non-combatants and may have been used in excess, an Amnesty International report said on Friday.

The investigation by the rights group on the bloody five-month battle was based on interviews with 48 witnesses from September until early November and called for an independent inquiry.

The conflict in Marawi, the only predominantly Muslim city in the mainly Catholic Philippines, was the country’s biggest and longest battle since World War Two. More than 1,100 people, mostly insurgents, were killed, including 166 soldiers and 47 civilians, according to the authorities.

At least 350,000 people were displaced and large parts of Marawi have been decimated by air strikes.

Witnesses described at least 10 separate incidents where at least 25 people were executed by the Muslim extremists because they were Christians. Amnesty described those as war crimes.

It also said 10 hostages may have been killed in a single bombing run by the armed forces, and said an independent inquiry should include an assessment as to whether the air strikes were proportionate to the threat.

“They must initiate a prompt, effective and impartial investigation into whether its bombings of civilian neighborhoods was proportional under international humanitarian law,” Tirana Hassan, Amnesty International’s crisis response director, said in a statement.

“The Philippine authorities must bring those responsible for torture and other violations to justice and ensure that the victims receive adequate reparations.”

Major-General Restituto Padilla, armed forces spokesman, said the military was aware of the report and would respond in full later. He said troops were given strict instructions to observe and respect international humanitarian law and human rights.

“We will not tolerate and condone these abuses and will act on them,” he told a regular news briefing on Friday.

The 34-page report, “The Battle of Marawi: Death and destruction in the Philippines”, quotes a survivor who said he was spared by rebels because he could recite the “shahada”, a statement of Islamic faith, but a Christian ambulance driver was shot dead because he could not do the same.

Other survivors said hostages were executed or physically abused, forced into labor and used as human shields.

Some hostages who escaped alleged they were detained and tortured by security forces who suspected them to be militants. Amnesty said it talked to eight men, including seven Christians, who said they were badly treated by the authorities.

“I was punched and kicked. They tied our hands and feet with electrical wire,” the report quoted one survivor as saying. “The military was angry because 13 of their men were killed.”

Last month, U.S. Defense Secretary Jim Mattis praised the Philippine military for ending the war without a single credible human rights abuse allegation.

Amnesty noted that the military was responding to concerns about looting by soldiers but “must follow through on promises of compensation”.

(Reporting by Manuel Mogato; Editing by Martin Petty and Michael Perry)

China, Philippines agree to avoid force in South China Sea dispute

BEIJING/MANILA (Reuters) – China and the Philippines have agreed to avoid force to resolve their differences over the South China Sea, according to a joint statement issued on Thursday by China at the end of a visit to Manila by Chinese Premier Li Keqiang.

China and the Philippines have long sparred over the South China Sea, but relations have improved considerably under Philippine President Rodrigo Duterte.

Malaysia, Taiwan, Brunei, Vietnam and the Philippines claim some or all of the South China Sea and its myriad shoals, reefs and islands. China claims most of the waterway and has been aggressively building and militarizing artificial islands.

The joint statement, carried by China’s official Xinhua news agency, said China and the Philippines reaffirmed the importance of peace in the South China Sea and of freedom of navigation and overflight.

There should be no violence or threats of violence and the dispute should be resolved via talks between the “relevant sovereign countries”, it added.

“Both sides believe that the maritime dispute is not the full sum of the China-Philippines relationship,” the statement said.

In a separate statement summing up discussions at the Association of Southeast Asian Nations summit, Duterte took note of the “improving relations between ASEAN and China” in the South China Sea.

“In view of this positive momentum, we looked forward to the announcement of the start of substantive negotiations on the Code of Conduct (COC) with China” he said, hopefully in early 2018 in Vietnam, where the two sides will meet at the earliest.

ASEAN and China have been discussing a set of rules on how to behave in the disputed waters to avoid accidents and raising tension.

Duterte said the two sides also had successfully tested the hotline among foreign ministries on how to manage maritime emergencies.

“In our view, these are practical measures that could reduce tensions, and the risks of accidents, misunderstandings and miscalculation,” he said.

(Reporting by Ben Blanchard in BEIJING and Manuel Mogato in MANILA; Editing by Nick Macfie)

Philippines’ Duterte lauds China’s help at ‘crucial moment’ in Marawi battle

By Karen Lema and Martin Petty

MANILA (Reuters) – Philippine President Rodrigo Duterte on Wednesday heaped praise on visiting Chinese Premier Li Keqiang for what he said was China’s “critical” role in expediting the end of a five-month war with Islamist insurgents in a Philippine town.

Duterte credited China with supplying what he said was the rifle that on Oct. 16 killed Islamic State’s regional point man, Isnilon Hapilon, and said he would present that weapon to China as a mark of appreciation for its help in the war in Marawi City.

“I am going to return to you the rifle so that the Chinese people would know, it was critical, it is a symbol of the critical help,” Duterte told Li, the first Chinese premier to visit the Philippines in a decade.

There are doubts, however, about if it really was a Chinese sniper rifle that killed Hapilon, and uncertainty about whether the military has used any of the 6,100 guns Beijing has donated since June.

The Philippine defense minister recently said all those weapons were given to the police.

Hapilon was killed by members of the 8th Scout Ranger Company. “Scout Ranger Books”, a Facebook page of one of the ranger officers, gave a blow-by-blow account of the operation and said the shot that killed Hapilon came from a gun mounted on an armored vehicle.

Members of the unit also told media the shot came from a fixed weapon controlled remotely. Such weapons are typically 50-calibre machine guns.

“The arms you gave us, helped abbreviate, shorten the military fight there,” Duterte said.

On Friday, he said something similar to Russian President Vladimir Putin. He told him Russia had “helped us turn the tide and to shorten the war” by supplying weapons that Philippine soldiers used to kill militant snipers in Marawi.

The Russian arms were actually delivered two days after military operations were declared over.

The conflict was the biggest and longest battle in the Philippines since World War Two. More than 1,000 people, most of them rebel gunmen, were killed and 353,000 were displaced.

Duterte told Li China’s help came at “the crucial moment when we needed most and there was nobody to help us at that time”.

His remarks may not sit well with the United States and Australia, which from the early stages of the conflict were providing technical support to Philippine forces, including surveillance aircraft to pinpoint locations of militants.

Li said China would provide 150 million yuan ($22.7 million) to help with reconstruction in Marawi. He praised Duterte for last year putting aside festering disputes with China and visiting Beijing, a trip he said was an “ice-breaker”.

Philippine security analyst Renato De Castro said the information Duterte gave to Li was inaccurate, but consistent with his policy of “total appeasement” of China.

“I’m really surprised, I don’t know whether it’s flattery or an outright lie,” he told news channel ANC.

(Editing by Robert Birsel)

We’ll buy arms from Russia, Philippines’ Duterte tells Putin

DANANG, Vietnam (Reuters) – Philippine President Rodrigo Duterte thanked Moscow on Friday for its “timely assistance” in defeating pro-Islamic State militants who took over a southern city for months, expressing his willingness to buy Russian weapons.

Duterte last month declared the liberation of Marawi City from Islamist militants after 154 days of fighting, which killed more than 1,100 people, including 165 soldiers, and displaced nearly 400,000 residents.

“I want to build a strong armed forces and a strong police and the reason is very important for you to know that we are eyeing – we are buying arms from Russia this time,” Duterte told Russian President Vladimir Putin on the sidelines of the Asia-Pacific Economic Cooperation (APEC) summit in Vietnam.

The Philippines was to buy more than 20,000 assault rifles from the United States, but some senators, concerned with Duterte’s human rights record and rising killings, blocked that sale.

But China and Russia, whose relations with the Philippines have vastly improved in recent months, donated a total of 11,000 assault rifles and trucks.

“Your timely assistance to my country helped us replenish the old arms and the spent bores that were fired repeatedly and we have a new stock,” he said, in transcripts sent to Manila by the presidential communications office.

Manila and Moscow signed a military deal on logistics, including a contract with a state-owned company for the supply of equipment, during the first-ever visit by a Russian defense minister to the Philippines last month.

The Philippines will have a 125 billion pesos ($2.44 billion) fund to modernize the military from 2018 to 2022 through a multi-year congressional allocation to upgrade its hardware, a senior military official told Reuters.

“We are looking at helicopters, small arms and equipment for humanitarian assistance and disaster relief operations, but we are still discussing the specifics,” said the same military official who declined to be named because he was not authorized to talk to the press.

“We still prefer U.S. and Western equipment but they are very expensive. If the Russians and Chinese equipment can be comparable in quality, then they can be excellent alternatives.”

(Writing by Manuel Mogato in Manila; Editing by Nick Macfie)

Trump, Duterte meet for first time at APEC summit

DANANG, Vietnam (Reuters) – U.S. President Donald Trump met Philippine President Rodrigo Duterte for the first time at the Asia Pacific Economic Cooperation (APEC) summit in Vietnam on Saturday.

The meeting was “short but was warm and cordial,” Duterte’s spokesman, Harry Roque, told reporters.

“The leaders were generally pleased to finally meet each other in person,” he said.

Trump told Duterte “see you tomorrow,” Roque said.

Both the leaders are in Danang, Vietnam for the APEC summit. Trump will head to Manila on Sunday for the Association of Southeast Asian Nations (ASEAN) summit on the last leg of his 12-day Asian trip.

Duterte – sometimes described ‘Trump of the East’ because of his brash and mercurial style – had said on Wednesday that he would tell the U.S. president to “lay off” if he raised the issue of human rights when they met.

More than 3,900 Filipinos have been killed in what the police call self-defense in Duterte’s war on drugs. Critics say executions are taking place with zero accountability, allegations the police reject.

But Trump, who has been criticized at home for neglecting rights issues in dealings abroad, in May praised Duterte for doing an “unbelievable job on the drug problem”.

Human rights, rule of law and due process were among topics Trump and Duterte would likely discuss during their bilateral talks, Sung Kim, U.S. ambassador to Manila, had said last month.

(Reporting by Mai Nguyen; Editing by Stephen Coates)

Philippines hunts for possible new Islamic State ’emir’ in South East Asia

By Manuel Mogato

MANILA (Reuters) – Philippine authorities were on the lookout on Monday for a Malaysian who could be the new leader of pro-Islamic State groups in Southeast Asia, security chiefs said, following the deaths of several high-profile regional extremists.

The army terminated combat operations in southern Marawi two weeks ago after killing what it believed were the last remnants of a rebel alliance that held parts of the lakeside city for five months.

Following the country’s biggest security crisis in decades, troops have made significant gains in the week since they killed Isnilon Hapilon, a leader of the Abu Sayyaf group and anointed “emir” of Islamic State in Southeast Asia.

His assumed deputy, Malaysian Mahmud Ahmad, was also believe killed, as was Omarkhayan Maute, a top operative in the alliance.

“We are still looking for Amin Baco,” Defence Secretary Delfin Lorenzana said, describing the Malaysian as the likely new “successor as the emir of those terrorists”.

More than 1,100 people – mostly militants – were killed and 350,000 displaced by the Marawi unrest, a crisis that shocked predominantly Catholic Philippines and led to unease about Islamic State gaining traction in Muslim parts of the island of Mindanao.

Police chief Ronaldo dela Rosa said he received similar information that Baco, an expert bomb-maker, had assumed the role of Islamic State’s point man.

Experts say Baco was trained under Malaysian militant Zulkifli bin Hir, alias Marwan, who was killed in 2015 in a clash in marshlands in Maguindanao province that left 44 police commandoes dead.

The information that Baco could be in charge came from an Indonesian arrested in Marawi last week, dela Rosa said.

Despite declaring the end of operations, troops are still fighting some hold-outs hiding amid the ruins of a city battered by months of air strikes. Troops have since killed nine gunmen in Marawi, Colonel Romeo Brawner said on Monday, emphasizing why residents were being kept out of the pulverized battle zone.

Baco was reported to have been killed in Marawi but intelligence sources said he had fled.

“He could be somewhere on Jolo island or in nearby Maguindanao,” an army colonel familiar with Islamist militant groups in Mindanao, told Reuters.

He said Baco had been in the Philippines for a long time and had links with regional extremist group Jemaah Islamiah. He was married to a daughter of a local militant sub-leader.

As early as 2011, he was facilitating movements into the Philippines of funds, arms and fighters from Indonesia and Malaysia, but his links to the Islamic State network were not known to be strong, another military intelligence official said.

He said Baco was in a position to take over because of his familiarity with extremists from various groups in Mindanao.

(Writing by Neil Jerome Morales and Manuel Mogato; Editing by Martin Petty and Michael Perry)

Trump heads to Japan with North Korea on his mind

U.S. President Donald Trump shouts to reporters as he and and first lady Melania Trump board Air Force One for travel to Hawaii, on his way to an extended trip to five countries in Asia, from Joint Base Andrews, Maryland, U.S. November 3, 2017.

By Steve Holland

HONOLULU (Reuters) – U.S. President Donald Trump heads to Japan on the first stop of his five-nation tour of Asia on Saturday, looking to present a united front with the Japanese against North Korea as tensions run high over Pyongyang’s nuclear and missile tests.

Trump, who is on a 12-day trip, is to speak to U.S. and Japanese forces at Yokota air base shortly after arriving in Japan on Sunday and looked to stress the importance of the alliance to regional security.

Ballistic missile tests by North Korea and its sixth and largest nuclear test, in defiance of U.N. Security Council resolutions, have exacerbated the most critical international challenge of Trump’s presidency.

Aerial drills conducted over South Korea by two U.S. strategic bombers have raised tensions in recent days.

In a display of golf diplomacy, Trump is to play a round of golf with Japanese Prime Minister Shinzo Abe. The two leaders also played together in Florida earlier this year.

Trump will also have a state call with the Imperial Family at Akasaka Palace during his visit. Abe and Trump will meet families of Japanese citizens abducted by North Korea.

Joined by his wife Melania on part of the trip, Trump’s tour of Asia is the longest by an American president since George H.W. Bush in 1992. Besides Japan, he will visit South Korea, China, Vietnam and the Philippines.

Trump extended the trip by a day on Friday when he agreed to participate in a summit of East Asian nations in Manila.

His trip got off to a colorful start in Hawaii. He was taken by boat out to the USS Arizona Memorial, where lies the World War Two ship that was sunk by the Japanese during the Pearl Harbor attack in 1941.

The Trumps tossed white flower petals into the waters at the memorial in honor of those who died at Pearl Harbor.

TRADE, NORTH KOREA

Trump’s trip is to be dominated by trade and how to muster more international pressure on North Korea to give up nuclear weapons.

“We’ll be talking about trade,” Trump told reporters at the White House on Friday. “We’ll be talking about obviously North Korea. We’ll be enlisting the help of a lot of people and countries and we’ll see what happens. But I think we’re going to have a very successful trip. There is a lot of good will.”

Trump has rattled some allies with his vow to “totally destroy” North Korea if it threatens the United States and his dismissal of North Korean leader Kim Jong Un as a “rocket man” on a suicide mission.

White House national security adviser H.R. McMaster, briefing reporters on Friday, defended Trump’s colorful language.

“What’s inflammatory is the North Korean regime and what they’re doing to threaten the world,” McMaster said.

Trump will seek a united front with the leaders of Japan and South Korea against North Korea before visiting Beijing to make the case to Chinese President Xi Jinping that he should do more to rein in Pyongyang.

Trade will factor heavily during Trump’s trip as he tries to persuade Asian allies to agree to trade policies more favorable to the United States.

A centerpiece of the trip will be a visit to the Asia Pacific Economic Cooperation summit in Danang, Vietnam, where he will deliver a speech in support of a free and open Indo-Pacific region, which is seen as offering a bulwark in response to expansionist Chinese policies.

(Reporting By Steve Holland; Editing by Paul Tait)

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