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)

With eye on Obamacare, Price takes helm as U.S. health secretary

Tom Price

By Susan Cornwell

WASHINGTON (Reuters) – Tom Price was sworn in as U.S. secretary of health on Friday, putting in place a determined opponent of Obamacare to help President Donald Trump fulfill his pledge to dismantle his predecessor’s law and reshape the country’s healthcare system.

As head of the Department of Health and Human Services (HHS) Price has the authority to rewrite rules implementing the 2010 Affordable Care Act, also known as Obamacare. He could move quickly to rework the regulations while waiting for Republicans in Congress to keep their pledge to scrap the law entirely.

The Republican president signed an order on Jan. 20, his first day in office, to freeze regulations and take other steps to weaken the law enacted by former Democratic President Barack Obama, a directive that will fall largely on Price. But Trump said in a recent Fox News interview that a replacement for the law may not come until next year.

Trump said on Friday the effort was a “difficult process” but could now get going with Price in place.

“Now we get down to the final strokes,” he told reporters at a separate news conference at the White House alongside visiting Japanese Prime Minister Shinzo Abe. He did not offer more details but said the country would end up with “tremendous healthcare at a lower price.”

Republicans, who have long viewed Obamacare as federal overreach and who have the majority in Congress, are trying to craft a replacement but have not agreed on one. Twenty million Americans gained health insurance under the law.

“Having Dr. Tom Price at the helm of HHS gives us a committed ally in our work to repeal and replace Obamacare,” said U.S. House of Representatives Speaker Paul Ryan, who has vowed to pass a new plan this year.

Price, a member of the House since 2005 who chaired the budget committee, offered legislation in 2015 to repeal Obamacare and replace it with age-adjusted tax credits for the purchase of health insurance.

While Price’s fellow Republicans have controlled the House since 2011, they did not advance his bill and it was not considered by the full chamber.

The Senate voted 52-47 earlier on Friday to approve Price, a former orthopedic surgeon, to oversee the HHS, which has an annual budget of more than $1 trillion.

Price’s nomination was dogged by questions about his trading in hundreds of thousands of dollars in health company stocks while working on healthcare legislation. Democrats accused him of making misleading statements. Price defended his actions.

Democrats also criticized Price for his opposition to Obamacare, his ideas about restructuring the Medicare program for the elderly and disabled, and his opposition to Planned Parenthood, an organization that provides abortions and other affordable healthcare and education services.

With Price confirmed, the Senate is expected to vote on Monday on Trump’s U.S. Treasury secretary designate, Steven Mnuchin.

(Additional reporting by Susan Heavey and Steve Holland in Washington, and Brendan O’Brien in Milwaukee; Editing by Bernadette Baum and Frances Kerry)