Philippines halts sale of Sanofi’s dengue vaccine

A nurse displays vials of Sanofi’s dengue vaccine Dengvaxia, which have been recalled from local health centers, in the district of Manila on Dec. 5, 2017. Philippines has suspended the sale and distribution of Sanofi’s dengue vaccine, authorities said on December 5, after the French pharmaceutical giant last week warned it could worsen symptoms for people who had not previously been infected. (AFP/Ted Aljibe)
Updated 05 December 2017
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Philippines halts sale of Sanofi’s dengue vaccine

MANILA: The Philippines has suspended the sale and distribution of Sanofi’s dengue vaccine, authorities said Tuesday, after the French pharmaceutical giant last week warned it could worsen symptoms for people who had not previously been infected.
Regulators on Friday froze the country’s world-first public dengue immunization program, that has seen more than 733,000 children receive the Dengvaxia vaccine.
Authorities have now ordered a blanket suspension for private use as well.
“Whether (the vaccine) is used in the public health program or used by a private practitioner, it is the same product that was licensed. Everyone is covered by the FDA advisory,” health undersecretary Gerardo Bayugo told AFP.
The Philippine Food and Drug Administration (FDA), a regulatory agency under the health department, said in a public advisory on Monday it had pulled the vaccine from the market to “protect the general public.”
“The (FDA) immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA,” the advisory said.
Sanofi’s announcement has caused major fears in the Philippines — where the mosquito-born disease is extremely prevalent — particularly for parents of the children immunized in the public program.
More than 1,000 people in the Philippines died from dengue last year, out of more than 211,000 suspected cases, according to the government.
Sanofi on Monday sought to allay fears about the new study that led it to release the warning, saying Dengvaxia would not cause anyone who was immunized to die.
Philippine authorities have given conflicting messages on the safety or otherwise of the vaccine.
Presidential spokesman Harry Roque said Sunday that the government would “leave no stone unturned” in making those responsible for putting “hundreds of thousands of young lives at risk” accountable for their actions.
The justice department then on Monday formally launched an inquiry over “the alleged danger to public health.”
But Roque also said on Monday there was “no danger” for people who had been immunized with Dengvaxia.
“The worst that can happen is for those who have not had dengue before... they may get infected with dengue but falling under our previous classification of ‘mild’, having fever and bruises,” Roque said.
When asked to comment on the Philippine government’s decision to suspend all sales of Dengvaxia, Sanofi said on Tuesday it would continue to work with authorities and highlighted its proposal to re-label the vaccine.
The proposed label update would “include the new data findings and instructions to ensure that physicians can make appropriate vaccination decisions with their patients,” said a Sanofi statement emailed to AFP.


Tension builds in row over women’s entry into Hindu temple in Kerala

In this file photo taken on October 18, 2018 Indian Hindu devotees are pictured at the Lord Ayyappa temple at Sabarimala in the southern state of Kerala. (AFP)
Updated 13 November 2018
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Tension builds in row over women’s entry into Hindu temple in Kerala

  • Hindu women demand their right of religious freedom as 41-day festival approaches
  • Kerala polarized over female entry into the hilltop temple

NEW DELHI: Tension in the air as Sabarimala Hilltop temple in the South Indian state of Kerala is being prepared to open on Nov. 17 for a 41-day Hindu festival.
The tension pertains to the entry of females between the ages of 10 to 50 into the ancient temple of Ayyappa, a deity who devotees believe is celibate and abhors the entry into the temple of women of marriageable age.
The Indian Supreme Court, in a landmark judgment in the last week of September, laid down a rule that bars the entry of young women into the temple. This led to a severe protest across the state, with women being stopped forcefully from entering the temple.
Last month, when the temple opened for six days, at least 12 women tried to enter the hillside temple but a violent crowd blocked their passage, with police looking helpless. At least 560 women in the barred age group have enrolled for the annual pilgrimage that starts in less than a week.
“We are taking all kinds of steps to see that devotees can pay their obeisance to the deity in a peaceful manner,” S. Sreejith, the Kerala inspector general of police, told Arab News.

Political mileage
Before coming to the temple, devotees observe celibacy for 41 days and avoid all kinds of meat and alcohol. They also don black robes for the period.
“The soul of any temple is the deity inside. The deity Aayyappa is a bachelor and that’s why the entry of young women is regulated in the temple,” says Rahul Easwar, a Hindu right-wing activist with close links to the Sabarimala temple.
Talking to Arab News, Easwar said: “We will never say anything against the Supreme Court. We are fighting for our rights to believe and our rights to have our own faith.”
However, women rights activist Kavita Krishnan claimed that “the entire controversy is clearly politically manufactured by the Bharatiya Janata Party (BJP).”
The BJP is looking for political mileage in Kerala — the state where it is a small marginal player,” added Krishnan, secretary of All India Progressive Women’s Association.
She pointed out that “the entire debate is concocted. It is well known that women’s entry was allowed until the 1990s, and it was stopped upon a court order. The Supreme Court order has only undone that order.”
The local government of Kerala, a coalition of communist parties, supports women’s entry into the temple.
Kerala Chief Minister Pinarayi Vijayan, in a news conference on Saturday, said: “Opposition to changes in customs is quite natural. But there is no going back. Toilets, bathing facilities and accommodation facilities at Nilakkal will be set up for women devotees. The current crisis is temporary.”
K. Surendran of the BJP, however, said: “This is a matter of belief and the court should not interfere. Why does the court not interfere in the affairs of other minority religions?”
The BJP spokesperson in Kerala told Arab News: “The women who want to enter the temple are not devotees but activists. They are not believers.
“The local government is trying to polarize the issue by supporting women’s entry because it wants to gain the support of other religious minorities,” added Surendran.
Sandhya Acharya, a woman devotee who has registered to go to the Sabarimala temple, told Arab News that there is an “attempt to deny entry to women by calling them activists.
“Why should there be discrimination in the house of God in the name of gender?” she asked.
Rajesh Krishnan, a Kerala-based activist and intellectual, said: “The whole issue has polarized the society in Kerala. The issue has become all the more vicious after the BJP entered the debate and saw it as an opportunity to win over the people and make an entry into the southern Indian state.”
Around 42 review petitions have been filed in the Supreme Court and Tuesday the Apex court will decide whether it should revisit its judgment or not.