THE government has ordered French drug maker Sanofi to stop the sale, distribution and marketing of its Dengvaxia dengue vaccine after the company last week warned it could worsen the disease in some cases.
The move comes days after the suspension of a government program to immunize hundreds of thousands of children with Dengvaxia following Sanofi’s findings released last week.
“In order to protect the general public, the Food and Drug Administration (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 agency said in a statement on its Web site released late on Monday, Dec. 4.
The FDA also directed Sanofi to conduct an information dissemination campaign and said all drug establishments should report any incidence that showed Dengvaxia has caused death or serious illness to any person.
Sanofi officials said on Monday there had been no reported deaths related to the vaccine which was used to immunize nearly 734,000 children aged nine and above.
They have received at least one dose of the vaccine as part of a government program that cost P3.5 billion ($69.13 million).
Dengvaxia, the first approved dengue vaccine, had been forecast by Sanofi to eventually bring in nearly $1 billion in annual sales.
But even recent more modest analysts’ sales forecasts are now looking unattainable given the safety issue and clinical evidence revealing unequal protection against different strains of dengue.
The World Health Organization said on Monday it hopes to review safety data on Sanofi’s dengue vaccine this month. The fears involve possible increased risk to people who had not previously been exposed to the dengue virus prior to vaccination with Dengvaxia.
Meanwhile, Senate President Pro Tempore Ralph G. Recto in a statement on Tuesday said the “government has no choice but to follow the Procurement Law, which compels it to demand refund for the P3.5 billion in taxpayer’s money paid to the French manufacturer of ineffective dengue vaccines.”
“RA 9184 has an anti-lemon provision. It is discussed extensively in Section 62, which deals with faulty, defective substandard goods and services. The bottom line is that the government is entitled to restitution,” Mr. Recto said.
“In fact, RA 9184 requires the supplier to post [a] ‘retention money,’ which the government shall hold on to until the warranty has lapsed, to ensure that goods supplied are free from defects,” said the senator, who also noted, “This is a standard clause in government contracts.”
Mr. Recto cited some enterprises that have been paying huge fines upon orders of regulatory bodies, “a path Sanofi should follow if it wants to retain public goodwill,” he said.
“Uber, Metrobank, RCBC, PAL are some of the companies which have willingly paid a fine, or settled obligations, for operational oversights committed,” the senator said.
“Kaya ito ang reseta natin sa Sanofi: Isauli ninyo ang bayad,” he added. (This is our prescription to Sanofi: Return our payment.) — main report by Reuters