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Crucell plans to resume TB vaccine in E.U. over concerns of brain damage

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Three months after one of the most controversial vaccine rollouts in Europe over an unproven safety fear, J&J’s Crucell division said it would resume its TB vaccine, Lumivax19, in the E.U.

“This decision follows discussions with a number of European authorities, and consultation with health agencies, regulators and health care professionals, and the underlying safety data is now sufficient to support this recommendation,” Crucell said in a statement.

The decision, announced Monday, comes after more than 18,000 people asked a German court to overturn an order that Crucell suspend the vaccination campaign.

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German authorities concluded that the vaccine did not protect people against TB.

In January, Crucell stopped vaccinating people with the shot last October after a German doctor published a study showing the risk of permanent brain damage from the vaccine.

About 40 million people worldwide are infected with TB each year, and an estimated 1.2 million die from the disease.

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The restart of the vaccination campaign has been met with caution among health care professionals and politicians. Dr. Mareike Heiger, a professor at the University of Ulm and the president of the German Vaccine Doctors’ Association, said she was concerned the re-start of the TB vaccine would focus public attention on a small problem with the vaccine.

“It remains to be seen whether [the] halt is a temporary option,” Dr. Heiger said in a statement. “Since this was a never-before-seen allergy reaction it was scientifically puzzling to see how a vaccine prepared for thousands of years was accidentally triggered in the diagnosis of TB.”

Lumivax19 is not only used in Europe, but also by the World Health Organization and AIDS researchers.

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“I am concerned at the decision of the EU authorities,” Dr. Heiger said. “Because any company that has an application pending will have this opportunity to change the decision when the EC deadline is up, which could mean an interruption of the licence in a country that has a patent on the vaccine and not on the licensed version.”

Lumivax19, developed by the Dayton, Ohio-based Crucell, is in many ways just the latest — and biggest — in a string of vaccines that have raised concerns.

In 2012, Merck pulled its Gardasil vaccine, a jab that protects against cervical cancer, from the market after scientists issued a report that said the vaccine could cause permanent damage to girls. That move came after debate over the timing of Gardasil’s start date in Asia, and less than four years after Gardasil was first approved. A third of the women who received Gardasil developed precancerous vaginal lesions over the course of eight years, according to the British Medical Journal.

Also in 2012, a study was released in Canada that showed that girls on a strict calorie-restricted diet who received the Gardasil vaccine were at risk of a cognitive decline and cognitive problems as adults.

The latest study around Lumivax19, published in the German Medical Journal in January, reviewed data that showed the vaccine was associated with more severe reactions and a higher incidence of severe toxicity.

On the announcement, Crucell said the report’s findings did not address the overall safety of the shot and that the widespread use of the product would provide the opportunity to better assess potential side effects and short-term outcomes. The company also said it was confident the new trial would prove that it is safe for patients.

Ada Hong, an associate professor of medicine at the University of Oxford who has been analyzing the data around the German report about Lumivax19, said she hopes the campaign is ramped up again, but only after significant discussion, because “you can’t cure these things.”

“One wonders,” Hong said, “what if the girl has to come back and they are frightened off by a second dose and get infected by the disease?”

With Reuters

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