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Pfizer posts positive Trumenba vaccine data

Results from two new trials support FDA decision for accelerated approval

Pfizer's Trumenba vaccine for meningitis B has shown favourable results in two phase III trials.

Trumenba was approved by the FDA in 2014 to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B.

The serogroup B strain accounted for over 30% of around 500 reported cases of meningitis in the US in 2013.

As it stands today nearly 15% of patients with menB ultimately die and many of those who survive are burdened with long-term and life-altering disabilities.

One of the trials used 3,600 people between 10 and 18 years with the other including 3,300 people aged 18 to 25.

Both studies met all primary immunogenicity endpoints, and showed strong immune responses against menB after the vaccine was administered.

Kathrin Jansen, senior VP of vaccine and research development at Pfizer, said: “We are very pleased with these phase III data that show immunogenicity and safety data consistent with findings that formed the basis for the accelerated FDA approval of Trumenba.

“The phase III data extends the body of evidence that supports vaccination of adolescents and young adults.”

Earlier this year, the FDA also approved Novartis' Bexsero vaccine for protection against menB, which was later sold to GlaxoSmithKline in a major asset swap.

After months of negotiations with GSK, the UK became the first country in the world to implement a widespread menB vaccination programme with infants aged over two years to be immunised with Bexsero from next month.

Article by
Nikhil Patel

25th August 2015

From: Research



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